Seamless Oncology-Drug Development
Signé par des responsables de la "Food and Drug Administration", cet article argumente en faveur de la généralisation des essais avec expansion de cohorte pour une première évaluation de traitements anticancéreux chez l'humain
For more than half a century, the clinical development of anticancer drugs has followed a predictable and orderly set of sequential stages: phase 1 trials were designed to determine the drug’s safety, tolerability, and dose; phase 2 trials then explored the drug’s activity in a variety of cancers; and phase 3 trials compared the new drug with existing treatments and served as the basis for regulatory approval...
New England Journal of Medicine , article en libre accès, 2015