Did you know there is now a legal requirement for improving diversity in U.S. clinical trials?
According to a recent article by Jeannie Baumann on Bloomberglaw.com, part of a new Senate Bill includes the “Diverse Trials Act,” which requires diversity in clinical trials at the U.S. Food and Drug Administration (FDA).
The FDA has long worked to encourage diverse participation in clinical trials. People participating in clinical trials should represent the patients that will eventually use the medical products. Unfortunately, this is often not the case. Surveys show that people from racial and ethnic minorities and other diverse groups are underrepresented in clinical research.
Overcome Knowledge Gaps in Clinical Trials
The new bill, writes Baumann, aims to address decades of testing drugs primarily on White men. In recent years, White participation in clinical trials has ranged from 50%-90%. In contrast, Black or African American participation in clinical trials typically ranges from 5%-45%; Asian participation ranges from 0.75%-4%; and Hispanic or Latino participation ranges from 1%-2%. This has created gaps in knowledge on how drugs would work in a larger, more diverse population.
Baumann advises that drug and device companies should prepare “diversity action plans” to help them meet the new requirements for more diverse clinical trials, as stipulated under the 2023 spending bill.
The bill encourages research investigators to develop early strategies for reaching a broader, more diverse study population from the start as part of their clinical trial design. Having diversity built into the plan from the beginning helps to avoid failing the requirement or scrambling later in the trial process to try and comply.
For her article, Baumann interviewed bill sponsor Rep. Anna G. Eshoo (D-CA), who said, “This is the first time that there is a statutory requirement for diversity in clinical trials. The FDA has made efforts to encourage this since the 1980s, but it’s always been through voluntary guidance. This changes it.”
The draft guidance recommendations from the FDA include setting clinical trial enrollment goals based on the populations that are affected by a disease being studied in a clinical trial.
Several experts that Bauman interviewed for the article said that designing clinical trials should proceed with an understanding of their relevance, usefulness, and application at the end of the trial. They advised that moving forward, diversity action plans from companies and trial sponsors should effectively say, “Here’s who we want to reach and here’s our plan to reach them.”
Reach Broad, Diverse Study Populations
Clinical trial managers already find it challenging to recruit enough research volunteers. Bauman reports that more than 80% of clinical trials fail to enroll enough patients on time. Now Congress is asking them to enroll research volunteers with a focus on race and ethnicity, while also providing demographic information such as age, sex, geographic location, and socioeconomic status.
How can trial managers reach more diverse communities?
According to Donna M. O’Brien, a national adviser at Manatt Health, it is important to choose research sites that optimize enrollment, saying “If you want diverse populations, you have to go to the community.”
What if study volunteers could participate from home?
Decentralized clinical trials (DCTs) can be designed with remote enrollment and an option for remote specimen collection through sampling kits that are mailed to participants at home.
Study volunteers can use remote microsampling devices with easy-to-follow instructions & supplies in the kit boxes to self-collect blood samples.
They can mail their specimen samples to the research lab.
Follow-up visits can be virtual visits conducted online or via phone or video conference. The remote DCT approach removes the common barriers to clinical trial enrollment: travel, related costs, and inconvenience.