Later this month, scientists, ethicists and policy-makers will start debating the use of placebos in drug trials as the first step in putting a made-in-Canada stamp on this global discussion.
Participants in the Mar. 22–23 National Conference on Appropriate Placebo Use in Clinical Trials, jointly sponsored in Ottawa by Health Canada and the Canadian Institutes of Health Research (CIHR), will create draft recommendations for a unified policy on the use of placebos. A final report is expected in about a year.
“We're looking for a basis to move forward in policy development,” says Dr. Robert Peterson, director of Health Canada's Therapeutic Products Directorate. “Health Canada is intimately aware of the sensitivity of this area. We don't want a lack of clarity.”
In Canada, research ethics guidelines now differ from regulatory policy with respect to the ethical use of placebos in clinical trials. Regardless of the nature of the trial, proponents say a single policy would be less confusing, be subject to less interpretation and would provide assurances to the public and research subjects.
“The more harmonization the better,” agrees CIHR President Alan Bernstein. “We'll see what comes out of the discussions [this month]. I think it's a controversial area.”
Currently, researchers who depend on funding from CIHR must abide by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (1998). Meanwhile, industry and regulators, including Health Canada, follow the International Conference on Harmonisation's (ICH) Harmonised Tripartite Guideline for Good Clinical Practice.
Further complicating the matter is an oft-cited international document, the World Medical Association's Declaration of Helsinki (1964). That document and the Canadian tri-council statement both prohibit placebo-controlled trials if there is an existing, effective therapy available, and they deem placebo-controlled trials that deprive people of effective treatment unethical.
However, Health Canada follows the ICH guidelines, which provide conflicting directions. One ICH document (E-10) allows the use of placebo controls even when effective treatment exists as long as subjects are not exposed to the risk of death or permanent injury. A contradictory document (E-6) directs that trials be conducted in accordance with the Declaration of Helsinki.
Peterson says Health Canada supports the ICH guidelines because Canada agreed to participate in that group and helped develop its policies. The ICH is a committee with representatives industry and regulatory authorities in Europe, Japan and the US. Health Canada is an observer and sits on the steering committee.
Peterson says both the Helsinki and Tri-council documents are in flux. “We're seeking a made-in-Canada solution to this debate.” For information on the National Placebo Initiative including the March conference, visit www.cihr.ca/placebo/placebo_e.shtml.