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Foundation Outlines Strategies for Improving Clinical Research Recruitment

NEW YORK - As medical researchers across disease states pursue better treatments, they all share one limiting factor. Estimates hold that 85 percent of all studies face delays and 30 percent never get off the ground due to a lack of clinical research volunteers. Slow patient enrollment diminishes the scientific power of studies, drives costs up and, most notably, delays improved therapies for patients.

Partnership of patients and scientists in clinical research -- not only implementation, but also design -- is vital to advancing understanding of disease and developing new therapies. However, engagement with and recruitment of study volunteers can be challenging. To shorten the gap between intention and actualization, The Michael J. Fox Foundation for Parkinson's Research (MJFF) has published a paper in this issue of Clinical Investigation on tactics to improve recruitment.

"There are a myriad of challenges preventing an individual from participating in a clinical study," says Sohini Chowdhury, MJFF vice president of research partnerships and first author on the paper. "However, there are strategic actions -- some simple and others more coordinated -- that study sponsors and research sites can take to mitigate those obstacles and make progress in our shared drug development goals."

The Foundation occupies a multitude of roles in the Parkinson's disease research environment: advising awardees on recruitment best practices, strategizing and implementing plans for its own sponsored studies, and communicating directly to patients through a multitude of platforms. Lessons learned from these activities spurred staff to author this perspective piece, which represents the collective Parkinson's experience, but is applicable across disease states.

Awareness building, education and actionable next steps can improve research participation, the paper states. Health care providers and disease advocacy organizations should integrate discussion of clinical research participation into standard communications with patients and their family members. Easily accessible education materials should include information on what it means to participate in research and what patient protections are in place, among other important background. Finally, an easy way to identify studies near one's home and to contact the research team can be the key to enrolling an interested patient.

The paper offers tactile suggestions for study leaders and sites as well:

  • Involve patients: Convene a recruitment committee of coordinators, investigators and patients to offer varied perspectives on messaging and platforms to use.
  • Devote money: Earmark funds for recruitment to invest in pilot strategies and support high-yield enrollment tactics more broadly.
  • Streamline communications: Create recruitment materials centrally in multisite studies and share with sites for cost and time efficiency.
  • Avoid obstacles: Brainstorm what "leaks" could discourage enrollment (e.g. transportation, lack of education, difficult procedures) before the study begins and address them.
  • Maximize reach: Take a multipronged approach to engage more potential volunteers.

The authors offer the Parkinson's Progression Markers Initiative (PPMI), a large-scale biomarkers study sponsored by the Foundation, as a case study. Between June 2010 and April 2013, the study enrolled 423 early-stage Parkinson's patients and 196 controls.

Additionally, the paper outlines Fox Trial Finder (, an online Parkinson's clinical study matching tool from MJFF. The tool has become a reference for neurologists treating Parkinson's patients, and the site contains a Clinical Trials 101 page with information on the types of studies, how they lead to new therapies, and volunteer rights and safety protections. Fox Trial Finder has amassed more than 27,000 volunteers (Parkinson's patients and controls) who have created a profile and are matched with studies in their area that they may be eligible for.

"Recruitment challenges are felt by all of us in research, especially by the patients and families who are waiting for improved treatments," says Todd Sherer, PhD, MJFF CEO. "Patients are our partners in research, but we must give them the tools to get involved. At MJFF, we have found a few things that have worked, and our goal in this perspective is to share those lessons learned to move us all forward."

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