Clinical Trials Registration and Results Reporting

Background

The following guidelines were developed by Unity Health Toronto (Unity Health) in accordance with the requirements of the United States Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Canadian Institutes of Health Research (CIHR) related to the registration and reporting of clinical trials.

In 2016, NIH published the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information in NIH Guide Notice NOT-OD-16-149. This policy establishes that all investigators conducting clinical trials funded by the NIH will ensure that these trials are registered at ClinicalTrials.gov, and that results information of these trials is submitted to ClinicalTrials.gov.

In 2017, the FDAAA 801 mandated that all “Applicable Clinical Trials” (defined here and also below) be registered on ClinicalTrials.gov and have results reported on ClinicalTrials.gov no later than 12 months after the last patient has been followed up for the primary outcome.

In 2020, the CIHR signed the World Health Organization’s Joint Statement on Public Disclosure of Results from Clinical Trials and has recently introduced a Policy Guide with new requirements. Principal Investigators (PIs) receiving CIHR grant funds for clinical trial research on or after January 1, 2022, must register and post results in a publicly available, free-to-access searchable clinical trial registry no later than 12 months after the primary completion date (the date of final data collection for the primary outcome measures).

Policy Decision

At Unity Health, we are committed to the complete and unbiased reporting of all research results and we believe that the results of all clinical trials conducted at our organization should be analyzed, posted and published in a timely manner. We have therefore established reporting requirements for all interventional clinical trials. Consistent with the requirements of the FDA, the NIH and the CIHR, Unity Health requires summary results to be reported on ClinicalTrials.gov no later than 12 months after the primary completion date. Please refer to our institutional guidelines posted on the UnityNet Intranet.

Information Specific to ClinicalTrials.gov

Note: Although CIHR published a list of approved clinical trial registries, our researchers are required to use ClinicalTrials.gov for all Unity Health clinical trials to facilitate the internal compliance review.

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