Flawed evidence underpins approval of new cancer drugs
A partir de documents réglementaires européens, de données de registres d'essais cliniques et de publications scientifiques, cette étude examine les caractéristiques et les risques de biais des essais cliniques d'anticancéreux autorisés entre 2014 et 2016 par l'Agence Européenne du Médicament
We must raise the bar to ensure real benefits for patientsCancer drugs are at the coalface of current tensions between commercial and public health interests in medicine because of high prices and expedited market approvals. The aim of faster approvals is to get potentially life saving care to patients as soon as possible, especially those with rare cancers or life threatening diseases whose conditions do not respond to existing treatments. However, faster approval comes at a high cost. Several studies have shown that the evidence of patient benefit that underpins approval is limited and uncertain. Overall survival was evaluated as a primary endpoint in only 26% of trials of new cancer drugs and indications approved in Europe from 2009 to 2013. The remaining approvals were based on surrogate measures such as progression-free survival or response rate,1 which have a low or modest correlation with overall survival.23Postapproval confirmatory trials found a survival advantage for only 19/93 (20%) cancer drugs with accelerated approvals in the United States from 1992 to 2017.4 Quality of life …
BMJ , éditorial en libre accès, 2018