Having volunteered with the Parkinson Pipeline Project for several years and being a trial participant myself, we saw a need for a Bill of Rights.

Please see The Declaration of Clinical Research Rights and Responsibilities for People With Parkinson’s (PWP) at: http://www.pdpipeline.org/advocacy/rights.htm

The Parkinson Pipeline Project is beginning to seek endorsements for the Declaration among the various stakeholders in the clinical trial process, and your comments are welcomed.

The Declaration is intended to help speed the clinical trial process by encouraging more of our fellow PWP to participate and remain in clinical trials. Currently only 1% of PWP participate -- far below the number needed. This delays many promising trials for those of us who need a cure TODAY. Many of us do not have the average 17 years it takes for neurological treatments to make it through the drug development pipeline.

Among the factors that we believe discourage people from participating in trials are:
· A lack of awareness and understanding of the research process.
· Widespread public distrust of the pharmaceutical industry.
· Complicated and easily misunderstood informed consent documents.
· A system that asks clinical trial participants to accept considerable risks to their health and lives, but excludes them from the decision-making process.

To address these areas, the Parkinson Pipeline Project and other interested Parkinson's advocates, with the support of the Parkinson's Disease Foundation, developed the Declaration. It reflects the experiences of PWP who have participated in clinical trials and incorporates their suggestions for improving the process and the treatment of human trial participants. An accompanying guide/checklist of questions for patients considering clinical trial participation is also being developed.

We believe that acceptance of this Declaration and adherence to its principles by all stakeholders, will help to:

· Educate the Parkinson’s community about the clinical research process, and empower PWP to make more informed decisions about their participation.
· Improve communication and understanding, and create an atmosphere of mutual trust, respect, and collaboration among all stakeholders.
· Inspire a culture shift where the trial participant is viewed as a partner, not a passive subject in the clinical research process.
· Adopt shared decision-making processes for discontinuing investments in research or halting clinical trials.
· Protect the safety of trial participants more effectively.
· Clarify administrative and financial obligations for clinical trial participation.
· Increase participation in clinical trials to speed the evaluation and approval of new treatments that will ultimately bring us closer to that long-awaited cure for Parkinson’s disease.

Bringing about change to improve the clinical trial process requires the commitment of all stakeholders, which includes you. We encourage you to read this document, and consider the benefits it might provide to clinical trial participants. We welcome your comments. Please reply to the thread, or you can email me at: tnpeg@yahoo.com or leave a private message.

thank you!

Peggy
Parkinson Pipeline Project

Thanks, Peg

I, too, am a trial participant, and I heartily support the efforts of all the writers. The checklist covers so many things I'd never thought of when I was at the Trial Centers! And the Declaration is an important document - written by thoughtful, committed advocates whose goal is to bring about much needed change and protections for all those considering joining a trial.

I know there are other trial participants who frequent this forum. I hope you will read the declaration http://www.pdpipeline.org/advocacy/rights.htm and give your comments.

Jean