Erica Prowisor, Global Head, Patient Recruitment & Retention
Decentralized clinical trials and a more patient-centric approach can make trials more appealing to all demographics
In 2001, the U.S. National Institute of Health (NIH) mandated that women and members of minority groups must be included in all NIH-funded clinical research, unless developers could make a compelling rationale otherwise. It was a foundational moment in clinical research, requiring the biopharmaceutical industry to acknowledge that diverse studies deliver safer and more effective new drugs.
20 years later, sponsors are still struggling to recruit diverse populations in a truly representative way based on therapeutic incidence levels. Among new molecular entities and biologics approved in 2020, just 11 percent of participants were Hispanic, eight percent were Black, and only six percent were Asian.
Sponsors have discovered that it is not easy to assemble a perfectly diverse patient population that also meets all inclusion/exclusion criteria. Facing the simultaneous pressure to lower costs and accelerate timelines, diversity goals can often slide down the priority list.
However, the growing adoption of decentralized clinical trials (DCTs) may now help make recruiting diverse, representative groups of participants more achievable – without adding significant time and cost to the trial.