Article type
Abstract
Background
Many funders now require results of clinical trials to be reported on trial registries within 12 months of study completion. This would enable systematic reviewers to access results for the ~50% of studies that are unpublished, reducing publication bias. However, reporting practices and requirements vary greatly between different clinical trial registries and the limited reporting of results undermines their importance and usability for research transparency and evidence synthesis purposes.
Objective
To (1) provide an overview of results reporting practices on clinical trial registries and (2) improve the frequency and quality of results reporting in clinical trial registries by identifying barriers and facilitators.
Methods
We will perform a 2-part mixed-methods study. Part 1: Descriptive analysis of results reporting practices on selected clinical trial registries within the World Health Organization (WHO) Registry Network (1 per region). The study cohort will comprise a random sample of randomized clinical trials from each registry that were completed between 2020 and 2022. Part 2: Online survey of registrants regarding their experience in reporting results in a clinical trial record, as well as a separate online survey of evidence users regarding their experience in using data from clinical trial records, including key barriers and facilitators.
Results
We will present our findings of parts 1 and 2, as well as recommendations to improve results reporting in clinical trial registries at the conference.
Conclusion
Addressing barriers to results reporting in clinical trial registries is a critical step in ensuring research transparency and usability of clinical trial registry data for systematic reviews and other further analysis.
Relevance and Importance for Patients
This research seeks to improve reporting of clinical trial results on clinical trials registries. This increased transparency honors the contributions of trial participants by enabling re(use) of clinical trial data (eg, for meta-analysis), mitigates bias, and can prevent patients from being overburdened by participating in unnecessary duplicative research.
Many funders now require results of clinical trials to be reported on trial registries within 12 months of study completion. This would enable systematic reviewers to access results for the ~50% of studies that are unpublished, reducing publication bias. However, reporting practices and requirements vary greatly between different clinical trial registries and the limited reporting of results undermines their importance and usability for research transparency and evidence synthesis purposes.
Objective
To (1) provide an overview of results reporting practices on clinical trial registries and (2) improve the frequency and quality of results reporting in clinical trial registries by identifying barriers and facilitators.
Methods
We will perform a 2-part mixed-methods study. Part 1: Descriptive analysis of results reporting practices on selected clinical trial registries within the World Health Organization (WHO) Registry Network (1 per region). The study cohort will comprise a random sample of randomized clinical trials from each registry that were completed between 2020 and 2022. Part 2: Online survey of registrants regarding their experience in reporting results in a clinical trial record, as well as a separate online survey of evidence users regarding their experience in using data from clinical trial records, including key barriers and facilitators.
Results
We will present our findings of parts 1 and 2, as well as recommendations to improve results reporting in clinical trial registries at the conference.
Conclusion
Addressing barriers to results reporting in clinical trial registries is a critical step in ensuring research transparency and usability of clinical trial registry data for systematic reviews and other further analysis.
Relevance and Importance for Patients
This research seeks to improve reporting of clinical trial results on clinical trials registries. This increased transparency honors the contributions of trial participants by enabling re(use) of clinical trial data (eg, for meta-analysis), mitigates bias, and can prevent patients from being overburdened by participating in unnecessary duplicative research.