Viktoryia Karchynskaya, Jaroslava Kopcakova, Andrea Madarasova Geckova, Boris Katrusin, Sijmen A Reijneveld, Andrea F de Winter
Barriers and enablers for sufficient moderate-to-vigorous physical activity: The perspective of adolescents
PloS one
new cancer drugs approved us food drug administration fda basis surrogate endpoints data overall survival still incomplete immature deaths meaningful analysis aimed evaluate whether clinical trials immature survival data generated evidence overall survival benefit period marketing authorisation evidence reported retrospective analysis searched drugsfda identify cancer drug indications approved jan 1 2001 dec 31 2018 basis immature survival data systematically collected publicly available data postapproval overall survival results labelling drugsfda journal publications medline via pubmed clinical trial registries clinicaltrialsgov primary outcome availability statistically significant overall survival benefits period marketing authorisation march 31 2023 additionally evaluated availability timing overall survival findings labelling journal publications clinicaltrialsgov records study period fda granted marketing authorisation 223 cancer drug indications 95 overall survival endpoint 39 41 95 indications immature survival data minimum 43 years followup period marketing authorisation median 82 years iqr 53120 since fda approval additional survival data pivotal trials became available either revised labelling publications 38 97 39 indications additional data overall survival showed statistically significant benefit 12 32 38 indications whereas mature data yielded statistically nonsignificant overall survival findings 24 63 indications statistically significant evidence overall survival benefit reported either labelling publications median 15 years iqr 0823 initial approval median time availability statistically nonsignificant overall survival results 33 years 2245 availability overall survival results clinicaltrialsgov varied considerably fewer third indications approved immature survival data showed statistically significant overall survival benefit approval notable inconsistencies timing availability information approval across different sources emphasise need better reporting standards none