Tammy Guld, Head, Central Clinical Planning and Solutions

Our Medicines, Our Patients, Our Responsibility

June 18, 2017 | By Tammy Guld, Head, Central Clinical Planning and Solutions

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any of the medicines on the market today are approved to treat people in countries around the world, regardless of gender or race.  However, a great number of these treatments aren’t necessarily studied in all populations that represent the true demographics of our diverse world. For example, in the U.S., African-Americans make up 12 percent of the population but represent only five percent of clinical trial participants.1 Hispanics comprise 16 percent of the population, but just one percent of clinical trial participants.2

Furthermore, some conditions such as heart disease or cancer affect certain groups in different ways, as can certain medicines.  For example, it has been shown that African-Americans have a less anti-hypertensive response to several classes of anti-hypertensive agents.

While challenges exist, I do believe as an industry we can, and must, take steps to improve the diversity in clinical trials by:

  1. Leveraging patient engagement techniques to understand barriers of clinical trial participation. Patient community and faith-based organizations can each provide a means to establish relationships with patients and caregivers and help reduce patient burden in clinical trial participation.3
  2. Increasing our efforts to better raise awareness of the availability of clinical trials, using not only traditional methods but also through digital and social media channels.
  3. And harnessing the power of analytics and real-world evidence to identify patients and potential new investigators within the community setting.

Working together as an industry dedicated to improving the lives of patients, we can improve the racial, ethnic and gender disparity in clinical trials, which I believe will ultimately make a difference in the lives of patients and, I hope, one day enable a more personalized approach to medicine.

References

  1. Multiple race. 2010 U.S. Census: Overview of Race and Hispanic Origin (Available at http://www.census.gov/prod/cen2010/briefs/c2010br-02.pdf). Accessed Feb 15, 2015
  2. FDA: Clinical Trials Shed Light on Minority Health (Available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm349063.htm). Accessed Feb 17, 2015
  3. Food and Drug Administration Good Review Practice: Clinical Review of Investigational New Drug Applications (Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM377108.pdf). Accessed Jan 28, 2015