When to include clinical study reports and regulatory documents in systematic reviews

BMJ Evidence-Based Medicine

Volumn 23, Issue 6, 2018, Pages

  Jefferson, Tom ^a,b   Doshi, Peter ^b,c   Boutron, Isabelle ^d,e   Golder, Su ^f,g   Heneghan, Carl ^a,b   Hodkinson, Alex ^f,h   Jones, Mark ^b,i   Lefebvre, Carol ^j,k   Stewart, Lesley A ^f,l  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b Acute Respiratory Infections Group   (Australia)

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

^d PARIS DESCARTES UNIVERSITY   (France)

^e Risk of Bias Methods Group   (Australia)

^f UNIVERSITY OF YORK   (United Kingdom)

^g Adverse Effects Methods Group   (Australia)

^h UNIVERSITY OF MANCHESTER   (United Kingdom)

ⁱ UNIVERSITY OF QUEENSLAND   (Australia)

^j Lefebvre Associates Ltd   (United Kingdom)

^k Information Retrieval Methods Group   (Australia)

^l IPD Meta analysis Group   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; HUMAN; ORGANIZATION; SYSTEMATIC REVIEW; VALIDITY; EVIDENCE BASED MEDICINE; METHODOLOGY; PROCEDURES; RESEARCH; STATISTICAL BIAS;

BIAS; EVIDENCE-BASED MEDICINE; HUMANS; RESEARCH DESIGN; RESEARCH REPORT; SYSTEMATIC REVIEWS AS TOPIC;

EID: 85054922091     PISSN: 2515446X     EISSN: 25154478     Source Type: Journal    
DOI: 10.1136/bmjebm-2018-110963     Document Type: Article

References (42)

1. Dickersin K, Min YI. Publication bias: the problem that won't go away.Ann N Y Acad Sci 1993;703:135-48.
2. Dwan K, Altman DG, Arnaiz JA, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008;3:e3081.
3. Hopewell S, Loudon K, Clarke MJ, et al. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev 2009;1:MR000006.
4. Ross JS, Tse T, Zarin DA, et al. Publication of NIH funded trials registered in ClinicalTrials. Gov: cross sectional analysis. BMJ 2011;344:d7292.
5. Vedula SS, Bero L, Scherer RW, et al. Outcome reporting in industrysponsored trials of gabapentin for off-label use. N Engl J Med 2009;361:1963-71.
6. McGauran N, Wieseler B, Kreis J, et al. Reporting bias in medical research-a narrative review. Trials 2010;11:37.
7. Golder S, Loke YK, Wright K, et al. Most systematic reviews of adverse effects did not include unpublished data. J Clin Epidemiol 2016;77:125-33.
8. Schroll JB, Bero L, Gøtzsche PC. Searching for unpublished data for Cochrane reviews: cross sectional study. BMJ 2013;346:f2231.
9. Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open 2013;3:e002496.
10. Maund E, Tendal B, Hróbjartsson 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:g3510.
11. European Medicines Agency, 2017. Clinical data publication. Http://www.ema. Europa. Eu/ema/? Curl= pages/special-topics/general/general-content-000555. Jsp (cited 2 Oct 2017).
12. European Medicines Agency. European medicines agency policy on publication of clinical data for medicinal products for human use (POLICY/0070; EMA/240810/2013), 2014.
13. Health Canada, 2017. Public Release of Clinical Information in Drug Submissions and Medical Device Applications. Https://www. Canada. Ca/en/health-canada/programs/public-release-clinical-information-drugsubmissions-medical-device-applications. Html (cited 2018 Feb 8).
14. Food and Drug Administration, 2018. Clinical data summary pilot program. Http://www. Fda. Gov/Drugs/Deve lopm entA ppro valP rocess/ucm589210. Htm
15. 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.
16. Anderson ML, Chiswell K, Peterson ED, et al. Compliance with results reporting at ClinicalTrials. Gov. N Engl J Med 2015;372:1031-9.
17. National Institutes of Health, U.S. Department of Health and Human Services, 2016. NIH Policy on dissemination of NIH-funded clinical trial information. NOT-OD-16-149. Https://grants. Nih. Gov/grants/guide/noticefiles/NOT-OD-16-149. Html
18. Ross JS, Tse T, Zarin DA, et al. Publication of NIH funded trials registered in ClinicalTrials. Gov: cross sectional analysis. BMJ 2012;344:d7292.
19. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 2010;8:18.
20. Hopewell S, Dutton S, Yu LM, L-m Y, et al. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2010;340:c723.
21. Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review.Med J Aust 2006;185:263-7.
22. Loder E, Groves T. The BMJ requires data sharing on request for all trials.BMJ 2015;350:h2373.
23. Jefferson T, Jones MA, Doshi P, et al. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev 2014;4:CD008965.
24. Rodgers MA, Brown JV, Heirs MK, et al. Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion. BMJ 2013;346:f3981.
25. Fu R, Selph S, McDonagh M, et al. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis. Ann Intern Med 2013;158:890-902.
26. Eyding D, Lelgemann M, Grouven U, et al. 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.
27. Hodkinson A, Dietz KC, Lefebvre C, et al. The use of clinical study reports to enhance the quality of systematic reviews: a survey of systematic review authors. Syst Rev 2018;7:117.
28. Sharma T, Guski LS, Freund N, et al. Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports. BMJ 2016;352:i65.
29. Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320.
30. 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;17:207.
31. Vedula SS, Li T, Dickersin K. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin. PLoS Med 2013;10:e1001378.
32. Chan AW, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457-65.
33. Turner EH, Matthews AM, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252-60.
34. 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.
35. Coyne DW. The health-related quality of life was not improved by targeting higher hemoglobin in the Normal Hematocrit Trial. Kidney Int 2012;82:235-41.
36. 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:e1001526.
37. 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:h796.
38. Beaumier J, Lawrence K, Puil L, et al. Olanzapine for schizophrenia: what do the unpublished clinical trials reveal? 23rd Cochrane Colloquium.Vienna, Austria, 2015.
39. Cosgrove L, Vannoy S, Mintzes B, et al. Under the influence: the interplay among industry, publishing, and drug regulation. Account Res 2016;23:257-79.
40. Jureidini JN, Amsterdam JD, McHenry LB. The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance. Int J Risk Saf Med 2016;28:33-43.
41. Schroll JB, Penninga EI, Gøtzsche PC. Assessment of adverse events in protocols, clinical study reports, and published papers of trials of orlistat: a document analysis. PLoS Med 2016;13:e1002101.
42. Mayo-Wilson E, Li T, Fusco N, et al. Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy. J Clin Epidemiol 2017;91:95-110.