Diversity In Clinical Trials: Ensuring Appropriate Representation

June 21, 2019

Hands Up

With an increasing focus on personalization of medicine in all aspects of patient care, it is more important than ever to ensure that the results of a clinical trial are applicable to the broader population and not just select subgroups.  Population subgroups may have varying responses with respect to safety and efficacy, and for it to be meaningful for the entire population, the observations of a trial must be applicable to a diverse group with representation from multiple socio-economic, gender, age, race and ethnicity subgroups. However even today majority of the studies do not reflect the diversity of our population, with particularly low participation observed in adults age 75 or older and those from specific race and ethnic groups.

Alarmingly, while it is known that certain populations have a higher risk of developing, or dying from, certain diseases, clinical trials being conducted in these areas fail to incorporate appropriate representation from the susceptible subgroups. For example, while African Americans represent 20% of the US population affected by multiple myeloma, on an average this subgroup constituted only 4.5% of the patient population recruited for trials that focused on this indication.

Recognizing the importance of having appropriate representation, sponsors, researchers, regulatory bodies, and other stakeholders have repeatedly advocated for greater diversity in trials. The US FDA states, “To make sure that the FDA has a full picture of the risk or benefit of a medical product, patients enrolled in a trial should be representative of the types of patients who are likely to use the medical product if it is approved or cleared by the FDA.” Yet diversity in clinical trials remains a challenge. To develop an effective solution, it is important to first identify and recognize the barriers that are contributing to the problem. Using an approach that included in-depth literature review, gap analysis and expert interviews, a study identified the following barriers influencing participation by minority patients in clinical trials:

  • Mistrust in research and the research community

  • Lack of comfort with the clinical trial process

  • Lack of information about clinical trials

  • Lack of awareness of the value and existence of clinical trials

  • Time and resource constraints such as financial burden and lack of transportation

These factors have been studied in depth by other researchers as well. Another study found that patients with annual household incomes below $50,000 had a 27% less likelihood of participating in clinical trials further supporting the findings around hesitation associated with time and resource constraints. An underlying theme that factors into multiple barriers listed above is one of lack of information and awareness. This underscores the importance of improving channels of communication and engagement across the board for those involved in clinical research.

The solution to increasing diversity in clinical trials requires an approach across multiple stakeholders including:

  • Being more inclusive of primary care doctors who are the trusted provider for the general population and are typically not engaged in the clinical research process

  • Improving channels of communication and quality of content made available to the general population with respect to clinical trials

  • Developing creative and technological solutions that increase the ease of participation e.g. promoting virtual collaborations and improving delivery of relevant content to targeted populations

  • Continuing advocacy and guidance by regulatory bodies such as the FDA

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