Kristin Mauri
Solution Services Director, Remarque Systems
As the interrelationship of race, socioeconomic status and healthcare outcomes has begun making international headlines, achieving clinical trial diversity has surfaced as a priority in successful trial conduct.
The fundamental premise of diversity in clinical trials seems obvious on the surface. If a prospective therapy, diagnostic, vaccine, or medical procedure is meant to be used on everyone suffering with a certain disease, then its safety and efficacy must be proven in a correspondingly diverse population.
Yet, historically, clinical trials have not employed that breadth of inclusion. Among the myriad reasons:
- Standardised eligibility criteria used as a template across trials may exclude certain populations from trials without strong clinical and scientific justification.
- Relying on a consistent group of lead investigators and sponsors that may inadvertently limit access to trial participation.
- Many minority groups have a deep mistrust of the healthcare system due to historical missteps.
Despite these challenges, experts agree that the pandemic could mark a turning point for diversity in clinical trials. Our trial participants deserve it; regulatory bodies are demanding it; technology is enabling it.
Searching for diversity in trials
In November 2020, the U.S. Food and Drug Administration published new recommendations that state broadening eligibility criteria and adopting more inclusive enrolment practices should improve study quality.
New metrics must be woven into studies from the very beginning, broadening eligibility criteria and targeting study sites in areas with diverse populations—even when that requires training new investigators.
Experts agree that the pandemic could mark a turning point for diversity in clinical trials.
Concurrently, trust must be rebuilt among potential trial participants; one way is through patient-centric groups that engage the stakeholder community, helping them understand that their trial participation advances the overall research into that particular disease.
Yet, no matter which strategies are employed, study personnel also need to understand and track how successful their efforts to diversify enrolment are—not just anecdotally but in real numbers. Technology can help.
Remarque’s Demographic Roll-up is a single screen technology which centralises up-to-the-minute reports. The team can program the desired levels of diversity, then assess their success in achieving those percentages at a glance.
Ensuring trials represent total population
As the crucial importance of diversity in clinical trial populations rises to the fore of public consciousness, the industry itself is taking a stand. Urged by the expectations of regulatory bodies and their own moral compasses, pharmaceutical companies are seeking ways to ensure that the population in their studies mirrors the entire population. With technology, they can measure and monitor their success.