Once the clinical trial has finished and the results have been analysed, the results should be shared with other researchers and with the trial participants.
The results of an investigator-initiated trial would seldom be written up as a Clinical Study Report (CSR). This would only be required if the clinical trial was going to form part of a submission to a regulatory authority to register a new medicine or device or register a new indication for an existing medicine/device.
When a CSR is required, the trial results need to be presented in the format defined by the ICH guideline, Structure and Content of Clinical Study Reports. The trial Sponsor would usually delegate the task of writing the CSR to a Medical Writer.
It is important to enable the sharing of individual participant data (IPD) from a trial with other researchers, see Data Sharing.
Publication of all clinical trial results, regardless of outcome or significance of findings, is not only an ethical responsibility but also enables the efficacy of interventions to be validated, while preventing undue risk to patients and waste of resources.
When reporting the results of trials, researchers should use the Consolidated Standards of Reporting Trials (CONSORT statement) and Better Reporting of Harms in Randomised Trials: An Extension of the CONSORT Statement, to facilitate quality reporting of efficacy and safety data.
The International Committee of Medical Journal Editors (ICMJE), the World Association of Medical Editors (WAME) and over 600 biomedical journals endorse the CONSORT 2019 Statement and The Lancet recommends authors follow the CONSORT harms extension in their Information for Authors.
The Sponsor-Investigator is also responsible for ensuring that any publication meets the requirements of the NHMRC guideline, Authorship: A guide supporting the Australian Code for the Responsible Conduct of Research when determining authorship rights and acknowledging any contribution from Aboriginal and Torres Strait Islander people and their knowledge.
The trial registry ClinicalTrials.gov requires summary results to be submitted for trials of investigational products approved, licensed or cleared by the FDA and meets one or more of the following:
Results to be submitted include participant flow, demographic and baseline characteristics, primary and secondary outcomes and adverse event information.
Results must be submitted no later than one year after the final study participant was examined or received an intervention for the purpose of the final collection of data for the primary outcome.
Further information may be obtained from the Frequently Asked Questions page on ClinicalTrials.gov.
A final letter should be provided to participants summarising the overall results of the trial and thanking them for their participation.
This letter must be approved by the approving HREC. Ethics review will consider requirements of the NHMRC: National Statement on Ethical Conduct in Human Research, in particular, Element 5: Communication of research findings or results to participants.
