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:

• Where in the current system are the greatest risks to subjects of research?
  1) Protection of personal information
  2) Quality of research conducted
  3) Informed consent process
  4) Injury/Illness due to participation in research

• Rate the problems with the current system.
• Rate the benefits of the current system.
• How would you characterize the overall coverage of clinical research in the press? (negative, somewhat negative, neutral, somewhat positive, positive)

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? 

1. Is there a public trust crisis?
2. What is your perspective on current efforts to minimize conflict of interest?
3. 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

1. Views regarding the status of the clinical research enterprise
2. Priority areas for improvement
3. Suggested changes/actions

5:30 pm       Adjourn

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