What we heard: Consulting on new policy and search portal to make clinical trials more transparent

Making clinical trials more transparent

Health Canada is committed to making information on Canadian clinical trials more transparent. We consulted with stakeholders to help inform our approach to increase access to information about trials that we have approved, within the context of the department's priority to modernize the clinical trials framework in Canada.

The consultation period was from February 23 to April 24, 2023. We sought feedback on:

a draft guidance document called Registration of clinical trials and public disclosure of results
- describes policy expectations for sponsors of clinical trials to register and report the summary results of their trials with international registries
mock-up images for a new clinical trials search portal that would help make Canadian clinical trial information more accessible to the public

Learn about this consultation.

Who we consulted

We held a public consultation on the draft guidance and new search portal.

A wide range of stakeholders, from industry and academia, to health care providers, took part. In total, we received 57 unique responses:

industry, including companies and associations – 29
academics, research institutes and networks – 15
health care providers, organizations and associations – 4
federal, provincial or territorial governments and agencies – 3
other groups such as non-profits that promote clinical trials – 3
patients and patient advocacy groups – 2
international regulators and agencies – 1

What we heard

The comments were similar to many that we received from the consultation we held on modernizing the clinical trials regulatory framework.

For example:

There was support for the draft policy measures to make clinical trials conducted in Canada more transparent.
- Respondents from industry and academia said they were accustomed to existing transparency initiatives.
Many welcomed efforts by Health Canada to align with international initiatives rather than introducing Canada-specific requirements.
Some respondents felt that requirements should be strengthened with regulation.

Specific recommendations were given on the scope of the proposed policy, timeframes for registration, timeframes for reporting summary results and the new clinical trials portal.

Learn more about the 2021 consultation on the clinical trials modernization initiative.

Support for stronger requirements

Some stakeholder groups, such as academia, industry, patient advocacy groups and health care providers, commented on the language we used in the policy. They pointed to existing legislative requirements for registering and reporting results internationally.

Some respondents said the registration requirements should be stronger and made mandatory through regulation. Some said it should be mandatory to report summary results, and there should be consistent monitoring and enforcement, with financial penalties.

"Putting in place a system of mandatory requirements for registration and reporting of clinical trials with penalties for non-compliance would align with policy in the US and EU and is essential for improving transparency in clinical trial research."

academic and research institutes and networks stakeholder group

Scope of the policy

Some respondents commented on the section in the draft guidance on scope and application, in particular about which clinical trials would apply.

Some respondents did not understand the meaning of some terms. For example, they asked if "single individual trials" referred to studies where only 1 participant was enrolled due to low recruitment or to single patient use studies. Note: The term "single individual trials" refers to studies that are designed as single patient trials.

Some respondents felt it should be clearer whether sponsors would be expected to follow the requirements of the international registry or Health Canada's guidance. (Once implemented, stakeholders would be expected to follow our guidance.)

There were some suggestions to change the scope, such as:

include interventional and observational clinical trials
include phases 1 through 4 for clinical trials investigating drugs
do not include phase 1 drug clinical trials

Some respondents from the industry stakeholder group said the scope should match the requirements set by the United States and Europe. For example, Health Canada should:

align with ClinicalTrials.gov (in the U.S.) by not including phase 1 and including phase 4 clinical trials
- registering phase 1 studies would represent a Canadian-specific expectation and could be a barrier to conducting these studies in Canada
regulate the registration and public disclosure of phase 4 clinical trials to align with the U.S. and Europe
- these clinical trials may provide important information about a drug's safety and effectiveness
define applicable clinical trials to align with ClinicalTrials.gov

Clinical trial registration

Some respondents pointed out that registration is common practice and already required in many jurisdictions. They said Health Canada should take advantage of existing sponsor registration practices by extracting information from international registries rather than creating a new registry.

Respondents who thought that we would be creating a new registry said:

adding another registry would be an extra step
the requirement for sponsors to register a study in both a World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) registry and in Health Canada's clinical trials portal is a duplication of effort
- The final guidance document will clarify that we are not creating a new registry.
- We would extract and display some information from existing international registries in the portal.
- Sponsors would not have extra responsibilities around providing information to us in regard to expectations in this policy.

Some respondents said we should allow up to 30 days after recruitment begins to add a Canadian site to an existing registry record rather than requiring registration in advance.

Some industry respondents said our policy expectation for timing of registration should match the required timing in the U.S., as many Canadian researchers use ClinicalTrials.gov. Some respondents in this industry group said that a Canadian-specific timeline could cause delays in recruiting participants in Canada. Suggestions were to:

match international timelines, as global (U.S.) teams often manage the registration of global studies
allow registration within 21 days of the first participant being enrolled
be flexible and allow registration within 30 days of the start of recruitment
base timing on when the first participant is enrolled, not recruited

"As proposed, the requirement to register a Health Canada-authorized clinical trial before recruitment is a Canadian-specific expectation. Should sponsors follow this expectation in timing of registration, there would reasonably be expected delays in the recruitment of patients in Canada. This is inconsistent with the importance of the prioritized recruitment of participants."

industry stakeholder group

Reporting summary results

Respondents from academic institutions supported the proposed timeframes outlined in the section on "reporting of results". They said the timeframes align with World Health Organization (WHO) international standards for registries and the Canadian Institutes of Health Research (CIHR) requirements for funded trials.

This stakeholder group also said there should not be any exceptions to or deferrals from the 12-month timeframe for reporting clinical trial results. Any commercial benefit from delaying reporting is less important than the benefit to public health from greater transparency.

However, some industry respondents want to see more exceptions to the timeframes. For example:

There should be exceptions for all health product categories when a sponsor intends to bring a new product to market after completing a trial.
- should be extended to phase 1 studies as well
ClinicalTrials.gov allows delays in trial results up to 2 extra years if either:
- an unapproved, unlicensed or uncleared product studied in the trial is still under development by the manufacturer or
- approval will be sought within 1 year after the primary study completion date for a new use of an approved product

Some industry respondents said summary results should be reported within 12 months of the global end date for a trial (also called "overall study completion date" or "final last participant, last visit date"). For example:

Data from primary outcome measures may be available several years before data from secondary outcome measures are available.
- Some respondents said that even though WHO encourages disclosing results within 12 months of primary study completion, there are cases where this may impact the future conduct of the trial:
  - for example, introducing bias in how the trial is conducted, impacting patient recruitment or compromising blinding of an ongoing study
The primary completion date is a U.S.-only timepoint. Secondary endpoint data are due within 12 months of each secondary endpoint being completed.

Some respondents from several stakeholder groups also said there should be:

timelines for providing final results and any substantive changes to protocols in the policy
plain language summaries in clinical trial reports to align with recent international standards
information on how results are to be shared with patients in clinical trial reports

Clinical trials portal

We received several comments about the proposed clinical trials portal, including the mock-ups we provided as part of the consultation.

In general, respondents supported our approach to using global registries rather than developing a registry for Canada. They stressed the importance of making the portal easy to find and promoting it, as it will be a great tool for the public.

"This is timely. Often investigators indicate that the results of a clinical trial can be viewed by visiting a site not housed in Canada, yet the study is conducted in Canada. Often times the primary sponsor will host a site to provide information to participants which is better but having a dedicated Canadian based and operated site is best."

academic and research institutes and networks stakeholder group

Some industry and academia respondents did not understand the purpose of the portal. They believed the sponsor would be required to:

The final guidance document will clarify our intent to use some information from existing international registries for the portal. Sponsors would not be required to provide duplicate information to Health Canada.

In the consultation, we asked respondents to tell us which controlled vocabularies they use in their data management and transparency practices.

The top 4 are:

Medical Dictionary for Regulatory Activities (MedDRA) – 46%
Systematized Nomenclature of Medicine - Clinical Terms (SNOMED-CT) – 18%
Medical Subject Headings (MeSH) vocabulary - 11%
World Health Organization International Classification of Diseases (WHO ICD) – 9%

Used less frequently are:

Cochrane Vocabulary
Universal Patient Language (UPL)
Unified Medical Language System (UMLS)
Common Terminology Criteria for Adverse Events (CTCAE)
Health Canada's Natural Health Products Ingredients Database (NHPID)

We also asked stakeholders where they go online for more information about clinical trials.

The top 6 are:

ClinicalTrials.gov – 34%
European databases – 24%
- European Union Clinical Trials Information System (CTIS)
- European Union Drug Regulating Authorities Clinical Trials Database (EudraCT)
WHO ICTRP – 8%
Health Canada's Clinical Trials Database – 4%
Google – 4%
United Kingdom's ISRCTN – 4%

Other sources were the Australian New Zealand Clinical Trials Registry (ANZCTR), PubMed, Canadian Cancer Trials, trialfinder.cysticfibrosis.ca, OncoQuebec and the Mayo clinic.

Mock-ups for the portal

In the consultation, we provided mock-ups of the proposed portal.

Some respondents did not understand how each of the screens related to each other.

Overall, the comments were positive, with many in favour of the similar appearance and functionality with other clinical trial sites.

Many respondents said the language was appropriate for a general, non-technical audience. They liked that there are definitions for more technical terms and obscure concepts.

Some respondents said there should be general information about the portal, such as:

its purpose
its limitations
what's included
when it's updated
general instructions for proper use

Some respondents said we should consult with specific user groups, such as older populations (65 and over), patients and caregivers, to make sure the language is appropriate and relevant for them. Some French language users said it's important to consider regional differences and data dictionaries used when we translate content. For example, terms from France may not be similar to those used in Canada and may affect the ability to search.

Next steps

The comments we received during the consultation process helped to guide changes, which are reflected in the final published guidance document and the clinical trials search portal.

As we move toward proposed future regulations, we intend to continue to engage stakeholders and subject matter experts.

Acknowledgments

Health Canada thanks everyone who took part in the consultation. We heard from several sectors, including academia and research institutes, industry, patient advocacy groups, health care providers and health care organizations.

Contact us

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St
6th Fl, Holland Cross, Tower B
Ottawa ON K1A 0K9
Mail stop 3106C
Email: ct.portal.team-equipe.portail.ec@hc-sc.gc.ca

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2026-07-28