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Eight Detectives
Written by: Alex Pavesi
Narrated by: Emilia Fox
Categories: Mystery, Thriller & Suspense, Thriller & Suspense
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Moonflower Murders
Magpie Murders, Book 2
Written by: Anthony Horowitz
Narrated by: Lesley Manville, Allan Corduner
Retired publisher Susan Ryeland is living the good life. She is running a small hotel on a Greek island with her long-term boyfriend, Andreas. It should be everything she's always wanted - but is it? She's exhausted with the responsibilities of making everything work on an island where nothing ever does, and truth be told she's beginning to miss her old life in London.
Captivating murder mystery
Written by: Richard Osman
Narrated by: Lesley Manville, Richard Osman, Marian Keyes
In a peaceful retirement village, four unlikely friends meet up once a week to investigate unsolved killings. But when a local property developer shows up dead, 'The Thursday Murder Club' finds themselves in the middle of their first live case. The four friends, Elizabeth, Joyce, Ibrahim and Ron, might be octogenarians, but they still have a few tricks up their sleeves. Can our unorthodox but brilliant gang catch the killer, before it's too late?
Plot twists and depth of character
By Indimom3 on 17-01-21
Hidden in Plain Sight
Written by: Jeffrey Archer
Narrated by: George Blagden
Newly promoted, Detective Sergeant William Warwick has been reassigned to the drugs squad. His first case: to investigate a notorious south London drug lord known as the Viper. But as William and his team close the net around a criminal network unlike any they have ever encountered, he is also faced with an old enemy, Miles Faulkner. It will take all of William's cunning to devise a means to bring both men to justice; a trap neither will expect, one that is hidden in plain sight....
Masterpiece Composition
Written by: Matt Haig
Narrated by: Carey Mulligan
Thirty-four-year-old Nora's life could be better. She's lonely, single and has just lost her job. Her cat dying feels like the last straw. What else is there to live for? Then she finds a library between life and death where she gets to try all the other lives she could have lived. The Midnight Library is a gloriously relatable novel about life, death and the in-between. It is about finding hope, playing chess, dumping regrets and picking the right people around you.
Written by: Fredrik Backman
Narrated by: Marin Ireland
In a small town in Sweden it appears to be an ordinary day. But look more closely, and you'll see a mysterious masked figure approaching a bank. Two hours later, chaos has descended. A bungled attempted robbery has developed into a hostage situation - and the offender is refusing to communicate their demands to the police. Inside the building, fear quickly turns to irritation for the seven strangers trapped inside. But as the minutes tick by, they begin to suspect that the criminal mastermind holding them hostage might be more in need of rescuing than they are.
Wonderful, emotive narration
The Postscript Murders
Written by: Elly Griffiths
Narrated by: Nina Wadia
The death of a 90-year-old woman with a heart condition should absolutely not be suspicious. DS Harbinder Kaur certainly sees nothing to concern her in carer Natalka's account of Peggy Smith's death. But then Natalka reveals that Peggy lied about her heart condition and that she had been sure someone was following her....
Written by: Neil Gaiman, Dirk Maggs
Narrated by: Riz Ahmed, Kat Dennings, Taron Egerton,
When The Sandman, also known as Lord Morpheus - the immortal king of dreams, stories and the imagination - is pulled from his realm and imprisoned on Earth by a nefarious cult, he languishes for decades before finally escaping. Once free, he must retrieve the three "tools" that will restore his power and help him to rebuild his dominion, which has deteriorated in his absence.
it's fantastic!
By nerdzster on 29-07-20
Written by: Amor Towles
Narrated by: Nicholas Guy Smith
Soon to be a major TV series starring Kenneth Branagh. On 21 June 1922, Count Alexander Rostov - recipient of the Order of Saint Andrew, member of the Jockey Club, Master of the Hunt - is escorted out of the Kremlin, across Red Square and through the elegant revolving doors of the Hotel Metropol. Deemed an unrepentant aristocrat by a Bolshevik tribunal, the Count has been sentenced to house arrest indefinitely. But instead of his usual suite, he must now live in an attic room while Russia undergoes decades of tumultuous upheaval. Can a life without luxury be the richest of all?
Joy in the details!
The Crow Trap
Written by: Ann Cleeves
Narrated by: Janine Birkett
Three very different women come together at isolated Baikie's Cottage on the North Pennines to complete an environmental survey. Rachael, the team leader, is still reeling after a double betrayal by her lover and boss, Peter Kemp. Anne, a botanist, sees the survey as a chance to indulge in a little deception of her own. And then there is Grace, a strange, uncommunicative young woman hiding plenty of her own secrets.
Written by: Ruth Ware
Narrated by: Imogen Church
Snow is falling in the exclusive alpine ski resort of Saint Antoine, as the shareholders and directors of Snoop, the hottest new music app, gather for a make-or-break corporate retreat to decide the future of the company. At stake is a billion-dollar dot-com buyout that could make them all millionaires or leave some of them out in the cold. When an avalanche cuts the chalet off from help and one board member goes missing in the snow, the group is forced to ask - would someone resort to murder to get what they want?
Written by: Catherine Ryan Howard
Narrated by: Alana Kerr Collins, John Keating
I was the girl who survived the Nothing Man. Now I am the woman who is going to catch him.... You've just read the opening pages of The Nothing Man, the true-crime memoir Eve Black has written about her obsessive search for the man who killed her family nearly two decades ago. Supermarket security guard Jim Doyle is reading it too, and with each turn of the page his rage grows. Because Jim was - is - the Nothing Man. The more Jim reads, the more he realises how dangerously close Eve is getting to the truth.
Rules for Perfect Murders
Written by: Peter Swanson
Narrated by: Graham Halstead
A series of unsolved murders with one thing in common: each of the deaths bears an eerie resemblance to the crimes depicted in classic mystery novels. The deaths lead FBI Agent Gwen Mulvey to mystery bookshop Old Devils. Owner Malcolm Kershaw had once posted online an article titled 'My Eight Favourite Murders,' and there seems to be a deadly link between the deaths and his list - which includes Agatha Christie's The ABC Murders, Patricia Highsmith's Strangers on a Train and Donna Tartt's The Secret History.
summary of many mystery novels
By Ehsanullah Shaikh on 04-11-20
Magpie Lane
Written by: Lucy Atkins
Length: Not Yet Known
When the eight-year-old daughter of an Oxford College Master vanishes in the middle of the night, police turn to the Scottish nanny, Dee, for answers. As Dee looks back over her time in the Master's Lodging - an eerie and ancient house - a picture of a high achieving but dysfunctional family emerges: Nick, the fiercely intelligent and powerful father; his beautiful Danish wife Mariah, pregnant with their child; and the lost little girl, Felicity, almost mute, seeing ghosts, grieving her dead mother.
The Stranger Diaries
Narrated by: Anjana Vasan, Andrew Wincott, Esther Wane,
Clare Cassidy is no stranger to murder. As a literature teacher specialising in the Gothic writer R. M. Holland, she teaches a short course on it every year. Then Clare's life and work collide tragically when one of her colleagues is found dead, a line from an R. M. Holland story by her body. The investigating police detective is convinced the writer's works somehow hold the key to the case.s....
By Ashok on 05-01-19
Written by: Jo Nesbo
Narrated by: Sean Barrett
In the far north of Norway a man lives a peaceful existence. However one day his younger brother, always the more successful and charming of the two, turns up to visit, accompanied by his new wife. It soon turns out that the little brother is not quite as angelic as he seems.
A dark and depressing story
By Mechdrone on 09-01-21
These Women
Written by: Ivy Pochoda
Narrated by: Bahni Turpin, Frankie Corzo
The dancer. The mother. The cop. The artist. The wife. These women live by countless unspoken rules. How to dress; who to trust; and which streets are safe and which are not. The rules grow out of a kaleidoscope of fear, anguish, power, loss and hope. Maybe it is only these rules which keep them alive. When their neighbourhood is rocked by two murders, the careful existence these women have built for themselves begins to crumble.
The Empress of Salt and Fortune
Singing Hills Cycle, Book 1
Written by: Nghi Vo
Narrated by: Cindy Kay
A young royal from the far north, is sent south for a political marriage in an empire reminiscent of imperial China. Her brothers are dead, her armies and their war mammoths long defeated and caged behind their borders. Alone and sometimes reviled, she must choose her allies carefully. Rabbit, a handmaiden, sold by her parents to the palace for the lack of five baskets of dye, befriends the emperor's lonely new wife and gets more than she bargained for.
A Good Marriage
Written by: Kimberly McCreight
Narrated by: Sarah Zimmerman, Karissa Vacker, George Newbern
When young lawyer Lizzie gets a call for help from an old friend accused of murdering his wife, she reluctantly says yes. Zach is the chief suspect in his wife, Amanda's, murder but there's no way he could be guilty – is there? The further Lizzie dives into the glossy world of Brooklyn's Park Slope, the more she realises that things don't add up. Zach doesn't know the most basic details of his wife's past, and Amanda's friends barely know he exists.
All murder mysteries follow a simple set of rules. Grant McAllister, an author of crime fiction and professor of mathematics, once sat down and worked them all out.
But that was 30 years ago. Now he's living a life of seclusion on a quiet Mediterranean island - until Julia Hart, a sharp, ambitious editor, knocks on his door. His early work is being republished, and together the two of them must revisit those old stories: an author hiding from his past and an editor keen to understand it.
But as she reads, Julia is unsettled to realise that there are things in the stories that don't make sense. Intricate clues that seem to reference a real murder, one that's remained unsolved for 30 years.
Julia realises she's unwittingly entered a battle of wits where there can be only one winner. But Grant will soon realise that he underestimates her at his peril....
©2020 Alex Pavesi (P)2020 Penguin Audio
"When did you last read a genuinely original thriller? The wait is over." (A. J. Finn, best-selling author of The Woman in the Window)
Eleven Minutes
The Sins of the Father: Clifton Chronicles, Book 2
What listeners say about Eight Detectives
4.5 out of 5 stars 4.6 out of 5.0
Audible.in reviews
sense of familiarity
loved the narrator. Emilia Fox easily drew me into the story ......the individual stores were ok ...but had a feeling it was nothing new .....similar to Ellery Queen, Agatha Christie etc.....in the last one third I felt the author tried too much to give us twists nad unfortunately it did not appeal to me.....wanted everything in a bow and contrived. overall average ...but could have been great :(
Sayantan Auddy
A unique book in every way (well almost). The ending was a bit predictable but overall, I enjoyed it a lot. The narration was excellent. She really made the characters come alive.
Janet biglari
Great listen highly recommend
This was a really unusual debut and I really enjoyed it. Is is essentially seven short detective stories linked together by the narrative of a writer trying to solve a further murder. They were all great stories and I enjoyed them all individually, there is a really clever twist in the last third of the novel which took it off into a different direction altogether along with the twist at the end. I would recommend this very different thriller.
Sararara
Nasty versions of Christie tales
I wanted to like this book but I really didn't. The premise of an editor dissecting a tale to find the solution to a contemporary mystery is familiar from Anthony Horowitz's Magpie Murders, and more recent Moonflower Murders. But this book is unnecessarily convoluted, and very drawn out. It's more about the author being clever than writing a good story. Moreover, the Golden Age murder mysteries are far more gruesome than the Christie ones they copy. The details are needlessly nasty and the stories are curiously dull and flat. The book becomes tiresome after a while as there are no likeable characters in any of the stories, and the whole book is cold and clinical. The 1960s setting is ill-defined and unconvincing plus the feisty female 'editor' is too young to be sent on any such assignment. In addition, the language grates (a 30s starlet would have been called an actress not an actor) and the lumpy metaphors are too numerous to mention. Rules for Perfect Murders by Peter Swanson is much better.
Eight Detectives: absolutely original
Even one of these stories and subsequent conversations between the presumed author and acting publisher would have stood out as a most satisfying and thought-provoking book but the full book offers a rich, multi-layered ingenious treat.
Alexander Johnston
Just a series of short stories...
The book is a series of short stories tying together different forms of the detective genre, with a loose overarching storyline to link them together. Overall, the common thread is tenuous and the short stories necessarily lack depth. Maybe enjoyable for diehard fans of murder mysteries but perhaps give it a miss if you looking for a good story!
Suzanne Poole
It was quite clever, some of the individual stories were better than others. Why was chess mentioned in most of them but it was never explained. When I finish a really good book I am left wanting more. In this case I am left feeling a bit irritated.
AndyT
This book kept me guessing until the very end. A riveting story, start to finish.
Bad short stories
If you enjoy short stories you might like this book, I personally found it terrible - I would have returned it but we had no internet for about a week so I stuck with it hoping it would get better. Several stories were so bad I fast forwarded to the last couple of minutes just to hear the solutions.
Eight detective stories
Overall interesting but could have done with less laboured Conversation chapters...they did go on a bit and we're sometimes repetitive. Very well read.
Anvilius
Thumbs up from me
I actually really liked this book! I liked being misled! Emilia was really good too!
Several listens, no wiser
Really this should have been a book of short stories rather than the poor one that has attempted to weave them together. The author's stories within the book are written in the same tone as the rest of the book, so it doesn't feel like a separate character from the overall book. This is definitely unintentional because Grant is the mystery and not the main voice for the book. It is fees like it is trying so very hard to be very clever and not really achieving that. There is no mathematical equation that I can be convinced of, and none of the inner stories are that interesting nor intelligent. And poor Emilia being asked to say police several times throughout. Very grating that some of the narration is incorrectly pronounced. The story not strong enough for me to ignore.
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Get Out and Get Under (1920, Hal Roach)
Leave a Comment	/ 1920, Film, Not Recommended, Short / Fred McPherson, Get Out and Get Under, H.M. Walker, Hal Roach, Harold Lloyd, Mildred Davis, Pathe, Walter Lundin / 1 April 2012 1 April 2012
Like a lot of silent shorts, Get Out and Get Under has three distinct phases. The first phase involves Harold Lloyd as a suitor for Mildred Davis. He's got to race to stop her wedding. This phase sets a certain expectation for Get Out's pace; the rest of the short doesn't live up to it.
Instead, the second phase is this incredibly laid back comedy of inconvenience. It's not errors, just little things adding up. There are some good laughs in this section (the best laughs in the short), but it also establishes Lloyd's character as a callous dimwit. Lloyd's still likable because he's Lloyd but there's nothing to the character.
The third section is a lengthy chase involving Lloyd and some motorcycle cops. Again, it's boring. The most compelling moment is when the cops think their shooting him for speeding.
Get Out isn't bad, it's just wholly uninspired filmmaking.
Produced and directed by Hal Roach; titles by H.M. Walker; director of photography, Walter Lundin; released by Pathé Exchange.
Starring Harold Lloyd (The Boy), Mildred Davis (The Girl) and Fred McPherson (The Rival).

redpajama_set_name: RedPajamaCommonCrawl


I am a local painter, and live at the beautiful Muriwai Beach. Around four years ago, after spending many years photographing the West Coast, I suddenly discovered I could paint.
I am self taught, with influences and inspiration for my paintings coming from the wild and elemental environs of the West Coast. I have been very fortunate to have spent much of my childhood and adult life living in Titirangi, and on the Coast, and have a family history linked to Huia and Whatipu, going back three generations.
My favorite medium is oil on canvas, with a focus on the sea and coast landscapes in muted and quite often moody tones and hues. I generally paint from photos taken of the coast.
I also have an avid interest in the history of the West Coast, and find inspiration in the rich tapestry of it's past.
it is my aim to try to encapsulate the feel and energy of the West Coast, whether it be a ferocious winter storm or gentle summer morning . Enjoy!


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F/X 2 – Die tödliche Illusion (F/X2) ist ein US-amerikanischer Thriller von Richard Franklin aus dem Jahr 1991. Er ist eine Fortsetzung des Thrillers F/X – Tödliche Tricks aus dem Jahr 1986.

Handlung
Der Ex-Ehemann der Freundin von Roland Tyler ist ein Polizist. Er fragt Tyler, ob dieser bei der Verhaftung eines Serienmörders helfen könnte. Als der Polizist unter merkwürdigen Umständen getötet wird, verdächtigt Tyler die Polizeibehörde hinter dem Mord zu stecken. Sein Freund Leo McCarthy hilft ihm, das Geheimnis um vor Jahrzehnten gestohlene Goldstücke des Vatikans zu lösen.

Die Verbrecher werden von Tyler, der deren Anwesen zuvor infiltrierte, überwältigt. Die Goldstücke werden von Tyler und McCarthy der katholischen Kirche zurückgegeben.

Kritiken
Roger Ebert schrieb in der Chicago Sun-Times vom 10. Mai 1991, der Film sei weder gut noch schlecht. Er kritisierte die Handlung.

Das Lexikon des internationalen Films lobte "einige überraschenden Trickeffekte" und kritisierte die "klischeehafte Handlung".

Auch TV Spielfilm lobte "dolle Spezialeffekte", bemerkte doch auch, der Film weise "nur 'ne dünne Story" auf.

Hintergrund
Der Film wurde in Toronto gedreht. Er spielte in den Kinos der USA ca. 21,1 Millionen US-Dollar ein.

Für den australischen Regisseur Richard Franklin war es der letzte Hollywood-Film, bevor er nach Australien zurückkehrte.

Weblinks

Einzelnachweise

Filmtitel 1991
US-amerikanischer Film
Thriller

redpajama_set_name: RedPajamaWikipedia


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Eventos históricos

 811 — O imperador bizantino Nicéforo I saqueia a capital búlgara de Plisca e rouba o tesouro de Crum.
 1319 — A frota dos Cavaleiros Hospitalários obtém uma esmagadora vitória sobre uma frota aidinida de Quios.
 1793 — Reino da Prússia reconquista Mainz da França.
 1821 — Enquanto a Rebelião Mora continua, os gregos capturam o Castelo de Monemvasia. Tropas e cidadãos turcos são transferidos para as costas da Ásia Menor.
 1829 — Nos Estados Unidos, William Austin Burt patenteia o tipógrafo, precursor da máquina de escrever.
 1833 — Travada a Batalha da Cova da Piedade entre as forças absolutistas e liberalistas em Portugal
 1840
Declaração da Maioridade: Dom Pedro de Alcântara torna-se imperador do Brasil, com 14 anos, e foi o fim da regência da Pedro de Araújo Lima exercia no Império do Brasil.
A Província do Canadá é criada pelo Ato de União.
 1862 — Guerra Civil Americana: Henry Halleck torna-se general-chefe do Exército da União.
 1871 — É descoberto o asteroide 114 Kassandra.
 1881 — Assinado em Buenos Aires o Tratado de Fronteiras de 1881 entre Chile e Argentina.
 1874 — Aires de Ornelas e Vasconcelos é nomeado arcebispo do enclave colonial português de Goa, na Índia.
 1914 — Áustria-Hungria emite uma série de exigências em um ultimato ao Reino da Sérvia, exigindo que a Sérvia permita que os austríacos determinem quem assassinou o arquiduque Francisco Fernando. A Sérvia aceita todas as exigências, exceto uma, e a Áustria declara guerra em 28 de julho.
 1921 — Criado formalmente o Partido Comunista da China (PCC) no 1.º Congresso Nacional.
 1926 — A Fox Film compra as patentes do sistema de som Movietone para gravar som em filme.
 1929 — O governo fascista da Itália proíbe o uso de palavras estrangeiras.
 1936 — Na Catalunha, Espanha, o Partido Socialista Unificado da Catalunha é fundado através da fusão dos partidos Socialista e Comunista.
 1940 — O subsecretário de Estado dos Estados Unidos, Sumner Welles, emite uma declaração sobre a política norte-americana de não reconhecimento da anexação soviética e incorporação de três estados bálticos: Estônia, Letônia e Lituânia.
 1945 — Começam os processos judiciais do pós-guerra contra Philippe Pétain.
 1952 — O General Muhammad Naguib lidera os Oficiais Livres (formados por Gamal Abdel Nasser, o verdadeiro poder por trás do golpe) na deposição do Rei Faruk do Egito.
 1961 — A Frente Sandinista de Libertação Nacional é fundada na Nicarágua.
 1967 — Distúrbios de Detroit: em Detroit, um dos piores motins da história dos Estados Unidos começa no centro da cidade predominantemente afro-americano. Em última análise, tem 43 mortes e queima milhares de edifícios.
 1970 — Qaboos bin Said al Said se torna o sultão de Omã após derrubar seu pai, Said bin Taimur, iniciando reformas massivas, programas de modernização e fim de uma década de guerra civil.
 1972 — Os Estados Unidos lançam o Landsat 1, o primeiro satélite de observação dos recursos naturais terrestres.
 1974 — A junta militar grega entra em colapso, e o ex-primeiro-ministro Konstantínos Karamanlís é convidado a liderar o novo governo, iniciando a era metapolitefsi na Grécia.
 1976 — Toma posse em Portugal o I Governo Constitucional após a Revolução dos Cravos, chefiado pelo primeiro-ministro Mário Soares.
 1980 — Pham Tuan torna-se o primeiro cidadão vietnamita e o primeiro asiático no espaço quando voa a bordo da missão Soyuz 37 como um Cosmonauta de Pesquisa Intercosmos.
 1992 — Abecásia declara independência da Geórgia.
 1993 — Oito crianças e adolescentes são mortos no centro do Rio de Janeiro, no que ficou conhecido como a Chacina da Candelária.
 1995 — O cometa Hale-Bopp é descoberto; torna-se visível a olho nu na Terra quase um ano depois.
 1997 — Digital Equipment Corporation registra acusações antitruste contra a fabricante de chips Intel.
 2015 — NASA anuncia a descoberta do Kepler-452b pela sonda Kepler.

Nascimentos

Anteriores ao século XIX
 1301 — Otão, duque da Áustria (m. 1339).
 1339 — Luís I, Duque de Anjou e Rei de Nápoles (m. 1384).
 1401 — Francisco I Sforza, duque de Milão (m. 1466).
 1503 — Ana Jagelão, Rainha da Boêmia e da Hungria (m. 1547).
 1649 — Papa Clemente XI (m. 1721).
 1773 — Thomas Brisbane, militar e astrônomo britânico (m. 1860).
 1775 — Étienne-Louis Malus, físico e matemático francês (m. 1812).
 1777 — Philipp Otto Runge, pintor alemão (m. 1810).
 1785 — Francisco Antonio Pinto, militar e político chileno (m. 1858).
 1788 — Prideaux John Selby, ornitólogo, botânico e ilustrador britânico (m. 1867).
 1796 — Franz Berwald, compositor sueco (m. 1868).

Século XIX
 1806 — Félix Arvers, poeta e dramaturgo francês (m. 1850).
 1816 — Jean Laurent, fotógrafo francês (m. 1886).
 1823 — Coventry Patmore, poeta e crítico britânico (m. 1896).
 1850 — Daniel Elmer Salmon, microbiologista e veterinário estadunidense (m. 1914).
 1851 — Peder Severin Krøyer, pintor norueguês (m. 1909).
 1856 — Bal Gangadhar Tilak, ativista e político indiano (m. 1920).
 1857 — Carl Meinhof, linguista alemão (m. 1944).
 1864 — Apolinário Mabini, político filipino (m. 1903).
 1865 — Max Heindel, teósofo, ocultista e místico dinamarquês (m. 1919).
 1867 — Koda Rohan, escritor japonês (m. 1947).
 1872 — Edward Adrian Wilson, explorador polar britânico (m. 1912).
 1880
Antonio Rocco, pintor ítalo-brasileiro (m. 1944).
Elias, Duque de Parma (m. 1959).
 1884
Emil Jannings, ator e produtor de cinema suíço (m. 1950).
José do Patrocínio Dias, bispo e militar português (m. 1965).
 1886
Walter Schottky, físico alemão (m. 1976).
Salvador de Madariaga, político, diplomata e escritor espanhol (m. 1978).
 1888 — Raymond Chandler, escritor estadunidense (m. 1959).
 1889 — Louis Ségura, ginasta francês (m. 1963).
 1891 — Harry Cohn, produtor de cinema estadunidense (m. 1958).
 1892 — Haile Selassie, imperador etíope (m. 1975).
 1894 — Dezső László, militar húngaro (m. 1949).
 1895 — Florence Vidor, atriz estadunidense (m. 1977).
 1898 — Carlos Augusto de Thurn e Taxis (m. 1982).
 1899 — Gustav Heinemann, político alemão (m. 1976).
 1900 — John Babcock, militar canadense (m. 2010).

Século XX

1901–1950
 1901
Helen Ferguson, atriz estadunidense (m. 1977).
Donald Reed, ator mexicano (m. 1973).
 1902 — Otto Laporte, físico teuto-estadunidense (m. 1971).
 1905
Leopold Engleitner, religioso austríaco (m. 2013).
Otto Kippes, astrônomo alemão (m. 1994).
 1906 — Vladimir Prelog, químico croata (m. 1998).
 1910 — Fernando de Santiago y Díaz de Mendívil, militar e político espanhol (m. 1994).
 1911 — Amadeu Gonzales Ferreiros, bispo brasileiro (m. 1995).
 1914
Reidar Kvammen, futebolista norueguês (m. 1998).
Carl Foreman, roteirista estadunidense (m. 1984).
Alf Prøysen, escritor e músico norueguês (m. 1970).
 1915 — Aníbal Ciocca, futebolista uruguaio (m. 1981).
 1917 — Knut Brynildsen, futebolista norueguês (m. 1986).
 1921
Robert Brown, ator britânico (m. 2003).
Camilo de Mendonça, engenheiro agrônomo e político português (m. 1984).
 1923 — Morris Halle, linguista letão-estadunidense (m. 2018).
 1924
Gazanfer Bilge, lutador turco (m. 2008).
Camilo de Oliveira, ator, encenador e argumentista português (m. 2016).
 1925
Pierre Baugniet, patinador artístico belga (m. 1981).
Quett Masire, político botsuano (m. 2017).
Oliver Smithies, biólogo estadunidense (m. 2017).
 1926
Ludvík Vaculík, escritor e jornalista tcheco (m. 2015).
Cedella Booker, cantora e escritora jamaicana (m. 2008).
 1927
Gérard Brach, diretor e roteirista francês (m. 2006).
Elliot See, astronauta, engenheiro e aviador naval estadunidense (m. 1966).
 1928
Vera Rubin, astrônoma estadunidense (m. 2016).
Walter Beerli, ex-futebolista suíço.
Hubert Selby Jr., escritor estadunidense (m. 2004).
 1930
Roger Hassenforder, ciclista francês (m. 2021).
Richard Van Genechten, ciclista belga (m. 2010).
 1931 — Arata Isozaki, escritor japonês (m. 2022).
 1932 — Oswaldo Loureiro, ator brasileiro (m. 2018).
 1933
Raimund Abraham, arquiteto austríaco (m. 2010).
Richard Rogers, arquiteto britânico (m. 2021).
 1935
Jim Hall, ex-automobilista estadunidense.
John Cordts, ex-automobilista canadense.
 1936 — Anthony Kennedy, jurista estadunidense.
 1938
Juliet Anderson, produtora e atriz estadunidense (m. 2010).
Ronny Cox, cantor, compositor e ator estadunidense.
Charles Harrelson, criminoso estadunidense (m. 2007).
 1941 — Sergio Mattarella, político e jurista italiano.
 1942
Eduardo Araújo, cantor brasileiro.
Allen Danziger, ator estadunidense.
Jean-Claude Rudaz, ex-automobilista suíço.
 1944 — Maria João Pires, pianista portuguesa.
 1946
Tim Johnson, político estadunidense.
Alexander Kaidanovsky, ator e cineasta russo (m. 1995).
Edoardo Bennato, cantor e compositor italiano.
 1947
Torsten Palm, ex-automobilista sueco.
Raimundo Sodré, cantor e compositor brasileiro.
 1949 — Flavio Venturini, músico, cantor e compositor brasileiro.
 1950 — Ramón Quiroga, ex-futebolista argentino-peruano.

1951–2000
 1951 — Edie McClurg, atriz estadunidense.
 1952 — Nicholas Hooper, compositor britânico.
 1953
Georgina Rizk, ex-modelo libanesa.
Bornito de Sousa, professor universitário e político angolano.
Najib Razak, político malaio.
 1954 — Nicolae Negrilă, ex-futebolista romeno.
 1955 — Vital Lima, músico e compositor brasileiro.
 1956
Tengiz Sulakvelidze, ex-futebolista georgiano.
Mike Bruner, ex-nadador estadunidense.
 1957 — Theo van Gogh, cineasta neerlandês (m. 2004).
 1958 — Frank Mill, ex-futebolista alemão.
 1960
Manfred Bockenfeld, ex-futebolista alemão.
Jon Landau, produtor de cinema estadunidense.
 1961
Woody Harrelson, ator estadunidense.
Martin Gore, cantor, compositor e produtor musical britânico.
Luis Fernando Montoya, treinador de futebol colombiano.
 1962 — Eriq La Salle, ator, diretor e produtor de cinema estadunidense.
 1963
Renato Borghetti, músico brasileiro.
Andy Townsend, ex-futebolista irlandês.
Slobodan Živojinović, ex-tenista sérvio.
 1964
Nick Menza, músico alemão (m. 2016).
Matilda Ziegler, atriz britânica.
Teófilo Barrios, ex-futebolista paraguaio.
 1965 — Slash, músico britânico.
 1966 — Javad Zarincheh, ex-futebolista iraniano.
 1967
Philip Seymour Hoffman, ator e diretor teatral estadunidense (m. 2014).
Noboru Ueda, ex-motociclista japonês.
 1968
Stephanie Seymour, modelo estadunidense.
Gary Payton, ator e ex-jogador de basquete estadunidense.
Antônio Hora Filho, ex-árbitro de futebol brasileiro.
Shawn Levy, ator, diretor e produtor de cinema canadense.
 1969 — Marco Bode, ex-futebolista alemão.
 1970
Charisma Carpenter, atriz estadunidense.
Povilas Vanagas, ex-patinador artístico lituano.
 1972
Giovane Élber, ex-futebolista brasileiro.
Marlon Wayans, ator estadunidense.
Roger, ex-futebolista e político brasileiro.
 1973 — Monica Lewinsky, escritora e ativista estadunidense.
 1974
Maurice Greene, ex-atleta estadunidense.
Stephanie March, atriz estadunidense.
Martin Amerhauser, ex-futebolista austríaco.
 1975
Alessio Tacchinardi, ex-futebolista italiano.
Mario Tokić, ex-futebolista e treinador de futebol croata.
Sandami, cantor, ator, instrumentista e compositor brasileiro.
 1976
Judit Polgar, enxadrista húngara.
Juanito, ex-futebolista espanhol.
 1977 — Néicer Reasco, ex-futebolista equatoriano.
 1978
Sheila Mello, dançarina e atriz brasileira.
Tasia Sherel, atriz e modelo estadunidense.
 1979
Íris Stefanelli, apresentadora brasileira.
Ricardo Sperafico, automobilista brasileiro.
Rodrigo Sperafico, automobilista brasileiro.
Iain Canning, produtor de cinema britânico.
Sotirios Kyrgiakos, ex-futebolista grego.
 1980
Michelle Williams, cantora, atriz, modelo e dançarina estadunidense.
Fernando Ventura, quadrinista brasileiro.
Jimmy Tau, ex-futebolista sul-africano.
 1981
Jarkko Nieminen, ex-tenista finlandês.
Romana, cantora portuguesa.
Raphaël Personnaz, ator francês.
 1982
Paul Wesley, ator estadunidense.
Sérgio Moraes, lutador brasileiro de artes marciais mistas.
 1983
Aaron Peirsol, nadador estadunidense.
Andrew Eiden, ator estadunidense.
Jelly Selau, futebolista tuvaluano.
 1984
Walter Gargano, futebolista uruguaio.
Yann Jouffre, ex-futebolista francês.
Krysta Rodriguez, atriz e cantora estadunidense.
 1985
Anna Maria Mühe, atriz alemã.
Bráulio Bessa, poeta brasileiro.
 1986
Nelson Philippe, automobilista francês.
Ayaka Komatsu, modelo, atriz e cantora japonesa.
 1987
Felipe Dylon, músico brasileiro.
Alessio Cerci, futebolista italiano.
Luiz Gustavo Dias, futebolista brasileiro.
Imanol Landeta, ator e cantor mexicano.
Kosuke Ota, futebolista japonês.
Felipe Seymour, futebolista chileno.
Julian Nagelsmann, treinador de futebol alemão.
Philipp Boy, ex-ginasta alemão.
 1988 — Cheikh M'Bengue, futebolista senegalês.
 1989
Daniel Radcliffe, ator britânico.
Tim Agaba, jogador de rugby sul-africano.
Donald Young, tenista estadunidense.
Shinichiro Kawamata, futebolista japonês.
 1990
Gracie Carvalho, modelo brasileira.
Kevin Reynolds, patinador artístico canadense.
Rafael Forster, futebolista brasileiro.
 1991
Lauren Mitchell, ginasta australiana.
Penelope Mitchell, atriz australiana.
 1992
Jhon Cifuente, futebolista equatoriano.
Britne Oldford, atriz canadense.
 1994
Wilson Manafá, futebolista português.
Gabi Lopes, atriz brasileira.
Claudia Salas, atriz espanhola.
 1996
Rachel G. Fox, atriz estadunidense.
Danielle Bradbery, cantora estadunidense.
 1998 — Deandre Ayton, jogador de basquete bahamense.
 2000 — Malte Gårdinger, ator sueco.

Século XXI
 2001 — Christian Lundgaard, automobilista dinamarquês.
 2002 — Benjamin Flores Jr., ator, dançarino, rapper e dublador estadunidense.

Mortes

Anteriores ao século XIX
 1373 — Brígida Birgersdotter da Suécia, santa e escritora (n. 1303).
 1531 — Luís de Brézé, nobre francês (n. 1463).
 1757 — Domenico Scarlatti, compositor italiano (n. 1685).

Século XIX
 1862 — José María Bocanegra, político mexicano (n. 1787).
 1896 — Aristides Lobo, político brasileiro (n. 1838).

Século XX
 1901 — Gaspar Silveira Martins, político brasileiro (n. 1835).
 1927 — William Ashley, historiador econômico britânico (n. 1860).
 1932 — Alberto Santos Dumont, inventor brasileiro (n. 1873).
 1951 — Philippe Pétain, militar e estadista francês (n. 1856).
 1957 — Giuseppe Tomasi di Lampedusa, escritor italiano (n. 1896).
 1966 — Montgomery Clift, ator estadunidense (n. 1920).
 1971 — Van Heflin, ator estadunidense (n. 1908).
 1993 — Megan Taylor, patinadora artística britânica (n. 1920).
 1999 — Hassan II de Marrocos (n. 1929).

Século XXI
 2002 — Euler Bentes Monteiro, general brasileiro (n. 1917).
 2004 — Carlos Paredes, músico português (n. 1925)
 2007 — Mohammed Zahir Shah, político afegão (n. 1914).
 2009 — Duse Nacaratti, atriz brasileira (n. 1933).
 2011 — Amy Winehouse, cantora e compositora britânica (n. 1983).
 2013
Dominguinhos, cantor, compositor e músico brasileiro (n. 1941).
Djalma Santos, futebolista brasileiro (n. 1929).
 2014 — Ariano Suassuna, escritor e poeta brasileiro (n. 1927).
 2017 — Waldir Peres, futebolista e treinador de futebol brasileiro (n. 1951).
 2019 — Juarez Soares, jornalista esportivo e político brasileiro (n. 1941).
 2020 — Sérgio Ricardo, cantor, compositor e músico brasileiro (n. 1932).

Feriados e eventos cíclicos

 Dia do Guarda Rodoviário / Dia do Policial Rodoviário (no Brasil) , em alusão à data de criação do primeiro quadro de profissionais da Polícia Rodoviária Federal (PRF), em 23 de julho de 1935.

Santos do dia
 Santa Brígida da Suécia.

Outros calendários
 No calendário romano era o 10.º dia () antes das calendas de agosto.
 No calendário litúrgico tem a letra dominical A para o dia da semana.
 No calendário gregoriano a epacta do dia é iv.


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Mutual Fund Trader
Investing and Money Blog
What is an SEP IRA?
July 29, 2008 by Finance and Investing
Individual retirement accounts, or IRAs, are a way to start planning for future financial needs. Putting money in a retirement account allows it to be invested in other vehicles such as stocks, bonds, and mutual funds. The level of risk and the diversity will grow your money over time. When you need it, it will be at a comfortable level to meet your needs.
Individual retirement accounts are set up through a bank or credit union or a mutual fund company. Each retirement account sets its limits for contributions that can be made each year. The investments that you make each year are tax-deferred. This means that taxes are not assessed on the contributions until such time as the money is withdrawn from the account.
People who have invested in a defined contribution plan (like a 401(k)) with their employer can roll their money over into an IRA when they leave their job. The money will continue to grow without penalty and the person will reallocate their funds for investing with the new IRA. There are traditional forms of individual retirement accounts and Roth accounts.
One such individual retirement account is the SEP IRA. This is a Simplified Employee Pension Plan. This is an employer sponsored individual retirement account. The employer makes contributions to an individual retirement account on behalf of their employees. The account is in the name of the employee and owned by them. The IRA can be set up by the employer or the employee, but the contributions are managed by the employer.
With defined contribution plans, there is no federal guarantee of benefits. The employee and the employer assume the risks of investing. A plan official is responsible for seeing that the monies are invested properly on behalf of the company and its employees.
Employers decide when an employee can open an account. There may be an age limit, or the employee may have to have been with the company at least a year in order to be eligible for an SEP IRA. Check with the human resources department at your job for more details on the SEP that they offer.
An SEP is a traditional IRA account. The contributions are limited to $4,000 annually. If the employee is aged fifty to sixty-nine, the contribution limit goes up to $4,500. Employers are allowed to contribute at most twenty-five percent of an employee's pay for their individual account. Employers can also put away money for themselves in these plans. SEP IRAs are also options for self-employed individuals who want an alternative to the Keogh plan.
SEP individual retirement accounts are options that some companies choose for their employees instead of a traditional 401(k) plan. The account can be rolled over when employment ends and is tax-free until distribution.
Filed Under: Blog, IRA
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text:
The Exclusive Men of the Year Africa Awards are a set of awards established in 2015 to honour and celebrate eminent men exclusively. The awards are presented annually. It is usually occasioned with the period around Fathers Day.

Notable winners

2016
 2016 Man Of The Year (Entertainment) / Best Entertainer - Michael Owusu Addo (Sarkodie)
 2016  Man of the Year (Communication)- Nathan Kwabena Adisi (Bola Ray)
 2016  Rising star award (Special Award) - Kofi Amoa-Abban

2017
 2017  Rising Star Award  (Special Award) -Nana Kwame Bediako
 2017 Ultimate Man Of The Year (The Flagship Award) – Dr. Kwabena Duffour
 2017 Man Of The Year (Entertainment) Joe Mettle

2018
 2018 Ultimate Man of the Year - Togbe Afede XIV
 2018 Icon/Legend of Entertainment  - Daddy Lumba

2019
 2019 Discovery of the Year - Kofi Genfi (Founder of Mazzuma)
 2019 Man of the Year (Sports) - Ezekiel Nana Ziggy Ansah
 2019 The Pav Ansah Communicator Award - Giovani Caleb

2020
 2020 Man of the Year Entertainment - Clemento Suarez
 2020 Ultimate Man of the Year-  Ernest Bediako Sampong
 2020 Lifetime Achievement Award - Prof. Emeritus Stephen Adei
 2020 Humanitarian Award - Rev. Fr. Andrew Campbell
 2020  Female category of the Young Achiever's Award - Beryl Agyekum Ayaaba

2022
 2022  Ultimate Man of the Year - Ibrahim Mahama
 2022  Man of the Year  (Africa) - Dr. Akinwumi Ayodeji Adesina
 2022 Man of the Year (Sports) - Benjamin Kwaku Azamati
 2022 Young Achiever (Female) - Audrey Maame Esi Swatson
 2022 Lifetime Achievement -  Joe Lartey
 2022 Actor of the year - Adjetey Anang
 2022 Woman of the Year - Elsie Effah Kaufmann
 2022 Continental Music Icon - Michael Collins Ajereh
 2022 Continental Film Icon -  Richard Mofe Damijo
 2022 Media Excellence  - Ayodele Animashaun
 2022 Young Achiever (Male) - Richie Mensah

References

Awards established in 2015
Ghanaian awards
African awards


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Barack Obama took time out from his campaign to appear on The Daily Show after the heated second debate in the US presidential electoral race. Hosted by comedian Jon Stewart, the award winning comedy show is sure to show Barack Obama's charismatic side. Here is a sneak preview of the interview due to air tonight in the UK at 11pm on Comedy Central.
To find out, watch The Daily Show on Comedy Central UK (Sky 112 Virgin 132) at 11pm on Friday 19th October after brand new South Park. Moved from its usual slot on Comedy Central Extra (Sky 128 Virgin 185), the show airs only 24 hours after the US screening. As the exclusive broadcaster of The Daily Show in the UK, Comedy Central UK will also make highlight clips available from Saturday at www.comedycentral.co.uk.
To coincide with the US election, The Daily Show will also be aired on Comedy Central UK from the 5th November 2012, moving from its traditional UK home of Comedy Central Extra.
Join in the conversation on Twitter with @ComedyCentralUK and @TheDailyShow using #DailyShow.


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Q: Table returned by ajax request not displayed properly I do an ajax request which returns a html table. When I just do a location redirect to that page the table is displayed properly but when I put the ajax response inside a div element, the table goes out of shape.
function submitQuery() {
  length = category_query.length;
  if(category_query.indexOf('ALL') != -1)
    category_query = category_query.substring(0,length-4);
  xmlhttp.onreadystatechange=function() {
    if(xmlhttp.readyState==4 && xmlhttp.status==200)
      document.getElementById('resultDiv1').innerHTML = xmlhttp.responseText;
  }
  xmlhttp.open("GET","cons_query.php?q="+category_query,true);
  xmlhttp.send();
  //window.location="cons_query.php?q="+category_query;
  //if i just redirect to this location, the table is displayed fine.
}

I want the table to look as it is even through ajax.

A: Hmm... looks like you are floating the row elements left side in your response page.
Just remove that formatting from css
It should look something like this
td { width: <>px; float: left; }

redpajama_set_name: RedPajamaStackExchange


text:
Control for Type I Error (or Adjustment for Multiplicity) for Secondary Endpoints
In clinical trial protocols, we usually specify one or more primary efficacy endpoints, then a list of secondary efficacy endpoints, and then more tertiary endpoints or exploratory endpoints. It is pretty standard that the primary efficacy endpoints are those the hypothesis testing or inferential statistics and sample size estimation are based on. If we have more than one primary efficacy endpoints, we will need to adjust for multiple tests or multiplicity. It is also clear that the tertiary or exploratory endpoints are for hypothesis generating or more bluntly for fishing expedition.
Questions we are asked very often are:
For secondary efficacy endpoints, do we need to do formal hypothesis testing?
If so, do we need to adjust for multiple tests and multiplicity?
What is the purpose of controlling the type I error for secondary efficacy endpoints?
While controlling Family Wise Error Rate (FWER) for primary efficacy endpoints (if multiple test situation exists) is necessary, controlling FWER for secondary efficacy endpoints is often questioned.
Controlling the FWER for secondary efficacy endpoints is valuable or is necessary if we are planning to include the secondary efficacy endpoints in the product label if the product is approved. In other words, if we would like to make the claim of the benefits based on the secondary efficacy endpoints. It is advisable to perform the formal hypothesis testing with controlling for FWER.
In FDA's guidance for industry "Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format", there is a statement about the primary and secondary endpoints:
§ Primary and Secondary Endpoints: The terms primary endpoint and secondary endpoint are used so variably that they are rarely helpful. The appropriate inquiry is whether there is a well-documented, statistically and clinically meaningful effect on a prospectively defined endpoint, not whether the endpoint was identified as primary or secondary.
FDA does not care whether or not a study endpoint is called primary or secondary. However, if the information from these endpoints are used for supporting evidence and for product label, the endpoints need to be predefined and tests for these endpoints need to be controlled for the overall alpha or overall type I error.
Even though FDA does not care about the terminology of primary/secondary endpoints, it is still very common in practice that the clinical trials (especially the industry-sponsored clinical trials) specify primary, secondary, and exploratory endpoints.
In a presentation by Kathleen Fritsch from FDA "Multiplicity Issues in FDA-Reviewed Clinical Trials", the difference between primary, secondary, and exploratory efficacy endpoints are clearly specified and it is stated that the secondary efficacy endpoints may be included in the product label if multiplicity issue is addressed.
It is not needed or rarely needed to control for FWER for exploratory efficacy endpoints.
In EMA's guidance "Points to Consider on Multiplicity Issues in Clinical Trials", adjustment for multiplicity is explicitly required if the secondary variables are used for additional claims.
A slide presentation regarding EMA guidance further explained the secondary efficacy endpoints for claims.
Norbert Benda (2013) The update of the multiplicityguideline
In FDA's guidance on "Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence", the secondary endpoints were called out:
Secondary Endpoints
FDA believes secondary endpoint measures, by themselves, are not sufficient to characterize fully the treatment benefit. However, these measures may provide additional characterization of the treatment effect. Specifically, secondary endpoints can:
supply background and understanding of the primary endpoints, in terms of overall direction and strength of the treatment effect;
be the individual components of a composite primary endpoint, if used;
include variables for which the study is underpowered to definitively assess;
aid in the understanding of the treatment's mechanism of action;
be associated with relevant sub-hypotheses (separate from the major objective of the treatment); or
be used to perform exploratory analyses.
Assuming that the primary safety and effectiveness endpoints of the study are successfully met, we recommend you analyze the secondary endpoints to provide supportive evidence concerning the safety and effectiveness of the device, as well as to support descriptions of device performance in the labeling. To minimize bias, your protocol should prospectively identify all secondary endpoints, indicating how the data will be analyzed and what success criteria will be applied.
Secondary Endpoint Analyses
We recommend your protocol prospectively define the statistical plan for performing secondary endpoint analyses in the event that the primary endpoint analysis has been successfully met. If the secondary endpoint analyses are intended purely as exploratory analyses, or are not intended to support the indication for use or device performance, we recommend you submit only simple descriptions of the analyses. If, on the other hand, any of the secondary endpoint analyses are intended to support the indication for use or the performance of your device in the labeling (e.g., comparing treatment and control groups using p-values or confidence intervals), we recommend you pre-specify this intention in your study protocol and describe in detail the statistical methods you plan to follow.
In summary, if we don't perform the hypothesis testing for these secondary endpoints or not having appropriate control for overall type I error, we will lose the chance to claim the benefit on the secondary endpoints and to list secondary endpoints into the product label. Therefore, it is always a wise decision to perform the hypothesis testing for secondary endpoints with appropriate control for type I error.
Posted by Web blog from Dr. Deng at 6:30 AM 3 comments:
the 21st Century Cures Act and Innovations in Clinical Trials
After the bill passed through house and senator, the president Obama signed the bill into law on December 13, 2016. The 21st Century Cures Act is now officially a law in effect.
If you have trouble to find the final version of the cures act, Here is the one signed into the law by the President Obama.
H.R.34 - 21st Century Cures Act
The NPR has a good summary of "who wins and who loses with the 21st Century Cures Act".
The 21st Century Cures Act will greatly benefit the NIH and NCI. Here is a latest article published in New England Journal of Medicine regarding NIH's perspectives on the Act.
The 21st Century Cures Act — A View from the NIH
Some sections in this act are very relevant to design and analysis of clinical trials. The section 3021 calls out the adaptive design and other novel clinical trial designs.
SEC. 3021. Novel clinical trial designs.(a) Proposals for use of novel clinical trial designs for drugs and biological products.—For purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), the Secretary of Health and Human Services (referred to in this section as the "Secretary") shall conduct a public meeting and issue guidance in accordance with subsection (b).
(b) Guidance addressing use of novel clinical trial designs.—
(1) IN GENERAL.—The Secretary, acting through the Commissioner of Food and Drugs, shall update or issue guidance addressing the use of complex adaptive and other novel trial design in the development and regulatory review and approval or licensure for drugs and biological products.
(2) CONTENTS.—The guidance under paragraph (1) shall address—
(A) the use of complex adaptive and other novel trial designs, including how such clinical trials proposed or submitted help to satisfy the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
(B) how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to—
(i) completion of such modeling or simulations; or
(ii) the submission of resulting information to the Secretary;
(C) the types of quantitative and qualitative information that should be submitted for review; and
(D) recommended analysis methodologies.
(3) PUBLIC MEETING.—Prior to updating or issuing the guidance required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, consumer groups, and disease research foundations, through a public meeting to be held not later than 18 months after the date of enactment of this Act.
(4) TIMING.—The Secretary shall update or issue a draft version of the guidance required by paragraph (1) not later than 18 months after the date of the public meeting required by paragraph (3) and finalize such guidance not later than 1 year after the date on which the public comment period for the draft guidance closes.
The act specifies that the real world evidence can be used to support the drug approval where Real world evidence means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.
The act creates a new pathway for medical device - breakthrough medical device - a similar pathway for breakthrough drug.
The act specified the importance of the biomarker in drug approval process where biomarker "(A) means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and
"(B) includes a surrogate endpoint.
The act contains a section for "targeted drugs for rare diseases"
SEC. 3012. Targeted drugs for rare diseases.Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by inserting after section 529 the following:
"SEC. 529A. Targeted drugs for rare diseases."(a) Purpose.—The purpose of this section, through the approach provided for in subsection (b), is to—
"(1) facilitate the development, review, and approval of genetically targeted drugs and variant protein targeted drugs to address an unmet medical need in one or more patient subgroups, including subgroups of patients with different mutations of a gene, with respect to rare diseases or conditions that are serious or life-threatening; and
"(2) maximize the use of scientific tools or methods, including surrogate endpoints and other biomarkers, for such purposes.
"(b) Leveraging of data from previously approved drug application or applications.—The Secretary may, consistent with applicable standards for approval under this Act or section 351(a) of the Public Health Service Act, allow the sponsor of an application under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act for a genetically targeted drug or a variant protein targeted drug to rely upon data and information—
"(1) previously developed by the same sponsor (or another sponsor that has provided the sponsor with a contractual right of reference to such data and information); and
"(2) submitted by a sponsor described in paragraph (1) in support of one or more previously approved applications that were submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act,
for a drug that incorporates or utilizes the same or similar genetically targeted technology as the drug or drugs that are the subject of an application or applications described in paragraph (2) or for a variant protein targeted drug that is the same or incorporates or utilizes the same variant protein targeted drug, as the drug or drugs that are the subject of an application or applications described in paragraph (2)."(c) Definitions.—For purposes of this section—
"(1) the term 'genetically targeted drug' means a drug that—
"(A) is the subject of an application under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act for the treatment of a rare disease or condition (as such term is defined in section 526) that is serious or life-threatening;
"(B) may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product; and
"(C) incorporates or utilizes a genetically targeted technology;
"(2) the term 'genetically targeted technology' means a technology comprising non-replicating nucleic acid or analogous compounds with a common or similar chemistry that is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition, including a disease or condition due to other variants in the same gene; and
"(3) the term 'variant protein targeted drug' means a drug that—
"(B) modulates the function of a product of a mutated gene where such mutation is responsible in whole or in part for a given disease or condition; and
"(C) is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition.
"(d) Rule of construction.—Nothing in this section shall be construed to—
"(1) alter the authority of the Secretary to approve drugs pursuant to this Act or section 351 of the Public Health Service Act (as authorized prior to the date of enactment of the 21st Century Cures Act), including the standards of evidence, and applicable conditions, for approval under such applicable Act; or
"(2) confer any new rights, beyond those authorized under this Act or the Public Health Service Act prior to enactment of this section, with respect to the permissibility of a sponsor referencing information contained in another application submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.".
Posted by Web blog from Dr. Deng at 10:45 PM No comments:
Commonly Used Procedure for Multiplicity Adjustment: Fixed Sequence Procedure, Holm Step-down Procedure, Hochberg Step-up Procedure
In clinical trials, we often have the multiple tests or multiplicity issue when there are more than one hypothesis tests built in the same study and we want to claim the trial success if one of multiple hypothesis tests is significant. For example, in steoporosis/breast cancer trial, there may be two endpoints:
Endpoint 1: Incidence of vertebral fractures
Endpoint 2: Incidence of breast cancer
We would like to claim the success if at least one endpoint is significant. In a trial with a low dose group, a high dose group, and a placebo control, if we want to claim the success if either lower dose versus placebo or high dose group versus control is statistically significant. In both of these situations, adjustment for multiplicity must be employed.
On the other hand, not all studies with more than one hypothesis tests will need the adjustment for multiplicity. With Alzheimer's disease trial as example, FDA guidance requires two endpoints
Endpoint 1: Cognition endpoint (ADAS-Cog)
Endpoint 2: Clinical global scale (CIBIC plus)
and requires that both endpoints must be significant in order to claim success. In this case, both hypotheses are tested at significant level of 0.05 and there is no adjustment for multiplicity is needed.
In late phase clinical trials, if multiplicity issue exists, adjustment for multiplicity must be built into the statistical analysis plan to avoid the inflation of the family-wise type 1 error rate (usually 0.05 or 5%).
Many different approaches have been proposed for handling the multiplicity issue. In a recent article by Wang et al (2015) "Overview of multiple testing methodology and recent development in clinical trials", the following procedures were reviewed.
Multiple testing procedures for non-hierarchical hypotheses
Non-parametric or semi-parametric procedures
Bonferroni procedure
Simes procedure
Holm step-down procedure
Hochberg step-up procedure
Hommel procedure
Parametric procedures
Dunnett procedure
Multiple testing procedures on hierarchical hypotheses
Simple procedures for hierarchical hypotheses
Fixed-sequence procedure
Fallback procedure
Gatekeeping procedures
Serial gatekeeping procedures
Parallel gatekeeping procedure
Other extensions of gatekeeping procedures
Graphical approaches
In a presentation by Bretz and Xun "introduction to multiplicity in clinical trials" at IMPACT meeting, the multiple testing procedures for non-hierarchical hypotheses were organized based on whether the test is a single step or stepwise and based on whether or not the correlations are considered.
They also made the following remarks:
· Single step methods are less powerful than stepwise methods and not often used in practice
· Accounting for correlations leads to more powerful procedures, but correlations are not always known
· Simes-based methods are more powerful than Bonferroni-based methods, but control the FWER only under certain dependence structures
· In practice, we select the procedure that is not only powerful from a statistical perspective, but also appropriate from clinical perspective
For a specific clinical trial with multiplicity issue, the choice of the procedure for multiplicity adjustment depends on the study design, if there is an order in clinical importance of multiple hypothesis tests, or sometimes if there is a prior evidence that one hypothesis test may be more likely to be significant. For example, for a dose-response study, Dunnett procedure or stepdown Dunnett procedure may be preferred. If Multiplicity problems in clinical trials have multiple sources of multiplicity (for example, multiple endpoints + different type of tests (superiority and non-inferiority)), then the gatekeeping procedure may be preferred.
In industry clinical trials, some procedures are more commonly used than others because they are more powerful or more likely to declare the statistical significance. It may usually be the case that the clinical trial sponsor side (the pharmaceutical/biotech companies) would like to choose a procedure that is more powerful (such as Hochberg procedure) while the regulatory side (such as FDA) would prefer a procedure that is more conservative (such as Bonferroni or Holm's procedure).
We are still waiting for FDA to issue its formal guidance on multiplicity issues. In the meantime, we see that some procedures for handling the multiplicity issue are mentioned in therapeutic area specific guidance or presentations by FDA statisticians. For example, in CDRH's guidance "Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence", the following paragraph was mentioned in dealing with the multiplicity issue when performing the statistical tests for multiple secondary endpoints.
The primary statistical challenge in supporting the indication for use or device performance in the labeling is in making multiple assessments of the secondary endpoint data without increasing the type 1 error above an acceptable level (typically 5%). There are many valid multiplicity adjustment strategies available for use to maintain the type 1 error rate at or below the specified level, three of which are listed below:
Hierarchical closed test procedure
Holm's step-down procedure
Because each of these multiplicity adjustment strategies involves balancing different potential advantages and disadvantages, we recommend you prospectively state the strategy that you intend to use. We recommend your protocol prospectively state a statistical hypothesis for each secondary endpoint related to the indication for use or device performance.
EMA has a guideline "Points to consider on multiplicity issues in clinical trials". The document was issued in 2002 and might be time for revision. The document mainly focused on when the adjustment for multiplicity is needed and when the adjustment for multiplicity is not needed. There is no mention about the procedures that could be used for multiplicity adjustment.
A recent paper by Sakamaki et al (2016) "Current practice onmultiplicity adjustment and sample size calculation in multi-arm clinicaltrials: an industry survey in Japan" revealed that fixed sequence procedure, gatekeeping procedure, and Hochberg procedure are most commonly used and Holm procedure is rarely used.
Assuming that there are two hypothesis tests and the left column indicates the p-values for these two hypothesis tests. Claiming the statistical significance depending on which procedure to use for multiplicity adjustment. In this specific case, the Hochberg step-up procedure is more power than other multiplicity adjustment procedures.
Without any adjustment for multiplicity
Bonferroni correction
Fixed sequence hierarchical
Holm stepdown procedure
Compare p1 with 0.05
If p1 lt 0.025
If p1 lt 0.05, comparing p2 with 0.05;
If p1 gt 0.05, p2 will not be tested
If min(p1, p2) lt 0.025
Then test
if max(p1, p2) lt 0.05
then claim both groups are successful;
if max(p1, p2) gt 0.05 then test
if min(p1,p2) lt 0.025
p1=0.04
p1 gt 0.05
p1 gt .05
Wang et al (2015) "Overview of multiple testing methodology and recent development in clinical trials"
Bretz and Xun (2014)"introduction to multiplicity in clinical trials"
Alex Dmitrienko (2013) "Multiple Testing Procedures in Clinical Trials"
Huque and R¨ohmel (2010) "Multiplicity Problems in Clinical Trials: A Regulatory Perspective"
Alex Dmitrienko and Brian Millen (2011) "Multiple testing methodology in the context of subgroup analysis"
Thomas Permutt (2013) Multiplicity in Regulatory Statistical Review"
Mohammad Huque et al (2013) Multiplicity Issues in Clinical Trials With Multiple Objectives
Should the Percent of Confidence Confidence Interval Match the Significance Level?
In statistics, a confidence interval (CI) is a type of interval estimate of a population parameter. Confidence intervals consist of a range of values (interval) that act as good estimates of the unknown population parameter; however, the interval computed from a particular sample does not necessarily include the true value of the parameter. It has been a normal practice that when a point estimate is calculated and a p-value is presented, the confidence interval will also be provided. If a corresponding hypothesis test is performed, the confidence level is the complement of the level of significance i.e. a 95% confidence interval reflects a significance level of 0.05. Confidence intervals are typically stated at the 95% confidence level that is corresponding to the significance level of 0.05. Confidence intervals may also be presented as 90% or 99% that is corresponding to the significance level of 0.10 or 0.01. It will be odd if the constructed confidence interval is not in 90%, 95%, or 99%. It is odd to present a confidence interval of 97.31%.
The significant levels should match the confidence levels. That is why we usually say "corresponding xx% confidence interval". If the significance level is 0.05, the corresponding confidence interval should be 95%. If the significant level is 0.01, the corresponding confidence interval should be 99%.
Issue arrives when we present the confidence interval for studies with interim analyses. To maintain the experimental wise alpha level at 0.05, with interim analysis, the final analyses will be tested at a significant level that is less than 0.05 and could be a number not commonly used otherwise. For example, with an interim analysis at 50% of information available, the significant level for interim analysis should be 0.005 and the significance level for the final analysis should be 0.048 (based on O'Brien Fleming method). Now the corresponding confidence interval will be an odd number of 95.2%.
This is exactly what was done in COMPASS-2 study "Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension" (ERJ, 2015). Because of the interim analysis, the alpha level for the final analysis is 0.0269. To match the alpha level, the study presented a 97.31% confidence interval. The article stated the following (note: I believe that it is pre-planned unblinded interim analysis, not blinded interim analysis in the sentence below):
With an overall study-wise Type I error (alpha) set to 0.05 (two-sided) based on the log-rank test, when adjusted for two pre-planned blinded interim analyses at 50% and 75% of the target number of primary end-point events, the alpha for the final analysis of the primary end-point was 0.0269 and, thus, 97.31% confidence intervals were used in reporting the HRs.
However, presenting a 97.31% confidence interval is odd (even though it is correct). In majority of the publications, the confidence interval were presented not according to their adjusted significance level due to the interim analysis. Here are several articles describing the studies with interim analysis and alpha-spending. The final analysis were tested at a significance level less than 0.05. However, no matter what the significance level was, the confidence interval was always presented as 95% confidence interval.
In an article by Schwartz et al (JAMA 2001) "Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial", "the study protocol specified 3 interim analyses of safety and efficacy by the data safety monitoring board. A significance level of p=0.001 was used for each interim analysis, with a significance level for the final analysis adjusted to P=0.049 to preserve to the overall type I error rate at P=0.05". However the results were presented with 95% confidence interval instead of 95.1%.
In an article by Combs et al (AJOG, 2011) "17-hydroxyprogesterone caproate for twin pregnancy: a double-blind, randomized clinical trial", two interim analyses were performed and the primary efficacy endpoint was tested at alpha=0.0466, however, the 95% confidence interval was presented anyway.
"Interim analyses of the primary outcome were planned upon completion of 50% and 75% of the case reports. Only the first of these was actually performed. By the time 75% of the patients had delivered and case report forms had been completed, all but 8 of the planned total of 240 subjects had been enrolled and the data and safety monitoring board determined that a second interim analysis would have been moot. To correct for the interim analysis, the alpha level for the primary outcome was adjusted to 0.0466 based on the O'Brien-Fleming spending function. For all other analyses, no adjustments were made and an alpha level of 0.05 was used."
In an article by Reck et al (NEJM, 2016) "Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer", there is a lengthy discussion about the alpha level adjustment for interim analysis (see below), however, all results were presented with 95% confidence interval no matter what the alpha level is.
The overall type I error rate for this trial was strictly controlled at a one-sided alpha level of 2.5%. The full statistical analysis plan is available in the protocol. The protocol specified two interim analyses before the final analysis. The first interim analysis was to be performed after the first 191 patients who underwent randomization had a minimum of 6 months of followup; at this time, the objective response rate would be analyzed at an alpha level of 0.5%. The primary objective of the second interim analysis, which was to be performed after approximately 175 events of progression or death had been observed, was to evaluate the superiority of pembrolizumab over chemotherapy with respect to progression-free survival, at a one-sided alpha level of 2.0%. If pembrolizumab was superior with respect to progression-free survival, the superiority of pembrolizumab over chemotherapy with respect to overall survival would be assessed by means of a group-sequential test with two analyses, to be performed after approximately 110 and 170 deaths had been observed. We calculated that with approximately 175 events of progression or death, the trial would have 97% power to detect a hazard ratio for progression or death with pembrolizumab versus chemotherapy of 0.55. At the time of the second interim analysis, the trial had approximately 40% power to detect a hazard ratio for death with pembrolizumab versus chemotherapy of approximately 0.65 at a one-sided alpha level of 1.18%.
The second interim analysis was performed after 189 events of progression or death and 108 deaths had occurred and was based on a cutoff date of May 9, 2016. The data and safety monitoring committee reviewed the results on June 8, 2016, and June 14, 2016. Because pembrolizumab was superior to chemotherapy with respect to overall survival at the prespecified multiplicity adjusted, one-sided alpha level of 1.18%, the external data and safety monitoring committee recommended that the trial be stopped early to give the patients who were receiving chemotherapy the opportunity to receive pembrolizumab. All data reported herein are based on the second interim analysis.
In an article by Rinke et al (J Clin Oncol 2009) "Placebo-Controlled, Double-Blind, Prospective,
Randomized Study on the Effect of Octreotide LAR in the Control of Tumor Growth in Patients With Metastatic Neuroendocrine Midgut Tumors: A Report From the PROMID Study Group", the alpha level is 0.0125, but the results were presented with 95% confidence interval.
On the basis of previous results, a median time to tumor progression of 9 months was assumed for the placebo group. An HR of 0.6 was postulated as a clinically meaningful difference to be detected with a power of 80%. An optimized group sequential design, with one interim analysis after observation of 64 progressions and the final analysis after observation of 124 progressions, with a local type I error level of 0.0122 at interim, was fixed in the protocol. A use function in the sense of DeMets and Lan was set up by reoptimization, resulting in the type I error level of 0.0125 after observation of 67 progressions. According to Schoenfeld and Richter and compensating for a lost to follow-up rate of 10%, recruitment of 162 patients was planned.
For survival time, a fixed-sample test based on 121 observed deaths was defined in the protocol. Controlling the family-wise error rate at the level of 5%, this test was planned as a confirmatory test in the event of a significant result for the primary end point, with the option of a redesign according to Mu¨ller and Scha¨fer.
In clinical trials with interim analysis where the final analysis is performed at a significance level less than 0.05, the correct way for presenting the confidence interval should be using the corresponding percentage.
In practice, the correct, but odd way was not usually followed. Instead, no matter what the significance level is for the final analysis, the confidence interval is always presented as 95% confidence interval.
It seems to be acceptable or has been accepted in publications to present a confidence interval that does not match the corresponding significance level or alpha level. If the overall significance level is 0.05, the 95% confidence interval can always be presented no matter what the alpha level or significance level is left for the final analysis due to the adjustment for multiplicity for performing interim analyses.
Posted by Web blog from Dr. Deng at 7:00 AM 1 comment:
Haybittle–Peto Boundary for Stopping the Trial for Efficacy or Futility at Interim Analysis
In clinical trials with group sequential design or the clinical trials with formal interim analysis for efficacy, we will need to deal with the alpha spending issue. To maintain the overall experimental wide alpha level at 0.05, the final analysis will usually tested at a significance level less than 0.05 due to the alpha spending at the interim analyses. Various approaches in handling the multiplicity issue due to the interim analyses have been proposed. The O'Brien-Fleming approach is the most common approach.
In an article by Schulz and Grimes (Lancet 2005) "Multiplicity in randomised trials II: subgroup and interim analyses", three approaches were listed where the stop boundaries were expressed in p-value format:
In the middle is the approach proposed by Peto. In practice, Peto approach is more commonly referred as Haybittle-Peto boundaries.
In an online course by "Treatment Effects Monitoring; Safety Monitoring", there is a following table comparing the different approaches for boundaries and Haybittle-Peto boundary is one of them.
In a lecture note by Dr Koopmeiners, the Haybitle-Peto boundaries are summarized as below with the boundaries expressed in critical values:
In short, the Haybittle–Peto boundary states that if an interim analysis shows a probability of equal to a very small alpha or greater than a very large critical value that a difference as extreme or more between the treatments is found, given that the null hypothesis is true, then the trial should be stopped early. The final analysis is still evaluated at almost the normal level of significance (usually 0.05). The main advantage of the Haybittle–Peto boundary is that the same threshold is used at every interim analysis, unlike other the O'Brien–Fleming boundary, which changes at every analysis. Also, using the Haybittle–Peto boundary means that the final analysis is performed using a 0.05 level of significance as normal, which makes it easier for investigators and readers to understand. The main argument against the Haybittle–Peto boundary is that some investigators believe that the Haybittle–Peto boundary is too conservative and makes it too difficult to stop a trial.
I have seen several high profiles clinical trials where the Haybittle-Peto boundary is used. In a very recent paper by Finn et al (NEJM 2016) "Palbociclib and Letrozole in Advanced Breast Cancer", the Haybittle-Peto boundary was used for the interim analysis.
We planned for the data and safety monitoring committee to conduct one interim analysis
after approximately 65% of the total number of events of disease progression or death were observed to allow for the study to be stopped early owing either to compelling evidence of efficacy (using a pre-specified Haybittle–Peto efficacy boundary with an alpha level of 0.000013) or to a lack of efficacy.
In a paper by Eikelboom et al (NEJM 2017) "Rivaroxaban with or without Aspirin in Stable
Cardiovascular Disease", the modified Haybittle-Peto boundary was used:
Two formal interim analyses of efficacy were planned, when 50% and 75% of primary efficacy events had occurred. A modified Haybittle–Peto rule was used, which required a difference of 4 SD at the first interim analysis that was consistent over a period of 3 months, and a consistent difference of 3 SD at the second interim analysis
In a paper by Sitbon et al (NEJM 2015) "Selexipag for the Treatment of Pulmonary
Arterial Hypertension", the Haybittle-Peto boundary was also used for the interim analysis. Notice that the overall alpha for this study was 0.005, not the typical 0.05. While it was not mentioned in the NEJM publication, the alpha level for interim analysis was 0.0001 according to FDA's statistical review of the NDA.
An independent data and safety monitoring committee performed an interim analysis,
which had been planned after 202 events had occurred, with stopping rules for futility
and efficacy that were based on Haybittle–Peto boundaries. The final analysis used a one-sided significance level of 0.00499.
In both case, we can see that with Haybittle-Peto boundaries, the boundaries are set up very high - making it almost impossible to stop the trial for efficacy (or futility).
In choosing the stop boundaries for interim analysis, Haybittle-Peto boundaries may be chosen when a sponsor has no real intention to stop the trial early, but give Data Monitoring Committee a chance to take a peek into the study results in in the middle of the study.
Haybittle-Peto boundaries are included in the major sample size calculation software such as Cytel's EAST SEQUENTIAL and SAS Proc SEQDESIGN.
Posted by Web blog from Dr. Deng at 5:00 AM No comments:
Control for Type I Error (or Adjustment for Multip...
the 21st Century Cures Act and Innovations in Clin...
Commonly Used Procedure for Multiplicity Adjustmen...
Should the Percent of Confidence Confidence Interv...
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text:
Q: Insert dictionary of lists as column into a sliced dataframe In a follow-up of my previous question I am trying add another column to the following sliced dataframe:
>>> df = pd.DataFrame(np.array([[1, 1, 1, 1, 2, 2, 2], [0, 0, 0, 1, 0, 0, 1], ['some text', 'other text', 'more text', 'new text', 'text sample', 'sample', 'sample text'], ['kw1, kw2', 'kw1, kw2, kw3', 'kw1', 'kw1, kw2, kw3, kw4', 'kw1', 'kw1, kw2, kw3', 'kw1, kw2']), columns=['value', 'cluster', 'text', 'keywords'])
>>> result = df.groupby(['value', 'cluster', 'text']).keywords.sum().to_frame()
>>> result =
value      cluster      text      keywords
  1           0      some text       kw1, kw2
                     other text      kw1, kw2, kw3
                     more text       kw1
              1      new text        kw1, kw2, kw3, kw4
  2           0      text sample     kw1
                     sample          kw1, kw2, kw3
              1      sample text     kw1, kw2

Based on the last question, the content of the column I want to add should be based on a dictionary like this:
>>> summary2 = {0: ['some, summary', 'this, too, summ'], 1: ['kws, of, summ', 'summ, based, kw']}

EDIT:
My plan is to match the keys of the dictionary with the column "value" and the items within the dictionary lists with the cluster. I want to match the values by position, e.g. key 0 matches value 1 and item "some, summary" matches cluster 0. So I receive this output:
value      cluster   summary            text       keywords
  1           0      some, summary    some text       kw1, kw2
                                      other text      kw1, kw2, kw3
                                      more text       kw1
              1      this, too, summ   new text        kw1, kw2, kw3, kw4
  2           0      kws, of, summ    text sample     kw1
                                      sample          kw1, kw2, kw3
              1      summ, based, kw  sample text     kw1, kw2

What I've tried so far is the following:
result['summary2'] = result.groupby(['value','cluster']).ngroup().map({item: k for k, v in summary2.items() for item in v})

The column however outputs only NaNs.

A: If you want to fill the "summary" column by position (i.e. no mapping of value/cluster to the keys), you could try:
#flatten all your dictionary values to a list
lst = [item for sublist in summary2.values() for item in sublist]

#map to ngroup
result['summary'] = result.groupby(["value", "cluster"]).ngroup().map(dict(enumerate(lst)))

#assign summary to index and reorder levels if needed
result = result.set_index("summary", append=True).reorder_levels(["value", "cluster", "summary", "text"])

>>> result
                                                     keywords
value cluster summary         text
1     0       some, summary   more text                   kw1
                              other text        kw1, kw2, kw3
                              some text              kw1, kw2
      1       this, too, summ new text     kw1, kw2, kw3, kw4
2     0       kws, of, summ   sample            kw1, kw2, kw3
                              text sample                 kw1
      1       summ, based, kw sample text            kw1, kw2

A: IIUC, you can try apply on rows
result = df.groupby(['value', 'cluster', 'text']).keywords.sum().to_frame()
summary2 = {0: ['some, summary', 'this, too, summ'], 1: ['kws, of, summ', 'summ, based, kw']}

result = (result.assign(summary=result.apply(lambda row: summary2[row.name[0]-1][row.name[1]], axis=1))
          .set_index('summary', append=True)
          .reorder_levels(["value", "cluster", "summary", "text"]))

print(result)

                                                     keywords
value cluster summary         text
1     0       some, summary   more text                   kw1
                              other text        kw1, kw2, kw3
                              some text              kw1, kw2
      1       this, too, summ new text     kw1, kw2, kw3, kw4
2     0       kws, of, summ   sample            kw1, kw2, kw3
                              text sample                 kw1
      1       summ, based, kw sample text            kw1, kw2


text:
Eric Dolphy – Out To Lunch
by Jim BurlongNov 12, 2022Album Reviews, Classic
Blue Note Records CDP 0777 7 46524 2 1
Recorded And Released 1964
Eric Dolphy (alt,flt,bs clt), Freddie Hubbard (tpt), Bobby Hutcherson (vbs), Richard Davis (bs), Tony Williams (drs)
Hat And Beard 8:24, Something Sweet Something Tender 6:02, Gazzelloni 7:22.
Out To Lunch 12:06, Straight Up And Down 8:19.
A timeless classic from the iconic Blue Note label, recorded just a few months ahead of the legendary Eric Dolphy's death at the age of only 36. He took his first steps to a staggering musical career at The U.S. Navy School Of Music in 1952 with his contemporaries Gerald Wilson and Buddy Collette. The saxophonist later came to the attention of the jazz listening public with Chico Hamilton's quartet in 58 at the well documented Newport Jazz Festival, where he played flute, before going on to make five albums with the band. He went on to be a cornerstone of the Mingus groups for a few years, recorded with them twelve times before forming a bond with John Coltrane at the turn of the decade, while also becoming a key part of the small groups led by Oliver Nelson and Booker Little. In his short career Eric Dolphy made only seven albums under his own name, although after his untimely death there were over twenty posthumous releases of archive recordings. In all he appeared on over eighty albums and became one of the most lauded and admired figures in the history of creative modern jazz.
Many say that this was the cornerstone recording of his career, it's a difficult one to argue against. The line-up of the quintet is awesome. Trumpet man Freddie Hubbard, aged 25 at the time, had already appeared on Dolphy's 1960 album Outward Bound, spent time with Art Blakey and made 9 albums as a leader. With his exquisite tonality and improvising ability there were few above him. Only three years into a five decade recording career Bobby Hutcherson was to become a staple of the Blue Note groupings and destined to take his instrument into more complex environments than even the more well known vibraphonists of the period. He enhanced many forward thinking bands including those led by McCoy Tyner, Jackie McLean plus The San Francisco Jazz Collective. The multi genre Chicago musician Richard Davis who is still going strong at 90 years of age, was Dolphy's choice on bass. A man who was just as comfortable during his long career with Van Morrison, Bruce Springsteen or the orchestras of Leonard Bernstein and Gunther Schuller, as he was with small group progressive jazz, centered the band with his usual commanding presence as he did for many. Still a teenager at the time it was obvious to many that Tony Williams had the talent to become one of the greatest drummers of all time. As we all know he went on to hold the drum chair with Miles during his most creative period as well as becoming first call for Herbie Hancock and a Blue Note regular. This session provided an ideal window into his many yet to be revealed triumphs.
It almost goes without saying, that most people agree that this is a cornerstone album of modern progressive jazz. All the compositions are by Dolphy himself and the musicianship is of the very finest order on a set that challenges many ears but rewards each playing with the secrets it gradually reveals. To some minds there is no sound so unique and infectious than Eric Dolphy on bass clarinet, and it is that instrument that holds sway on the opening cut, Hat And Beard. Double bass and vibes form the initial backdrop as Eric gently wails and quietly screams on the woodwind instrument. It's almost lyrical in parts and knit perfectly together throughout by the Chicago bass man, while Tony Williams resides in a heavenly world of his own, just as he continued to do with Miles, some five years later. Bobby Hutcherson is at his crystalline best when he solos, with Freddie Hubbard coming late to the party with an intense and lyrical solo which is the complete antithesis of what's gone before. Anyone hearing this opening track for the first time could only anticipate the glories to come, and they would not have been disappointed. There's an almost ambient feeling in parts about Something Sweet Something Tender which points the way to much later recordings. Eric remains on bass clarinet for this one, the arco bass is glorious at the beginning, leading to a beautiful and almost mournful trumpet solo from Freddie before the leader returns in strident mode to take stretching the capabilities of his instrument to their extreme towards the close. Side 1 ends with Eric taking up the flute on the upbeat Gazzelloni, his playing is almost "Kirkish" like at times. There are some perfectly placed prompts from Bobby's vibes while the bass holds it all together once more, before a searching solo from Freddie's trumpet preludes an ensemble close. The title track Out To Lunch takes up much of side 2, it opens with a short march like intro', before the leader takes up his alto for the first time, his playing is really "off the wall" on this one, you can tell Tony Williams likes it as he also goes off in multiple directions leaving only the bass to hold the early passages together. Davis remains central as the piece segues into a minimalist duet with vibes, later enhanced by imaginative cymbal work from Tony Williams before things come to a fitting close with snappy short statements between trumpet and saxophone. All good things must eventually come to an end, and so they do with the closer Straight Up And Down. There's lots of tension and release here on a tune and arrangement that's far more straight ahead than what's gone before. Eric remains on alto, is present for the majority of the time but seemingly holding something in reserve. Freddie gets more exposure than before with a well considered lyrical interlude, Bobby Hutcherson answers in similar mode before Eric takes it out almost playing the blues. The whole thing is one giant of an album easily holding a place at the pinnacle of recorded jazz.
This review is based on the 1985 re-released CD. It was originally available as a vinyl LP reference BLP 4163 and on various digital platforms.
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