This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsPreview
Unable to display preview. Download preview PDF.
References
Simes RJ (1986) Publication bias: the case for an international registry of clinical trials. J Clin Oncol 4: 1529–1541
Chalmers I (1990) Underreporting research is scientific misconduct. JAMA 263: 1405–1408
Davidoff F, DeAngelis CD, Drazen JM et al (2001) Sponsorship, authorship, and accountability. N Engl J Med 345: 825–826
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)
GlaxoSmithKline Clinical Trial register. Available at http;//ctr.gsk.co.uk/welcome.asp (Accessed 23 March 2005)
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)
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: 2813–2814
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: 1520–1528
Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M (2004) Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 364: 2021–2029
Bombardier C, Laine L, Burgos-Vargas R et al (2006) Response to expression of concern regarding VIGOR study. N Engl J Med 354: 1196–1199
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: 1247–1255
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: 1071–1080
Hrackovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 386: 2398
Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 286: 954–959
Pitt B, Pepine C, Willerson JT. Cyclooxygenase-2 inhibition and cardiovascular events. Circulation 106: 167–169
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: 481–486
Solomon DH, Schneesweiss S, Glynn RJ et al (2004) Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 109: 2068–2073
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: 475–481
Eckert CH. Bioequivalence of levothyroxine preparations: industry sponsorship and academic freedom. JAMA 277: 1200–1201
Rennie D (1997) Thyroid storm. JAMA 277: 1238–1243
Spigelman MK. Bioequivalence of levothyroxine preparations for treatment of hypothyroidism. JAMA 277: 1199–1200
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: 999–1003
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: 2771–2777
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)
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)
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)
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)
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)
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)
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: 1363–1364
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: 2927–2929
Abbasi K (2004) Compulsory registration of clinical trials. BMJ 329: 637–638
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)
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)
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)
Bennett NL, Casebeer LL, Kristofeo RE, Strasser SM (2004) Physicians’ Internet information-seeking behaviors. J Conting Ed Health Profess 24: 31–38
Lee J (2004) The power of negative thinking. Can J Emerg Med 6: 359–361
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2006 Birkhäuser Verlag Basel/Switzerland
About this chapter
Cite this chapter
Foote, M. (2006). Clinical trial registries and publication of results — a primer. In: Foote, M. (eds) Clinical Trial Registries. Birkhäuser Basel. https://doi.org/10.1007/978-3-7643-7583-6_1
Download citation
DOI: https://doi.org/10.1007/978-3-7643-7583-6_1
Publisher Name: Birkhäuser Basel
Print ISBN: 978-3-7643-7578-2
Online ISBN: 978-3-7643-7583-6
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)