The use of clinical study reports to enhance the quality of systematic reviews: A survey of systematic review authors

Systematic Reviews

Volumn 7, Issue 1, 2018, Pages

  Hodkinson, Alex ^a   Dietz, Kristina Charlotte ^b   Lefebvre, Carol ^c   Golder, Su ^b   Jones, Mark ^d   Doshi, Peter ^e   Heneghan, Carl ^f   Jefferson, Tom ^f   Boutron, Isabelle ^g   Stewart, Lesley ^b  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b UNIVERSITY OF YORK   (United Kingdom)

^c Lefebvre Associates Ltd   (United Kingdom)

^d UNIVERSITY OF QUEENSLAND   (Australia)

^e UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^f UNIVERSITY OF OXFORD   (United Kingdom)

^g INSERM   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; AWARENESS; BIBLIOGRAPHIC DATABASE; CLINICAL PROTOCOL; CLINICAL RESEARCH; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HEALTH SURVEY; HUMAN; MEDICAL LITERATURE; ONLINE ANALYSIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PUBLIC HEALTH; PUBLICATION; PUBLISHING; QUALITY OF LIFE; QUESTIONNAIRE; SYSTEMATIC REVIEW; SYSTEMATIC REVIEW (TOPIC); RESEARCH; WRITING;

AUTHORSHIP; HUMANS; PUBLICATION BIAS; RESEARCH REPORT; SURVEYS AND QUESTIONNAIRES; SYSTEMATIC REVIEWS AS TOPIC;

EID: 85051289878     PISSN: None     EISSN: 20464053     Source Type: Journal    
DOI: 10.1186/s13643-018-0766-x     Document Type: Article

References (31)

1. McGauran N, Wieseler B, Kreis J, Schüler Y-B, Kölsch H, Kaiser T. Reporting bias in medical research-a narrative review. Trials. 2010;11(1):1-15.
2. Page MJ, McKenzie JE, Kirkham J, Dwan K, Kramer S, Green S, Forbes A. Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Cochrane Database Syst Rev. 2014;10:MR000035.
3. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, Von Elm E, Gamble C, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3:e3081.
4. Dwan K, Gamble C, Williamson PR, Kirkham JJ, for the Reporting Bias Group. Systematic review of the empirical evidence of study publication bias and outcome reporting bias-an updated review. PLoS One. 2013;8(7):e66844.
5. Eyding D, Lelgemann M, Grouven U, Harter M, Kromp M, Kaiser T, Kerekes MF, Gerken M, Wieseler B. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737.
6. International Conference on Harmonisation of Technical requirements for registration of Pharmaceuticals for Human use (ICH): Structure and Content of Clincial Study Reports E3. [ http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf ].
7. 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.
8. Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.
9. Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. BMJ. 2009;339:b5106.
10. Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, Kamphuis M, Grouven U. 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.
11. Schroll JB, Bero L, Gotzsche PC. Searching for unpublished data for Cochrane reviews: cross sectional study. BMJ. 2013;346:f2231.
12. Hodkinson A, Gamble C, Smith CT. Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. Trials. 2016;17(1):1-11.
13. Golder S, Loke YK, Wright K, Norman G. Reporting of adverse events in published and unpublished studies of health care interventions: a systematic review. PLoS Med. 2016;13(9):e1002127.
14. Gotzsche PC, Jorgensen AW. Opening up data at the European Medicines Agency. BMJ. 2011;342:d2686.
15. Doshi P, Jefferson T. Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency. Trials. 2016;17(1):78.
16. Wieseler B, McGauran N, Kerekes MF, Kaiser T. Access to regulatory data from the European Medicines Agency: the times they are a-changing. Syst Rev. 2012;1(1):50.
17. European Medicines Agency (EMA) Policy on publication of clinical data for medicinal products for human use. Policy/0070. 2 October 2014 EMA/240810/2013. [ http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf ].
18. The YODA Project: Forging a unified scientific community. [ http://yoda.yale.edu/ ].
19. ClinicalStudyDataRequest.com. [ https://clinicalstudydatarequest.com/ ].
20. Duke Clinical Research Institute: From thought leadership to clinical practice. [ https://www.dcri.org/ ].
21. +AllTrials. All Trials Registered | All Results Reported. [ http://www.alltrials.net/ ].
22. OpenTrials. All the data on all the trials, linked. [ https://opentrials.net/ ].
23. Goldacre B, Lane S, Mahtani KR, Heneghan C, Onakpoya I, Bushfield I, Smeeth L. Pharmaceutical companies' policies on access to trial data, results, and methods: audit study. BMJ. 2017;358:j3334.
24. Doshi P. From promises to policies: is big pharma delivering on transparency? BMJ. 2014;348:g1615.
25. 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. [ https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/cer-methods-guide_overview.pdf ].
26. Lefebvre C, Manheimer E, Glanville J. Chapter 6: searching for studies. In: JPT H, Green S, editors. Cochrane handbook for systematic reviews of interventions version 5.1.0 (updated March 2011): The Cochrane Collaboration; 2011. http://training.cochrane.org/handbook.
27. Golder S, Loke YK, Wright K, Sterrantino C. Most systematic reviews of adverse effects did not include unpublished data. J Clin Epidemiol. 2016;77:125-33.
28. Qualtrics. Software to manage the entire customer experience-from surveys, to insights, to action. [ https://www.qualtrics.com/ ].
29. The National Institute for Occupational Safety and Health (NIOSH). [ https://www.cdc.gov/niosh/index.htm ].
30. Wolfe N, Gøtzsche PC, Bero L. Strategies for obtaining unpublished drug trial data: a qualitative interview study. Syst Rev. 2013;2(1):1-11.
31. Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]: The Cochrane Collaboration; 2011. Available from http://training.cochrane.org/handbook