Engaging Community Physicians in Parkinsonís Clinical Research
By David Eger, Ph.D.
Originally published in the Spring 2008 issue of News & Review
Whether you are a person with Parkinson’s disease (PD), a family member or a health professional, you are certainly familiar with the medications that are available to improve PD symptoms. Such treatments are available because they have been successfully navigated through the clinical research process — the phases of study that assess their safety and efficacy and allow physicians to prescribe them to you and me.
Crucial in this process is the role of the general physician or neurologist — the person to whom people with PD are likely to turn for suggestions about their medical care, including their participation in clinical trials. Yet within the PD community, according to a 2005 Harris Interactive® survey conducted on behalf of PDtrials, the vast majority of physicians neither serve as trial investigators themselves, nor tell their own PD patients about the availability of trials.
Why aren’t physicians talking to their patients about clinical trials? Why aren’t they using their skills to lead trials testing promising new therapies? What can be done to close this gap, so that people with PD have the option to participate in studies that could lead to new treatments?
Engaging Community Physicians in Parkinson’s Clinical Research
To help answer these questions, the Parkinson’s Disease Foundation (PDF) led a roundtable on February 14 entitled, Engaging Community Physicians in Parkinson’s Clinical Research — the second in a three-part series sponsored by PDF through Advancing Parkinson’s Therapies (APT), a program that aims to identify and address non-science barriers to the acceleration of PD treatments and therapies.
Held at the New York Academy of Sciences and facilitated by Ira Shoulson, M.D., professor at the University of Rochester and Founder and Former Co-Chair of the Parkinson Study Group (PSG), the roundtable brought together 26 community leaders, including physicians, people with PD, government officials, researchers, and pharmaceutical industry representatives to discuss the issues.
Challenges and Opportunities
Ken Getz, Co-Founder of the Center for Information and Study on Clinical Research Participation (CISCRP), began the day with a discussion on current trends in clinical research, highlighting the complicated environment that exists for physicians involved in the process. Problems commonly encountered include time delays, high participant drop-out rates, and complex protocol design requirements. His observations were confirmed by a community neurologist, who noted the excessive demands placed on his and his colleagues’ time. He said that asking them to serve also as clinical investigators would overburden the office infrastructure and cost the practice money.
As to why physicians are not referring their PD patients to clinical trials, participants expressed several concerns, including the fear of losing patients to other centers or not being kept properly informed about their patient during the course of the trial. One suburban physician said she had the opposite concern — she would recommend patients to participate in trials, but has found that many of them dislike traveling to the urban centers where trials are frequently conducted.
Models and Pilot Projects: The Neurology Community and Beyond
The group then heard reports on successful models of physician engagement in clinical research — both within and beyond the field of neurology.
One was a new initiative of the National Institute of Neurological Disorder and Stroke (NINDS), described by Anne Lindblad, Ph.D., which aims to raise community neurologists’ interest in trials by providing outreach and training in clinical research skills. Danna Jennings, M.D., of the Institute for Neurodegenerative Disorders in New Haven, CT, spoke of her experience working with an independent research institute which provides no regular clinical practice and thus does not compete with other community practitioners for patients. Her center provides constant feedback to referring physicians on care that their patients receive. As a result, it fosters mutual trust between the scientists and the community neurologists.
Dr. Jennings was followed by representatives of the cancer and dentistry communities, each of whom stressed the importance of physician input in trial design. Jonathan Ship, D.M.D., of New York University, reported on the success of the PEARL program (Practitioners Engaged in Applied Research and Learning), which creates studies that are of immediate relevance to practitioners and their patients and that can be conducted in practitioners’ own offices. He said that this model reduces the delay between clinical research outcomes and use of new treatments.
Identifying Core Issues and Action Items
The group concluded by analyzing the models presented and suggesting action steps to improve the PD model of physician involvement in trials. While it was generally agreed that the issues were complicated, a recurring theme was that clinical trial participation should become an appealing and easy part of physicians’ lives, rather than one that creates extra work, administration and costs.
Overall, the day was successful in opening up dialogue among people with varied perspectives and in suggesting that the process of sharing, and putting lessons into action, will help to improve the research process that is so crucial to developing therapies that will one day make your life, and mine, better.
David Eger is a member of PDF’s People with Parkinson’s Advisory Council. He is a practicing clinical psychologist with 25 years of experience.
PDF wishes to thank Vernalis Pharmaceuticals as the primary underwriter of the roundtable and Teva Pharmaceutical Industries for its support.
PDF is pleased to announce that the 2007 roundtable report, Building Patient Trust, is now available. Download the report today or call PDF to request a copy.