Nita Bhandari|Ravi Prakash Upadhyay|Ranadip Chowdhury|Sunita Taneja
Challenges of adopting new trial designs in LMICs
Society for Applied Studies|Society for Applied Studies|Society for Applied Studies|Society for Applied Studies
series four papers clinical trials global health presents useful understanding adaptive innovative trial designs well efficiency terms resources timeliness results compared conventional fixed randomised controlled trials first series paper1park jjh grais rf taljaard et alurgently seeking efficiency sustainability clinical trials global healthlancet glob health 2021 9 e681e690summary full text full text pdf scopus 4 google scholar discusses considerations needed implementing adaptive trial designs master protocols including need sustain research groups underscoring importance designs like master protocols platform designs optimising efficiency sustainability second series paper2park jjh ford n xavier et alrandomised trials level individuallancet glob health 2021 9 e691e700summary full text full text pdf pubmed scopus 3 google scholar focuses adaptive trial design context individually randomised controlled trials third series paper3dron l taljaard cheung yb et althe role challenges cluster randomised trials global healthlancet glob health 2021 9 e701e710summary full text full text pdf pubmed scopus 4 google scholar discusses challenges use cluster randomised design final series paper4park jjh mogg r smith ge et alhow covid19 fundamentally changed clinical research global healthlancet glob health 2021 9 e711e720summary full text full text pdf pubmed scopus 8 google scholar uses covid19 pandemic contextualise fundamental issues exist clinical trial research authors also emphasise need systematic longterm mechanisms enable realtime data generation sharing global public health use unconventional promising clinical trial methods tools concepts successful examples trial designs presented exciting seem encouraging elements however information insufficient associated challenges become clearer experience gained besides difficulties implementation challenges include securing funding considering funding agencies might comprehend designs appropriately organisation research consortium execute master protocol studies within acceptance study designs nature implementation ethics committees data safety boards statistical analysis data obtained given analysis probably require advanced models skill sets currently scarce lowincome middleincome countries lmics evident trial designs outlined series work well pharmaceutical trials application types trials scarce lmics especially using outcomes readily amenable intervention growth behaviour intellectual capacity although benefits trial designs understandable scientific perspective ethical implications premature termination trial change interventions ongoing trial well known one ethical ambiguity whether comprehension appropriately ensured trial coordinators populations low literacy acquiring informed consent interventions change midway stopped altogether premature stopping trial might also affect legalities regarding study staff employment settings experienced ethics committees data safety monitoring boards confidently handle designs trials addressing variety research questions needed say novel designs used lmics need identify challenges generate solutions several operational components widespread implementation settings important acknowledge generalised approach apply settings although study designs well accepted highincome countries hics contexts adoption lmics depends various factors existing research environment regulatory guidelines available human economic infrastructural capacity another integral component series theme fostering collaborations research groups lmics hics resistance researchers increased collaboration requires understanding coupled possible ways alleviate resistance engaging effective solutions identified due consideration given challenges regarding multicountry collaborations equitable distribution funds publication credit well countryspecific guidelines data sharing transfer biological specimens establishing multicountry collaborations might time consuming issues regarding site selection partnership agreements approval mechanisms regulatory nonregulatory studies authors highlight need developing master protocols implementing platform trials could marshal research efforts coordinated collaborative manner sustaining research infrastructure teams great ideas difficult operationalise funding agencies common interests would need harmonise way sustained financial support ensured allow realisation master protocols studies within would challenges regarding selection groups supported long term new research groups added subsequently funders stakeholders required deliberate extensively set standard guidelines processes fair transparent express enthusiasm use innovative designs conceivably provide timely findings ensure efficient use resources however designs early development believe aspects need greater clarity refinement used scale researchers lmics importantly concurrent dissemination findings sharing experiences use designs might aid increasing acceptability many issues emerging series well recognised however achieving solutions difficult hope series reach wider audience provide impetus adoption novel approaches conduct clinical trials funding lmics declare competing interests urgently seeking efficiency sustainability clinical trials global healththis paper shows scale global health research context frame subsequent papers series series paper provide historical perspective clinical trial research revisiting 1948 streptomycin trial pulmonary tuberculosis first documented randomised clinical trial english language discuss close connection global health describe current state clinical trial research globally providing overview clinical trials registered international clinical trial registry since 2010 fulltext pdf open accessrandomised trials level individualin global health research shortterm smallscale clinical trials fixed twoarm trial designs generally allow major changes throughout trial common study design building introductory paper series paper discusses datadriven approaches clinical trial research across several adaptive trial designs well master protocol framework help harmonise clinical trial research efforts global health research provide general framework efficient trial research discuss importance considering different study designs planning stage statistical simulations fulltext pdf open accessthe role challenges cluster randomised trials global healthevaluating whether intervention works trialled groups individuals pose complex challenges clinical research cluster randomised controlled trials involve random allocation groups clusters individuals receive intervention commonly used global health research paper describe potential reasons increasing popularity cluster trials lowincome middleincome countries also draw key areas global health research assessment common trial planning practices address methodological shortcomings pitfalls fulltext pdf open accesshow covid19 fundamentally changed clinical research global healthcovid19 negative repercussions entire global population despite common goal unified resources efforts overwhelmingly large number clinical trials registered questionable methodological quality final paper series discuss medical research community responded covid19 recognise incredible pressure pandemic put researchers regulators policy makers best move quickly safely time tremendous uncertainty fulltext pdf open access