1. Partners in Progress: Deciding to Participate in Parkinson’s Clinical Research

2. What do people with PD want from clinical research? Better ways to treat and manage the disease with fewer side effects! A way to stop the progression of PD! A cure!

3. What we will talk about today…  The role clinical studies play in gaining knowledge about Parkinson’s and treating the disease.  The types of Parkinson’s clinical studies that are conducted and the study process.  Why a person without PD (or family member/friend) may volunteer to participate in clinical research.  How to be an informed clinical study participant.  Where to find information about Parkinson’s clinical studies and clinical research participation.

4. What is a clinical study?  Research conducted with people to answer specific scientific questions.  Finds better ways to prevent, detect or treat disease, or to improve care.  A vital step in transforming scientific concept into medical reality.

5.  It is only through people volunteering to participate in studies that clinical research can occur.  People around the world live longer, healthier and happier lives because people they never met volunteered for clinical studies. It’s important to remember that…

6. Why are Parkinson’s clinical studies conducted?  To test a new treatment or test ways to use an existing treatment to determine whether it is medically useful.  To better understand the progression of PD.  To identify genetic and environmental factors that may trigger PD.

7. Why are Parkinson’s clinical studies conducted?  To study ways to improve quality of life for people with Parkinson’s disease.  To test new screening and diagnostic techniques.  To identify potential neuroprotection options, which may serve to protect neurons from injury or degeneration.

8. What are some examples of Parkinson’s clinical studies?  Testing the neuroprotective qualities of FDA-approved nutritional supplements.  Studying the genetics of people with PD and their relatives.  Studying the effect of types of exercise on various movement symptoms.

9. Where do clinical studies fit within the research process? Laboratory and Animal Studies Proposal to FDA Clinical Research FDA Approval Drug development New Treatment The drug development timeline is 10 to 15 years.

10. What is the clinical study process? Phase IPhase IIPhase IIIPhase IV Number of Participants 15-30 people Less than 100 people Generally, from 100 to thousands of people Several hundred to several thousand people Purpose Evaluates safety, determine the safe dosage and identify side effects. Determines effectiveness and further evaluates safety. Confirms effectiveness, monitors side effects, compares the potential treatment to current treatments and collects information on using the treatment safely. Post-marketing studies to determine more information about a treatment, including risks, benefits and optimal use.

11. How does clinical study participation affect the research process?  The majority of clinical studies have difficulty in enrolling participants, this leads to delays in study completion.  It is estimated that only one percent of people with PD participate in clinical studies. If more people with PD were study volunteers, more studies would be completed on time.

12. People with PD are likely to participate in a clinical study but… They do not have access to information themselves…  70 percent of PWPs report that they are not aware of studies in their area. They do not receive information from their physicians….  The majority of physicians report that they talk about clinical trials with 10 percent or fewer of their PD patients.

13. Why people with PD consider participation 2008 survey commissioned and funded by Boehringer Ingelheim Pharmaceuticals, Inc. GfK Roper Public Affairs & Media designed and conducted the survey on behalf of Boehringer Ingelheim in collaboration with the Parkinson’s Disease Foundation.

14. Other reasons why people consider participating  To learn more about Parkinson’s (as well as other health conditions).  To gain information that helps in understanding PD and findings and treatments that are under development.  To enlarge (not substitute) one’s regular medical care team and support circle.  To engage and learn from other people with Parkinson’s.

16. The PDtrials Initiative… Dedicated to increasing education and awareness about clinical research by providing information to help people with Parkinson’s learn and make informed decisions about participating in clinical trials.

17. PDtrials Resources PDtrials.org

18. PDtrials Resources Clinical Trials Bulletin Participating in Clinical Research: A Checklist of Questions to Ask Guide to Understanding Clinical Research

19. Community Outreach and Education….  PDtrials staff and volunteers who have participated in clinical research conduct national as well as regional presentations.  Information and materials are available for individuals, support groups, and meetings. For more information on PDtrials and available resources, please contact us at info@pdtrials.org or call 800-457-6676.info@pdtrials.org PDtrials Resources

20.  Do I have all of the information that I need to make an informed decision?  What types of studies do I feel most comfortable engaging in? Two essential questions that you need to ask… Are you ready to participate in a clinical study?

21. Making an Informed Decision: Do Your Homework Learn about…  The details of the study.  The benefits and risks of the study.  What will be required of you.  How your expenses will be covered.

22. Making an Informed Decision: Do Your Homework Learn about…  Whether there are other treatment option to consider.  How your health and safety will be monitored and your privacy protected.  What happens at the end of the study.  How post-study information will be made available.

23. When You Decide to Participate  Engage your support network – don’t go it alone.  Your active involvement is critical to the clinical study.  Know your rights and recourse.  Recognize that study staff are partners in the process.

24. When You Decide to Participate  Don’t be afraid to ask questions and share your thoughts and concerns.  You have responsibilities – always communicate truthfully and follow the rules of the study.  Understand that informed consent is more than a form you sign – it continues during – and even after – your clinical trial has ended.

25. You can play a part in moving Parkinson’s research forward… Become a partner in progress today! For more information about Parkinson’s clinical research and how to get involved as a study participant, please contact us at info@PDtrials.org or (800) 457-6676.