Bolstering Enrollment in Parkinson’s Trials: Patient Support Groups

Novel treatments, accurate biomarkers and efficient diagnostic tests are direly needed in the fight against Parkinson’s Disease (PD), the second leading neurodegenerative disease in the world. One major avenue to support biomedical discoveries in the PD realm, paving the path to reach patients, is to bolster PD clinical research trials, yet only 5% of Parkinson’s patients join a clinical trial currently.

Challenges in clinical trial recruitment are particularly prevalent in PD studies of disease modification, where the population of interest is difficult to find and study design is more complex. In fact, a recent PD clinical study showed that 55.6% of sites fell below projected recruitment goals.

A major concern in the latter study was that gaps in patient knowledge around the availability of clinical research and the benefits of research participation constituted a significant barrier to recruitment. This confirmed a previous observation in a 2001 survey by Harris Interactive, which found that a whopping 85% of patients were unaware that participation in a clinical trial was an option at the time of diagnosis, and that 75% of these patients would have been willing to enroll had they known it was a possibility.

Thus, involvement of support groups that leverage their unique capabilities to engage with communities and raise awareness is a key and central avenue to addressing this barrier. Indeed, Biorasi often employs this strategy to boost recruitment in our PD studies and to enable its teams to connect with a more diverse patient population.

Since the leaders and organizers of these support groups are new contacts or ones who a researcher may not interact with regularly, this outreach may require some extra work to select the right support groups for any PD study. The framework for interacting with PD support groups is best laid out in the Michael J. Fox Foundation’s “Clinical Trials Recruitment Best Practices Manual”.

Many of the national stakeholder groups exhibit certain unique capabilities that a researcher should take into consideration when aligning with the study requirements, recruitment needs, budget, and timelines. For example, the Parkinson Disease Foundation (PDF) maximizes peer to peer engagement via the PAIR program and local events such as the Brain and Health Fair and the Unity Walk; The National Parkinson’s Foundation (NPF) harnesses the power of social media through webinars and press releases; The Michael J. Fox Foundation (MJFF) leverages technology such as Fox Trial Finder to connect volunteers to trial teams; and The Muhammad Ali Foundation focuses on increased participation of historically underrepresented minority populations via community engagement, translation of materials, and outreach via the “Southwestern Parkinson’s Newsletter”. In addition, the use of localized, grassroots events and social media activities, combined with a proactive approach to recruitment, helps to engage and raise awareness for a broader swath of the population than would have been possible by clinical trial sites alone. Initiating contact with support groups can be done via a variety of venues. The MJFF manual presents itself as a great resource in that matter, as well. As it turns out, support groups are always looking for speakers, newsletter content, information/handouts, etc. Hence, one could fill those needs by offering to speak at their meeting, providing an article about the study, as well as recruitment materials. Indeed, one can cast a wide net for support group outreach. Depending on location, patients may be willing to travel up to 5 hours to get to a study site. For support groups that one cannot attend in person, it is always possible to send packets of recruitment materials with a cover letter and talking points for the leader to use when they present a study. Moreover, the manual encourages researchers, if they are looking for newly diagnosed patients and worry that they won’t be in the support group, to still reach out as someone who has just been diagnosed is likely to connect with someone who has PD that may be in the room at the support group.

In a recently mentioned PD study, harnessing the power of patient support groups significantly boosted recruitment and helped meet enrollment goals. Although forging and maintaining connections with those groups is a diligent and time-consuming practice for CROs, this approach has again and again proven its worth in terms of support to meet recruitment goals, trial success and eventually PD patient benefit.