Harper Government launches Clinical Trials Database - New initiatives provide guidance and education on clinical trials for CanadiansFriday, June 7 2013
OTTAWA - The Honourable Leona Aglukkaq, Minister of Health, today announced the launch of the Government of Canada's new public database of Health Canada-authorized drug clinical trials involving patients, as well as the completion of a joint project to develop new standards for research ethics boards that oversee clinical trials.
Health Canada is also publishing guidance on the inclusion of women in clinical trials, a new It's Your Health educational piece for patients considering participating in trials, and providing updated general guidance for clinical trial sponsors.
"Canadians want to be active participants in their health care, and choosing to participate in a clinical trial can be an important decision," said Minister Aglukkaq. "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."
Patients, healthcare professionals and the public will now be able to find information on Health Canada's website about drug clinical trials involving patients and to verify whether a drug trial has received regulatory authorization in Canada. The database is mandatory for industry - it will be maintained and updated by Health Canada to include information about all phase I, II, and III clinical trials in patients that it has reviewed and authorized since April 1, 2013. Providing access to a central database of clinical trials is an initial step that will help fill an existing information gap as the government works to further increase transparency around clinical trials.
To further enhance research ethic review processes and increase the protection of clinical trial participants, in 2006, Health Canada commissioned the Canadian General Standards Board (CGSB) to manage the process of creating a new voluntary standard for Research Ethics Boards. This work is now complete and CGSB will make the new standard, entitled the Research Ethics Oversight of Biomedical Clinical Trials, available to users by the end of May. Research ethics boards help ensure that research meets the highest ethical standards, and that the greatest protection is provided to participants who serve as research subjects
Since research involving male subjects cannot always be relied on to show how women will respond to the same treatment, Health Canada is also updating guidance on the study and analysis of sex differences in clinical trials. This will support the optimal use of therapeutic products in both women and men, as well as give guidance on regulatory requirements for sponsors. These new documents, Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences and Guidance for Clinical Trial Sponsorsare available by request from Health Canada's website.
In addition, Health Canada is publishing a new It’s Your Health article on Clinical Trials and Drug Safety that explains different types of clinical trials and points for patients to consider when deciding whether or not to participate.
These initiatives further demonstrate the Government of Canada's commitment to transparency and ongoing efforts to support the safe use of medications by Canadians.