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How many patients does it — and should it — take to develop a new cancer drug?
March 30 @ 4:30 pm - 6:00 pm
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.
- A Harvard or affiliated teaching hospital ID is required to access the HMS campus.
- Non-Harvard guests must register and check-in with a photo ID at security.
Jonathan Kimmelman, PhD, is an associate professor at McGill University in the Biomedical Ethics Unit / social studies of medicine, with a cross appointment in experimental medicine.
His research centers on ethical, policy, and the scientific dimensions of drug and diagnostics development. He directs the Studies of Translation, Ethics and Medicine (STREAM) collaborative, whose members include researchers with a shared set of principles about the goals and methods for studying clinical translation.
In addition to his book, Gene Transfer and the Ethics of First-in-Human Experiments, his writing has been featured in Science, PLoS Medicine, BMJ, and Hastings Center Report.
Kimmelman received the Maud Menten New Investigator Prize in 2006, a CIHR New Investigator Award in 2008, and a Humboldt Bessel Award in 2014. He has served on various advisory boards within the National Heart, Lung and Blood Institute, the Institute of Medicine, and the Canadian Institutes for Health Research. He chaired the International Society of Stem Cell Research Guidelines for Stem Cell Research and Clinical Translation revision task force.
Jeffrey Peppercorn, MD, MPH
Medical oncologist specializing in breast cancer care Massachusetts General Hospital
Associate professor of medicine
Harvard Medical School
MGH Cancer Survivorship Program.
This event is free and open to the public and lunch will be provided, but seating is limited and registration is required.