National Placebo Initiative (NPI) Background

National Placebo Working Committee (NPWC)

The National Placebo Working Committee is responsible for drafting a Report on appropriate placebo use in clinical trials in Canada, and developing policy recommendations based on their deliberations and input from all stakeholders, including the Canadian public.

• Composition of the Working Committee
• Criteria for Membership
• Members of the Working Committee
• Terms of Reference of the Working Committee
• Contacting the Working Committee
• Minutes of the Working Committee

Composition of the National Placebo Working Committee
The members of the Working Committee represent the major stakeholders and the public, and may represent more than one constituency. Committee members were chosen from among the following constituencies:

• Citizen Representative
• Clinical Trial Nurse
• Ethicist
• Health Lawyer
• Patient Advocate
• Person with process expertise in conflict resolution
• Principal Investigator
• Regulatory/public health
• Research Ethics Board member
• Pharmaceutical Industry
• Statistician

A representative from CIHR and Health Canada are Ex-officio members of the Committee. The Chair was chosen by the Committee members.

Criteria for membership

• Canadian citizens and landed immigrant status
• Demonstrated ability to be open to various perspectives on placebo use
• No financial or other significant conflict of interest
• A commitment to the mandate, activities and time requirements of the Committee
• A willingness to serve in a voluntary capacity
• The appropriate qualifications to represent one or more of the constituencies identified

On striking the Committee consideration was given to an overall balance of perspectives, as well as regional, linguistic and gender representation.

Members of the Working Committee

Heather Sampson, Toronto ON, Chair
Penny Brasher, Edmonton, AB
John Fisk, Halifax NS
Kathleen Glass, Montreal QC
Vratislav Hadrava, Kirkland, QC
Bernard Keating, Quebec City QC
David Sackett, Markdale ON
Stan Shapiro, Montreal, QC
Maureen Smith, Ottawa ON
Phil Upshall, Guelph ON
George Webster, Winnipeg MN
James Wright, Vancouver, BC

Ex-Officio members are:

Patricia Huston, Ottawa ON
Thérèse Leroux, Montreal QC

Terms of Reference of the Working Committee

Mandate:

The mandate of the National Placebo Working Committee is to provide a recommendation to Health Canada and Canadian Institutes of Health Research (CIHR) on a common placebo policy that would be considered:

1. In the revision of Section 7 on the Tri-Council Policy Statement; and
2. In formulating a Canadian Addendum to ICH E-10 prior to formally adopting the guideline as policy for the Therapeutic Products Directorate.

Authority:

As an advisory body to Health Canada and CIHR, the Working Committee has no decision- making authority. Upon review of the information and recommendations of the Working Committee, Health Canada and CIHR will independently decide on the appropriate course of action.

Scope of Work:

• Determine the facts with respect to placebos and what is required to establish safety and efficacy of a new investigational treatment;
• Conduct an ethical and legal analysis of current policies, norms, and practices to inform the development and assessment of placebo policy options;
• Participate in widespread consultation among the stakeholders involved in placebo- controlled trials;
• Respond to the feedback from the stakeholders;
• Forge consensus among Working Committee members on what constitutes ethical and scientifically appropriate use of placebos in clinical trials; and
• Produce a Draft Report that includes:
  1. consideration of the feedback obtained from the National Conference and the Focus Groups;
  2. a brief history of the placebo debate;
  3. highlights of the major scientific, ethical, legal and regulatory issues surrounding the placebo debate;
  4. a draft recommended common placebo policy
• Produce a Final Report that includes:
  1. a summary of the stakeholder feedback obtained on the Draft Report, including feedback from public consultations
  2. a summary of the Working Committee=s response to that feedbackAnd then revised accordingly:
  3. a brief history of the placebo debate;
  4. highlights of the major scientific, ethical, legal and regulatory issues surrounding the placebo debate;
  5. the consensus achieved by the Working Committee on these issues
  6. the final recommended common placebo policy

Contacting the Working Committee

The Working Committee will consider any written communication sent to it; although it will be unable to respond personally to each communication. You can write to the Committee by sending it to ethics@cihr-irsc.gc.ca.

Minutes of the Working Committee

• National Placebo Working Committee - March 24, 2002, 9:00 am - 1:00 pm

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