Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses

BMJ (Online)

Volumn 356, Issue , 2017, Pages 1-7

  Baudard, Marie ^a,b   Yavchitz, Amélie ^a,b,c   Ravaud, Philippe ^a,b,c,d,e   Perrodeau, Elodie ^a,b,c,d   Boutron, Isabelle ^a,b,c,d  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b PARIS DESCARTES UNIVERSITY   (France)

^c Cochrane France ^*  (France)

^d HÔTEL DIEU   (France)

^e Columbia University ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DATA ANALYSIS; DATA EXTRACTION; HUMAN; INFORMATION PROCESSING; INFORMATION RETRIEVAL; INTERNET; META ANALYSIS (TOPIC); METHODOLOGY; OUTCOME ASSESSMENT; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; SYSTEMATIC REVIEW (TOPIC); TREATMENT OUTCOME; DRUG DATABASE; LITERATURE; REGISTER;

DATABASES, PHARMACEUTICAL; HUMANS; META-ANALYSIS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; REVIEW LITERATURE AS TOPIC;

EID: 85013290082     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.j448     Document Type: Article

References (37)

1. Cook DJ, Mulrow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Intern Med 1997;126:376-80. doi:10.7326/0003-4819-126-5-199703010-00006.
2. Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLoS Med 2010;7:e1000326. doi:10.1371/journal.pmed.1000326.
3. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. Cochrane Collab 2011; version 5. http://handbook. cochrane.org
4. Higgins J P, Altman DG, Gøtzsche PC, et al. Cochrane Bias Methods Group Cochrane Statistical Methods Group. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011;343:d5928. doi:10.1136/bmj.d5928.
5. Moher D, Tetzlaf J, Tricco AC, Sampson M, Altman DG. Epidemiology and reporting characteristics of systematic reviews. PLoS Med 2007;4:e78. doi:10.1371/journal.pmed.0040078.
6. Ebrahim S, Bance S, Athale A, Malachowski C, Ioannidis J P. Meta-analyses with industry involvement are massively published and report no caveats for antidepressants. J Clin Epidemiol 2016;70:155-63. doi:10.1016/j.jclinepi.2015.08.021.
7. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009;374:86-9. doi:10.1016/S0140-6736 (09) 60329-9.
8. Chan AW, Song F, Vickers A, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014;383:257-66. doi:10.1016/S0140-6736 (13) 62296-5.
9. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet 1991;337:867-72. doi:10.1016/0140-6736 (91) 90201-Y.
10. Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess 2010;14:iii, ix-xi, 1-193. doi:10.3310/hta14080.
11. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev 2009; MR000006: MR000006. doi:10.1002/14651858. MR000006.pub3.
12. Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 2008;5:e217, discussion e217. doi:10.1371/journal.pmed.0050217.
13. Dwan K, Gamble C, Williamson PR, Kirkham JJ. Reporting Bias Group. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review. PLoS One 2013;8:e66844. doi:10.1371/journal.pone.0066844.
14. Schmucker C, Schell LK, Portalupi S, et al. OPEN consortium. Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries. PLoS One 2014;9:e114023. doi:10.1371/journal.pone.0114023.
15. 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; CD008965: CD008965. doi:10.1002/14651858. CD008965.pub4.
16. 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. www.ncbi.nlm.nih.gov/pubmed/19995812. doi:10.1136/bmj.b5106.
17. De Angelis C, Drazen JM, Frizelle FA, et al. International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Ann Intern Med 2004;141:477-8. doi:10.7326/0003-4819-141-6-200409210-00109.
18. United States Congress. (2007) Food and Drug Administration Amendments Act (FDAAA) of 2007: public law no 110-85. www.gpo. gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
19. Groves T. Mandatory disclosure of trial results for drugs and devices. BMJ 2008;336:170. doi:10.1136/bmj.39469.465139.80.
20. Laine C, Horton R, DeAngelis CD, et al. Clinical trial registration: looking back and moving ahead. JAMA 2007;298:93-4. doi:10.1001/jama.298.1.jed70037
21. Shea BJ, Grimshaw JM, Wells GA, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol 2007;710. doi:10.1186/1471-2288-7-10.
22. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol 2009;62:e1-34. doi:10.1016/j.jclinepi.2009.06.006.
23. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009;339:b2535. doi:10.1136/bmj.b2535.
24. Keil LG, Platts-Mills TF, Jones CW. Systematic reviews published in emergency medicine journals do not routinely search clinical trials registries: a cross-sectional analysis. Ann Emerg Med 2015;66:424-7 doi:10.1016/j.annemergmed.2014.10.001.
25. van Enst WA, Scholten RJ, Hoof L. Identification of additional trials in prospective trial registers for Cochrane systematic reviews. PLoS One 2012;7:e42812. doi:10.1371/journal.pone.0042812.
26. Jones CW, Keil LG, Weaver MA, Platts-Mills TF Clinical trials registries are under-utilized in the conduct of systematic reviews: a cross-sectional analysis. Syst Rev 2014;3:126. doi:10.1186/2046-4053-3-126.
27. Cortés J, González JA, Campbell MJ, Cobo E. A hazard ratio was estimated by a ratio of median survival times, but with considerable uncertainty J Clin Epidemiol 2014;671172-7 doi:10.1016/j.jclinepi.2014.05.017
28. Hart B, Lundh A, Bero L Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ 2012;344:d7202. doi:10.1136/bmj.d7202.
29. Dechartres A, Boutron I, Trinquart L, Charles P, Ravaud P. Single-center trials show larger treatment effects than multicenter trials: evidence from a meta-epidemiologic study. Ann Intern Med 2011;155:39-51. doi:10.7326/0003-4819-155-1-201107050-00006.
30. Potthast R, Vervölgyi V, McGauran N, Kerekes MF, Wieseler B, Kaiser T. Impact of inclusion of industry trial results registries as an information source for systematic reviews. PLoS One 2014;9:e92067 doi:10.1371/journal.pone.0092067
31. Page MJ, Shamseer L, Altman DG, et al. Epidemiology and reporting characteristics of systematic reviews of biomedical research: a cross-sectional study. PLoS Med 2016;13:e1002028. doi:10.1371/journal.pmed.1002028.
32. 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:e1002127 doi:10.1371/journal. pmed.1002127
33. Glanville JM, Dufy 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? J Med Libr Assoc 2014;102:177-83. doi:10.3163/1536-5050.102.3.007
34. Riveros C, Dechartres A, Perrodeau E, Haneef R, Boutron I, Ravaud P. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals. PLoS Med 2013;10:e1001566, discussion e1001566. doi:10.1371/journal.pmed.1001566.
35. Strom BL, Buyse M, Hughes J, Knoppers BM. Data sharing, year 1-access to data from industry-sponsored clinical trials. N Engl J Med 2014;371:2052-4. doi:10.1056/NEJMp1411794.
36. Maruani A, Boutron I, Baron G, Ravaud P. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials. gov: cohort embedded pragmatic randomized controlled trial. BMJ 2014;349:g5579. doi:10.1136/bmj.g5579.
37. Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials. gov-the final rule. N Engl J Med 2016;375:1998-2004. doi:10.1056/NEJMsr1611785.