Registration and Disclosure of Clinical Trial Information

What is a clinical trial?

A clinical trial is an investigation of a drug for use in humans and involves human subjects. It determines the level of safety and efficacy of a drug, what dosages are most effective, and what side effects a drug may cause. More specifically, clinical trials

• discover or verify the clinical, pharmacological, or pharmacodynamic effects of a drug;
• identify any adverse events of a drug;
• study the absorption, distribution, metabolism, and excretion of a drug; and
• ascertain the level of safety or efficacy of a drug.

Access to information on clinical trials: Enhancing transparency

The transparency of clinical trials has become an important issue in Canada and abroad. Patients, prescribers, researchers, and regulators want greater access to information on clinical trials to help them make more informed decisions.

Publicly accessible registries. Making clinical trial information publicly accessible in registries has been identified as a key means of enhancing transparency. It makes the information more accessible to patients, physicians, researchers, and other interested stakeholders. Failure to publicly disclose information on clinical trials can

• reduce efficiency in research,
• result in the suppression of negative results,
• prevent prospective participants from becoming involved, and
• prevent the public from accessing safety and effectiveness information that is necessary to make informed choices.

Various organizations, domestic and international, are currently engaged in initiatives to encourage or require the registration and disclosure of clinical trial information. For example, the World Health Organization, through its
International Clinical Trials Registry Platform, is taking the lead in setting international standards for registering and reporting on all clinical trials, in order to improve transparency and increase public trust in clinical research.

Engaging Canadians. Health Canada has been working on an approach for the registration and disclosure of Canadian clinical trial information. In June 2005, Health Canada held consultations with a wide range of stakeholders to identify the needs and requirements that "end-users" would have for clinical trial registration. These Phase I consultations included an online questionnaire and three one-day workshops in Ottawa, Halifax, and Vancouver.

Feedback from the 2005 consultations provided the initial stages for policy development and background for an External Working Group, established to develop and advise on options for improving public access to clinical trial information of health products in Canada.

The External Working Group met on April 27 and 28, 2006 to develop preliminary options for consultation as part of Phase 2. Consultations with the public took place from June 13 to July 7, 2006, in the form of an online workbook. The External Working Group has considered the input received on the workbook in developing their final recommendations to Health Canada in Fall 2006.

Next Steps

Health Canada has considered the results of the public consultations and the External Working Group's recommendations in developing a Canadian approach for the registration and disclosure of clinical trial information. A Notice has been posted in order to provide an update on the initiative and guidance on how clinical trial sponsors may register their trials while Health Canada continues to explore the development of a regulatory requirement for clinical trial registration and results disclosure. Health Canada is also examining the creation of a Canadian search portal for clinical trials.

Reporting to Canadians. The results of the 2005 public consultation are now available. The results of the 2006 public consultation and the final report of the External Working Group are also now available on this Web site.

A November 2007 Notice has also been posted.

An updated Notice dated 2012-10-19, on ongoing activities related to registration and disclosure of clinical trials has been posted.

Consultation on Health Canada's Public Clinical Trials Database was launched on December 13, 2012. Comments may be submitted until February 13, 2013.

A notice regarding the publication of information about certain Clinical Trial Applications authorized by Health Canada has been posted.

Need more information?

If you have any questions, contact us at: Policy Bureau Enquiries