Regulatory Focus™ > News Articles > Health Canada Releases New Clinical Trials Transparency Database

Health Canada Releases New Clinical Trials Transparency Database

Posted 30 May 2013 | By Alexander Gaffney, RAC 

Health Canada has announced the launch of a new online clinical trials transparency database, a tool similar to the US' ClinicalTrials.gov database that now contains basic information about clinical trials and the conditions for which a drug product is being studied.

Background

The impending launch of the database was first announced in December 2012 by Health Canada, which said it was aiming for an April 2013 start date.

Registration will be required of all trials issued a No-Objection-Letter (NOL) as of 1 April 2013, and henceforth all Phase I, II and III trials. The information released will include the sponsor's protocol number, the protocol title, the drug name, the medical condition for which it is being studied, the drug's authorization date, the trial sponsor's name, the control number for the trial, the start/end date for the trial and the status of the trial.

Health Canada said the measure would be an interim step, with further reforms coming at a later date to provide still more information about the trials.

Finally Released

Now, just days before their revised deadline, Health Canada has announced the official launch of the new database.

In a statement, Minister of Health Leona Aglukkaq said the reforms were as much about patients as industry. "Canadians want to be active participants in their health care, and choosing to participate in a clinical trial can be an important decision," Aglukkaq said. "These initiatives will help Canadians to find and understand information about drug clinical trials so that they can decide whether participating in a trial is the right choice for them and their families."

Health Canada noted that for the first time, patients will be able to confirm whether a clinical trial has obtained government approval-now a mandatory requirement for all pharmaceutical trials.

The database, known simply as Health Canada's Clinical Trials Database, is available online.

In the same notice, Health Canada added that a review of Canada's Research Ethics Boards was complete and would be published in the form of a new standard, Research Ethics Oversight of Biomedical Clinical Trials, in the coming days. Officials said the new standard will "help ensure that research meets the highest ethical standards, and that the greatest protection is provided to participants who serve as research subjects." An additional guidance document regarding sex differences in clinical trials is also available.


Clinical Trials Database


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