Trends in global clinical trial registration: An analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

BMJ Open

Volumn 5, Issue 9, 2015, Pages

  Viergever, Roderik F ^a,b   Li, Keyang ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DATA BASE; HUMAN; INDIA; JAPAN; PUBLICATION; REGISTER; REGISTRATION; SYSTEMATIC REVIEW; ASIA; FACTUAL DATABASE; INTERNATIONAL COOPERATION; MEDICAL RESEARCH; PUBLISHING; TRENDS;

ASIA; BIOMEDICAL RESEARCH; DATABASES, FACTUAL; HUMANS; INTERNATIONAL COOPERATION; PUBLISHING; REGISTRIES;

EID: 84983203409     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-008932     Document Type: Article

References (80)

1. Dwan K, Altman DG, Arnaiz JA, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLo S ONE 2008;3:e3081.
2. Chan AW, Song F, Vickers A, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet2014;383:257-66.
3. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009;374:86-9.
4. Gülmezoglu AM, Pang T, Horton R, et al. WHO facilitates international collaboration in setting standards for clinical trial registration. Lancet2005;365:1829-31.
5. Clinical Trial Registration: a statement from the International Committee of Medical Journal Editors. 2004. http://www.icmje.org/news-and-editorials/clin-trial-sep2004.pdf.
6. All Trials. http://www.alltrials.net/(accessed 24 Jun 2015).
7. Ghersi D, Pang T. En route to international clinical trial transparency. Lancet 2008;372:1531-2.
8. WHO Trial Registration Data Set. http://www.who.int/ictrp/network/trds/en/
9. Spreckelsen C, Deserno TM, Spitzer K. The publication echo: effects of retrieving literature in PubMed by year of publication. Int J Med Inform 2010;79:297-303.
10. Glanville JM, Lefebvre C, Miles JN, et al. How to identify randomized controlled trials in MEDLINE: ten years on. J Med Libr Assoc 2006;94:130-6.
11. ICTRP search portal. http://apps.who.int/trialsearch/
12. Chakma J, Sun GH, Steinberg JD, et al. Asia's ascent-global trends in biomedical R&D expenditures. NEngl JMed2014;370:3-6.
13. Young AJ, Terry RF, Røttingen JA, et al. Global biomedical R&D expenditures. N Engl J Med 2014;370:2451.
14. Young AJ, Terry RF, Røttingen JA, et al. Global trends in health research and development R&D expenditures-the challenge of making reliable estimates for international comparison. Heal Res policy Syst 2015;13:7.
15. Viergever RF, Karam G, Reis A, et al. The quality of registration of clinical trials: still a problem. PLo S ONE2014;9:e84727.
16. Viergever RF, Terry RF, Karam G. Use of data from registered clinical trials to identify gaps in health research and development. Bull World Health Organ 2013;91:416-25C.
17. Califf RM, Zarin DA, Kramer JM, et al. Characteristics of clinical trials registered in Clinical Trials.gov, 2007-2010. JAMA 2012;307:1838-47.
18. Tasneem A, Aberle L, Ananth H, et al. The database for aggregate analysis of Clinical Trials.gov (AACT) and subsequent regrouping by clinical specialty. PLo S ONE2012;7:e33677.
19. Watson R. EU nations approve law to overhaul clinical trials. BMJ 2013;347:f7682.
20. Van Enst WA, Scholten RJ, Hooft L. Identification of additional trials in prospective trial registers for cochrane systematic reviews. PLo S One 2012;7:e42812.
21. Mathieu S, Boutron I, Moher D, et al. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009;302:977-84.
22. Røttingen JA, Regmi S, Eide M, et al. Mapping available health R&D data: what's there, what's missing and what role for a Global Observatory. Lancet 2013;382:1286-307.
23. Terry RF, Salm JF, Nannei C, et al. Creating a global observatory for health R&D. Science 2014;345:1302-4.
24. Viergever RF, Rademaker CM. Finding better ways to fill gaps in pediatric health research. Pediatrics 2014; 133:e824-6.
25. Van de Wetering FT, Scholten RJPM, Haring T, et al. Trial registration numbers are underreported in biomedical publications. PLo S ONE2012;7:e49599.
26. Reveiz L, Cortés-Jofré M, Asenjo Lobos C, et al. Influence of trial registration on reporting quality of randomized trials: study from highest ranked journals. J Clin Epidemiol2010;63:1216-22.
27. Korevaar DA, Bossuyt PM, Hooft L. Infrequent and incomplete registration of test accuracy studies: analysis of recent study reports. BMJ Open 2014;4:e004596.
28. Pinto RZ, Elkins MR, Moseley AM, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther2013;93:299-309.
29. Babu AS, Veluswamy SK, Rao PT, et al. Clinical trial registration in physical therapy journals: a cross-sectional study. Phys Ther 2014;94:83-90.
30. Milette K, Roseman M, Thombs BD. Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: a systematic review. J Psychosom Res 2011;70:205-17.
31. Mc Gee RG, Su M, Kelly PJ, et al. Trial registration and declaration of registration by authors of randomized controlled trials. Transplantation 2011;92:1094-100.
32. Kunath F, Grobe HR, Keck B, et al. Do urology journals enforce trial registration? A cross-sectional study of published trials. BMJ Open 2011;1:e000430.
33. Hardt JL, Metzendorf MI, Meerpohl JJ. Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions. Trials 2013; 14:407.
34. Reveiz L, Bonfill X, Glujovsky D, et al. Trial registration in Latin America and the Caribbean's: study of randomized trials published in 2010. J Clin Epidemiol2012;65:482-7.
35. Patrone D. Discrepancies between research advertisements and disclosure of study locations in trial registrations for USA-sponsored research in Russia. J Med Ethics 2010;36:431-4.
36. Huser V, Cimino JJ. Evaluating adherence to the International Committee of Medical Journal Editors' policy of mandatory, timely clinical trial registration. J Am Med Inform Assoc 2013;20:e169-74.
37. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.
38. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
39. World Medical Association Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. 2013. http://www.wma.net/en/30publications/10policies/b3/
40. IFPMA/EFPIA/JPMA/Ph RMA. Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. 2009. http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/EN/November-10-2009-Updated-Joint-Position-on-the- Disclosure-of-Clinical-Trial-Information-via-Clinical-Trial- Registries-and-Databases.pdf
41. Zarin DA, Tse T, Ide NC. Trial Registration at Clinical Trials.gov between May and October 2005. N Engl J Med 2005;353:2779-87.
42. Wager E, Williams P. 'Hardly worth the effort'? Medical journals' policies and their editors' and publishers' views on trial registration and publication bias: quantitative and qualitative study. BMJ 2013;347:f5248.
43. Bian ZX, Wu TX. Legislation for trial registration and data transparency. Trials2010;11:64.
44. Zarin DA, Tse T, Sheehan J. The proposed rule for U.S. clinical trial registration and results submission. N Engl J Med 2015;372:174-80.
45. International Clinical Trials Registry Platform (ICTRP): About Trial Registration: Organizations with Policies. http://www.who.int/ictrp/trial-reg/en/index2.html.
46. Pandey A, Aggarwal A, Maulik M, et al. Challenges in administering a clinical trials registry: lessons from the clinical trials registry-India. Pharmaceut Med 2013;27:83-93.
47. Li YP, Wu TX, Li J, et al. [Joint statement of establishing Chinese Clinical Trial Registration and Publishing system]. Zhong Xi Yi Jie He Xue Bao 2006;4:331-2.
48. Tang W, Fukuzawa M, Ishikawa H, et al. Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010-focus on Japan domestic, academic clinical trials. Trials 2013;14:333.
49. Chalmers I. Health Research Authority's great leap forward on UK trial registration. BMJ2013;347:f5776.
50. Laine C, Horton R, De Angelis CD, et al. Clinical trial registration: looking back and moving ahead. Lancet 2007;369:1909-11.
51. Viergever RF, Ghersi D. The quality of registration of clinical trials. PLo S ONE 2011;6:e14701.
52. Pfiffner PB, Oh J, Miller TA, et al. Clinical Trials.gov as a data source for semi-automated point-of-care trial eligibility screening. PLo S ONE2014;9:e111055.
53. International Standards for Clinical Trial Registries. Geneva, World Health Organization, 2012. http://apps.who.int/iris/bitstream/10665/76705/1/9789241504294-eng.pdf
54. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on Clinical Trials.gov: cross sectional study. BMJ2012;344:d7373-d7373.
55. Ross JS, Tse T, Zarin DA, et al. Publication of NIH funded trials registered in Clinical Trials.gov: cross sectional analysis. BMJ 2012;344:d7292.
56. Nguyen TA, Dechartres A, Belgherbi S, et al. Public availability of results of trials assessing cancer drugs in the United States. J Clin Oncol 2013;31:2998-3003.
57. Jones CW, Handler L, Crowell KE, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ2013;347: f6104.
58. Khan NA, Singh M, Spencer HJ, et al. Randomized controlled trials of rheumatoid arthritis registered at Clinical Trials.gov: what gets published and when. Arthritis Rheumatol2014;66:2664-74.
59. Huser V, Cimino JJ. Linking Clinical Trials.gov and PubMed to track results of interventional human clinical trials. PLoS One 2013;8: e68409-00.
60. Ross JS, Mulvey GK, Hines EM, et al. Trial publication after registration in Clinical Trials.Gov: a cross-sectional analysis. PLoS Med 2009;6:e1000144.
61. Zarin DA, Tse T, Williams RJ, et al. The Clinical Trials.gov results database-update and key issues. N Engl J Med 2011;364:852-60.
62. Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17). http://hc-sc.gc. ca/dhp-mps/legislation/unsafedrugs-droguesdangereuses-eng.php.
63. Watson R. European Medicines Agency pledges to publish clinical reports. BMJ 2014;349:g6086.
64. Ethical guidelines for medical research on human subjects. Ministry of Education, Culture, Sports, Science and Technology (Japan); Ministry of Health, Labour and Welfare (Japan), 2014. http://www.mext.go.jp/b-menu/houdou/26/12/icsFiles/af ieldfile/2014/12/22/1354186-1.pdf.
65. Wieseler B, Kerekes MF, Vervoelgyi V, et al. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ 2012;344:d8141.
66. WHO Statement on Public Disclosure of Clinical Trial Results. Geneva, World Health Organization, 2015. http://www.who.int/ictrp/results/Draft-WHO-Statement-results-reporting-clinical-trials.pdf? ua=1
67. Lehman R, Loder E. Missing clinical trial data. BMJ 2012;344:d8158.
68. Bonini S, Eichler HG, Wathion N, et al. Transparency and the European Medicines Agency-sharing of clinical trial data. N Engl J Med 2014;371:2452-5.
69. Institute of Medicine (IOM). Sharing clinical trial data: maximizing benefits, minimizing risk. Washington, DC, The National Academies Press, 2015.
70. Strom BL, Buyse M, Hughes J, et al. Data sharing, year 1-access to data from industry-sponsored clinical trials. N Engl J Med 2014;371:2052-4.
71. The Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations. Principles for Responsible Clinical Trial Data Sharing. 2013. http://www.phrma.org/sites/default/files/pdf/Ph RMAPrinciples For Responsible Clinical Trial Data Sharing.pdf
72. Hudson KL, Collins FS. Sharing and reporting the results of clinical trials. JAMA 2015;313:355-6.
73. Godlee F, Groves T. The new BMJ policy on sharing data from drug and device trials. BMJ 2012;345:e7888.
74. International Clinical Trials Registry Platform (ICTRP): About Registries-WHO Registry Criteria. http://www.who.int/ictrp/network/criteria-summary/en/index.html
75. Glanville JM, Duffy S, Mc Cool R, et al. Searching Clinical Trials.gov and the International Clinical Trials Registry Platform to inform systematic reviews: what are the optimal search approaches? J Med Libr Assoc 2014;102:177-83.
76. Ogino D, Takahashi K, Sato H. Characteristics of clinical trial websites: information distribution between Clinical Trials.gov and 13 primary registries in the WHO registry network. Trials 2014;15:428.
77. Williams RJ, Tse T, Harlan WR, et al. Registration of observational studies: is it time? CMAJ 2010;182:1638-42.
78. Loder E, Groves T, Macauley D. Registration of observational studies. BMJ 2010;340:c950.
79. Booth A, Clarke M, Dooley G, et al. The nuts and bolts of PROSPERO: an international prospective register of systematic reviews. Syst Rev 2012;1:2.
80. Shiokawa T. Background, introduction and activity of the Japan Primary Registries Network. J Evid Based Med 2009;2:41-3.