“As a signatory to the global AllTrials campaign, we believe all clinical trials should be registered and all trial results reported.”
Toronto, Ontario (PRWEB) May 17, 2017
Bad Science Watch submitted their response Monday to the ongoing Health Canada public consultation on the release of clinical trial information for medicines and medical devices. Bad Science Watch considers this information to be essential for good decision making about the health of Canadians and they want Health Canada to make this information public.
Currently, all information about unpublished clinical trials conducted to test the effectiveness and safety of medicines and medical devices has been kept secret by Health Canada and is considered to be a trade secret by pharmaceutical and medical device manufacturers.
A global movement to have the information from these trials released has been gaining momentum since the update in 2008 of the Helsinki Convention called for more respect for trial participants and the public release of trial information. The Helsinki Convention defines the international gold standard of how participants in clinical studies should be treated.
This data would not include any information that could identify study participants, but it would allow researchers to double check the data and doctors and patients to make more informed choices when choosing the best medicine.
The European Medicines Agency and the Food and Drug Association in the United States maintain a registry of trials conducted and are responsible for release of clinical trial information. Many drug companies have already signed on to this new convention. Health Canada is considering releasing some clinical trial information, but Bad Science Watch investigators think they do not go far enough.
“As a signatory to the global AllTrials campaign, we believe all clinical trials should be registered and all trial results reported.” says Bad Science watch executive director Michael Kruse, “This is the best way to honor the sacrifices made by trial participants and ensure drug and device manufacturers have evidence to back up their claims.”
The current Health Canada consultation is concerned with the release of clinical trial information and public submissions are being taken until May 26th, 2017. For more information:
Bad Science Watch’s submission: http://www.badsciencewatch.ca/wp-content/uploads/2013/04/BSW-NNHPD-Clinical-Trial-Information-2017-05-13-FINAL.pdf
Health Canada White Paper: https://www.canada.ca/en/health-canada/programs/consultation-public-release-clinical-information-drug-submissions-medical-device-applications.html
All Trials Campaign: http://www.alltrials.net
