-By Howard Chipman, MD, IMA Principal Investigator, St. Petersburg, Florida
There has been considerable discussion about “diversity in clinical trials” so I thought I would explore these concepts and think about what that really means. When the medical community investigates a new drug, we want to know the safety and effectiveness profile of that drug for the population that will be using it.
The FDA has issued guidance that promotes the inclusion of diverse populations in clinical trials to better understand the risk and benefits across all groups. The traits of these groups can include gender, race, ethnicity, age and location of residency.
We should consider more than that to ensure true diversity in clinical research. Non-demographic traits include patients with organ dysfunction, co-morbidities, disabilities, weight extremes and diseases of low prevalence.
Location. Location. Location.
Since the diversity of study participants often reflect the demographics of the study location, having locations in different socioeconomic and ethnic areas could help generate a more representative population.
What is unknown is the impact of those differences on these various groups and if they are significant for that particular new drug. Another concern is the possible increase in the size and complexity of trials if different subgroups are identified.
Therefore, it should be a priority to increase the diversity of study participants in clinical trials so that trials approximate the population to be treated, leading to more refined and improved FDA recommendations. Other approaches to consider include:
- Broadening eligibility criteria
- Increasing flexibility of visit windows
- Making the process more convenient for participants
- Offering “virtual” visits
Finding the right study site
While many of these changes need to be made by the study designer, study sites can prioritize their efforts to recruit from a diverse population by trying to obtain a representative sampling.
The IMA Group has a large footprint of offices, both in urban and rural areas, that see a significant volume of diverse individuals on a weekly basis. This allows us to reach clinical trial participants from every background, making sure that clinical trials are an available choice to everyone, everywhere, and enroll enough that mimic the population demographics.
IMA’s large geographic footprint allows an expanded reach to access these diverse populations. This reach fosters a greater likelihood of achieving a more robust diversity among the clinical study participants and thus, helps to ensure better outcomes from the study.