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dc.contributor.author Prayle, Andrew P.
dc.contributor.author Hurley, Matthew N.
dc.contributor.author Smyth, Alan R.
dc.coverage.spatial United States
dc.date.accessioned 2012-01-04T16:54:30Z
dc.date.available 2012-01-04T16:54:30Z
dc.date.issued 2012-01-04
dc.identifier doi:10.5061/dryad.j512f21p
dc.identifier.citation Prayle AP, Hurley MN, Smyth AR (2012) Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 343: d7373.
dc.identifier.uri http://hdl.handle.net/10255/dryad.36676
dc.description 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%; χ2 test, P=2.6x10^-9). Later phase trials were more likely to report results (P=4.4x 10^-11), as were industry funded trials (P=2.2 x10^-16). CONCLUSION: Most trials subject to mandatory reporting did not report results within a year of completion.
dc.relation.haspart doi:10.5061/dryad.j512f21p/1
dc.relation.haspart doi:10.5061/dryad.j512f21p/2
dc.relation.haspart doi:10.5061/dryad.j512f21p/3
dc.relation.haspart doi:10.5061/dryad.j512f21p/4
dc.relation.haspart doi:10.5061/dryad.j512f21p/5
dc.relation.haspart doi:10.5061/dryad.j512f21p/6
dc.relation.haspart doi:10.5061/dryad.j512f21p/7
dc.relation.isreferencedby doi:10.1136/bmj.d7373
dc.relation.isreferencedby PMID:22214756
dc.subject Reporting bias
dc.subject Clinical Trials
dc.title Data from: Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study
dc.type Article *
dc.contributor.correspondingAuthor Prayle, Andrew P.
prism.publicationName BMJ

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Title clinicaltrials.gov_search
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Description This is complete original dataset.
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Download clinicaltrials.gov_search.txt (73.36 Mb)
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Title identify completed trials
Downloaded 647 times
Description This is the R script which when run on "clinicaltrials.gov_search.txt" will produce a .csv file which lists all the completed trials.
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Title FDA_table_with_sens
Downloaded 770 times
Description This is the final dataset after cross referencing the trials. An explanation of the variables is included in the supplementary file "2011-10-31 Prayle Hurley Smyth Supplementary file 3 variables in the dataset".
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Title analysis_after_FDA_categorization_and_sens
Downloaded 571 times
Description This R script reproduces the analysis from the paper, including the tables and statistical tests. The comments should make it self explanatory.
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Title 2011-11-02 prayle hurley smyth supplementary file 1 STROBE checklist
Downloaded 414 times
Description This is a STROBE checklist for the study
Download 2011-11-02 prayle hurley smyth supplement...st.rtf (76.36 Kb)
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Title 2011-10-31 Prayle Hurley Smyth Supplementary file 2 examples of categorization
Downloaded 438 times
Description This is a supplementary file which illustrates some of the decisions which had to be made when categorizing trials.
Download 2011-10-31 Prayle Hurley Smyth Supplement...on.rtf (64.52 Kb)
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Title 2011-10-31 Prayle Hurley Smyth Supplementary file 3 variables in the dataset
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Description This file lists and describes the sources of all the variables used in the final analysis.
Download 2011-10-31 Prayle Hurley Smyth Supplement...et.rtf (78.62 Kb)
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