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The Underlying Condition: Increasing Diversity in Clinical Trials The Underlying Condition: Increasing Diversity in Clinical Trials

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The Underlying Condition: Increasing Diversity in Clinical Trials

Opinion: African-Americans, at 12 percent of the population, comprise only 5 percent of clinical-trial participants; the numbers for Hispanics are 16 percent and 1 percent. It's time for that inequity to change, PhRMA's CEO says.


(Photo courtesy of PhRMA)

When a patient picks up her prescription for rheumatoid arthritis, she knows it will enable her to hold her grandson with less pain. The heart-disease survivor takes his statin to avoid bypass surgery that could significantly impact his quality of life. Medical innovations have the power to change lives, as these examples demonstrate.

But these breakthroughs don't just happen. 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.


Studies have shown that genetic makeup can impact how individuals respond to medicines, so clinical testing of the effectiveness of potential new treatments should accurately reflect the patient population that will eventually take them if successfully developed. Currently, this is not always the case.

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.

Barriers to increasing diversity in clinical trials are extensive and varied, ranging from socioeconomic and worries among patients, to limited physician engagement. But despite these challenges, there is a significant opportunity to reach underrepresented groups with information about clinical trials. For example, a July 2013 survey by Research!America found that African-Americans, Asian-Americans, and Hispanics admire clinical trials volunteers more than Caucasians do and are more likely to volunteer for a clinical trial to help improve the health of others.


John J. Castellani is president and CEO of the Pharmaceutical Research and Manufacturers of America, which represents the country's leading biopharmaceutical research and biotechnology companies. (Courtesy photo)

Inclusion of participants with diverse ethnic and racial backgrounds can further research and help find better ways to fight diseases that disproportionately impact these populations. 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 in clinical trials in underrepresented populations.

That's why the Pharmaceutical Research and Manufacturers of America, known as PhRMA, is collaborating with the National Minority Quality Forum to launch a campaign to help increase awareness and participation in clinical trials among a diverse patient population. The initiative, launching in spring 2014, 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 patient--and their communities--from participating in clinical research.

Ensuring that underrepresented populations are included in clinical trials starts with a conversation. If we can encourage patients to visit the campaign website and use the information to begin a dialogue with their physicians about whether a clinical trial is right for them, we've taken one major step forward.


Increasing diversity in clinical trials won't make health disparities disappear, but it can help make a positive impact on the health of patients today and in the future.


The Next America welcomes op-ed pieces that explore the political, economic, and social impacts of the profound racial and cultural changes facing our nation. Email us. Please follow us onTwitter and Facebook.

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