A Landscape of Methodology and Implementation of Adaptive Designs in Cancer Clinical Trials

YY Zhu, WX Wang, SK Cheuk, GR Feng, XG Li… - Critical Reviews in …, 2024 - Elsevier
Background The use of adaptive designs in cancer trials has considerably increased
worldwide in recent years, along with the release of various guidelines for their application …

Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals

H Hakariya, F Moriarty, A Ozaki… - Clinical and …, 2024 - Wiley Online Library
Regulatory authorities must balance ensuring evidence of efficacy and safety of new drugs.
Various regulatory pathways, such as the accelerated approval program in the United States …