NOTICE - Registration and Disclosure of Clinical Trial Information

Date: 2007-11-30

Our file number: 07-128165-369

The purpose of this notice is to provide an update on Health Canada's initiative on the registration and disclosure of clinical trial information for therapeutic products (including drugs and medical devices) and to provide guidance on how clinical trial sponsors and manufacturers may register their clinical trials.

The registration and disclosure of clinical trial information in a publicly accessible registry will support the comprehensive reporting of clinical outcomes and allow Canadians to make more informed decisions about their health. Health Canada is currently exploring the development of a regulatory requirement for the registration of clinical trials and disclosure of results. While this work proceeds, Health Canada encourages sponsors to register their clinical trials of therapeutic products within 21 days of the trial's onset. Trials should be registered on one of the following publicly accessible registries of the World Health Organization's Register Network:

Both of these registries collect and display the World Health Organization's Registration Data Set for clinical trials, can be searched free of charge, and accept prospective registration of clinical trials taking place around the world by a variety of sponsors. Health Canada is also examining the creation of a Canadian search portal for clinical trials, which would allow information to be submitted and searched in both French and English.

Since this initiative was launched in 2005, Health Canada has conducted extensive consultations on the issue of registration and disclosure of clinical trial information, including the creation of an External Working Group in Spring 2006. These consultations have revealed a strong consensus among stakeholders that a Canadian approach should be consistent with international direction. Health Canada has considered this feedback, as well as work that is underway on international and domestic initiatives, in developing a Canadian approach for the registration and disclosure of clinical trial information. If a decision is made to proceed with a regulatory requirement, there will be further opportunity for stakeholders to provide feedback on issues such as timing of registration, the registration of early phase trials, and disclosure of clinical trial results.

More information on this initiative, including next steps, will be made available on the Health Canada website as our work on the registration and disclosure of clinical trial information initiative progresses.

Questions or concerns related to this initiative should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Holland Cross, Tower B, A.L. 3102C3
1600 Scott Street
Ottawa, ON K1A 0K9

Tel: 613-948-4623
Fax: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca

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