Diversity in Clinical Trials

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Clinical trials are the primary research method in which new drugs are tested to evaluate their effectiveness.  The Food and Drug Administration (FDA), the U.S. authority that regulates clinical trials and bringing new drugs to the market, must balance between introducing life-saving treatments to patients who need them as soon as possible and ensuring that these drugs have been thoroughly tested and are safe for the general population. A drug must undergo extensive testing in clinical trials before it gets approved as both safe and effective. Clinical trials document how well new treatments work on individuals and the likelihood of the occurrence of severe side effects.

Clinical trial participants should approximately represent the composition of those patients whom the new treatments are intended to serve. However, often clinical trials fail to achieve adequate representation for minorities. For instance, African Americans represent 12%, and Hispanics represent 16% of the U.S. population but are only represented as 5% and 1% of clinical trial participants, respectively.[i] Caucasians are still overly represented in clinical trials.[ii] The FDA and National Institute of Health (NIH) should address this situation.

Genetic variations in racial and ethnic groups may cause different reactions to treatments. These variations could put people at risk, as certain treatment side effects affect various groups differently. Differences in individuals’ genomes can alter the effectiveness of drugs as genes affect how a drug is metabolized and how individuals respond to a medication.[iii] A recent study on anti-HIV medications revealed that genetic differences could render medicines utterly ineffective in some patients.[iv] These genetic differences can differ between individuals of different races and ethnicities. Thus, it makes difficult for the physician to determine if the drug will be effective for their minority patients if minorities are not tested thoroughly in clinical trials.

One of the causes of the lack of minority representation in clinical trials is mistrust of the established medical system, and this is most notably seen with the infamous Tuskegee Syphilis Study in which physicians knowingly withheld treatment for African Americans infected with syphilis.[v] Physicians’ unconscious biases may play a role in the low amount of minority participants in trials. Physicians combine prior experiences treating patients of similar race, age, gender, and socioeconomic status into a stereotype in how to manage their current patients.[vi] Physicians may be unconsciously, or even consciously, arbitrating which patients to recommend for clinical trials. A study determined that physicians believe African Americans are two-thirds as likely to adhere to a clinical trial regimen compared to their Caucasian counterparts.[vii] Also, minority patient populations have historically had inadequate access to healthcare. Minorities are less likely than Caucasians to have access to health insurance, a requirement for some Phase III clinical trials.

The minority under-representation in clinical trials should be appropriately addressed. The NIH Revitalization Act of 1993 by Congress meant to solve this problem by mandating women and minority representation in clinical trials, but the results have not been promising, as the proportion of minorities in clinical trials is still significantly lower than the percentage of minorities in the U.S.[viii] Thus, before different methods other than passing acts in Congress will be implemented, minorities will continue to be at risk with their treatments. It is up to the entire healthcare establishment, from physicians and hospital administrators to pharmaceutical entities to address the problem. Only by including a representative sample of patients, can we ensure the new novel drugs and treatment being developed are safe and effective for all.

To cut to the heart of the problem, healthcare organizations need to start thinking more strategically about the diverse patient populations they serve. As highlighted in previous blog posts, the U.S. patient base is undergoing dramatic demographic changes. The development of new drugs and treatments should not be based predominantly on just Caucasian patients. Healthcare entities at-large need to understand the changing marketplace and take a proactive, strategic approach to serving the healthcare consumers up today and tomorrow.

To further explore how to think more strategically about the diverse, 21st-st century marketplace, The Kaleidoscope Group, LLC is a full service, diversity and inclusion (D&I) consulting firm. We are committed to providing customized strategic solutions to address the specific needs of an organization’s culture. We pride ourselves in being Real People having Real Conversations about Real Issues to create Real Change.

Join us for our complimentary, 1-hour webinar on July 17th from 11 am to Noon CDT as we discuss Diversity Working:  Building Inclusive Healthcare companies. 

 

Joseph Gaspero is a Consultant with the Kaleidoscope Group. He is a diversity and inclusion expert with a specific focus on the healthcare industry. Joseph has extensive knowledge and expertise in areas such as diverse patient groups, diversity in healthcare organizations, employee and business resource groups, diversity in clinical trials, and shifting U.S. demographics. He also has extensive knowledge and expertise on the intersection of diversity and inclusion with financial performance and other key organizational metrics. Joseph is also the CEO and Co-Founder of the Center for Healthcare Innovation (CHI), an independent, non-profit research and educational institute dedicated to making healthcare more equitable for all patients. CHI’s mission is to bring together experts and ideas from all over the world to improve healthcare for everyone, regardless of socioeconomic status, gender, race, ethnicity, or other social determinants. Joseph’s leadership stems from a wide array of experiences, including founding and operating several non-profit and for-profit organizations, serving in the U.S. Air Force in support of 2 foreign wars. His skills include strategy, management, entrepreneurship, healthcare, clinical trials, diversity & inclusion, life sciences, research, marketing, and finance. Joseph has lived in six countries, traveled to over 30 more, and speaks three languages, which help him view diversity and inclusion through a global lens.

 

  1. “Clinical Trials: MedlinePlus.” S National Library of Medicine. U.S. National Library of Medicine, 21 July 2015. Web. 5 Aug. 2015.”U.S. Food and Drug Administration.”
  2. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. 18 Sept. 2014. Web. 4 Aug. 2015.
  3. “U.S. Food and Drug Administration.” Clinical Trials Shed Light on Minority Health. 1 Apr. 2015. Web. 4 Aug. 2015.
  4. Culp-Ressler, T. “There Are Too Many White People In Clinical Trials, And It’s A Bigger Problem Than You Think.” ThinkProgress RSS. 4 Apr. 2014. Web. 4 Aug. 2015.
  5. Bradford, L. DiAnne. “Race, Genetics, Metabolism: Drug Therapy and Clinical Trials – MIWatch.” Race, Genetics, Metabolism: Drug Therapy and Clinical Trials – MIWatch. MIWatch, 10 Apr. 2008. Web. 18 Aug. 2015.
  6. “New Evidence That Genetic Differences May Help Explain Inconsistent Effectiveness Of Anti-Hiv Drug.” John Hopkins Medicine. 15 July 2015. Web. 4 Aug. 2015.
  7. Corbie-Smith, G., Thomas, S.B., Williams, M.V., Moody-Ayers, S.(1999) Attitudes and beliefs of African Americans toward participation in medical research. Gen. Intern. Med.14, 537–546.
  8. Smedley, B.D., Stith, A.Y., Nelson, A.R., editors. ,Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington, DC: National Academy of Sciences; 2003.
  9. van Ryn, M., Burke, J.(2000) The effect of patient race and socio-economic status on physicians’ perceptions of patients. Sci. Med. 50, 813–828.
  10. Regenstein, M., Huang, J.Stresses to the Safety Net: The Public Hospital Perspective. Washington, DC: Kaiser Family Foundation; 2005.
  11. Chen, M.S., Lara, P.N., Dang, J.H. T., Paterniti, D.A. and Kelly, K. (2014) Twenty years post-NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual. Cancer 120, 1091–1096.