How Can Clinical Trials be More Inclusive?
It’s universally understood that the biggest problem in clinical research is recruitment and retention — recruiting an adequate number of patients on time and keeping them engaged in the study to completion. It’s also true that pharmaceutical and biotech companies have always recruited well from white male Americans who have high socioeconomic status, excellent access to care, and are located in certain geographies. But trial recruitment from other groups within the U.S. is poor, and as we’ve discussed in our previous blog posts on the impact of underrepresentation and the challenges to creating diversity in clinical trials, the lack of diversity in clinical trials has profoundly impacted the health of underrepresented populations.
If sponsors engage with these underrepresented groups to create trials that work for them, they can open up access to new trial participants. And given the new law that recently passed (Public Law 117-328), pharmaceutical and biotech companies will soon be required to provide a diversity action plan documenting how they will recruit more diverse populations to their trials. Expanding diversity in trials is not just the right thing to do; it’s now becoming mandatory.
But how to successfully engage with patients from diverse populations? One of the keys is Patient Advocacy Groups (PAGs) that promote the needs and priorities of patients. These groups are usually major influencers in their communities and have built trust with patients. Working with a PAG to develop trial protocols, co-create materials, recruit patients into trials, and plan product launches gives pharmas and biotechs a bridge to the patients and to understanding their needs.
PAGs are already serving these diverse populations and are trusted sources of information. For example, in 2021, The Leukemia & Lymphoma Society, a strong PAG, gave a webinar in partnership with Native News Online about the importance of Native American representation in clinical trials. As we mentioned in the previous blog post, Native Americans have significant trust issues with clinical trial research, but a PAG working with diverse populations directly can help to assuage the concerns and get valuable information to them.
Another terrific example of PAG activities that benefit both patients and life sciences companies is the work of the PAG Breastcancer.org. This PAG recently published a special report entitled Increasing Racial Diversity in Breast Cancer Clinical Trials, which, in addition to discussing the problems created by a lack of diversity in trials, shares advice on how breast cancer patients can participate in clinical trials and personal stories from patients.
Many PAGs have clinical trial finders on their site, and will gladly advertise trials in their newsletter to their patient members. Companies can also leverage PAGs for Patient Advisory Boards, which we highly recommend for live interaction and engagement with patients and patient leaders. It’s important to give dedicated time and space to each underrepresented group and have more than one patient leader participating so that they can truly spark new ideas. It’s also ideal to have a moderator from that group, so that the person leading the discussion has a similar lived experience. This can also increase the comfort level of participants and ensure honest feedback.
If a trial requires in-person interactions, an approach that can help with recruitment and retention is to leverage community medical centers as research sites. Selecting sites for a trial that are in the communities where patients live and are already receiving care can provide more diverse representation.
Decentralized studies and PAGs can also help overcome geographic barriers. Patients can be recruited for a decentralized study through a PAG, ideal because it eliminates the problem of geography completely. One example is a program called Not One More Life. The program was started in Atlanta by a pediatric pulmonologist who was concerned about the asthma disparities he saw in communities of color. For twenty years, he has leveraged Black churches and schools to bring medical professionals to the community for screenings and education. Through this PAG program, a sponsor conducted a study on asthma symptom monitoring using a tablet device. The study, focused on Black patients, was fully decentralized, and the PAG and sponsor worked together to co-create marketing materials. They used community sites — churches and barber shops — for recruitment centers to activate and enroll these patients, which was very effective. Allergy & Asthma Network. The program was started in Atlanta by a pediatric pulmonologist who was concerned about the asthma disparities he saw in communities of color. For twenty years, he has leveraged Black churches and schools to bring medical professionals to the community for screenings and education. Through this PAG program, a sponsor conducted a study on asthma symptom monitoring using a tablet device. The study, focused on Black patients, was fully decentralized, and the PAG and sponsor worked together to co-create marketing materials. They used community sites — churches and barber shops — for recruitment centers to activate and enroll these patients, which was very effective.
When working with a PAG, strive to co-create with them, rather than just asking for feedback. Collaborate during protocol design, incorporate their input, and return to them for confirmation before submission to IRB. Ask, “Have we addressed your needs/concerns?” Show that you’ve listened and taken them seriously in order to build trust with that community.
If companies engage with PAGs early on in their process, involving them in trial design and patient recruitment, they will then have ambassadors for the product ready when it comes time to launch. Don’t wait until launch to decide that you want to reach patients from underrepresented groups. Instead, publish trial data that shows you had participants from those groups, and engage community influencers who can share your product with their communities. When two similar drugs come to market, one with PAG involvement and one without, the company that has worked with a PAG throughout the product development process will almost always have more success.
Apply these tools broadly, but make sure to treat each underrepresented group as unique. The reasons underrepresented groups don’t participate in clinical trials are very different. You need to understand these reasons, find out the specifics, and then address them accordingly. PAGs are an invaluable source of knowledge and access to patients who can provide the necessary insight.
Working with patients and patient leaders early and often can help life science companies to advance the mission of diversifying clinical trials and ultimately, bringing products to a wider, more diverse market successfully.
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