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).
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 intranet.
The following provides Q&A to help you understand general information about trial registration and results reporting as well as the changes with the FDA, NIH and CIHR rules.
Why are we implementing the guidelines across Unity Health Toronto (St. Michael’s Hospital, St. Joseph’s Health Centre, Providence Healthcare)?
- Patients who have agreed to participate in clinical trials expect the results to be analyzed and communicated in a timely manner. Registering clinical trials and providing timely updates including results allows the public to have access to ongoing clinical trials and summary results. This action also reduces publication bias and duplication of research efforts.
- As a public institution, we are accountable for our use of public funds and committed to transparency by reporting all trial results, or reporting explicitly why results have not been published.
- The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial.
- Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to Applicable Clinical Trials (ACTs), certain clinical trials of drugs (including biological products) and medical devices.
- CIHR-funded clinical trials are required to be registered and submit summary results in a publicly available, free-to-access, searchable clinical trial registry. For more information, please view the CIHR Policy Guide and FAQs.
- NIH-funded clinical trials research are expected to register and submit results information to ClinicalTrials.gov. For more information, please view the requirements for registering and reporting NIH-funded clinical trials.
Who is responsible for registering the trial?
- Industry-sponsored trials: Where there is a contract between the industry Sponsor, Unity Health or any of its sites, and the PI, then the industry Sponsor should register the trial. Before enrolling study subjects, every PI should ensure the industry Sponsor has registered the trial.
- Investigator-initiated trials:
- The lead PI of an investigator-initiated trial (“Sponsor-Investigator”) is responsible for study registration, even if a corporate partner provides the study drug, device and/or grant funds. If the lead PI is at Unity Health, then it is their responsibility to register the trial.
- Where the lead PI is at Unity Health and/or trial funding is held and administered through Unity Health, the lead Unity Health PI is responsible for registration.
- Multi-site trials: Where Unity Health is a sub-site and the lead PI is not at Unity Health, registration should be coordinated by the “lead sponsor/institution/PI” or lead PI of the trial.
How early should I register a clinical trial?
- The ICMJE requires (and recommends all medical journal editors to require) registration of all interventional clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication (see more information).
- The World Medical Association (WMA) Declaration of Helsinkistates “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.”
- FDAAA 801 requires ACTs to be registered within 21 days of enrollment of the first participant.
- Although ClinicalTrials.gov allows registration of a non-ACT study at any time (even after it has started, has closed to recruitment, or has been completed; see more information), this is not recommended given the requirements above.
Information specific to clinicaltrials.gov
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.
How do I get a user account for clinicaltrials.gov?
If you wish to register your trial through clinicaltrials.gov and need a user account, please contact the PRS Administrator: Marianna Betro (Marianna.Betro@unityhealth.to) and a user account will be created for you so that you can register your trial.
How should I automatically index my publication with my clinical trial registered on ClinicalTrials.gov?
You must include the registration number/National Clinical Trial (NCT) Identifier at the time submitting your publication (to be specified in the article summary/abstract).
What are the requirements for record updates?
- ClinicalTrials.gov has specific deadlines for record updates (see details here).
- Within 30 days of a change to the recruitment status of an individual site, overall recruitment status or completion date
- Every 12 months for any other changes or updates to the record (e.g., protocol amendment)
How detailed are the results required by ClinicalTrials.gov and what is the time commitment required to update the clinicaltrials.gov registry with a summary report of the results?
- Summary results are submitted in structured tabular forms and require the following information:
- Participant Flow
- Baseline Characteristics (demographics, study-specific measures)
- Outcome Measures and Statistical Analyses: If your trial did not collect all of the pre-specified Primary and Secondary Outcome Measures that were initially included in the registration, describe why data could not be summarized to include in the data table (e.g., specify zero (“0”) for the Number of Participants Analyzed in each Arm/Group, leave the data fields blank, and provide an explanation in the Analysis Population Description for why zero participants were analyzed.)
- Adverse Events: If Adverse Events were not assessed/collected, “0’s” can be included for the Numbers of Participants Affected and Numbers of Participants at Risk and explain in the Additional Description field that adverse events were not collected.
- For ClinicalTrials.gov, adding a link to a publication on PubMed does not fulfill their requirements of summary results reporting.
- Even for Non-Applicable Trials, complete clinical trial results must be submitted as per the above.
- It is difficult to estimate the time it will take to report the results of a study on ClinicalTrials.gov because it varies according to the size/complexity of the trial and how readily available and organized the results are. For a small single-site trial, summary results reporting will take 30 minutes to 2 hours.
- Tables must be completed by an individual who is familiar with the study design and data analysis (e.g., PI, coordinator).
What are the changes in the U.S. Department of Health and Human Services (HHS’s) and NIH’s rules for Clinical Trials Results Submission to ClinicalTrials.gov?
- The changes clarify and expand the regulatory requirements and procedures for submitting registration and summary results information of clinical trials on ClinicalTrials.gov, in accordance with FDAAA801. For example, it outlines which trials must be submitted, when they must be submitted, and whether compliance has been achieved.
- Under FDAAA 801, reporting results is not required for a clinical trial that is not an Applicable Clinical Trial.
- According to FDAAA 801, Applicable Clinical Trials (ACTs)are interventional clinical studies of drug, biological and device products that are regulated by the FDA and involve a US site or products manufactured in the US. The final rule applies to ACTs except for phase 1 trials of FDA-regulated investigational new drug and biological products, or small feasibility studies of device products. For full definitions, see the checklist.
- Effective on January 18, 2017
- Any ACTs that have their primary completion date on or after January 18, 2017, must submit summary results as specified in the rule (i.e., within 12 months).
- Primary completion date is the date of final data collection for the primary outcome measures.
- Responsible parties were expected to be in compliance as of April 18, 2017.
- Note: NIH applies the final rule to all NIH-funded interventional clinical trials (whether partial or fully funded, phase 1, feasibility studies, behavioural interventions, etc.).
- There may be consequences for non-compliance to the responsible party (which can include hefty fines and suspension of grant funding) which is often a sponsoring institution such as Unity Health (see here).
Will the ICMJE consider clinical trial results posted on ClinicalTrials.gov in compliance with FDAAA 801 to be prior to publication?
- The ICMJE does not consider results data posted in the tabular format required by ClinicalTrials.gov to be prior to publication (See more information).
For any questions regarding ClinicalTrials.gov and the Final Rule, contact the U.S. National Library of Medicine (NLM) Customer Support: