The Best Trials Are Diverse Trials
The diversity in clinical trials needs to reflect the diversity in the target population. Only then can we determine the safety and efficacy of drugs and medical products across all ages, races, ethnic groups, and genders that could benefit from the drug or product. With that acknowledgement, however, comes the hard reality that diversity is hard to achieve and requires both strategic know-how and expert execution to deliver.
The Call for Diversity
The call for diversity has been driven by the world’s highest healthcare and regulatory bodies. In the United States, for example, the National Institutes of Health (NIH) Revitalization Act of 1993 directed the NIH to develop guidelines ensuring that clinical research include women and minorities and analyze study results carefully. Additionally, in 2016, the Food and Drug Administration (FDA) issued guidance related to the collection of race and ethnicity data in clinical trials. This guidance encourages a standardized approach to collecting and reporting race and ethnicity data to facilitate analysis and comparisons. The FDA also voiced the expectation that trial participants reflect the demographics of the clinically relevant population for the drug or medical product being studied.
Yet, 20 years later, discussions about the lack of diversity in clinical trials are still occurring. For instance, in 2015, the FDA approval of a drug to treat multiple myeloma was based on a trial in which only 1.8% of the sample was Black, despite the fact that 20% of people affected by multiple myeloma are Black. The 2019 FDA Drug Trials Snapshots Summary Report indicates that, for all 48 drugs approved by the FDA in 2019, the samples were only 9% Black or African American, 9% Asian, and 18% Hispanic. And, most recently, coronavirus vaccine developers have publicly vowed that they will strive to include diverse populations in their studies.
Barriers to Diversity
There are many barriers to trial participation for minority populations. These include:
- Logistical issues. Clinical trial sites are frequently located in hard-to-reach neighborhoods in urban areas or miles away from rural locations, making it challenging for minority populations to participate.
- Financial issues. Lower socioeconomic populations, which can be disproportionately represented by minority groups, often cannot afford to take time off work or commute long distances to the site.
- Cultural issues. Language barriers, cultural reasons, and a lack of awareness and knowledge of clinical trials can prevent people from participating.
- Medical issues. Stringent inclusion criteria limit participants with multiple comorbid conditions, a situation that is more likely in minority populations (where conditions such as high blood pressure, diabetes, and heart disease are more prevalent).
- Marketing issues. Traditional recruitment methods such as blanket Google ads and billboards often do not target or attract participants from minority populations.
Strategies for Diversity
Organizations conducting clinical research must overcome these barriers and meet patients where they are during recruitment to ensure diversity in clinical studies. Multiple strategies can be employed effectively to accomplish this end. For example:
- Leveraging claims data to generate heat maps of patient clusters and using electronic health record (EHR) data to identify health care organizations with the target population can overcome logistical and financial barriers.
- Staffing sites with health professionals of the same ethnicity, language, or culture as the surrounding population can counteract cultural barriers.
- Considering the feasibility of protocol criteria and recruitment strategies can help make informed decisions about with whom, how, and when to conduct your trial.
- Employing outreach strategies that are relevant and specific to the intended audience (and in the appropriate language) can eliminate marketing barriers.
Diversity in clinical trials is essential – it is also possible. Download our infographic describing our patient recruitment strategies to learn how we can help ensure a diverse patient population for your trials.