FDA Considering New Guidance on Cancer Clinical Trials


 

My favorite stories are the ones that fork from the thing you initially set out to cover.

I was already looking forward to interviewing Dr. Richard Pazdur, who heads the Food and Drug Administration’s new oncology center for excellence, and his colleague Julia Ann Beaver on this paper they published about eligibility criteria for cancer clinical trials.

Essentially the FDA wants clinical trial sponsors and investigators to be more judicious instead of copying eligibility criteria from one study to the next.

“We want people who are writing protocols and designing protocols really to think critically of the eligibility criteria,” Pazdur told me, adding that the main reason for excluding patients is to protect them. But there also needs to be consideration of how the people testing the experimental cancer treatment should better reflect the population who ultimately will receive the drug once it hits the market.

Beaver added the FDA is working with stakeholder groups that are publishing more in-depth papers. “In addition, at FDA we are in the process of working on a guidance delineating some of these issues regarding eligibility,” she told me.

Hold up.

Did you say guidance?

New guidance?

One that isn’t on the FDA’s list of planned guidance documents yet?

Pazdur picked up from Beaver’s comment and said, “We would like clinical trials to more accurately reflect the patient population that will actually be using the drug, rather than a very artificial construct of patients that are handpicked to go on the clinical trial.”

This is, of course, a great quote—one I used as my top one.

But, hey, can we go back to that guidance thing?

Pazdur said they are in the preliminary stages of even thinking about a draft guidance. The New England Journal Medicine paper—the original basis for this interview—is just a first step in engaging in dialogue about eligibility criteria for clinical trials. All those aforementioned papers from the Friends of Cancer Research and the American Society of Clinical Oncology have to be published first, which the FDA will evaluate. So there’s no timeline yet, but stay tuned.

Read my full story here.

Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.

Learn more about Bloomberg Law and sign up for a free trial.