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Abstract
Introduction
Methods
Results
Discussion
Comparison with literature
Strengths and limitations of study
Conclusions and policy implications
What is already known on this topic
- Reporting bias prevents the dissemination of results of clinical trials
- Where trial data are not accessible to practitioners, clinical decisions cannot be based on the best evidence and may be flawed
- Recent US legislation mandates publication of a results summary on ClincalTrials.gov for recent trials of drugs approved by the Food and Drug Administration and should improve access to trial results
What this study adds
- At the time of the search, many trials that should have published data on ClincalTrials.gov had not done so
Notes
Footnotes
- Contributors: APP, MNH, and ARS designed the study. APP wrote the script to webscrape additional data from ClinicalTrials.gov. APP categorised the trials, MNH cross checked a subset, and ARS arbitrated. All authors had full access to the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors wrote the manuscript. APP and MNH contributed equally to this work. ARS is the guarantor.
- Funding: The study was not externally funded.
- Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that APP is supported by a National Institute for Health Research fellowship (DRF-2009-02-112) and MNH is supported by a Wellcome Trust fellowship (WT092295AIA). ARS declares relevant activities outside the submitted work of membership of a REMPEX steering committee, consultancies for Novartis and Biocontrol, and a lecture paid for by Chiesi Pharma. ARS has registered trials on ClinicalTrials.gov and other registries.
- Ethical approval: Not needed.
- Data sharing: Technical appendix, statistical code, and dataset available from the corresponding author (andrew.prayle@nottingham.ac.uk) or at http://dx.doi.org/10.5061/dryad.j512f21p. Participants’ consent for data sharing not required.