Report: Gaps exist between research volunteers and Parkinson's clinical studies
De-identified data in Fox Trial Finder could illuminate trends about how Parkinson's family history or connection, length of time since diagnosis, previous medical procedures and simple geography affect recruitment, helping studies connect with eligible volunteers and vice versa.
This data appears in a paper, authored by The Michael J. Fox Foundation for Parkinson's Research (MJFF), which highlights baseline findings from the first three years of operating Fox Trial Finder. These key findings point to insights for both patients and trial teams on aspects of life with Parkinson's that may affect research recruitment and participation. The MJFF analyzed data from registrants (26,231) and studies (329 at 627 sites) with a location in the U.S. as of July 2014.
"We know that people with Parkinson's and their loved ones want to engage in efforts toward the next generation of treatments," said Todd Sherer, Ph.D., CEO of MJFF. "Fox Trial Finder provides an accessible on-ramp to that participation and their vital partnership toward our shared goal of a world without this disease."
Fox Trial Finder aims to match volunteers to the right studies for them, increasing the flow of participants into studies that historically are delayed by snail's-pace recruitment, slowing research progress.
Of 19,243 registrants with Parkinson's, only 12% listed an immediate family history of the disease—not unexpected given that the vast majority of Parkinson's cases are idiopathic. In contrast, 49% of control registrants reported a familial connection. This finding highlights the motivating nature of a family connection for spouses, adult children and other caregivers who can play a key role in research as control volunteers.
Patients at every stage of disease can be invaluable participants in research. Most studies were recruiting for patients with a Hoehn & Yahr score (a measure of disease progression) of one or two, but even patients with the highest score of five were eligible for 66% of listed studies. Additionally, most studies did not specify length of time since diagnosis as a major eligibility factor. (The average time since diagnosis among registered patients was 5.7 years and average age at diagnosis was 58, with less than 5% reporting young-onset Parkinson's.)
While some patients may think such a procedure would exclude them from participating in studies, those who had undergone deep brain stimulation were eligible for 73% of studies.
Analysis also revealed a geographical imbalance of registrants and studies. Ranked by number of active Parkinson's clinical sites and registered volunteers, only half of the country's top 20 clinical regions also were in the top 20 for registration. Several cities with intensely concentrated research activity did not make it into the top 20 for registration. These include Portland, Ore.; Cleveland, Ohio; Boston, Mass.; and Birmingham, Ala. Such distribution makes the case for increased outreach to potential volunteers in hotbeds of research and for tele-research methods to involve willing participants in areas without recruiting studies.
Potential volunteers and study teams are both using the tool, and in fact many patients are Fox Trial Finder ambassadors, spreading the word about its utility.
Fox Trial Finder launched in April 2012 (following a beta release in July 2011). It has registered more than 40,000 potential research volunteers and lists more than 400 ongoing Parkinson's studies in its database. Utility of the tool continues to grow: Fox Trial Finder currently is available in five languages, and MJFF has conducted targeted outreach efforts in Australia, Austria, Canada, Germany, Ireland, Italy, Spain, the U.K., France and the U.S.