clinical trial

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[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]

Notes

  • a control group for comparison with an experimental or study group forms the basis for data analysis[9]
  • positive results of pharmaceutical trials tend to be published
  • negative results of pharmaceutical trials tend not to be published or to tend to be published in a manner that portrays a positive effect, often conflicting with FDA's analysis[6]
  • this may lead to clinicians overestimating efficacy of drugs.
  • only ~75% of completed trials listed in www.clinicaltrials.gov are published (online or in print)[10]
  • U.S. Department of Health and Human Services on proposed new rules that would expand the number of clinical trials that companies and researchers are required to report
    • new rule would expand the reporting requirements to include all trials of unapproved, unlicensed, and uncleared products
    • second proposal would also require the publication of all clinical trials funded by the NIH[11]
  • expanded recommendations for open data access[12][13][14]

More general terms

More specific terms

References

  1. ↑ http://www.clinicaltrials.gov
  2. ↑ Applying Study Results to Patient Care: Glossary of Study Design and Statistical Terms Prescriber's Letter 11(5):25 2004 Prescriber's Letter 11(7):37 2004 (updated chart) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200715&pb=PRL (subscription needed) http://www.prescribersletter.com
  3. ↑ Prescriber's Letter 11(10): 2004 Worksheet to Evaluate Drug Studies Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=201012&pb=PRL (subscription needed) http://www.prescribersletter.com
  4. ↑ Prescriber's Letter 12(5): 2005 Worksheet to Evaluate Drug Studies Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210610&pb=PRL (subscription needed) http://www.prescribersletter.com
  5. ↑ Junghans C et al, Recruiting patients to medical research: Double blind ramdomized trial of 'opt-in' vs 'opt-out' strategies. BMJ 331:940, 2005 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16157604
  6. ↑ 6.0 6.1 Turner EH et al, Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008, 358:252 PMID: https://www.ncbi.nlm.nih.gov/pubmed/18199864
  7. ↑ McCormack J, Greenhalgh T. Seeing what you want to see in randomised controlled trials: versions and perversions of UKPDS data. United Kingdom prospective diabetes study. BMJ. 2000 Jun 24;320(7251):1720-3. PMID: https://www.ncbi.nlm.nih.gov/pubmed/10864554
  8. ↑ Trotta F, Apolone G, Garattini S, Tafuri G. Stopping a trial early in oncology: for patients or for industry? Ann Oncol. 2008 Apr 9. [Epub ahead of print] <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/18304961 <Internet> http://dx.doi.org/doi:10.1093/annonc/mdn042
  9. ↑ 9.0 9.1 Ho PM, Peterson PN, Masoudi FA Evaluating the evidence: is there a rigid hierarchy? Circulation. 2008 Oct 14;118(16):1675-84 PMID: https://www.ncbi.nlm.nih.gov/pubmed/18852378
  10. ↑ 10.0 10.1 Jones CW et al. Non-publication of large randomized clinical trials: Cross sectional analysis. BMJ 2013 Oct 29; 347:f6104 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24169943 <Internet> http://www.bmj.com/content/347/bmj.f6104
  11. ↑ 11.0 11.1 National Institutes of Health. News & Events. Nov. 19, 2014 HHS and NIH take steps to enhance transparency of clinical trial results. http://www.nih.gov/news/health/nov2014/od-19.htm
  12. ↑ 12.0 12.1 Institute of Medicine. Jan 14, 2015 Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. http://www.iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx
    Drazen JM Sharing Individual Patient Data from Clinical Trials. N Engl J Med 2015; 372:201-202. January 15, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25587944 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMp1415160
  13. ↑ 13.0 13.1 Taichman DB et al Sharing Clinical Trial Data - A Proposal from the International Committee of Medical Journal Editors. N Engl J Med. January 20, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26786954 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1515172
  14. ↑ 14.0 14.1 Haug CJ From Patient to Patient - Sharing the Data from Clinical Trials. N Engl J Med. May 10, 2016 Perspective <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27168009 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMp1605378
  15. ↑ The Yoda project Yale University Open Data Access http://yoda.yale.edu/
  16. ↑ van Delden JJ, van der Graaf R Revised CIOMS International Ethical Guidelines for Health- Related Research Involving Humans. JAMA. Published online December 6, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27923072 <Internet> http://jamanetwork.com/journals/jama/fullarticle/2592245
  17. ↑ Tinetti ME. The gap between clinical trials and the real world: extrapolating treatment effects from younger to older adults. JAMA Intern Med. 2014 Mar;174(3):397-8. PMID: https://www.ncbi.nlm.nih.gov/pubmed/24424303
  18. ↑ Tatsioni A, Karassa FB, Goodman SN et al. Lost evidence from registered large long-unpublished randomized controlled trials: A survey. Ann Intern Med 2019 May 7; PMID: https://www.ncbi.nlm.nih.gov/pubmed/31060046 https://annals.org/aim/article-abstract/2732839/lost-evidence-from-registered-large-long-unpublished-randomized-controlled-trials
    Wallach JD, Krumholz HM. Not reporting results of a clinical trial is academic misconduct. Ann Intern Med 2019 May 7; PMID: https://www.ncbi.nlm.nih.gov/pubmed/31060050 https://annals.org/aim/article-abstract/2732840/reporting-results-clinical-trial-academic-misconduct
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