Accelerated Approval and Breakthrough Therapy Designation: Oncology Drug Development on Speed?
Cet article passe en revue les limites des processus d'autorisation accélérée de mise sur le marché de nouveaux traitements à partir d'essais cliniques portant sur de petites populations de patients
Recent advances in biotechnology have led to discoveries resulting in major improvements in the therapy of refractory malignancies, although most advanced cancers remain incurable. Thus, there is global consensus around the need to streamline the drug approval process for effective agents. Accelerated approval and Breakthrough Therapy Designation hold the promise of making new treatments available sooner through the use of smaller studies employing intermediate endpoints. Here we consider the inherent limitations of smaller studies and discuss strategies for hastening oncology drug development while maintaining high efficacy standards.
Clinical Cancer Research , résumé, 2013