1. DiGiulio, Sarah

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In oncology, what is the role of race in terms of variability in response to drugs? How many African Americans versus Asians versus Caucasians should be enrolled in a clinical trial? What about age? What about sex?

JOHN J. WHYTE, MD, M... - Click to enlarge in new windowJOHN J. WHYTE, MD, MPH. JOHN J. WHYTE, MD, MPH

Those questions form the basis of what would be a very interesting discussion in oncology, explained John J. Whyte, MD, MPH, Director of Professional Affairs and Stakeholder Engagement in the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration. And it was those types of questions that prodded the FDA to launch its new Drug Trials Snapshots online database, he added. "The first step was really just putting all of that information out there."


For every new molecular entity approved since January 1, 2015 the Snapshots database-available via information about who participated in the clinical trials that supported the FDA approval of that drug, showing any differences in the benefits and side effects among sex, race, and age groups.


In a phone interview, Whyte elaborated on why the FDA created the online database and what it means for the future of drug development.


1 How did the creation of this database come about?

"In July 2012 President Obama signed the FDA Safety and Innovation Act that required the FDA report to Congress by 2013 on the diversity of participants in clinical trials and the extent to which safety and effectiveness data is based on factors such as sex, age, race, and ethnicity.


"So there has been this effort and directive to be transparent in terms of demographic data in clinical trials. And really it was the vision of the FDA's Center for Drug Evaluation and Research, Dr. Janet Woodcock, to implement this Drug Trial Snapshots program, a place where anyone can go and find-in an easy-to-read and easy-to-analyze format-all of the participants in clinical trials, based and grouped by sex, race, and age. And anyone can notice any differences in safety and efficacy based on this demographic data."


2 Is that information all reported in clinical trials anyway? Was all of that information already publicly available?

"The information that's being captured in Snapshots general existed in different documents and databases that were available to the public, but it might have been hard to find.


"For instance, all of the Medical Officer Reviews for new molecular entities are on the [FDA] website, but those data might be in very lengthy documents. So now the Drug Trials Snapshot provides you that information in text and in pictorial format that may not have existed elsewhere."


3 How do you expect the database to be used? Will it change physicians' day-to-day practice in terms of what drugs they prescribe to patients?

"This [initiative] is about transparency. There have been a lot of advocacy groups that have said the number of women in all clinical trials should be 50 percent, or that the number of African Americans should be proportionate to prevalence of the disease in the population. What is the right number of people in clinical trials to make statements about safety and efficacy based on sex, race, and age? The first step is really putting all of that information out there.


"You're asking-should we change our actions because there aren't enough Asians enrolled in a trial for breast cancer or thyroid cancer? We're not saying that. We're saying here is one more piece of information that you want to consider. This information is intended to spur the debate and the discussion about what is the right number of people.


"And we know we likely do need to enroll more women and more African Americans in clinical trials. But, what we're really interested in right now is to what endpoint? How do we know we've reached the right number?


"We're saying let's continue to study it to find out what is the right number. And in the meantime physicians and patients should look at this information and take it in the broader context of does it matter if only two percent of a trial's participants were African Americans. It's not a simple answer."


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