{"entity":{"id":"paper-anderson-n-engl-j-med","kind":"paper","name":"Compliance with results reporting at ClinicalTrials.gov","aka":[],"tldr":"Paper cited by one bottleneck page and 14 idea pages, indexed on Europe PMC as PubMed record 25760355 and published in New England Journal of Medicine; the citing pages link this DOI, which is how the record was matched.","summary":"Background: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.\n\nMethods: Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period.\n\nResults: From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.\n\nConclusions: Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).\n\nIndexed on Europe PMC as PubMed record 25760355 (DOI 10.1056/nejmsa1409364). Matched by DOI alone: one bottleneck page and 14 idea pages cite this DOI among their external links (the pages are listed under Related), and this page was written so that the citation resolves inside OnCo. No figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"N Engl J Med 2015","url":"https://doi.org/10.1056/nejmsa1409364"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/25760355/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/25760355"}],"tags":["europepmc-ingest"],"related":["b-negative-results","idea-tr2-negative-results-journal","idea-moon-negative-results-ledger","idea-tr2-failure-taxonomy","idea-tr2-reversal-registry","idea-tr2-preclinical-negative-registry","idea-tr2-negative-plenaries","idea-tr2-null-result-reporting","idea-tr2-material-failure-disclosure","idea-tr2-irb-results-gate","idea-tr2-termination-reports","idea-tr2-off-label-outcome-registry","idea-tr2-failed-trial-biobank","idea-tr2-model-report-cards","idea-tr2-writeup-grants"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2015,"doi":"10.1056/nejmsa1409364","pmid":"25760355","authors":"Anderson ML, Chiswell K, Peterson ED, et al.","paperType":"observational","findings":[],"whatItMeans":"One bottleneck page and 14 idea pages on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.","caveats":["Matched to the citing OnCo records by DOI alone; the summary reproduces the Europe PMC abstract and no figure has been verified against the full paper."]},"route":"/key-papers/paper-anderson-n-engl-j-med/","neighbours":{"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"}],"idea":[{"id":"idea-tr2-negative-results-journal","kind":"idea","name":"A funder-backed, indexed journal of negative and inconclusive cancer results","route":"/ideas/idea-tr2-negative-results-journal/"},{"id":"idea-moon-negative-results-ledger","kind":"idea","name":"A global ledger of negative results and failed compounds with mandatory deposition","route":"/ideas/idea-moon-negative-results-ledger/"},{"id":"idea-tr2-failure-taxonomy","kind":"idea","name":"A machine-readable taxonomy of why cancer drugs fail","route":"/ideas/idea-tr2-failure-taxonomy/"},{"id":"idea-tr2-reversal-registry","kind":"idea","name":"A public registry of cancer treatments that were later shown not to work","route":"/ideas/idea-tr2-reversal-registry/"},{"id":"idea-tr2-preclinical-negative-registry","kind":"idea","name":"A registry for preclinical experiments that did not work","route":"/ideas/idea-tr2-preclinical-negative-registry/"},{"id":"idea-tr2-negative-plenaries","kind":"idea","name":"Give negative trials plenary slots at the big cancer conferences","route":"/ideas/idea-tr2-negative-plenaries/"},{"id":"idea-tr2-null-result-reporting","kind":"idea","name":"Grant progress reports must list what did not work","route":"/ideas/idea-tr2-null-result-reporting/"},{"id":"idea-tr2-material-failure-disclosure","kind":"idea","name":"Listed companies must disclose top-line data, not just 'did not meet endpoint'","route":"/ideas/idea-tr2-material-failure-disclosure/"},{"id":"idea-tr2-irb-results-gate","kind":"idea","name":"No new trial approval until the sponsor has reported its old ones","route":"/ideas/idea-tr2-irb-results-gate/"},{"id":"idea-tr2-termination-reports","kind":"idea","name":"Public post-mortem reports when a cancer drug programme is stopped","route":"/ideas/idea-tr2-termination-reports/"},{"id":"idea-tr2-off-label-outcome-registry","kind":"idea","name":"Record what happens when doctors use cancer drugs off-label","route":"/ideas/idea-tr2-off-label-outcome-registry/"},{"id":"idea-tr2-failed-trial-biobank","kind":"idea","name":"Rescue the biological samples from failed trials for biomarker research","route":"/ideas/idea-tr2-failed-trial-biobank/"},{"id":"idea-tr2-model-report-cards","kind":"idea","name":"Score every preclinical model by how often it predicted the clinical result","route":"/ideas/idea-tr2-model-report-cards/"},{"id":"idea-tr2-writeup-grants","kind":"idea","name":"Small grants that pay scientists to write up abandoned projects","route":"/ideas/idea-tr2-writeup-grants/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}