Consultation on Health Canada's Public Clinical Trials Database

Health Canada has the mandate to review applications to sell or import drugs for the purposes of a clinical trial.  Health Canada will deny authorizations to provide access to a drug in a clinical trial setting if the sponsor of the clinical trial has not met regulatory requirements or where there are reasonable grounds to believe that the use of the drug for the purposes of the clinical trial endangers health, is contrary to the best interests of the clinical trial subject or if the objectives of the clinical trial will not be achieved.

Health Canada is committed to making information about drug clinical trials easier for Canadians to find and use so that they can make informed decisions about their health.  As part of the modernization of the Food and Drug Regulations, Health Canada has plans to pursue the development of mandatory requirements for the registration and disclosure of clinical trials and study results.

In the interim and for the first time, Health Canada intends to provide access to its clinical trial database.  Health Canada's clinical trial database is generally updated by about 800 clinical trials per year, for the study of drugs (including biologics) in patients.  A survey of the international registries "clinicaltrials.gov" and "controlled-trials.com" showed that between May 2011 and May 2012, only about 50% of the patient clinical trials filed with Health Canada were publically registered.  Providing access to a central database of these clinical trials will help fulfill an existing information gap.  With this proposal, patients, healthcare professionals and the public may be able to independently confirm when and if Health Canada has authorized access to a drug in a clinical trial setting.  This new initiative is in keeping with the Government of Canada's commitment to transparency that supports Canadians' informed health decisions.

In addition to this current proposal, Health Canada encourages sponsors to register their trials on publically accessible registries of the World Health Organization (WHO's) Register Network such as "clinicaltrials.gov" and "controlled-trials.com/isrctn".

Key information about the proposed database:

• A web-based search tool will be implemented in Health Canada's website to allow access to the clinical trials database.
• The database will be a central index of  information about phase I, II, and III drug (including biologics) clinical trials (please see sample below; medical devices and natural health products are excluded at this time).
• The database will include all clinical trials involving patients, thereby excluding studies in healthy subjects.
• The database will also exclude phase IV trials since these studies do not require Health Canada authorization to sell or import a drug for the purposes of a clinical trial, and therefore, are not contained within Health Canada's database.
• The database will be updated nightly as applications are authorized.
• The database will provide firsthand information about regulatory approvals and may complement information that sponsors provide on other publicly accessible registries.
• The database is planned to be launched in April 2013, and will include all clinical trials in patients going forward as of the launch date.

Information proposed to be included in Health Canada's Public Clinical Trials Database:

Sponsor's Protocol Number	Protocol Title	Drug Name	Medical Condition	Study Population	Authorization Date	Sponsor	Health Canada's Control Number	Started	Ended
Date on which Health Canada allowed access to the drug for the purpose of the clinical trial Start date of the clinical trial, when known End date of the clinical trial, when known
ABC123	A randomized, multicenter, phase III study to evaluate the efficacy and safety of ABC versus XYZ in patients with stage IV lung cancer	ABC	Stage IV lung cancer	Male and female adult patients greater than 18 years of age	11-06-2012	ABC Company	123456	Day/ Month/ Year	Day/ Month/ Year

How to get Involved

This consultation is open for comment starting December 13, 2012 until February 13, 2013 Please read the questions below and submit your comments as indicated:

E-Consultation Questions:

1) Are you currently accessing information on Canadian clinical trials through available registries? If so, which ones?

Comment field

2) With respect to the proposed plan for Health Canada's clinical trial database, please provide any comments you may have including the usefulness of the proposed database, the importance of various information in the database and any additional information that should be included.

Comment field

3) The category that best describes your perspective is:

------Please choose category------ a. Federal government official; b. Provincial government official; c. Drug submission sponsor; d. Medical device manufacturer; e. Patient; f. Healthcare professional; g. Public interest group; h. Concerned citizen; i. Academic/researcher; j. Other (please specify).

Interested parties are encouraged to provide responses to the consultation questions by February 13, 2013. If you have any questions regarding the consultation, please send them to:

Clinical Trials Information_Renseignements sur les essais cliniques@hc-sc.gc.ca

Bureau of Policy, Science, and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812