Substandard Control Arms in Clinical Trials for Prostate Cancer
Van Wambeke et. al.
Journal of Clinical Oncology, 02/22/2022
A substantial number of anticancer drugs receive marketing authorization on the basis of data that do not prove their superiority over standard-of-care treatment because of the use of substandard control arms in clinical trials. Use of a substandard control arm exaggerates the clinical benefit of the experimental agent and can mislead physicians, patients, and regulatory and health technology assessment bodies.