Canadians: now is our best chance to get Health Canada to take a big step towards making results from all clinical trials available.
Back in 2014, the Canadian government passed the Protecting Canadians from Unsafe Drugs Act, commonly known as Vanessa’s Law. Following pressure from AllTrials, the law gave the Minister of Health the authority to publicly disclose clinical trial information. However, many of the details were left to regulations.
Those regulations are finally being drafted and Health Canada has released a whitepaper on the “Public Release of Clinical Information in Drug Submissions and Medical Device Applications.”
While the proposed policy would see Health Canada release the important clinical study reports that researchers use to figure out what happened in a trial, the devil is in the details. The proposal contains a number of loopholes that could allow the regulator to restrict access to trial information or exemptions that allow trial sponsors to withhold important information. It’s also silent on other parts of the AllTrials call, such as the need to publicly register trials before they begin, how quickly results must be released and providing any mechanism for Health Canada to release past results.
Together with colleagues at Canadian AllTrials signatory Bad Science Watch, I helped draft a response to Health Canada. A number of academics, led by Joel Lexchin of York University, have also co-signed a letter (endorsed by Bad Science Watch) making similar recommendations.
Ian Bushfield worked on the AllTrials campaign from 2013-15. He’s currently the Executive Director of the British Columbia Humanist Association.