Health Canada launched a consultation paper on May 20, 2021. This paper outlines the key policy proposals for the modernization of Canada’s clinical trials regulatory framework. One of the points discussed is clinical trial transparency.
Currently, Health Canada’s Clinical Trials Database provides information related to Phase I, II and III clinical trials involving drugs and conducted in patients. Health Canada also encourages the sponsors to register the clinical trials on public registries like ClinicalTrials.gov and ISRCTN. Health Canada is examining options for how to best design and implement measures to promote the registration of Canadian clinical trials in public registries as well as public disclosure of the results (results reporting). These measures may include the development of new policies and regulations while making clinical trial information more accessible to the public with help of information technology such as artificial intelligence (AI).
One approach being considered would be to develop a new policy that would guide sponsors step by step with processes related to registration and results reporting. Alternatively, the department could begin with new regulatory requirements for registration in the initial phase, with policy measures to address results reporting.
Some of the elements of registration and results reporting under consideration are outlined below:
Health Canada is exploring policy and regulatory options for the registration of authorized Canadian clinical trials investigating drugs, medical devices and natural health products (NHPs). Canadian trial sponsors may be asked to register their trials in an existing, international registry that has been deemed eligible by the department within a prescribed timeframe. The trial sponsor might also be asked to notify Health Canada with proof of their registration (e.g., registry link and trial identifying number), within a certain timeframe after completing registration.
Public Disclosure of Results
Health Canada is also exploring policy and regulatory options for the requirement of public disclosure or reporting of trial results. This would mean that Canadian trial sponsors would be asked to publicly report trial results, and may be asked to notify Health Canada within prescribed timeframes once the results have been made public.