OA: Reaffirming and Clarifying the American Society of Clinical Oncology’s Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment

Reaffirming and Clarifying the American Society of Clinical Oncology’s Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment 

On behalf of ASCO, we thank Dr Jonathan Kimmelman for highlighting a number of important issues in the design and conduct of phase I clinical trials in oncology.¹ The ethics surrounding cancer phase I trials have been an important topic of discussion throughout the modern history of clinical cancer research and continue to be important in the development of new drugs. We would like to reaffirm and clarify ASCO’s position on phase I cancer clinical trials² and to agree or disagree with some of Dr Kimmelman’s points.
ASCO and Dr Kimmelman agree that phase I trials have therapeutic intent and that such intent is necessary, but not sufficient, to support conduct of such trials in patients with cancer. As noted in ASCO’s 2015 policy statement update on this topic,² these trials must also have the potential to provide clinical benefit. In offering an interventional trial, the physician and patient have the goal of attempting to treat the cancer. The same goal applies when a physician and patient pursue therapeutic options outside a clinical trial........