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.
Health Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs.
Patients can access the database to determine if a clinical trial has met the regulatory requirements. The database may also assist Canadians in finding clinical trials that might be relevant to their medical condition.[Our emphasis] The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. To maximise use of the database and available information, users are advised to link to external resources, including publicly available registries, to obtain further information such as trial objectives and patient eligibility. Note however that not all clinical trials are necessarily registered and thus found in these registries. Health Canada continues to encourage sponsors to register their clinical trials in publically accessible registries such as Clinical Trials.gov and ISRCTN. A Canadian-based registry for cancer trials is also available at Canadian Cancer Trials. Additionally, the search portal provided by the World Health Organization (WHO) can be used to access a central database that contains information about trials registered in several international registries.