Clinical Trials Can Make Anyone a Hero
It started with a piece of paper I tore from an advertisement on a bulletin board at the National Institutes of Health: it was an ad for a clinical trial that needed participants. Like many young people working in labs there, I just wanted to make a little extra money, but it turned out to be much more–it made me an accidental hero and helped me save lives.
For the first study I spent two hours in an MRI machine watching videos, some funny, others scary, while researchers scanned me to determine which parts of my brain were most active when I expressed different emotions to what I was watching.
The next day, when I returned to the lab, a colleague showed me her arm that was wrapped in cellophane to protect the injection sites from doses of an investigational intradermal drug. She was enrolled in a study assessing a new, and potentially safer, method of administering an old drug.
At the time, neither of us thought about the profound impact of what we were doing, but as I pursued my career into the world of clinical research and medicine I realized the enormity of my participation. Without human clinical trials like those, researchers could never develop newer, safer, or more effective ways to treat disease–and save lives.
Respecting the volunteers
In addition, patient volunteers are often consulted on the design of a clinical trial, forming a “patient panel” of experts. Clinical research is conducted under international rules and regulations to protect the safety and wellbeing of trial participants, irrespective of where the trials are conducted.
Diversity in clinical trials
However, the third principle from the Belmont Report, “Justice”, has yet to be truly achieved. There is still a troubling lack of diversity among clinical trial participants with far too few people like me taking part. People of color and members of minority communities are underrepresented in research studies, many of which disproportionally affect those same communities.
We need to actively encourage more participation in trials by minorities, particularly women. The research community is actively reaching out to these groups to let them know how their participation could contribute to fight diseases that affect their communities, but those efforts must be intensified as most people don’t even know that they have the chance to be a hero.
Under-representation in research
A 2020 report from the United States Food and Drug Administration (FDA) estimates that globally, 76% of all clinical trial participants are white, while Asians represent 11% and black participants of African descent 7%.4 This skewed distribution fails to capture the diversity of human populations. The US FDA also reported5 that in 2019, 48 new medicines were approved thanks to 46,931 volunteer participants in clinical trials. Of those participants, 9% were Black or African American, and in oncology trials only 4% were Black or African Americans.5 Yet, this group represents 13.4% of the population.6
This has enormous implications, given the prevalence of aggressive cancers among African Americans. For example, lung cancer occurrence is 15% higher in black men compared to their white counterparts, and multiple myeloma is 2.5 to 3.5 times higher in black men and women under age 50.7 We also know that women and people of color may respond differently to the same medication due to genetic variances.8
Diversity in clinical trials can help save lives
Without broadly diverse participation in clinical trials, we are unlikely to understand the impact of race, ethnicity, and gender-related differences in how the human body responds to drugs–and those differences could save lives.
For example, drugs against enzymes called "tyrosine kinase inhibitors" can have a positive impact in Asian females with certain types of lung cancer. These drugs have led to a 26% reduction in premature death for Asian females, compared to about 16% for non-Asian males.9 That life-saving knowledge is thanks to the heroes who volunteered to participate in studies on those drugs.
The path to becoming a clinical trial hero
On International Clinical Trials Awareness Day, and every day, I hope you will connect with someone you know who has participated in research, ask them about their experience, and thank them for advancing medicine. I was fortunate: Working in a research laboratory setting, my opportunity was right in front of me on that bulletin board, but we can’t always rely on such happy accidents to bring the diverse participation that science and society so desperately need. We have to be actively engaged to meet that third goal of justice and ensure human clinical trials benefit everyone.
By Raolat Abdulai, Global Clinical Lead at Sanofi
- Al Idrus A (2020) 2021 forecast: Clinical trial diversity has long been a thorn in biopharma's side, but 2020 could turn things around. Fierce Biotech, published online 22 December. Accessed 28 April 2021 from https://www.fiercebiotech.com/biotech/clinical-trial-diversity-has-long-been-a-thorn-biopharma-s-side-but-2020-could-turn-things
- United States Department of Health, Education, and Welfare (1979) The Belmont Report. Accessed on 20 April 2021 at https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
- United States Centers for Disease Control. The Tuskegee Timeline. Last updated 2 March 2020; accessed 20 April 2021 at https://www.cdc.gov/tuskegee/timeline.htm
- United States Food and Drug Administration (2020) 2015-2019 Drug Trials Snapshots: Five-Year Summary and Analysis of Clinical Trial Participation and Demographics. Accessed on 19 May 2021 at https://www.fda.gov/media/143592/
- United States Food and Drug Administration (2020) 2019 Drug Trials Snapshots: Summary Report. Accessed on 20 April 2021 at https://www.fda.gov/media/135337/download
- United States Census Bureau (2020) Demographic Analysis. Accessed on 20 April 2021 at https://www.census.gov/programs-surveys/decennial-census/about/coverage-measurement/da.html
- DeSantis CE, Miller KD, Goding Sauer A, et al. (2019) CA: A Cancer Journal for Clinicians 69:211-233; doi: 10.3322/caac.21555
- Coakley M, Fadiran EO, Parrish LJ, et al. (2012) J Womens Health 21:713-716; doi: 10.1089/jwh.2012.3733
- Becker DJ, Wisnivesky JP, Grossbard ML, et al (2017) Clin Lung Ca 18 :e35-340 ; doi : doi.org/10.1016/j.cllc.2016.08.008.