Registering Clinical Trials

JAMA

Volumn 290, Issue 4, 2003, Pages 516-523

  Dickersin, Kay ^a,b   Rennie, Drummond ^b  

^a BROWN UNIVERSITY   (United States)

^b US Cochrane Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CLINICAL TRIAL; CONSUMER; ETHICS; FINANCIAL MANAGEMENT; HUMAN; LAW; METHODOLOGY; ORGANIZATION; PHYSICIAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLICATION; REVIEW; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CONTROLLED CLINICAL TRIAL; DRUG INDUSTRY; ECONOMICS; EMPIRICAL APPROACH; HEALTH CARE ORGANIZATION; MANAGEMENT; PROFESSIONAL STANDARD; PUBLISHING; RANDOMIZED CONTROLLED TRIAL; REGISTER; STANDARD; STATISTICS; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

CLINICAL TRIALS; DRUG INDUSTRY; ETHICS COMMITTEES; LEGISLATION; NATIONAL INSTITUTES OF HEALTH (U.S.); POLICY MAKING; PUBLICATION BIAS; PUBLISHING; RANDOMIZED CONTROLLED TRIALS; REGISTRIES; RESEARCH SUPPORT; UNITED STATES;

EID: 0038455700     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.290.4.516     Document Type: Review

References (88)

1. Hubbard S, DeVita VT. PDQ: an innovation in information dissemination linking cancer research and clinical practice. In: DeVita VT, Hellman S, Rosenberg SA, eds. Important Advances in Oncology. Philadelphia, Pa: JB Lippincott Co; 1987.
2. Chalmers TC. Randomize the first patient! N Engl J Med. 1977;296:107.
3. Manheimer E, Anderson D. Survey of public information about ongoing clinical trials funded by industry: evaluation of completeness and accessibility. BMJ. 2002;325:528-531.
4. Gøtzsche PC. Multiple publication of reports of drug trials. Eur J Clin Pharmacol. 1989;36:429-432.
5. Huston P, Moher D. Redundancy, disaggregation, and the integrity of medical research. Lancet. 1996;347:1024-1026.
6. Tramèr MR, Reynolds DJM, Moore RA, McQuay HJ. Impact of covert duplicate publication on meta-analysis: a case study. BMJ. 1997;315:635-640.
7. Johansen HK, Gøtzsche PC. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA. 1999;282:1752-1759.
8. Rennie D. Fair conduct and fair reporting of clinical trials. JAMA. 1999;282:1766-1768.
9. Flanagin A, Fontanarosa PB, DeAngelis CD. Authorship for research groups. JAMA. 2002;288:3166-3168.
10. Dickersin K, Scherer R, Suci E, Gil-Montero M. Problems with indexing and citation of articles with group authorship. JAMA. 2002;287:2772-2774.
11. Chalmers I. Unbiased, relevant, and reliable assessments in health care. BMJ. 1998;317:1167-1168.
12. Grady D, Herrington D, Bittner V, et al, for the HERS Research Group. Cardiovascular disease outcomes during 6.8 years of hormone therapy. JAMA. 2002;288:49-57.
13. Hulley S, Furberg C, Barrett-Connor E, et al. Noncardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA. 2002;288:58-66.
14. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321-333.
15. Petitti DB. Hormone replacement therapy for prevention: more evidence, more pessimism. JAMA. 2002;288:99-101.
16. The Medical Research Council. Streptomycin treatment of pulmonary tuberculosis. BMJ. 1948;2:769-782.
17. Dickersin K, Manheimer E, Wieland S, Robinson K, Lefebvre C, McDonald S. Development of the Cochrane Collaboration's CENTRAL register of controlled clinical trials. Eval Health Prof. 2002;25:38-64.
18. Dickersin K. How important is publication bias? a synthesis of available data. AIDS Educ Prev. 1997;9(suppl A):15-21.
19. Scherer RW, Langenberg P. Full publication of results initially presented in abstracts [Cochrane Methodology Review]. Oxford, England: Cochrane Library, Update Software; 2003; issue 1.
20. Pich J, Carne X, Arnaiz JA, Gomez B, Trilla A, Rodes J. Role of a research ethics committee in follow-up and publication of results. Lancet. 2003;361:1015-1016.
21. Hayward S, Brunton G, Thomas K, Ciliska D. Searching for the evidence: source, time and yield. In: Proceedings of the Second International Conference, Scientific Basis of Health Services and the 5th Annual Cochrane Colloquium; October 5-12, 1997; Amsterdam, the Netherlands.
22. Brazier H. Poorly executed and inadequately documented? an analysis of the literature searches on which systemic reviews are based. In: Proceedings of the Second Symposium on Systematic Reviews: Beyond the Basics; January 5-7, 1999; Oxford, England.
23. Hopewell S, Clarke M, Lusher A, Lefebvre C, Westby M. A comparison of handsearching versus MEDLINE searching to identify reports of randomized controlled trials. Stat Med. 2002;21:1625-1634.
24. Jull A, Chalmers I, Rodgers A: Clinical trials in NZ: does anybody know what's going on? N Z Med J. 2002;115:U269.
25. Hetherington J, Dickersin K, Chalmers I, Meinert CL. Retrospective and prospective identification of unpublished controlled trials: lessons from a survey of obstetricians and pediatricians. Pediatrics. 1989;84:374-380.
26. McManus RJ, Wilson S, Delaney BC, et al. Review of the usefulness of contacting other experts when conducting a literature search for systematic reviews. BMJ. 1998;317:1562-1563.
27. Sterling TD. Publication decisions and their possible effects on inferences drawn from tests of significance: or vice versa. J Am Stat Assoc. 1959;54:30-34.
28. Dickersin K, Chan S, Chalmers TC, Sacks HS, Smith HJR. Publication bias and clinical trials. Control Clin Trials. 1987;8:343-353.
29. Ioannidis JP. Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA. 1998;279:281-286.
30. Furberg CD. Effect of antiarrhythmic drugs on mortality after myocardial infarction. Am J Cardiol. 1983;52:32C-36C.
31. Teo KK, Yusuf S, Furberg CD. Effects of prophylactic antiarrhythmic drug therapy in acute myocardial infarction: an overview of results from randomized controlled trials. JAMA. 1993;270:1589-1595.
32. Cowley AJ, Skene A, Stainer K, Hampton JR. The effect of Iorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. Int J Cardiol. 1993;40:161-166.
33. Chalmers I. Using systematic reviews and registers of ongoing trials for scientific and ethical trials design, monitoring, and reporting. In: Egger M, Smith GD, Altman DG, eds. Systematic Reviews in Health Care: Meta-analysis in Context. London, England: BMJ Books; 2001:429-443.
34. Moore T. Deadly Medicine: Why Tens of Thousands of Heart Patients Died in America's Worst Drug Disaster. New York, NY: Simon & Schuster; 1995.
35. Chalmers I. Underreporting research is scientific misconduct. JAMA. 1990;263:1405-1408.
36. The Macmillan Publishing Staff. The Baseball Encyclopedia: The Complete and Definitive Record of Major League Baseball. 10th ed. New York, NY: MacMillan; 1996.
37. Thorn J, Palmer P, Gershman M, Silverman M, Lahman S, Spira G, eds. Total Baseball: The Official Encyclopedia of Major League Baseball. 7th ed. Kingston, NY: Total Sports Publishing; 2001.
38. Simes RJ. The case for an international registry of clinical trials. J Clin Oncol. 1986;4:1529-1541.
39. Levine J, Guy W, Cleary P. Therapeutic trials of psychopharmacologic agents: 1968-1972. In: McMahon G, ed. Psychopharmacological Agents. Armonk, NY: Futura Publishing Co; 1974.
40. Horton R, Smith R. Time to register randomised trials: the case is now unanswerable. BMJ. 1999;319:865-866.
41. Horton R, Smith R. Time to register randomised trials. Lancet. 1999;354:1138-1139.
42. Meinert CL. Toward prospective registration of clinical trials. Control Clin Trials. 1988;9:1-5.
43. Dickersin K. Report from the panel on the case for registers of clinical trials at the Eighth Annual Meeting of the Society for Clinical Trials. Control Clin Trials. 1988;9:76-81.
44. Ad Hoc Working Party of the International Collaborative Group on Clinical Trials Registries. Position paper and consensus recommendations on clinical trial registries. Clin Trials Metaanal. 1993;28:199-201.
45. Institute of Medicine Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: National Academy Press; 2000.
46. Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academy Press; 2002.
47. Dickersin K. Why register clinical trials? revisited. Control Clin Trials. 1992;13:170-177.
48. Schiff H, Haran C. On the trials trail: clinical trial watch. MAMM. October/November. 1998:86.
49. Horton R. Pardonable revisions and protocol reviews. Lancet. 1997;349:6.
50. BioMed Central. Information for authors: publish your study protocols. Available at: http://www.biomedcentral.com/info/authors/protocols. Accessed January 24, 2003.
51. Vale CL, Stewart LA. The International Standard Controlled Trial Number (ISRCTN): what does it mean for reviewers? In: Proceedings of the 9th International Cochrane Colloquium; 2001; Lyon, France.
52. McCray AT. Better access to information about clinical trials. Ann Intern Med. 2001;133:609-614.
53. Information for Authors. Writing for the Lancet. Available at: http://thelancet.com.authorinfo. Accessed January 24, 2003.
54. Information for Authors. Manuscript format and style: trial registry information. Ann Intern Med. Available at: http://www.annals.org/shared/manu_format.html. Accessed January 24, 2003.
55. Sykes R. Being a modern pharmaceutical company: involves making information available on clinical trial programmes. BMJ. 1998;317:1172.
56. CenterWatch. Clinical Trials Listing Service. Available at: http://www.centerwatch.com. Accessed May 20, 2003.
57. Dickersin K, Min YI. NIH clinical trials and publication bias. Online J Curr Clin Trials. 1993;Doc No. 50.
58. AIDSinfo. Available at: http://www.aidsinfo.nih.gov. Accessed January 28, 2003.
59. The UK National Health Service National Research Register (NRR). Available at: http://www.doh.gov.uk/research. Accessed January 30, 2003.
60. MRC Trials Register. Available at: http://www.controlledtrials.com. Accessed February 5, 2003.
61. Dickersin K, Garcia-Lopez F. Regulatory process effects clinical trial registration in Spain. Control Clin Trials. 1992;13:507-512.
62. Chalmers I, Hetherington J, Newdick M, et al. The Oxford Database of Perinatal Trials: developing a register of published reports of controlled trials. Control Clin Trials. 1986;7:306-324.
63. Verstraete M. International Committee on Thrombosis and Haemostasis Basil, 8-11: September 1974 subcommittee on clinical investigations: registry of prospective clinical trials. Thromb Diath Haemorrh. 1975;33:655-663.
64. Chalmers I. Current Controlled Trials: an opportunity to help improve the quality of clinical research. Curr Control Trials Cardiovasc Med. 2000;1:3-8.
65. Anderson D, Costa I, Dickersin K. Building Trials Central, an online register of clinical trials registers. Control Clin Trials. 2001;22(suppl 2):40S.
66. Pub L No. 100-607 (1988).
67. Pub L No. 105-115, §113 Stat 2296 (1997).
68. DeMarinis AD. Current considerations: regulatory: clinical trials databank. Res Practitioner. 2002;3:105-106.
69. Rowland D, Di Guiseppi C, Roberts I, et al. Prevalence of working smoke alarms in local authority inner city housing: randomized clinical trial. BMJ. 2002;325:998-1001.
70. Information for authors. Ann Intern Med. 1995;123:1-10.
71. European Science Foundation Policy Briefing No. 13, May 2001. Available at: http://www.esf.org/publication/90/ESPB13.pdf. Accessibility verified June 27, 2003.
72. Moses H 3rd, Martin JB. Academic relationships with industry: a new model for biomedical research. JAMA. 2001;285:933-935.
73. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289:454-465.
74. PhRMA. Public Disclosure of Clinical Trial Results. June 24, 2002. Available at: http://www.phrma.org/publications/policy//2002-06-24.430.pdf. Accessed May 21, 2003.
75. Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin. 2003;19:149-154.
76. MacLean CH, Morton SC, Ofman JJ, et al, for the Southern California Evidence-Based Practice Center. How useful are unpublished data from the Food and Drug Administration in meta-analysis? J Clin Epidemiol. 2003;56:44-51.
77. Gibbs TG, Wager E. Clinical trial registration: the Glaxo Wellcome experience. Int J Pharm Med. 2000;14:203-205.
78. Kmietowicz Z. UK drugs industry sets up trials register. BMJ. 2000;321:850.
79. Tonks A. A clinical trials register for Europe. BMJ. 2002;325:1314-1315.
80. Pharmaceutical Research and Manufacturers of America. 2002 Industry Profile: Research and Development - The Key to Innovation. Washington, DC: PhRMA; 2002.
81. Pharmaceutical Research and Manufacturers of America. 2003 Industry Profile: Dramatic Growth of Research and Development. Available at: http://www.phrma.org/publications/profile02/2003%20chapter%202.pdf. Accessed June 4, 2003.
82. Research! America. How much is really spent on medical and health research? Available at: http://www.reseacrhamerica.org/members/4.6_cents.html. Accessed October 17, 2001.
83. Derbis J, Toigo T, Woods J, Evelyn B, Banks D. FDAMA section 113: information program on clinical trials for serious and life-threatening diseases. Poster presented at: 9th Annual FDA Science Forum; April 24, 2003; Washington, DC.
84. Reynolds T. Researchers push for publication, registration of all clinical trials. J Natl Cancer Inst. 2003;95:772-774.
85. Benson DA, Karsch-Mizrachi I, Lipman DJ, et al. GenBank. Nucleic Acids Res. 2002;30:17-20.
86. Harlan WR. Creating an NIH Clinical Trials Registry: a user-friendly approach to health care. JAMA. 1994;271:1729.
87. Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? some suggestions for improving performance and accountability. BMJ. 1996;313:1390-1393.
88. Blunt J. Research ethics committees must ensure registration of research and accessibility of results. BMJ. 1998;316:312.