Health Canada's Clinical Trials Database
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.
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.
Health Canada is the federal regulator responsible for authorizing the importation and sale of drugs for the purpose of clinical trials. This responsibility is fulfilled through the review of clinical trial applications (CTAs) for phase I, II, and III clinical trials, filed by clinical trial sponsors. One of the objectives of Health Canada's review is to ascertain that subjects participating in the trial will not be exposed to undue risks.
Every year, Health Canada authorizes approximately 900 clinical trials in patients. The database lists trials that were authorized by Health Canada starting April 1, 2013. The database will be populated with information about each clinical trial after Health Canada issues its No-Objection-Letter (see terminology section for a definition). Thus, following the launch, the number of clinical trials available in the database is expected to be small, but the number will increase with time as the database is populated.
Information Listed in the Database
The database will provide the following information on clinical trials for which a CTA has been authorized:
- Protocol Number;
- Protocol Title;
- Drug Name;
- Medical Condition;
- Study population;
- Date of No Objection Letter;
- Sponsor Name;
- Control Number;
- Study Start Date;
- Study End Date;
- Trial Status.
Please consult the CTA terminology section of this website for a definition of each of these terms.
The sponsor of the clinical trial should be contacted for more information about a trial's objectives, patient enrolment criteria, potential clinical trial sites, and to confirm the status of a trial. Health Canada will not be providing detailed sponsor contact information, or any other details about the clinical trial, other than what is found in the database. Sponsor contact information should be obtained through an internet search.
It is important to note that Health Canada is not a sponsor of clinical trials, and the Clinical Trials Database is not meant to be a patient recruitment tool. Individuals wishing to obtain more information on clinical trials found in the database should speak with their own physician and contact the clinical trial sponsor.
Although the database includes information about all drug clinical trials in patients, the database does not contain the following:
- Clinical trials in healthy volunteers. Health Canada authorizes clinical trials involving healthy volunteers, such as bioavailability or bioequivalence trials, first-in-human trials (that is, when a new drug is administered for the first time in humans), pharmacokinetic studies, drug-drug interaction studies, etc.; however, information about these trials is not included in the database.
- Clinical trials conducted with natural health products and medical devices. Health Canada also authorizes trials involving natural health products and devices; however, information about these trials is not contained within the database at this time.
- Phase IV trials. Phase IV trials are studies carried out with a marketed drug under its approved conditions of use, and a CTA is not required to be filed with Health Canada. Therefore, information about these studies is not reviewed by Health Canada prior to the start of the trial, and is not contained within the database.
The information in the database is provided by the sponsor of the trial. The database may be updated with new information, such as a change in sponsor name and trial start and end date.
Clinical trial sponsors are not required to inform Health Canada when a trial is completed. Although sponsors typically provide this information, some information can be missing, or dates can change leading to some discrepancies. Therefore, it is possible that trials that appear to be ongoing may actually be completed. Sponsors should be contacted for the most up-to-date and accurate information about the status of a clinical trial.
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