Challenges of identifying unpublished data from clinical trials: Getting the best out of clinical trials registers and other novel sources

Research Synthesis Methods

Volumn 9, Issue 4, 2018, Pages 561-578

  Isojarvi, Jaana ^a   Wood, Hannah ^a   Lefebvre, Carol ^b   Glanville, Julie ^a  

^a UNIVERSITY OF YORK   (United Kingdom)

^b Lefebvre Associates Ltd   (United Kingdom)

Author keywords

clinical trials; information retrieval; trials registers; unpublished data

Indexed keywords

BIBLIOGRAPHIC DATABASE; CLINICAL TRIAL (TOPIC); DOCUMENTATION; EVIDENCE BASED MEDICINE; HUMAN; INFORMATION RETRIEVAL; INTERNET; LITERATURE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; STANDARDS; TRENDS;

ABSTRACTING AND INDEXING AS TOPIC; CLINICAL TRIALS AS TOPIC; DATABASES, BIBLIOGRAPHIC; EVIDENCE-BASED MEDICINE; HUMANS; INFORMATION STORAGE AND RETRIEVAL; INTERNET; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; REVIEW LITERATURE AS TOPIC;

EID: 85042177742     PISSN: None     EISSN: 17592887     Source Type: Journal    
DOI: 10.1002/jrsm.1294     Document Type: Conference Paper

References (76)

1. U.S. National Institutes of Health. Glossary of common site terms. [webpage]. 2017; https://clinicaltrials.gov/ct2/about-studies/glossary. Accessed 18 September, 2017.
2. World Health Organisation. WHO International Clinical Trials Registry Platform (ICTRP). [database]. 2017; http://www.who.int/ictrp/en/. Accessed 18 September, 2017.
3. Open Knowledge International, Goldacre B. OpenTrials. [webpage]. 2017; https://opentrials.net/. Accessed 18 September, 2017.
4. Viergever RF, Li K. 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. 2015;5(9):e008932.
5. U.S. National Institutes of Health. Trends, charts, and maps: number of registered studies over time. [webpage]. 2017; https://clinicaltrials.gov/ct2/resources/trends#RegisteredStudiesOverTime. Accessed 18 September, 2017.
6. U.S. National Institutes of Health. Trends, charts and maps: types of registered studies. [webpage]. 2017; https://clinicaltrials.gov/ct2/resources/trends#TypesOfRegisteredStudies. Accessed 18 September, 2017.
7. Arber M, Cikalo M, Glanville J, Lefebvre C, Varley D, Wood H. Annotated Bibliography of Published Studies Addressing Searching for Unpublished Studies and Obtaining Access to Unpublished Data. York Health Economics Consortium: York; 2013.
8. Baudard M, Yavchitz A, Ravaud P, Perrodeau E, Boutron I. Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses. BMJ. 2017;356:j448.
9. Higgins JPT, Altman DG. Assessing risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. Oxford, UK: Wiley; 2008.
10. Huynh L, Scherer R, Ervin A, Dickersin K. Primary outcomes reported in abstracts and ClinicalTrials.gov—do they agree? Oral presentation at the 19th Cochrane Colloquium; 2011 Oct 19–22; Madrid, Spain [abstract]. Cochrane Database Syst Rev (Suppl). 2011;(Cd000003):18. http://www.mrw.interscience.wiley.com/cochrane/clcmr/articles/CMR-16524/frame.html
11. Scherer RW, Huynh L, Ervin A-M, Taylor J, Dickersin K. ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study. BMC Med Res Methodol. 2013a;13(1):79.
12. Scherer RW, Huynh L, Ervin A-M, Dickersin K. Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study. PLoS One. 2015;10(6):e0130619.
13. Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. NEJM. 2011;364(9):852-860.
14. Liu X, Li Y, Yin S, Song S. Result publication of Chinese trials in World Health Organization primary registries. PLoS One. 2010;5(9):e12676.
15. Halfpenny NJ, Thompson JC, Quigley JM, Scott DA. Clinical trials registries for systematic reviews-an alternative source for unpublished data. Value Health. 2015;18(3):A12.
16. Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials.gov. NEJM. 2015;372(11):1031-1039.
17. Tang E, Ravaud P, Riveros C, Perrodeau E, Dechartres A. Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles. BMC Med. 2015;13(1):189.
18. Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014;160(7):477-483.
19. Jones CW, Keil LG, Holland WC, Caughey MC, Platts-Mills TF. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Med. 2015;13(1):282.
20. Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA. 2014;311(10):1063-1065.
21. Chahal J, Tomescu SS, Ravi B, et al. Publication of sports medicine-related randomized controlled trials registered in ClinicalTrials.gov. Am J Sports Med. 2012;40(9):1970-1977.
22. De Oliveira GS Jr, Jung MJ, McCarthy RJ. Discrepancies between randomized controlled trial registry entries and content of corresponding manuscripts reported in anesthesiology journals. Anesth Analg. 2015;121(4):1030-1033.
23. Hannink G, Gooszen HG, Rovers MM. Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions. Ann Surg. 2013;257(5):818-823.
24. Killeen S, Sourallous P, Hunter IA, Hartley JE, Grady HLO. Registration rates, adequacy of registration, and a comparison of registered and published primary outcomes in randomized controlled trials published in surgery journals. Ann Surg. 2014;259(1):193-196.
25. Rongen JJ, Hannink G. Comparison of registered and published primary outcomes in randomized controlled trials of orthopaedic surgical interventions. J Bone Joint Surg. 2016;98(5):403-409.
26. Rosenthal R, Dwan K. Comparison of randomized controlled trial registry entries and content of reports in surgery journals. Ann Surg. 2013;257(6):1007-1015.
27. Chan AW, Pello A, Kitchen J, et al. Association of trial registration with reporting of primary outcomes in protocols and publications. JAMA. 2017;318(17):1709-1711.
28. Köhler M, Haag S, Biester K, et al. Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports. BMJ. 2015;350(feb26 5).
29. 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(e1):e169-e174.
30. Xuemei L, Youping L, Shangqi S, Senlin Y. Publication of the results of Chinese trials after registration in ClinicalTrials.gov versus ChiCTR. Curr Med Res Opin. 2010;26:S10.
31. Earley A, Lau J, Uhlig K. Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications—a cross-sectional study. BMJ Open. 2013;3(1):18.
32. Baudart M, Ravaud P, Baron G, Dechartres A, Haneef R, Boutron I. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov. BMC Med. 2016;14(1):7.
33. Schroll JB, Bero L, Gotzsche PC. Searching for unpublished data for Cochrane reviews: cross sectional study. BMJ. 2013;346(apr23 1):f2231.
34. Wolfe N, Gotzsche PC, Bero L. Strategies for obtaining unpublished drug trial data: a qualitative interview study. Syst Rev. 2013;2(1):31.
35. Yu T, Fain K, Puhan MA. Systematic reviews of benefits and harms in clinical trials. Response to: MAUND, E., TENDAL, B., HROBJARTSSON, A., JORGENSEN, K. J., LUNDH, A., SCHROLL, J. & GOTZSCHE, P. C. 2014. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. BMJ. 2014;348:g3510.
36. Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Med. 2012;9(4):e1001201.
37. Wieseler B, Kerekes MF, Vervoelgyi V, McGauran N, Kaiser T. 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(jan03 1):d8141.
38. Wieseler B, Wolfram N, McGauran N, et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med. 2013;10(10):e1001526.
39. Maund E, Tendal B, Hrobjartsson A, et al. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. BMJ. 2014;348(jun04 2):g3510.
40. Glanville J, Lefebvre C. Finding clinical trials, research registers and research results. [webpage]. 2017; https://sites.google.com/a/york.ac.uk/yhectrialsregisters/. Accessed 6 February, 2017.
41. Wikipedia. Clinical trials registry. [webpage]. 2017; https://en.wikipedia.org/wiki/Clinical_trials_registry. Accessed 6 February, 2017.
42. National Institutes of Health. NIH Clinical Research Trials and You: List of registries. [webpage]. 2016; https://www.nih.gov/health-information/nih-clinical-research-trials-you/list-registries. Accessed 6 February, 2017.
43. World Health Organization. Joint statement on public disclosure of results from clinical trials. 2017; http://www.who.int/ictrp/results/jointstatement/en/. Accessed December, 2017.
44. Smail-Faugeron V, Fron-Chabouis H, Durieux P. Clinical trial registration in oral health journals. J Dent Res. 2015;94(3 Suppl):8S-13S.
45. Stegeman I, Leeflang M, Hooft L. Implementation of prospective trial registration in the field of otolarynchology. Paper presented at: Evidence-Informed Public Health: Opportunities and Challenges. Abstracts of the 22nd Cochrane Colloquium; 2014 21–26 Sep2014; Hyderabad, India.
46. Reveiz L, Bonfill X, Glujovsky D, Pinzon C, Asenjo-Lobos C, Cortes M, et al. Impact of the trial registration initiative in Latin America and the Caribbean: a study of randomized controlled trials published in 2010. Abstracts of the 19th Cochrane Colloquium; 2011 19–22 Oct 2011; Madrid, Spain.
47. Odutayo A, Emdin C, Hsiao A, Rahimi K, Hopewell S, Altman D. Registration of randomized controlled trials published in PubMed indexed journals: a cross-sectional analysis. Evidence-Informed Public Health: Opportunities and Challenges. Abstracts of the 22nd Cochrane colloquium; 2014 21-26 Sep.; 2014; Hyderabad, India
48. Jefferson T, Jones MA, Doshi P, et al. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev. 2012;1:CD008965.
49. Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open. 2013;3(2):e002496.
50. European Medicines Agency. European Medicines Agency Policy on Publication of Clinical Data for Medicinal Products for Human Use. London, UK: European Medicines Agency; 2 October 2014; 2014.
51. Goldacre B, Lane S, Mahtani KR, et al. Pharmaceutical companies' policies on access to trial data, results, and methods: audit study. BMJ. 2017;358:j3334.
52. Ogino D, Takahashi K, Sato H. Characteristics of clinical trial websites: information distribution between ClinicalTrials.gov and 13 primary registries in the WHO registry network. Trials. 2014;15(1):428.
53. Glanville JM, Duffy S, McCool R, Varley D. Searching ClinicalTrials.gov and the International Clinical Trials Registry Platform to inform systematic reviews: what are the optimal search approaches? JMLA. 2014;102(3):177-183.
54. Chang M, Chang M, Reed JZ, Milward D, Xu JJ, Cornell WD. Developing timely insights into comparative effectiveness research with a text-mining pipeline. Drug Discov Today. 2016;21(3):473-480.
55. Quessy SN. How should we interrogate the ClinicalTrials.gov database? J Pain. 2013;14(9):997-998.
56. Tai FM, Willson ML, Ghersi D. Implications of searching multiple trial registries: how should we search ClinicalTrials.gov and WHO ICTRP? 2012 Cochrane Colloquium; 2012; Auckland, New Zealand.
57. Tse T. Beta version of ClinicalTrials.gov available for testing. NLM Technical Bulletin. 2017:Jan-Feb;(414):e414.
58. Le Cleach L, Doney E, Katz KA, Williams HC, Trinquart L. Research techniques made simple: workflow for searching databases to reduce evidence selection bias in systematic reviews. J Invest Dermatol. 2016;136(12):e125-e129.
59. McDonagh MS, Peterson K, Balshem H, Helfand M. US Food and Drug Administration documents can provide unpublished evidence relevant to systematic reviews. J Clin Epidemiol. 2013;66(10):1071-1081.
60. Schroll JB, Abdel-Sattar M, Bero L. The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports. J Clin Epidemiol. 2015;68(1):102-107.
61. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. Current Step 4 version dated 30 November 1995 Geneva: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 1995.
62. Citeline. Trialtrove. 2016; https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/trialtrove. Accessed 18 September, 2017.
63. Chalmers I, Altman DG. How can medical journals help prevent poor medical research? Some opportunities presented by electronic publishing. Lancet. 1999;353(9151):490-493.
64. Shanahan DR. Clinical trial data and articles linked for the first time [Blog]. 2016; https://www.crossref.org/blog/linked-clinical-trials-are-here/. Accessed 28 Feb 2017.
65. Goldacre B, Gray J. OpenTrials: towards a collaborative open database of all available information on all clinical trials. Trials. 2016;17(1):164.
66. Arena Pharmaceuticals. BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus. Identifier: NCT00603291. In: ClinicalTrials.gov [internet]. Bethesda, MD: National Library of Medicine: 2008. [cited Feb 2017] Available from https://explorer.opentrials.net/trials/227fbd2c-b23f-47a3-9aaf-0fefe9cfe2fb.
67. Goldacre B, Turner E. You can now search FDA approval documents easily at fda.opentrials.net. BMJ. 2017;356:j677.
68. Merabti T, Lelong R, Darmoni S. InfoRoute: the CISMeF context-specific search algorithm. Stud Health Technol Inform. 2015;216:544-548.
69. Shao W, Adams CE, Cohen AM, et al. Aggregator: a machine learning approach to identifying MEDLINE articles that derive from the same underlying clinical trial. Methods (Duluth). 2015;74:65-70.
70. Hao T, Rusanov A, Boland MR, Weng C. Clustering clinical trials with similar eligibility criteria features. J Biomed Inform. 2014;52:112-120.
71. Krauth C, Kuchinke W, Eckert M, et al. Clinical trial information mediator. J Biomed Inform. 2016;63:157-168.
72. EMBL-EBI. BioSamples. 2017; https://www.ebi.ac.uk/biosamples/. Accessed 14 Feb 2017.
73. Institute of Medicine. Finding what works in health care: standards for systematic reviews. Washington, DC: National Academies Press; 2011.
74. Agency for Healthcare Research and Quality. Methods Guide for Effectiveness and Comparative Effectiveness Reviews AHRQ Publication No. 10(14)-EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality; January 2014.
75. Hopewell S, Clarke MJ, Stewart L, Tierney J. Time to publication for results of clinical trials. Cochrane Database Syst Rev. 2007;2007(2):No.: MR000011.
76. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev. 2007;2007(2):Art. No.: MR000005.