Agenda: Engaging the Public in Clinical Research: Views of Patients Advocates
8:30 am Welcome and Introduction
Fran Visco, Workshop Chair
President
National Breast Cancer Coalition
How Do the Existing Systems of Clinical Research Sponsors Work From the Public's Perspective? (Audience members will be provided response devices.)
8:45 am Public Involvement in Priority Setting/Research Agendas
Fran Visco
President
National Breast Cancer Coalition
Question to audience:
- Please classify yourself according to one of the following groups: patient advocate/public interest perspective; researcher; clinical research sponsor (government or private sector); other
- How does the current system of priority setting for public research sponsors work from your perspective?
- How effective are the mechanisms to provide input to the research agenda?
- How effective are the mechanisms for access to information and communication of results?
- How does the focus and scope of research meet your needs?
- How does the current system of priority setting for private research sponsors work from your perspective?
- How effective are the mechanisms to provide input to the research agenda?
- How effective are the mechanisms for access to information and communication of results?
- How does the focus and scope of research meet your needs?
9:45 am Protection of Participants Involved in Clinical Research
Bernard Schwetz. D.V.M., Ph.D.
Director
Office for Human Research Protections
Questions to audience:
10:30 am Break
10:45 am Conflict of Interest in Clinical Research (Audience Response Continued)
Susan Weiner, Ph.D.
President
The Children's Cause, Inc.
Questions to audience:
- How does the current system of protection from conflict of interest work from your perspective?
- Are you or your constituents concerned about:
- Biases that physician/investigators bring to gathering or analyzing data?
- Biases when enrolling patients in clinical trials?
- Physicians' potential financial conflicts of interest during the conduct of a trial?
- Physicians' potential conflicts of role between researcher and investigator?
- Do you think that $5,000 is an appropriate threshold for declaring a conflict of interest?
- What is the most appropriate financial threshold for declaring a conflict of interest? ($500, $1,000, $2,500, $5,000, >$5,000)
- How effective do you believe current protection mechanisms, such as Institutional Review Boards, are in monitoring potential conflicts of interest?
12:00 pm Lunch
1:30 pm Patient Advocate Views (Panel Discussion)
Ellen Stovall
National Coalition for Cancer Survivorship
Suzanne Pattee
Cystic Fibrosis Foundation
Nancy Loving
National Coalition for Women with Heart Disease
Nicole Johnson Baker
American Diabetes Association
Carolina Hinestrosa
National Breast Cancer Coalition
What is your perspective of the current process for participant involvement in priority setting?
- Is there a public trust crisis?
- What is your perspective on current efforts to minimize conflict of interest?
- What are the key barriers to public participation in clinical trials?
3:30 pm Break
3:45 pm Clinical Trial Registries
Kay Dickersin, Ph.D.
Professor, Community Health
Brown University School of Medicine
Larry Hirsch, M.D.
Executive Director, Medical Communications
Merck Research Laboratories
4:30 pm Roundtable Member Comments Concerning Public Engagement
- Views regarding the status of the clinical research enterprise
- Priority areas for improvement
- Suggested changes/actions
5:30 pm Adjourn
Back to Meeting