Language selection

Government of Canada / Gouvernement du Canada

Search

Draft guidance on the registration of clinical trials and public disclosure of results: Reporting results

On this page

Declaration of Helsinki

The 2013 World Medical Association, Declaration of Helsinki states:

"Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject… Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports... Negative and inconclusive as well as positive results must be published or otherwise made publicly available."

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (The World Medical Association)

When to report results

Sponsors should strive to submit the summary results of their clinical trial within 12 months following primary study completion.

Primary study completion is understood to be the final study visit for collection of data on the primary outcome for the last participant.

Health Canada recommends this timeframe as it aligns with international best practices, including WHO international standards for registries.

More than the 12-month timeframe may be needed under special circumstances, including:

For clinical trials investigating NHPs involving a new investigational product or a new indication, sponsors may submit their results within whichever timeframe comes first:

This timeframe takes into account time for a company to bring a new product to market after completing a trial.

Signatories of the WHO Joint Statement on Public Disclosure of Results from Clinical Trials also commit to implementing policies for timely public disclosure of results for all clinical trials that they fund. This includes a 12-month timeframe from primary study completion for posting results to a clinical trial registry.

The Canadian Institutes of Health Research (CIHR), Canada's federal funding agency for health research, is now aligned with the joint statement. The agency became a signatory and strengthened its open science and transparency requirements for investigators who receive CIHR grant funds for clinical trials on or after January 1, 2022.

Investigators must have summary results publicly available within 12 months from primary study completion. Publications must be open access from the date of publication and include the registration number. Compliance with the policy requirements is necessary to remain eligible for any new CIHR funding.

Joint statement on public disclosure of results from clinical trials (WHO)

CIHR Policy Guide – Requirements for Registration and Disclosure of Results from Clinical Trials

Where to report results

Sponsors are expected to provide the summary results of their Health Canada-authorized clinical trials to the same registry where their clinical trial is registered. This is the sponsor's registry of choice that complies with WHO international standards.

What results information to report

Sponsors should update their registry information with the summary results of their clinical trials. Summary results information does not include individual patient data. In line with the content requirements under the WHO Trial Registration Data Set, this guidance describes summary results as including 4 areas.

Participant flow

Information that documents the numbers of research participants:

This is for both the study arm and comparator arm.

Demographics and baseline characteristics

Data collected at the beginning of a clinical study for all participants, for each investigational arm and the comparator arm. These data include demographics such as disaggregated data on:

Outcome measures

Data for each primary and secondary outcome measure for the investigational and comparator arms, including the summary result(s) of statistical analyses that were performed on the outcome measure data.

Adverse events

Information relating to an unfavorable change in the health of a participant, and all serious adverse events and deaths that happen:

This data should include demographic data, where possible.

Journal publications

Health Canada's policy expectations for prospective registration of clinical trials and summary results reporting align with guidance set out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E8(R1), implemented by Health Canada, for drug trials, which states that:

Making objective and unbiased information publicly available can benefit public health in general, as well as the indicated patient populations, through:

This international standard is considered of critical scientific and ethical importance for research involving humans.

Sponsors are also encouraged to:

Use of open access peer-reviewed journals for publication is aligned with the Chief Science Advisor of Canada's Roadmap for Open Science. It promotes a science culture that is "open by design and by default", which means open science is an integral part of the scientific process.

Although the roadmap recommendations are intended for science and research funded by federal government departments and agencies, the imperative for making scientific information available to all is universal. In particular, sponsors are encouraged to apply the principles that research outputs are "FAIR":

Although journal publication increases transparency of clinical trials, it should not replace the reporting of summary results with registries that comply with WHO international standards, where full study protocols and statistical analysis plans, along with the informed consent forms may also be found.

International Council for Harmonisation

Providing results to participants

The inclusion of summary results in the registry provides an important resource for participants. However, sponsors, including researchers, are also encouraged to adhere to any guidelines that describe best practices for communicating results with clinical trial participants. For example, ICH E8(R1) states that:

"Consideration should be given to providing a factual summary of the overall study results to study participants in an objective, balanced and non-promotional manner, including relevant safety information and any limitations of the study… Participants should be informed about the information they will receive and when they will receive it at the time of providing informed consent."

How to submit results to registries

Generally, summary results from registered and completed studies are submitted in a standard format without discussions or conclusions. Sponsors should comply with any standards or requirements of their chosen registry, including those relating to the type of information to be submitted.

Typical processes include a review of results submissions by registry staff members to help ensure that they are clear and informative before they are published. There may be different validation steps for different registries. Sponsors are responsible for ensuring that the submitted information is accurate and complete.

Sponsors are encouraged to work directly with the international registry they have chosen if they are experiencing any difficulty uploading their clinical trial information. A contact email and phone number are typically listed on a registry's webpage.

Page details

Date modified: