As a part of the regulatory modernization process, Health Canada had published a consultation paper in May 2021. Health Canada gathered feedback from stakeholders on the consultation paper through an online questionnaire, email submissions, and interactive webinars. Overall, 122 written submissions and close to 1000 stakeholders participated in webinars.
The respondents agreed with the proposals to modernize the clinical framework. Health Canada posted “What we heard: an executive summary” on their portal on February 23, 2022. One of the topics in the post was transparency. Most respondents saw value in the new transparency policy/ regulation for registering trials and reporting results. Support from the academic community was 73% and that from the industry was 54%.
Most respondents (86%) register their trials with an international registry like ClinicalTrials.gov. Some use the EU Clinical Trial Register and 1 respondent recommended ISRCTN. For device trials, EUDAMED will be also be used once it becomes a law.
Feedback suggested that academic researchers have challenges in keeping their international registration up to date as compared to the industry researchers. The major challenge included the burden of being required to use multiple registries in different countries for multinational trials. Other challenges included resource requirements to keep up-to-date registry information and some registries being not user-friendly.
Public disclosure of results:
Most respondents (73%) report trial results in the international registries. Respondents explained that reporting results is a part of their good clinical practices and some explained that reporting is an international, research ethics board or publication requirement. Of the 27% of respondents who were contract research organizations (CROs) said they do not report their results. Most of them said it is the sponsor’s responsibility. Some (20%) who do not report their results on international registries said they publish results on their company websites.
The detailed information can be found here.