Clinical Trials

Clinical trials are tests in medical research to determine safety and efficacy of health interventions. Such interventions include drugs, diagnostics, medical devices and therapy protocols. The Canadian government has mandated The Standing Senate Committee on Social Affairs, Science and Technology to examine four issues with clinical trials: 1) the process to approve prescription pharmaceuticals; 2) the post-approval monitoring of prescription pharmaceuticals; 3) the off-label use of prescription pharmaceuticals; and 4) the nature of unintended consequences in the use of prescription pharmaceuticals.

Clinical Trial Infrastructure

In May 2012, Matthew Herder presented evidence (Remarks Before the Senate Committee on Social Affairs, Science, and Technology [PDF - 391 KB] and The Standing Senate Committee on Social Affairs, Science and Technology evidence) to the Senate Committee on the need for greater transparency as a fundamental principle of research ethics. Françoise Baylis, Anne Silversides and Trudo Lemmens also presented on the need for Canada to be doing more to regulate clinical trials (Presentation to the Standing Senate Committee on Social Affairs, Science and Technology on Clinical Trial Registration [PDF - 162 KB] and Proceedings of the Standing Senate Committee on Social Affairs, Science and Technology). Following their respective testimony, Matthew Herder, Françoise Baylis and Trudo Lemmens co-authored a set of recommendations regarding clinical trial registration, results reporting, and raw data sharing [PDF - 596 KB].

The Committee's first report, Canada's Clinical Trial Infrastructure: A Prescription for Improved Access To New Medicines [PDF - 1.5 MB] was tabled in November 2012. The Senate report referenced Matthew Herder's testimony (page 23) in its call for greater transparency through clinical trial registration so that the results of trials – both good and bad – are available to everyone.

It also referenced Françoise Baylis' testimony (page 16) on the need for evidence-based health care for all Canadians including pregnant and nursing women.

In May 2013, Health Canada introduced a Clinical Trials Database (not a registry), and therefore, it does not contain comprehensive information about all clinical trials.

Page last updated Fall 2014.