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Diversity in Clinical Trials: Why It's Important
By Tina Pavane
Before a new medicine, vaccine, medical device, or other medical therapy is available for doctors to prescribe to treat a disease or its symptoms or help prevent a health problem, it must be thoroughly tested in humans in studies called clinical trials. Data from clinical trials on a treatment’s safety and efficacy is required as a condition of approval by regulatory authorities such as the U.S. Food and Drug Administration. These clinical data provide insights for prescribers about how people are likely respond to medicines and, therefore, how the medicines may best be used.
Differences between people can often lead to different responses to the same medication. Age, genetics, gender, weight, ethnic origin, even geographic location – all of these may play a role in how treatment may work or how safe it may be. For instance, African Americans sometimes need a different dosage -- or a different drug altogether -- for certain asthma, blood pressure, and heart conditions than white, Asian, or Hispanic patients with the same diagnoses. For this reason, the diversity in clinical trial populations can be critical to public health and well-being through increased representation of the populations who experience a condition.1
There was a time when drug study subjects were predominantly white males.2 This left a lot of unanswered questions about the safety and efficacy of these medications in women, children, and people of other ethnic or racial backgrounds. In an effort to address the lack of adequate diversity in clinical trials, the National Institutes of Health (NIH) adopted a policy in 1993 mandating all federal grants for clinical research to include women and minorities. And the FDA has instituted policies to better understand the barriers for, and increase participation among, more diverse participants.
In 2014, the FDA launched a website called Drug Trials Snapshots to provide the public with information about the demographic composition of the data collected in clinical trials of newly approved medications. Anyone can look up the name of a recently approved drug to see facts about the population enrolled in the studies that led to the drug’s approval. To improve transparency in the drug development process, the FDA Drug Trials Snapshot program also issues a summary report. The 2015-2016 summary report showed African Americans were represented at a rate of 5 percent in 2015 and 7 percent in 2016. While this represents a slight increase in African American participants, under-representation of African Americans and other non-white ethnic populations in clinical research continues to be a problem.3
What are the reasons for this?
Recruiting study participants is notoriously difficult across all populations, and many issues and questions are universal, from scheduling, travel and compensation to questions about potential risks and benefits.4 5 6
But, on top of these issues, people who are underrepresented in health care generally are likely to be underrepresented in clinical research. The barriers may be economic, linguistic, cultural, religious, or even physical (such as a lack of access to a nearby healthcare center). Many study sponsors recruit patients from large academic medical centers, where some patient populations are represented disproportionate to others.
Physician referrals are also vital to clinical trial recruitment, but some physicians are reluctant to refer their patients if it means the patients will be receiving care at a different practice.
What can be done to increase diversity in clinical trials?
By taking a holistic view of both patient and public health needs, doctors can be integral to improvements in diversification of clinical trial research. Patients would also benefit from more education on clinical trials. Trial sponsors, including Pfizer, have been taking new approaches to getting the word out — such as outreach and education programs in churches, schools, town hall meetings, and community centers — to help bring better awareness of clinical trials to all communities. At Pfizer, we have also incorporated several innovative programs -- including creation of a real-time dashboard for recruitment tracking, new investigator training programs, and a collaborator network -- to help establish diversity as a key scientific variable across our research portfolio.
What can the medical community do to make sure all ethnic groups are properly represented? Doctors can talk to their patients about clinical trials and may also want to look into becoming trial investigators themselves.
What can you do to make sure that patients like you are properly represented in medical research? Ask your doctor about clinical trial opportunities.
To learn more about clinical trials, visit the Pfizer Clinical Trial Center.
1FDA Drug Trials Snapshots and Diversity When Testing New Drugs Web. 15 Feb. 2018.
2 Dresser R, “Wanted Single, White Male for Medical Research” Hastings Center Report, 22: 24–29
3 Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. Oh SS, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, et al. PLoS Med 12(12): e1001918. (2015)
4 Rivers, Desiree et al. “A systematic review of the factors influencing African Americans' participation in cancer clinical trials.”Contemporary Clinical Trials, Volume 35 , Issue 2 , 13 – 32 Web. 15 Feb. 2018.
5 Sheba George, Nelida Duran, Keith Norris, “A Systematic Review of Barriers and Facilitators to Minority Research Participation Among African Americans, Latinos, Asian Americans, and Pacific Islanders”, American Journal of Public Health 104, no. 2 (February 1, 2014): pp. e16-e31 Web. 15 Feb. 2018
6 Durant, Raegan W. et al. “Perspectives on Barriers and Facilitators to Minority Recruitment for Clinical Trials among Cancer Center Leaders, Investigators, Research Staff and Referring Clinicians.” Cancer 120.0 7 (2014): 1097–1105. PMC. Web. 15 Feb. 2018.