This article by Ambra Health CEO, Morris Panner, was originally published in Forbes on October 15, 2019.
Rigorous clinical trials are key to ensuring that newly developed drugs and treatments are both safe and effective for patients. Success in trials gives researchers, regulatory bodies, and patients reason to believe that a drug or therapy will go on to help the general population with similar results.
But what if the clinical trials aren’t actually reflective of the general population? An unfortunate reality of clinical trials is that there is often a worrying lack of diversity among those participating.
“Most clinical research includes participants who are overwhelmingly white, non-Hispanic, and, until recently, male,” reports STAT. “For the most part, current medical therapies, as well as most of those in development, have been tested inadequately — or not at all — in women, children, older adults, individuals with multiple chronic conditions, low-income individuals, and racially and ethnically diverse populations.”
Although the general public may not be aware of the extent of the problem, this disturbing underrepresentation is well-known in the research community, which has been trying for some time to address the issue.
The Food and Drug Administration Safety and Innovation Act, for instance, directs the FDA to consider the representation of demographic subgroups in applications for medical products. But that guidance is not necessarily leading to sufficient results.
Why The Lack Of Representation?
There was a time when the lack of diversity in trial participants may have been due more to biases or indifference on the part of the researchers. But if the scientific community is now cognizant of the need for diversity and is actively seeking it, why is there still such poor representation of so many different subgroups in clinical trials?
As biochemist Chelsea Weidman Burke points out in BioSpace, factors like logistical challenges, financial burdens and distrust account for much of the participation gap among minorities today. Participating in a trial, which may require traveling a significant distance, can be logistically difficult if the potential participant is unable to get off of work, can’t find suitable childcare or doesn’t have access to a vehicle. And solutions to these problems, like paying for childcare or renting a car, may be financially unfeasible.
Among some communities, there is a well-founded distrust of scientific experimentation due to horrible deceptions like the decades-long Tuskegee syphilis experiment, in which black men were intentionally denied proper treatment or a contraceptive study in which poor Mexican-American women were unknowingly given a placebo instead of birth control.
This history of exploitation and carelessness — often directed at minorities, the poor or women — causes skepticism among many potential trial participants.
What Can Be Done To Increase Diversity Among Trial Participants?
Recruiting more diverse populations for clinical trials will require overcoming some of the logistical and financial challenges, as well as building trust. A few strategies that researchers might consider employing to engage a wider array of participants include:
• Make it easier for participants to do parts of the study remotely: Advances in wearable technology make it possible for medical professionals to gather some health data and information remotely, so designing studies that utilize this kind of technology could relieve some of the logistical burdens.
• Use clinical trial investigators from diverse backgrounds: In a panel discussion at this year’s BIO Conference, panelists felt that one way of dealing with the trust problem is to make sure that the clinical trial investigators themselves reflect a range of backgrounds.
• Work with patient advocacy organizations: PharmaTimes suggests collaborating with organizations (e.g., European Patients’ Academy, the ECRAN Project) that are already dedicated to building relationships with patients and their allies can help bring more awareness to clinical research.
• Engage clinicians and physicians from the community to raise awareness: As Clinical Research Pathways attests, patients from minority communities are more likely to enroll when they learn about studies from doctors in their own communities.
• Pharmaceutical companies can develop programs to address the issue: Eli Lilly & Company has created its own clinical trial diversity strategy to increase the ethnic and racial diversity of its U.S. clinical trials.
• Appeal to people’s desire to help others: In PharmaVoice, Denise Myshko reports on a study that suggests a good method for attracting participants is by appealing to their altruism. “African American and Hispanic patients, in particular, consider the opportunity to improve the lives of others when evaluating a trial,” writes Myshko.
• Drug regulators could make more stringent requirements: The editors of Scientific American believe that regulators like the FDA should create and enforce tougher rules, suggesting that, “For a drug to be approved for market, the patient panels of its clinical trials should closely resemble the makeup of the patient populations who will actually use the candidate medicine.”
Everyone Benefits When We Embrace Diversity In Studies
Fixing the diversity problem in clinical trial enrollment could have a broad range of benefits. Burke explains in the aforementioned BioSpace article that the advantages would include underserved communities getting better access to novel therapies, an improved understanding of the disease biology in various races and greater drug efficacy across different populations.
Though it may be challenging to balance costs with the desire to enroll truly representative patient populations, a priority must be put on bringing diversity to clinical trials. In the long run, it will result in drugs and treatments that are safer and more effective for everyone.