Participation in Clinical Trials Critical to Development of New Medicines for Patients

Inclusion of Diverse Patient Populations Necessary to Address Health Disparities

02.26.14 | By Stephanie Fischer

Developing new medicines is a lengthy and complex process, relying heavily on volunteer participation to evaluate potential therapies for safety and effectiveness in clinical trials. Without the patients who volunteer to participate in clinical research, the development of new treatments would not be possible.

Challenges in Patient Recruitment

The Courier-Post is the latest to report the difficulty in recruiting patients for clinical trials, despite vigorous safeguards and the opportunity to help advance science.  Delays in recruitment can mean delays in the approval of potential new medicines for the patients who may benefit from them.

While the recruitment of patients for clinical trials is challenging, it is even more so among groups such as African Americans, Asian Americans and Hispanics which have been historically underrepresented in clinical trials.  The FDA reports that even though African Americans are 12 percent of the U.S. population, they make up only 5 percent of clinical trial participants. Hispanics represent 16 percent of the U.S. population, but only 1 percent of clinical trial participants.

Gary Puckrein, President and CEO of the National Minority Quality Forum (NMQF), included even more chilling statistics in a blog post on health disparities and African American History Month.  According to Dr. Puckrein, “One of the great challenges for those working to eliminate health disparities in minority communities is their underrepresentation in clinical trials.”

Diverse Patient Population Critical in Clinical Trials

As PhRMA President and CEO John Castellani noted in a recent guest opinion for the National Journal, inclusion of participants with diverse ethnic and racial backgrounds in clinical trials can further research and help find better ways to fight diseases that disproportionately impact those populations.

This sentiment was echoed in a guest editorial in the Washington Post this weekend by David Satcher, honorary chairman of the African American Network Against Alzheimer’s and a former surgeon general of the U.S.  In his editorial, Dr. Satcher noted the critical importance of increasing African American enrollment in clinical trials for potential new treatments of diseases such as Alzheimer’s:

“Without higher levels of participation among African Americans, we will never unlock the root causes of the disparate impact of a disease such as Alzheimer’s. Every day that African Americans continue to live in fear of such trials is another day that we fall further behind in the fight against Alzheimer’s and other diseases…

Researchers believe it is possible to stop Alzheimer’s with investments in research equal to the size and scope of the disease. But funding can go only so far without a corresponding increase in patients willing to participate in innovative clinical trials. As one of the groups that has the most to gain from Alzheimer’s clinical trials, African Americans should lead by example. In doing so, we just might gain meaningful insight into the causes of the disparate impact of Alzheimer’s and help speed our pace to a cure.”

Changing the Status Quo

The biopharmaceutical industry has long made increasing diversity in clinical trials a priority, and individual companies have made substantial investments to improve clinical trial participation. However, we recognize that an industry-wide, collaborative effort is needed to increase participation of underrepresented populations in clinical trials.

Next month, PhRMA will join NMQF to launch a campaign to help increase awareness and participation in clinical trials among a diverse patient population. The initiative will include joint outreach efforts as well as support for the creation of online tools to empower individuals to learn more about clinical trials and the benefits to patients--and their communities--from participating in clinical research.

Please check back on March 12th to learn how you can join us in making a difference.


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