We have the utmost respect for oncology researchers in academic and pharmaceutical environments. We have often lauded their dedication to advancing and improving the care of patients with cancer and their attention to the safety of clinical trial participants.
Nevertheless, there are important ethical questions that must be fully considered when scientific research of any kind is conducted. It is with this consideration in mind that our physician editor, Maurie Markman, MD, tackles key issues that have arisen in the modern era of medical discovery in his column, “Innovative Clinical Trial Designs Generate New Ethical Dilemmas.”
We’ve been hearing much discussion of novel clinical trial designs for the molecular era. These are intended to be nimble methods of testing patients who might respond to a targeted therapy or immunotherapy without launching a study that requires hundreds or even thousands of patients and takes years to finish. The goal of these trials is to “graduate” therapies with a high likelihood of success in a future randomized study.
Yet Dr Markman asks a very important question. If 1 of 2 therapeutic approaches to be tested has already demonstrated a high likelihood of superiority, why would any patient want to participate in a randomized trial where he has an equal chance of getting an inferior therapy? And, why would the trial be designed to put patients in that position?
Over the years, we have heard anecdotally about the importance of allowing crossover in trials so that patients can be assured they will have a chance at a more successful therapy, and about the reluctance that some researchers have had to conduct a randomized trial comparing a novel therapy with an obviously inferior regimen.
Although the research community has often participated in discussions of clinical trials ethics, Dr Markman is suggesting that patients be part of this conversation. There currently is no established mechanism for ensuring that participation, but it makes a lot of sense to develop a model that includes patients.
After all, the oncology research community is constantly encouraging participation in clinical trials yet fewer than 5% of patients with cancer enroll. Perhaps a robust conversation would enhance confidence in the clinical trial apparatus.