Maximising the impact of every clinical trial using the ANZCTR
Once a trial is complete, sharing its results and documents on a publicly accessible website can substantially extend its impact – benefiting not only those who participated in or conducted the trial, but also the wider community.
Why share trial results and documents?
- Greater visibility of the trial – adding trial results online makes them easier to find, increasing the chance they will be discovered and used by others
- Wider dissemination – publicly available results can help inform policy, clinical practice and future research
- Support re-use of trial information – sharing results can be used in, for example:
- Health technology assessments that guide government decisions on funding new medicines and devices,
- Systematic reviews and meta-analyses that combine results from multiple similar trials to answer health questions that an individual trial alone cannot address, and
- New analyses that address emerging health questions using existing trial results
- Comply with international reporting requirements for clinical trials
- Build public trust – being transparent about how a trial is conducted and the results when finished helps build confidence in research.
How can the ANZCTR help?
The ANZCTR makes it easy to share trial results and documents with the public. It is free to use and offers options on how to provide published and unpublished information. If there are concerns about sharing results due to intellectual property or confidentiality – this can wait. Results and documents can be uploaded later, once concerns are resolved.
There are three ways this can be done:
- Add the ACTRN (registration number) in all trial documents. The ANZCTR can automatically detect and display many of these documents on its public website.
- Upload unpublished documents directly to the ANZCTR. This can be a Word document (using the ANZCTR template) or a PDF. The upload process is quick.
- Add published documents to the ANZCTR. This includes uploading a PDF or Word document, or by submitting a digital object identifier (DOI) or full citation details.
Below is a summary of international rules in place on reporting trial results, and a table outlining options available to report trial results on the ANZCTR.
Are there rules about making trial results public?
Yes. Sharing trial results and documents isn’t just good practice – it’s often a requirement. Timeframes may vary but results are generally expected to be reported with 24 months of the last participant’s follow-up.
Internationally:
- World Health Assembly Resolution 78.5 (section 1, 6, c)1 and World Health Organization (WHO) Joint Statement, endorsed by the world’s largest funders2, require results from all trials to be publicly reported on WHO-compliant trial registries
- ICH E6 (R3) Good Clinical Practice guidelines (section 3.17.2)3 and Joint Statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO4 reinforce the obligation to publicly disclose results of medicine and vaccine trials
- International Committee of Medical Journal Editors (ICMJE) encourages linking published trial results to public trial registry entries
- In the USA5 and EU6, it is legally required to report results from medicine or device trials, or both, on public trial registries.
New Zealand: the Health Research Council of New Zealand7 requires trial results to be reported within 12 months of the last participant’s visit. They actively monitor compliance and encourage researchers to post trial results on the ANZCTR.
Australia: while there are no mandatory requirements yet, the ANZCTR is committed to improving trial results reporting. It continues to advocate that funders adopt international standards.
How to share trial results on the ANZCTR
Document type | Required under WHO or other policies? | How to share on the ANZCTR? |
Trial protocol, including major amendments | Yes – as per: - WHO Joint Statement (endorsed by major funders)
- WHO trial registry standard
- some funders (e.g. National Institute for Health and Care Research UK, Wellcome Trust)
- Health Studies Australian National Data Asset (HeSANDA) initiative for Australian trials part of a HeSANDA node
| Upload a document, or provide a DOI or link |
Statistical analysis plan | Yes – as per: | Upload a document, or provide a DOI or link |
Data dictionary | Sometimes – required if part of HeSANDA initiative | Upload a document, or provide a DOI or link |
Trial results | Yes – as per: | Upload a document, or provide a DOI or link |
Lay result summaries for the public | Not required, but encouraged | Upload a document, or provide a DOI or link |
Individual participant data (IPD) of all collected data or a subset of collected data | Not required, but trials recruiting since 1 January 2019 must indicate whether they intend to share IPD. As per: | Complete the IPD sharing questions in the ANZCTR form |