Act now for clinical trial transparency

As Humanists, we want to create compassionate world using the best available evidence.

Unfortunately, the policies that govern our pharmaceutical medicines rely on neither our compassion nor the best evidence.

The AllTrials Campaign, which I worked with Sense About Science on from 2013-2015, calls for every clinical trial to be registered and the results of all trials to be reported. Otherwise, we can't know whether the medicines we take work and we betray the trust of patients who participate in those trials.

This video and AllTrials.net have more information on the importance of this campaign.

While the European Union, USA and WHO have all made strides toward greater clinical trial transparency, Canada has been an international laggard, until very recently.

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.

For us in Canada, now is our best chance to get Health Canada to catch up with the rest of the world and make results from all clinical trials available.

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.

The consultation closes on 26 May 2017 and you can send your response in by email to: rmod_stakeholders-intervenants_dgro@hc-sc.gc.ca



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