Hearkening back to my former life as the chair of an Institutional Review Board: you do not promise or imply a potential for benefit to clinical trial participants.
Why? Because clinical trials aren’t designed to benefit participants. Participants may be randomized to the “standard of care” arm. The trial drug may not have any improvement in efficacy over the “standard of care”. Worse, the trial drug may, in fact, have greater toxicity than the current options. Finally, there are the frequent – and frequently invasive – trial procedures: blood draws, repeat imaging, and repeat tumor sampling.
The perception remains clinical trials produce better outcomes for some trial participants – but the whole of the literature does not support this conclusion. This systematic review and meta-analysis from JAMA clearly shows the data are insufficient to support a net benefit from cancer clinical trial participation. Small signals of benefit are most likely the result of trial effects and publication bias.
The unquestioned benefit? To pharma – and, distantly, potentially to future patients.
While this study does not exclude such benefits for cancer clinical trial participation, it remains unsubstantiated.