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THE IMPORTANCE OF DATA DIVERSITY IN CLINICAL RESEARCH STUDIES


by Alfonso Coro, MPH


White males have historically been the majority of participants in clinical research studies (The Atlantic, 2016). As new drugs with more complex and focused medical indications are being developed, clinical research studies need to strive to enroll more diverse populations (e.g., different races, ethnicities, genders, and ages) in order to attain a better understanding of drug safety and side effects.


By focusing on improving the way that clinical research studies are designed, how eligibility criteria are defined, and by creating more inclusive and diverse enrollment practices, researchers and pharmaceutical companies can recruit individuals with diverse backgrounds to participate, and thereby acquire more accurate and comprehensive data that can benefit more diverse populations overall.


Think about it: if research is only being conducted on white males, and the drugs are approved by the FDA and then marketed by the drug companies, we actually have people taking these drugs (people of color, women, etc.) who have not had the drug adequately tested for safety and efficacy. The way drugs are being developed and tested makes most medications an absolute wild card for non-white males to take.


Study Design: Historically, study design has been based on stringent criteria to try and maintain tight controls. Some ways that study designs can be more diverse in their data are:

  1. Looking at the way different drugs are metabolized in different populations

  2. Using expansion cohorts to assess for safe drug doses in populations with differences in systematic exposure to the study drug

  3. Using adaptive clinical trials,. This would allow for a more conservative approach at the beginning of a trial, but once interim safety data analyses are complete, the cohort can be expanded to more diverse populations in order to assess for differences in drug interactions.

Eligibility Criteria: Many people are excluded from participating in clinical trials without strong scientific evidence or clinical justification to do so (e.g., people living with HIV, people over the age of 65, people under the age of 18, individuals who have a high Body Mass Index). Including more complex and diverse participants would allow for richer data and better safety information about study drug effects on different populations.


Enrollment Practices: By making clinical research trial participation more accommodating to the participants, recruitment and enrollment sustainability can be achieved. A typical clinical trial requires a participant to often drive long distances and miss work because of the location of the clinics and the typical hours of operation. People of low socioeconomic status may not have access to reliable transportation or cannot afford to miss work or pay for gas. Using telemedicine technologies, bringing clinical trials to the participants’ homes, reducing clinic visits, conducting outreach events, and providing expanded access to study drug for individuals who may have no other options for treatment, can all help to boost enrollment and reduce attrition in clinical research trials, which would allow for more diverse data collection.


Going beyond the aforementioned suggestions from the FDA for clinical research trial diversity, it is good to point out that historically, many communities of color have a lack of trust in the government and medical field for justifiable reasons, especially when it comes to participating in clinical research studies (NYT, 2016). That is why engaging diverse communities to build trust and rapport, working with patient advocates, and understanding the apprehensions and doubts about research and our medical system are all extremely important components when it comes to acquiring diverse data from underrepresented and underserved populations.


Resources for Further Reading:

https://www.theatlantic.com/health/archive/2016/06/why-are-health-studies-so-white/487046/

https://www.fda.gov/media/127712/download

https://www.nytimes.com/2016/06/18/upshot/long-term-mistrust-from-tuskegee-experiment-a-study-seems-to-overstate-the-case.html

https://www.scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/

https://www.sciencedirect.com/science/article/pii/S0146280618301889

https://medcitynews.com/2019/07/as-precision-medicine-grows-so-does-the-importance-of-clinical-trial-diversity/?rf=1

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