Clinical Trials: Registration and Disclosure of Information

To develop options for the registration and disclosure of clinical trial information of health products in Canada, Health Canada began consulting with Canadians in 2005.

Phase 1 of the consultations, which took place in June and July 2005, focuses on issue identification; Phase 2 which began in April 2006, focuses on options development. Health Canada established an External Working Group, which met in April 2006 to develop preliminary options for consultation.

Consultation is an important step in Health Canada's strategy to gather information and engage stakeholders in developing options for improving public access to clinical trial information.

2006 Consultation--Phase 2: Options Development

• Workbook from 2006 Consultation
  From June 15 to July 7, 2006, Health Canada conducted a public consultation in the format of an online workbook. The workbook provided stakeholders with the opportunity to review and comment on the External Working Group's proposed options. Issues included the purpose of registration in Canada, types of trials to be registered, timing of registration, disclosure of results, roles and responsibilities, and registry characteristics.
• 2006 Consultation Report
  The Consultation Report describes the findings of the 2006 online workbook.

Next Steps

The External Working Group has considered the results of the workbook consultation in developing their recommendations to Health Canada . 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 final report of the External Working Group and results of the 2006 public consultation are now available on this Web site.

A November 2007 Notice has also been posted.

Need more information?

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