New approach to improving clinical trial enrollment and diversity
Before new therapies can reach patients, they must be tested in clinical trials in representative populations to show that they work and are safe. Failure to enroll enough participants in trials can delay the arrival of new therapies in the clinic and inflate their eventual price tags. Failure to recruit diverse patients could diminish the relevance and generalizability of trial findings. For example, a drug that proves effective for White patients might not work as well in people of other races or ethnicities.
Despite the urgency to increase both the volume and diversity of clinical trial participants, the stats are not good.
A 2018 study showed that 55% of terminated studies in a clinical trials database closed due to under-enrollment. In a 2020 U.S. survey, only 9% of respondents reported being invited to participate in a trial, and 41% acknowledged not knowing anything about clinical trials.
The numbers are no better when it comes to diversity. According to a 2011 Food and Drug Administration white paper, African Americans make up 12% of the U.S. population but only 5% of clinical trial participants. Hispanic people make up 16% of the population but only 1% of clinical trial participants.
The ultimate fix is, of course, to increase the number of clinical trial participants, especially diverse ones. However, community members can only choose to participate in clinical trials if they are aware of their existence. Some may hear about them from their doctors or see flyers or commercials. But many people remain unaware and therefore are unable to participate.
An innovative approach
The South Carolina Clinical & Translational Research (SCTR) Institute’s patient outreach recruitment (POR) team and its partners are trying a new approach at the Medical University of South Carolina (MUSC) – making patients eligible, by default, to learn of clinical trials in which they could participate. However, they are also offering them ways to opt out of being contacted about research opportunities. The team describes this new approach and its implementation in a recent article in the Journal of Clinical and Translational Science (JCTS). This is a departure from MUSC’s previous opt-in model requiring patients to indicate in the patient portal that they want to receive research-related contact.
“We learned from many of our patients that they wanted to have greater opportunity to participate in research, but they had no knowledge of those opportunities,” said SCTR co-director Patrick Flume, M.D., who is also the associate vice president of clinical research at MUSC and senior author of the JCTS article.
“We sought to address this request to learn about and participate in research opportunities, while being respectful of the wishes of those patients who would prefer not to be contacted,” he said.
Once aware of a trial, patients can make an informed choice about whether to participate, said Tara Pittman, recruitment manager at SCTR’s SUCCESS Center and lead author of the article.
“We believe that the opt-out approach really grants people the autonomy to choose whether they want to be engaged in research,” said Pittman. “They can only have that choice if they know of that choice and that opportunity.”
Since this new approach essentially put patients throughout the MUSC Health System into the pool of research participants, it dramatically increased the number of potential participants – from just over 51,000 to 1.7 million. The approach also ensured that the participant pool better reflected the demographics of the community. The acquisition of new regional hospitals in rural, underserved regions of the state further diversified the clinical participant pool.