Health Canada Notice regarding Registration and Disclosure of Clinical Trial Information – October 19, 2012

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On October 19, 2012 Health Canada issued a Notice that it intends (at some point in future) to publish an administrative list of clinical trials authorized by Health Canada on its website.

The purpose of the list as stated is to inform and provide information to patients, healthcare providers and the public about clinical trials that have been authorized by Health Canada.

Health Canada is in the process of developing mandatory requirements for the registration of clinical trials and indicated it will provide further information on the initiative, including the opportunity for consultation.

Since November of 2011 Health Canada has encouraged sponsors to register their clinical trials within 21 days of the trial’s onset on either: or Current Controlled Trials International Standard Randomised Controlled Trials Number Register.

In its Notice, Health Canada also provided a link to the World Health Organization’s search portal for trial registration data, stating that the portal “can bridge multiple records pertaining to one trial”: International Clinical Trials Registry Platform Search Portal.

In my experience, researchers and universities have required sponsors to register their clinical trials on a public register for some years, so depending on the still-to-be-determined and/or made public mandatory requirements, Health Canada may (for the most part) be mandating industry practice.

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