Fulfillment of postmarketing requirements to the FDA for therapies granted oncology indications between 2011 and 2016
Menée aux Etats-Unis à partir de l'analyse des données de la FDA puis à l'aide de la base ClinicalTrials.gov et des sites internet de financeurs, cette étude analyse le respect des engagements concernant la réalisation d'études complémentaires pour les traitements anticancéreux ayant reçu entre 2006 et 2011 une autorisation anticipée de mise sur le marché
The US Food and Drug Administration (FDA) attempts to strike a balance between approving newer therapies expeditiously while assuring that patients consuming these products are not harmed with unrecognized adverse events.1 The rapidity of approving novel agents in oncology allows patients access to potentially lifesaving therapies and incentivizes investigators in academic and pharmaceutical industries to continue clinical research efforts. The FDA strives to mitigate the risk of early market entry through the use of an accelerated approval (AA) program by requiring postmarketing studies.
JAMA Oncology , résumé, 2017