Non-publication, incomplete publication and excessively slow publication of clinical trial outcomes contribute to research waste and can harm patients. In this cohort study, we used public ClinicalTrials.gov registry records to identify 81 paediatric clinical trials in the United States that appear to have violated the FDA Amendments Act 2007 (FDAAA) reporting requirements. We then searched the literature for the outcomes of these 81 trials and contacted trial sponsors about the status of results. We found that only 22/81 trials (27.2%) had made their results public in a full-length peer-reviewed publication, and that only 8/81 (9.9%) trials had done so within one year of their primary completion date. Our findings highlight the need for US Food and Drug Administration and the National Institutes of Health to systematically monitor FDAAA compliance and enforce reporting requirements.
This study provides a snapshot of the scale of legacy research waste in the UK. It assesses the current publication status of 145 clinical trials sponsored by ten major UK non-commercial sponsors that were completed or terminated in 2017. Following outreach to sponsors and short-term follow-up, 116/145 trials (80%) had fully reported results, and 11/145 trials (8%) had reported results in the grey literature. Results for 18/145 trials (12%) that enrolled 637 people remained completely unpublished as of early March 2023. Sponsors indicated that they plan to make public the results of 14/18 unreported trials. Our study had an impact on accelerating the reporting of some results, and seems likely to lead to future reductions in research waste. We propose three changes to UK Health Research Authority policies that could improve clinical trial reporting.
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