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Fox Foundation Proposes Improving Trial Patient Recruitment

Sohini Chowdhury

Sohini Chowdhury (Michael J. Fox Foundation)

20 February 2014. Research managers at the Michael J. Fox Foundation for Parkinson’s Research in New York propose improvements in practices for recruiting patients for clinical trials to reduce obstacles that delay or even prevent trials from happening. The team led by Fox Foundation vice president Sohini Chowdhury presents its ideas in this month’s issue of the journal Clinical Investigation.

First-author Chowdhury and her colleagues investigated the factors behind slow recruitment of volunteers for clinical trials, from both the patients’ and researchers’ perspectives. Earlier studies indicate slow recruitment and the inability to retain trial participants threatens the validity of the research, as well as drives up costs, and delays the development of needed medications.

The authors highlighted the problems of creating and maintaining patient awareness of clinical trials. One of the key problems is reducing concerns of prospective patients. An informal survey by the Fox Foundation in 2012 of 832 Parkinson’s disease patients showed nearly half (46%) agreed with the statement that “Patients in clinical trials are guinea pigs.” Another one-third of the sample each agreed participation in a trial would interfere with their usual care (33%) or participating in a trial meant exposure to experiments to which they did not agree (32%).

The paper analyzes the efforts undertaken by the Fox Foundation in its Parkinson’s Progression Markers Initiative, a biomarkers study enrolling 423 early-stage Parkinson’s patients and 196 controls from June 2010 to April 2013. Recruitment was a particular challenge because of the need to find newly diagnosed patients willing to undergo repeated assessments over five years, including three lumbar punctures in the first year, and annually after that. Lumbar punctures, also known as spinal taps, collect cerebral spinal fluid for diagnosing neurological and other disorders.

The Fox Foundation, say the authors, undertook an extensive education campaign with prospects showing the value of biomarkers in designing effective treatments for Parkinson’s disease, and instituted peer-to-peer recruitment for the study. The foundation also held educational sessions with physicians to encourage referrals, then focused on specific target populations to recruit controls, including veterans for volunteers needed to fill quotas for older males.

“There are a myriad of challenges preventing an individual from participating in a clinical study,” says  Chowdhury in a Fox Foundation statement. “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 paper offers a number of recommendations to improve trial recruitment, such as committees involving patients early on to identify potential concerns. The authors recommend allocating adequate funds for recruitment at the outset and preparing common communications materials for use among multiple trial sites. The study also recommends anticipating problems that discourage patients from continuing their participation, such as transportation to and from sites and procedures like lumbar punctures that are likely to be difficult or uncomfortable.

The Fox Foundation offers an online service matching volunteers with or without Parkinson’s disease to clinical trials. As of February 2014, the Fox Trial Finder recruited nearly 28,000 trial participants.

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