By Cait Kearney
Experts debated positron emission tomography (PET) as a suitable surrogate endpoint for clinically meaningful outcomes and accelerated approval of Alzheimer’s drugs at an event held by the Internal Ethics Committee of the Alzheimer’s Clinical Trials Consortium (ACTC).
“Science precedes by open debate and discussion,” said Penn Memory Center (PMC) Co-Director Jason Karlawish, MD, who moderated the event and is co-chair of the ACTC Internal Ethics Committee.
Holly Fernandez Lynch, JD, MBe, assistant professor of medical ethics and health policy at the University of Pennsylvania, kicked off the event by reviewing the history of law and regulation for surrogate endpoints.
A surrogate endpoint — in this case, PET — is a measurement that is “reasonably likely” to predict clinical benefit.
Harvard University Professor of Neurologic Diseases Dennis Selkoe, MD, argued in favor of PET as a suitable surrogate endpoint for Alzheimer’s drugs. Chris van Dyck, MD, director of the Alzheimer’s Disease Research Center at Yale University, argued against PET.
At the conclusion of the debate, audience members voted “yes” or “no” in response to the question “PET is a suitable surrogate endpoint?” Only 25% of audience members voted “yes.”
ACTC works to accelerate the development of interventions for Alzheimer’s disease and related disorders. Click here to learn more ACTC.