Implementing diversity plans into clinical trials

Friends of Cancer Research recently hosted a virtual meeting which focused on enhancing diversity in clinical trials, emphasizing the implementation of diversity action plans. With key speakers Congresswoman Anna Eshoo and Dr. Namandjé Bumpus from the FDA, the group highlighted the importance of setting enrollment goals and strategies, as outlined in the Food and Drug Omnibus Reform Act (FedORA).

The discussion also covered the need for more inclusive clinical trials, addressing barriers, and leveraging real-world data and community engagement to achieve more representative enrollment targets.

I have summarized the key discussion points below and you can find the video of the discussion here.

• Importance of diversity in clinical trials - FDA data shows that for drugs approved in 2022 white patients comprised a majority of patients enrolled in clinical trials. Fixing this inequity is not only fair and just, it's good science. Diverse clinical trials ensure all Americans can be confident treatments being developed will work for them regardless of their background, their ethnicity, or their age.

• In the past, FDA have sought to provide diversity in clinical trials through voluntary measures. Last year however, legislation was passed that requires FDA to take action on this issue.

• The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires diversity action plans for pivotal clinical investigations which include enrollment goals based on what is known about the prevalence of the disease and demographics of the population. It should also include engagement plans for medical product marketing and a report on the progress of the plan annually.

• The research community should seek opportunities to reduce barriers for clinical trial participation including using digital health technologies to allow remote data collection and assessment, enabling decentralized clinical trials.

• In 2020, CFT guidance was issued on how to improve diversity in clinical trials. This was not just for ethnic minorities but also for age, gender and geography.

• For oncology trials, there is a collaboration with American Cancer Society to identify sources of data that can be used for benchmark setting. This also includes benchmarking for rare cancers, or small subsets of common cancers where it can be challenging to enroll enough patients.

• Using data from the census, the SEER cancer registry, and real -world data from sources such as medicare claims, EHR and other providers (Flatiron etc) can provide the information required about the population in order to generate these diversity plans.

• AI is likely to be instrumental in this space but they stressed that there should be rigorous testing of AI algorithms to eliminate bias.

• The importance of engaging with communities to promote trial participation was highlighted. One example was a project in Indiana that trained faith-based leaders using various platforms to change their attitudes towards participating in clinical trials. This project was instrumental in building trust and collaboration with diverse communities in the area.

• An Inclusive Research Site Alliance has been set up which includes six oncology centers and three Opthalmology centers that were built as a proof of concept for a ‘high touch’ model with the community to improve diversity. Data from this alliance was able to dispell the myth that being more inclusive slows down enrollment rates. In some cases it was faster due to engagement of the right physicians and sites.

• A discussion of the challenges faced in enhancing trial diversity highlighted the difficulty of medical professionals to easily find appropriate clinical trials for their patients. One initiative launched to aid in this is ‘Hope Pathways’ which is software allowing professionals to input details of the patient and identify clinical trials they are eligible for. This is expected to be rolled out at the national level.

• It was also stressed that some oncology trials have too much enrollment criteria which is over complicating the process. Being broader in these requirements will aid in diversity enrollment.

• Enrollment plans should also include how the trial will support individuals financially, eg transportation costs to avoid socio-economic discrimination.

• Wrap up- there is critical role for management of diversity in clinical trials towards achieving equitable healthcare outcomes.

#biopharma #inclusionmatters #clinicaltrials