A Clinical Perspective on Clinical Research Endpoints

>> Danny Benjamin: Hey, I'm Danny Benjamin. I'm distinguished professor of pediatrics at Duke University. And I want to talk about clinical research in a pandemic and the unique opportunity to establish a primary endpoint. So, whenever we're doing studies, we need to have a primary outcome or primary endpoint, and we need to have a primary exposure.

And I want to talk with you a little about thinking through endpoints, in particular, primary endpoints, especially for something where no one has thought through it before. So, in March of 2020, there was a hypothesis that children, if they attended school, would fuel the pandemic, and therefore, many folks believed that schools should be closed and shutdown

and go to remote learning. In July of 2020, most schools would be closed in the fall of 2020, and we didn't know if schools would be open that summer. And much of that depended on whether or not your child went to public, charter, or private school, and what part of the country they were in,

but most children underwent remote learning in the fall of 2020. And in July of 2020, I was approached, based on my history of working with a local school district, by a pediatrician who was a school board member at Chapel Hill-Carrboro City Schools. And Dr. Fowler asked me if I'd talk with her some about metrics for reopening.

I said, "You know, really, rather than metrics, maybe we could set up a collaboration where we could serve to answer some medical questions for you, and you all could kind of fit that into public policy because we certainly know the medicine, but we are not experts in education or education policy." That was amenable to that particular school board.