How many patients does it — and should it — take to develop a new cancer drug?

In every trial there is a balance between the risks and benefits to study participants, and the principles of research ethics require that the likely benefits of participation outweigh the risks.

Traditionally, the interpretation of this principle is applied to individual patients in individual trials. However, trials and research programs involve whole populations.

Although each trial protocol may seem ethically acceptable when considered individually, is it possible that when we consider all trials within a research program, the risks to the study population may be excessive?

Jonathan Kimmelman, PhD, will take up this question and present results from ongoing investigations of cancer drug development research programs. His investigations reveal, on the one hand, that drug developers are extraordinarily efficient at unlocking the clinical utility of new drugs. And on the other had, that mature drug development programs are characterized by a high level of redundancy, and that risk/benefit ratio tends to decline as drug development programs mature. Early evidence suggests these findings extend to other realms of drug development as well.

Dr. Kimmelman will consider the implications of the research for human protections, research policy, clinical trial inference, and drug pricing.

Registration for this event is closed.