Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study - PubMed (original) (raw)

Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

Andrew P Prayle et al. BMJ. 2012.

Free article

Abstract

Objective: To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation.

Design: Registry based study of clinical trial summaries.

Data sources: ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year. Selection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009.

Main outcome measure: Proportion of trials for which results had been reported.

Results: The ClinicalTrials.gov registry contained 83,579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; χ(2) test, P = 2.6 × 10(-9)). Later phase trials were more likely to report results (P = 4.4 × 10(-11)), as were industry funded trials (P = 2.2 × 10(-16)).

Conclusion: Most trials subject to mandatory reporting did not report results within a year of completion.

PubMed Disclaimer

Cited by

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study.
Earley A, Lau J, Uhlig K. Earley A, et al. BMJ Open. 2013 Jan 18;3(1):e001963. doi: 10.1136/bmjopen-2012-001963. BMJ Open. 2013. PMID: 23335556 Free PMC article.
Clinical Trial Outcomes in Urology: Assessing Early Discontinuation, Results Reporting and Publication in ClinicalTrials.Gov Registrations 2007-2019.
Magnani CJ, Steinberg JR, Harmange CI, Zhang X, Driscoll C, Bell A, Larson J, You JG, Weeks BT, Hernandez-Boussard T, Turner BE, Brooks JD. Magnani CJ, et al. J Urol. 2021 Apr;205(4):1159-1168. doi: 10.1097/JU.0000000000001432. Epub 2020 Oct 20. J Urol. 2021. PMID: 33079618 Free PMC article.
The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency.
Pansieri C, Pandolfini C, Bonati M. Pansieri C, et al. Eur J Clin Pharmacol. 2015 Oct;71(10):1159-64. doi: 10.1007/s00228-015-1897-9. Epub 2015 Aug 5. Eur J Clin Pharmacol. 2015. PMID: 26242226 Review.
Trial registration, publication rate and characteristics in the research field of otology: A cross-sectional study.
van Heteren JAA, van Beurden I, Peters JPM, Smit AL, Stegeman I. van Heteren JAA, et al. PLoS One. 2019 Jul 10;14(7):e0219458. doi: 10.1371/journal.pone.0219458. eCollection 2019. PLoS One. 2019. PMID: 31291350 Free PMC article.
Sponsorship, conflict of interest, risk of bias, and reporting of participant's flow and baseline demographic information in studies applicable to the federal law to post the results in clinicaltrials.gov.
Shamliyan TA, Sundarrajan R, Camper D, Middleton M, Kadambalithaya AP. Shamliyan TA, et al. Contemp Clin Trials Commun. 2016 Nov 24;5:19-25. doi: 10.1016/j.conctc.2016.11.005. eCollection 2017 Mar. Contemp Clin Trials Commun. 2016. PMID: 29740619 Free PMC article. No abstract available.

Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study - PubMed (original) (raw)