Advertisement

Clinical trial registries and publication of results — a primer

  • MaryAnn Foote

Keywords

Clinical Trial Registry Fair Access Clinical Trial Information Thrombotic Cardiovascular Event Drug Sponsor 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Simes RJ (1986) Publication bias: the case for an international registry of clinical trials. J Clin Oncol 4: 1529–1541PubMedGoogle Scholar
  2. 2.
    Chalmers I (1990) Underreporting research is scientific misconduct. JAMA 263: 1405–1408PubMedCrossRefGoogle Scholar
  3. 3.
    Davidoff F, DeAngelis CD, Drazen JM et al (2001) Sponsorship, authorship, and accountability. N Engl J Med 345: 825–826PubMedCrossRefGoogle Scholar
  4. 4.
    Office of the New York State Attorney General Eliot Spitzer. Major pharmaceutical firm concealed information. Available at http://www.oag.state.ny.us/press/2004/jun/jun2b_04.html (Accessed 17 March 2005)Google Scholar
  5. 5.
    GlaxoSmithKline Clinical Trial register. Available at http;//ctr.gsk.co.uk/welcome.asp (Accessed 23 March 2005)Google Scholar
  6. 6.
    Merck. Merck announces voluntary worldwide withdrawal of VIOXX. September 30, 2004. Available at http://www.merck.co.vioxx_withdrawl/pdf/vioxx_press_release_final.pdf (Accessed 13 April 2006)Google Scholar
  7. 7.
    Gregory D, Curfman GD, Morrissey S, Drazen JM (2005) Expression of concern: Bombardier et al., “Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis” N Engl J Med 353: 2813–2814CrossRefGoogle Scholar
  8. 8.
    Bombardier C, Laine L, Reicin A et al (2000) Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 343: 1520–1528PubMedCrossRefGoogle Scholar
  9. 9.
    Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M (2004) Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 364: 2021–2029PubMedCrossRefGoogle Scholar
  10. 10.
    Bombardier C, Laine L, Burgos-Vargas R et al (2006) Response to expression of concern regarding VIGOR study. N Engl J Med 354: 1196–1199PubMedCrossRefGoogle Scholar
  11. 11.
    Silverstein FE, Faich G, Goldstein JL et al (2000) for the Celecoxib Long-Term Arthritis Safety Study. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 284: 1247–1255PubMedCrossRefGoogle Scholar
  12. 12.
    Solomon SD, McMurray JJ, Pfeffer MA et al (2005) Adenoma Prevention with Celecoxib (APC) Study Investigators. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352: 1071–1080PubMedCrossRefGoogle Scholar
  13. 13.
    Hrackovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 386: 2398Google Scholar
  14. 14.
    Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 286: 954–959Google Scholar
  15. 15.
    Pitt B, Pepine C, Willerson JT. Cyclooxygenase-2 inhibition and cardiovascular events. Circulation 106: 167–169Google Scholar
  16. 16.
    Mamdani M, Rochon P, Juurlink DN et al (2003) Effect of selective cyclooxygenase-2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly. Arch Intern Med 163: 481–486PubMedCrossRefGoogle Scholar
  17. 17.
    Solomon DH, Schneesweiss S, Glynn RJ et al (2004) Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 109: 2068–2073PubMedCrossRefGoogle Scholar
  18. 18.
    Graham DJ, Campen D, Hui R et al (2005) Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclooxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 365: 475–481PubMedGoogle Scholar
  19. 19.
    Eckert CH. Bioequivalence of levothyroxine preparations: industry sponsorship and academic freedom. JAMA 277: 1200–1201Google Scholar
  20. 20.
    Rennie D (1997) Thyroid storm. JAMA 277: 1238–1243PubMedCrossRefGoogle Scholar
  21. 21.
    Spigelman MK. Bioequivalence of levothyroxine preparations for treatment of hypothyroidism. JAMA 277: 1199–1200Google Scholar
  22. 22.
    Weiss RB, Rifkin RM, Stewart FM et al (2000) High-dose chemotherapy for high-risk primary breast cancer: an on-site review of the Bezwoda study. Lancet 355: 999–1003PubMedCrossRefGoogle Scholar
  23. 23.
    Weiss RB, Gill CG, Hudis CA (2001) An on-site audit of the South African trial of high-dose chemotherapy for metastatic breast cancer and associated publications. J Clin Oncol 19: 2771–2777PubMedGoogle Scholar
  24. 24.
    European Commission. Enterprise an Industry Directorate-General. Guideline on the data fields from the European clinical trials database (EudraCT) that may be included in the European data base on Medicinal Products. Available at: http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/03_05/Draft_guid_EudraCT_data_20050303.pdf (Accessed 17 March 2005)Google Scholar
  25. 25.
    United States Food and Drug Administration. Section 113 Food and Drug Administration Modernization Act of 1997. Available at: http://lhncbc.nlm.nih.gov/clin/113.html (Accessed 8 February 2006)Google Scholar
  26. 26.
    Fair Access to Clinical Trials Act of 2004, US Senate, S 2933, 108th Congress, Second Session. Available at: http://www.govtrack.us/data/us/bills.text/108/s2933.pdf (Accessed 9 February 2006)Google Scholar
  27. 27.
    Fair Access to Clinical Trials Act of 2004, House of Representatives, HR 5252, 108th Congress, Second Session. Available at: http://www.govtrack.us/data/us/bills.text/108/h5252.pdf (Accessed 9 February 2006)Google Scholar
  28. 28.
    Virginia. HB 2831/SB 1278. Publication of clinical trial results. Available at http://leg1.state.va.us/cgi-bin/legp504.exe?051+ful+CHAP0199 (Accessed 6 April 2006)Google Scholar
  29. 29.
    Maine. Governor’s Office of Health Policy and Finance. An Act Regarding Advertising by Drug Manufacturers and Disclosure of Clinical Trials. Available at http://www.maine.gov/dhhs (Accessed 5 April 2006)Google Scholar
  30. 30.
    De Angelis C, Drazen JM, Frizelle FA et al (2004) Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 292: 1363–1364CrossRefGoogle Scholar
  31. 31.
    De Angelis C, Drazen JM, Frizelle FA, et al (2004) Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA 293: 2927–2929CrossRefGoogle Scholar
  32. 32.
    Abbasi K (2004) Compulsory registration of clinical trials. BMJ 329: 637–638PubMedCrossRefGoogle Scholar
  33. 33.
    Pharmaceutical Research and Manufacturer’s Association. PhRMA adopts principles for conduct of clinical trials and communication of clinical trial results. Available at: http://www.phrma.org/mediaroom/press/releases/20.06.2002.427.cfm (Accessed 28 May 2003)Google Scholar
  34. 34.
    Pharmaceutical Research and Manufacturer’s Association. Pharmaceutical companies to make more information available about clinical trials. Available at http://www.phrma.org/mediaroom/press/releases/06.01.2005.1112.cfm (Accessed 13 March 2005)Google Scholar
  35. 35.
    Pharmaceutical Research and Manufacturer’s Association. International alliance of pharmaceutical associations agrees on principles for disclosing information Available at http://www.phrma.org/mediaroom/press/releases/06.01.2005.1114.cfm (Accessed 13 March 2005)Google Scholar
  36. 36.
    Bennett NL, Casebeer LL, Kristofeo RE, Strasser SM (2004) Physicians’ Internet information-seeking behaviors. J Conting Ed Health Profess 24: 31–38CrossRefGoogle Scholar
  37. 37.
    Lee J (2004) The power of negative thinking. Can J Emerg Med 6: 359–361Google Scholar

Copyright information

© Birkhäuser Verlag Basel/Switzerland 2006

Authors and Affiliations

  • MaryAnn Foote
    • 1
  1. 1.Abraxis BioScience, Inc.Los AngelesUSA

Personalised recommendations