The Food and Drug Administration (FDA), the key regulatory authority in bringing new drugs to the market, must balance between introducing life-saving treatments to people 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. These trials document how well the treatment works on individuals and also of the likelihood of the occurrence of severe side effects.1 The FDA has programs to accelerate the usually rigorous process needed to test drugs that are the first proven treatment of an ailment or have a significant advantage over already approved drugs.2
Often clinical trials fail to achieve adequate representation for minorities. 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.3 Caucasians are still overly represented in clinical trials.4 The FDA and National Institute of Health (NIH) must urgently address this situation.
Significant genetic variations in various ethnic groups may cause different reactions to certain treatments. This difference puts people at risk as certain treatments’ side effects affect various groups differently. Differences in individuals’ genetic codes can alter the effectiveness of drugs as genes affect how a drug is metabolized and how an individual responds to a drug.5 A recent study on anti-HIV drugs revealed that genetic differences could render drugs completely ineffective in patients.6 These genetic differences can differ between individuals of difference races and/or ethnicities.5 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 with that drug in the clinical trials.
One of the reasons as to why there is a lack of minority representation is mistrust of the established medical system. This is most notably seen with the infamous Tuskegee Syphilis Study in which physicians knowingly withheld treatment for African Americans infected with syphilis.7 Physicians’ bias also plays 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 treat their current patients.8 Physicians use this bias to determine 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.9 In addition, minority populations have historically had poor access to healthcare. Minorities are less likely than Caucasians to have access to health insurance, a requirement for some Phase III clinical trials. This lack of insurance restricts many minorities to only receive health care in emergency rooms and unable to participate in trials.10
These and other obstacles prevent accurate minority representation in clinical trials need to be addressed and solved. 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 are not promising as the proportion of minorities in clinical trials is still significantly lower than the proportion of minorities in the United States.11 Thus, before different methods other than passing acts in Congress will be implemented, minorities will continue to be at risk with their treatments.
- “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.”
- Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. 18 Sept. 2014. Web. 4 Aug. 2015.
- “U.S. Food and Drug Administration.” Clinical Trials Shed Light on Minority Health. 1 Apr. 2015. Web. 4 Aug. 2015.
- 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.
- 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.
- “New Evidence That Genetic Differences May Help Explain Inconsistent Effectiveness Of Anti-Hiv Drug.” John Hopkins Medicine. 15 July 2015. Web. 4 Aug. 2015.
- 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.
- 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.
- 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.
- Regenstein, M., Huang, J.Stresses to the Safety Net: The Public Hospital Perspective. Washington, DC: Kaiser Family Foundation; 2005.
- 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.