A New Era in Collaboration:
The Road to a Parkinson's Clinical Trial Participants' Bill of Rights
Clinical trials are the stepping-stones to discovering new, more effective treatments for Parkinson’s disease. Research and approval of new treatments cannot be conducted without human volunteers, who agree to take substantial risks in hopes of improving their health and their lives, furthering scientific knowledge, and ultimately finding a cure for Parkinson’s.
To advance Parkinson’s treatments through clinical trials, members of the Parkinson Pipeline Project believe there is a critical need to improve communication and understanding, and create an atmosphere of mutual trust, respect, and collaboration among all stakeholders. The overriding goal is to include patients’ voices in decision making at all levels of the clinical trial process.
There is also a crucial need to improve the current informed consent procedures and guidelines to ensure the safety of patients, clarify administrative and financial obligations for clinical trial participation, adopt shared decision-making processes for discontinuing investments in research or halting clinical trials, and providing greater transparency of scientific data.
We are not alone. An editorial in the December 2005 issue of the Lancet Neurology, on the GDNF trial halt controversy, pointed out the tremendous need for:
“…Pharmaceutical companies, clinical researchers, and patients to join forces in modifying medical research in which study participants are commonly treated as passive subjects, have no control of the research process, and are often misled by the expectation of a therapeutic outcome.”
In a September 2007 editorial, the journal Nature Medicine called for an:
“…Overhaul” and legalization of informed consent rules “to guarantee that people fully understand what they are getting themselves into when they agree to participate in a clinical study.”
And an editorial in the October 3, 2007 New England Journal of Medicine (online version) endorsed greater transparency of clinical trial data and recognized the role of patients, stating:
"Once a clinical trial is mounted, the sponsor has an ethical obligation to publicly acknowledge the contribution of the participants and the risk they have taken by ensuring that information about the conduct of the trial and its principal results are in the public domain... human volunteers needed to complete a trial are more precious than the money required to mount it..."
"People interested in participating in trials should consider only studies whose sponsors have fully registered them in an appropriate public database and agreed to publish their results."
To address these issues, the Parkinson Pipeline Project and other interested people with Parkinson's, advised by the Parkinson's Disease Foundation, is developing a Parkinson’s Clinical Trial Participant’s Bill of Rights. We consider it an integral part of enhancing clinical trial participation and knowledge about safety and effectiveness of new therapies by:
Creating a framework for developing mutual trust and confidence among potential trial participants, sponsors, and clinical researchers that goes beyond informed consent.
Considering patient input equally as valuable as other stakeholders’ in the therapeutic development and approval process.
Providing a comprehensive educational component that informs and prepares participants for all aspects of the clinical trial process, and encourages participation.
Establishing a basis for training patient clinical trial advocates.
Resulting recommendations from a January 2007 roundtable discussion, “Building Patient Trust: A New Era of Clinical Research Rights and Responsibilities.” held by the Parkinson Disease Foundation (PDF) and the Parkinson Pipeline Project (PPP), enhanced the original draft of the Bill of Rights. “
Most importantly, PWP who have participated in clinical trials were consulted about their experience and their suggestions for improving the process and the treatment of human trial participants.
If the Bill of Rights is accepted by all stakeholders, we hope that the following outcomes will be realized:
It will provide criteria and standards to assess “patient-centered clinical research protocols” that warrant the support of patient advocacy groups with recruitment for sponsors of clinical trials.
It will help assure that the risks of participating in a clinical trial are minimized to the greatest extent possible and fully disclosed to participants.
It will increase fully informed clinical trial participation by PWP.
It will assure that the knowledge obtained from clinical trials will be used and shared with the Parkinson’s Community to advance science and find better treatments for PD in the timeliest way possible.
In developing our Research Participants Bill of Rights and Responsibilities, we consulted several internationally recognized documents on protecting human participants in biomedical research. These include:
The Nuremberg Code, 1947
Declaration of Helsinki, 1964 (last amended in October 2000)
The Belmont Report, 1979
The Council for International Organizations of Medical Sciences (CIOMS) Guidelines, 1982 (last amended in 2002)
Additionally the following current guidelines on clinical trial participants’ rights were consulted:
Center for Information and Study on Clinical Research Participation (CISCRP). The clinical trial volunteer’s Bill of Rights in Getz, K., & Borfitz, D. Informed Consent. Boston, MA: Thomson CenterWatch, 2000. Available online: http://www.ciscrp.org/information/documents/BillofRights.pdf
National Breast Cancer Coalition: Clinical Trials Initiative. Criteria for Trial Evaluation. Available online:
National Institutes of Health. Clinical Center. Clinical Center Patients’ Bill of Rights, 2000.
National Institutes of Health. NIH Guidance on Informed Consent for Gene Transfer Research.
U.S. Code of Federal Regulations. 21 CFR 50. Protection of Human Subjects.
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Declaration of Clinical Research Rights and Responsibilities
for People With Parkinson’s
Clinical research is essential to the development of new therapies and treatments for Parkinson’s disease. Yet, due to a number of factors, including a lack of awareness and understanding of the research process, only one percent of people with Parkinson’s participate. This is far below the number needed, delaying many promising trials. Read the entire Declaration!
The following article describing the Roundtable originally appeared in the Parkinson’s Disease Foundation’s Spring 2007 Newsletter and is reposted here with the permission of PDF. It can also be found on the PDF website
By Marshall Loeb
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.