Raising Trust in Parkinsonís Clinical Trials
By Marshall Loeb
Originally published in the Spring 2007 issue of PDF News & Review.
Some great day in the future, medical science will declare that at long last a cure has been found for Parkinson’s. We do not yet know what that cure will entail and require. But we can be reasonably certain that a significant part of it will be the result of widespread clinical trials — the sometimes daunting, always exciting testing of laboratory ideas on human subjects.
Expert opinions may differ on elements of those trials. But all agree on their importance.
There is, however, a problem. Less than one percent of people with Parkinson’s participate in PD clinical trials — far short of the number that scientists need in the next several years to test treatments in the pipeline.
To address the obstacles to participation, the Parkinson’s Disease Foundation (PDF) decided to stage a roundtable, Building Patient Trust: A New Era of Clinical Research Rights and Responsibilities. Held on January 24 at the New York Academy of Sciences, it brought together people with Parkinson’s, government representatives, researchers, clinicians and pharmaceutical industry representatives.
The event was the first in a series of three (the next two will be held later in 2007). The program featured three presentations, followed by discussion.
Engaging the community
The day began with a presentation by Christine Brunswick, Vice President of the National Breast Cancer Coalition (NBCC), on how advocates in a specific disease community can get a “seat at the table” in clinical trial design and implementation. NBCC’s philosophy is that breast cancer advocates should play an integral role in all research decision making — by the federal government, researchers and pharmaceutical companies — because of the unique and critical perspective as patients that they bring to the processes of scientific research and policy.
To achieve this, NBCC created Project LEAD®, a program that trains advocates to critically appraise research proposals and policy initiatives. Project LEAD graduates serve on Institutional Review Boards (independent groups that work to ensure that research is safe and ethical), work with centers to stimulate recruitment, assist companies with clinical trial protocols and development and participate in the review of grant proposals.
Ms. Brunswick’s presentation sparked interest among the roundtable participants on steps that may be taken by the Parkinson’s community to incorporate patients’ perspectives into the policies and practices of drug companies as they explore potential Parkinson’s treatments. One specific application of this idea, suggested by an industry representative, would be to incorporate patients’ views in decisions about inclusion and exclusion criteria for clinical trials.
Enhancing the informed consent process
The second discussion topic — informed consent in Parkinson’s clinical trials — was led by Dr. Ruth Fischbach, Director of the Center for Bioethics at Columbia University. She began by reviewing the roots of the mistrust in clinical trials that continues to exist, especially in minority communities. She went on to argue that in “overprotecting the vulnerable,” research ethicists may actually be excluding certain individuals, such as the cognitively impaired, who could benefit the most from such studies.
One way to involve vulnerable populations without compromising safety, Dr. Fischbach said, is to have participants appoint a surrogate to act for them in the informed consent process. In such situations, the surrogate should accompany the participant throughout the process, and communication should be encouraged among the study staff, the surrogate and the participant.
After Dr. Fischbach’s talk, one Parkinson’s advocate suggested that today’s legal climate has made the original purpose of the informed consent — to protect the participant — change to protecting the company that sponsors the research.
Encouraging data translation and transparency
In the third and final presentation, Kenneth Getz, co-founder and Board Chair of the Center for Information and Study on Clinical Research Participation (CISCRP), reported on the state of research participation and public trust. He noted that despite pharmaceutical companies’ recent efforts to be transparent with data by posting online registries, polls show that public trust in these companies has steadily declined. He also remarked that registries limit access to Internet users, excluding those who do not use the web.
One animated exchange concerned problems that can emerge when companies close or stop a trial, or when the sponsoring company informs investors of results before telling the trial participants. A person with Parkinson’s shared her recent experience with a clinical trial that was halted. She said that the company posted information of the interruption on a website before investigators had the opportunity to pass on the news to participants. This highlighted the need for better communication to demonstrate that participants are a valued part of the research process.
In summary, the roundtable paved the way to increased understanding, dialogue and partnership throughout the Parkinson’s community. It offered hope for identifying and addressing key barriers to clinical trial participation in a way that will ultimately advance treatments and therapies and bring us closer to that long-awaited cure for Parkinson’s disease.
PDF wishes to recognize the Parkinson Pipeline Project as collaborators on this roundtable, and to thank Vernalis Pharmaceuticals as the primary underwriter of the roundtable and Teva Pharmaceutical Industries for its support.
Marshall Loeb is a personal finance pioneer and has been Managing Editor of two of the most successful magazines in history, Fortune and Money. He currently writes a column about personal finance and public affairs for the MarketWatch website and he is a daily commentator on the CBS Radio Network. Mr. Loeb is a member of the PDF Board of Directors.