Drug approval based on randomized phase 3 trials for relapsed malignancy: analysis of oncologic drugs granted accelerated approval, publications and clinical trial databases

Conclusion Our analysis indicates that drug approval based on phase 3 trials is more challenging for relapsed hematological malignancies than for solid malignancies. Therefore, determining proper evaluation methods for the efficacy and safety of drugs for relapsed malignancy, without randomized trials, is important.

http://link.springer.com/10.1007/s10637-018-0572-2

Source: Investigational New Drugs - February 17, 2018 Category: Drugs & Pharmacology Source Type: research