Michael J. Fox Foundation Offers Educational Tool to Boost Participation in Parkinson’s Clinical Studies

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has launched an educational suite called “Parkinson’s Clinical Trial Companion” to increase patients’ participation in clinical trials.

The new resource educates patients and families about the benefits of participating in research, and provides teams conducting clinical trials with high-quality tools to recruit and retain volunteers.

Lack of volunteers greatly limits clinical research, causing 85 percent of trials to face delays and 30 percent to never begin. Results from a 2014 survey of more than 1,500 Parkinson’s patients, caregivers and physicians showed that 81 percent of patients who see a movement disorder specialist would be likely or very likely to participate in a trial if there was one in their area.

“Patient participation in research is key to driving scientific breakthroughs and cures. Yet clinical trials routinely encounter roadblocks that slow progress, including a chronic shortage of volunteers,” Todd Sherer, PhD, CEO at MJFF, said in a press release.

“We believe it is our obligation to foster partnerships among patients, families and researchers to bring more people with the disease into Parkinson’s clinical trials by educating potential study participants and supporting trial teams’ recruitment efforts,” he added.

MJFF’s Parkinson’s Clinical Trial Companion is designed to holistically address challenges in clinical trial recruitment. The suite is partly educational for those with Parkinson’s disease and partly a resource for clinical trial teams, and is composed of two packs.

In the “Trial Participant Pack“ patients and families will have a 52-page guide called “Navigating Clinical Trials” to explain diverse aspects of clinical research, including trials’ phases, informed consent processes, genetic testing, studies on every disease stage, international research opportunities, as well as the role of family and caregivers to support participation.

The guide will be available in Spanish, French, German and Italian to serve as a global resource. It also contains personal stories and videos featuring patients, care partners and clinical trials’ scientists.

In the “Trial Resource Pack” research teams can find a best practices manual, which centers on participant experience to optimize clinical trial design. The manual builds on new technologies that recently have showed success in increasing patient awareness and willingness to participate in clinical trials, while also facilitating data collection.

The guide also has a downloadable toolkit containing 34 templates that can be customized to better present a study to the Parkinson’s community and successfully recruit and retain patients.

Connecting participants

“The task of recruiting and retaining study participants need not be overwhelming,” said Tanya Simuni, MD, chief of Movement Disorders in the Department of Neurology at Northwestern University Feinberg School of Medicine.

“Parkinson’s Clinical Trial Companion offers trial teams a step-by-step, patient-centered approach to support progress in Parkinson’s research through practical resources designed to help streamline participant enrollment and ensure that volunteers continue through to the trial’s end,” she said.

The tool adds to MJFF’s online platform Fox Trial Finder, launched in 2012, which connects Parkinson’s patients and other potential volunteers with clinical studies in their area, to ultimately boost trial enrollment process and increase patients’ involvement in the discovery of new treatments.

MJFF often hosts and participates in clinical trial fairs and other Parkinson’s events across the U.S. The foundation also is the sponsor of the online clinical study Fox Insight, and the Parkinson’s Progression Markers Initiative, which aims to spot and validate biomarkers of the disease.

The new resource was funded by Acadia Pharmaceuticals, Adamas Pharmaceuticals, Cellular Dynamics International, Lundbeck, Pfizer, Prothena and Sunovion Pharmaceuticals, all members of MJFF’s 2017 Parkinson’s Disease Education Consortium.

“I am grateful to the researchers, neurologists and everyone in the Parkinson’s community for their contributions and dedication to the pursuit of a cure,” said Steve DeWitte, a member of the foundation’s Patient Council. “But there’s one thing patients must do ourselves: participate in clinical trials. By making the decision to get involved in research, we can help overcome a major roadblock on the path to a cure.”

As part of its ongoing mission to help find new therapies for Parkinson’s, MJFF recently announced a new $7 million funding program to support research and speed development of new therapeutic targets and biomarkers. Pre-proposals will be accepted through May. Funding is anticipated by November 2018.

Among the areas covered by the new funding are nonpharmacological interventions for gait and balance impairments, projects on brain circuitry and clinical experience of gait and balance problems, and research on the protein alpha-synuclein, the major component of Parkinson’s hallmark protein clumps, called Lewy bodies.