Journal of Clinical Epidemiology
Volume 63, Issue 10 , Pages 1071-1081 , October 2010

Unpublished data can be of value in systematic reviews of adverse effects: methodological overview

  • Su Golder

      Affiliations

    • Centre for Reviews and Dissemination (CRD), University of York, York, YO10 5DD, UK
    • Department of Health Sciences, University of York, York, YO10 5DD, UK
    • Corresponding Author InformationCorresponding author. Tel.: +44-1904-321095; fax: +44-1904-321041.
    • ,
  • Yoon K. Loke

      Affiliations

    • School of Medicine, Health Policy and Practice, University of East Anglia, Norwich NR4 7TJ, UK
    • ,
  • Martin Bland

      Affiliations

    • Department of Health Sciences, University of York, York, YO10 5DD, UK

,Accepted 5 February 2010.

References 

  1. Centre for Reviews and Dissemination. Systematic reviews: CRD's guidance for undertaking reviews in health care. York: University of York; 2009:1–281.
  2. In:  Higgins JPT,  Green S editor. Cochrane handbook for systematic reviews of interventions 5.0.0 [updated February 2008]. The Cochrane Collaboration; 2008;
  3. Song F, Eastwood A, Gilbody S, Duley L, Sutton AJ. Publication and related bias. Health Technol Assess. 2000;4:1–115
  4. Price D, Jefferson T, Demicheli V. Methodological issues arising from systematic reviews of the evidence of safety of vaccines. Vaccine. 2004;22:2080–2084
  5. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457–2465
  6. Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ. 2004;171:735–740
  7. Jefferson T, Smith S, Demicheli V, Harnden A, Rivetti A. Safety of influenza vaccines in children. Lancet. 2005;366:803–804
  8. Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol. 2006;24:3933–3938
  9. Von EE, Rollin A, Blumle A, Senessie C, Low N, Egger M. Selective reporting of outcomes of drug trials? Comparison of study protocols and published articles [abstract]. XIV Cochrane Colloquium; October 23–26, 2006; Dublin, Ireland.
  10. Mahoney MR, Sargent DJ. Adverse-event rates: journals versus databases. Lancet. 2007;369:171–172
  11. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA. 2004;292:2622–2631
  12. Hemminki E. Study of information submitted by drug companies to licensing authorities. BMJ. 1980;280:833–836
  13. Curfman GD, Morrissey S, Drazen MD. Expression of concern reaffirmed. N Engl J Med. 2000;354:1193
  14. Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., “Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis,” NEJM 2000:343:1520–1528.
  15. In:  Derry S,  Makinson G,  McQuay H,  Moore A editor. Tolerability and adverse events of celecoxib: meta-analysis of clinical trial reports. Birmingham, UK: Clinical Excellence; 2004;
  16. Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms. Ann Intern Med. 2005;142:1090–1099
  17. Moore RA, Derry S, Makinson GT, McQuay HJ. Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta-analysis of information from company clinical trial reports. Arthritis Res Ther. 2005;7:R644–R665
  18. Bennett CL, Nebeker JR, Lyons EA, Samore MH, Feldman MD, McKoy JM, et al. The Research on Adverse Drug Events and Reports (RADAR) project. JAMA. 2005;293:2131–2140
  19. Cosmi B, Castelvetri C, Milandri M, Rubboli A, Conforti A. The evaluation of rare adverse drug events in Cochrane reviews: the incidence of thrombotic thrombocytopenic purpura after ticlopidine plus aspirin for coronary stenting. 8th Annual Cochrane Colloquium Abstracts; October 2000; Cape Town, Africa.
  20. Hemminki E, McPherson K. Value of drug-licensing documents in studying the effect of postmenopausal hormone therapy on cardiovascular disease. Lancet. 2000;355:566–569
  21. Loke YK, Derry S, Aronson JK. A comparison of three different sources of data in assessing the frequencies of adverse reactions to amiodarone. Br J Clin Pharmacol. 2004;57:616–621
  22. MacLean CH, Morton SC, Ofman JJ, Roth EA, Shekelle PG Southern CE-BPC. How useful are unpublished data from the Food and Drug Administration in meta-analysis?. J Clin Epidemiol. 2003;56:44–51
  23. Ross SD, Kupelnick B, Kumashiro M, Arellano FM, Mohanty N, Allen IE. Risk of serious adverse events in hypertensive patients receiving isradipine: a meta-analysis. J Hum Hypertens. 1997;11:743–751
  24. Tramer MR, Moore RA, McQuay HJ. Propofol and bradycardia: causation, frequency and severity. Br J Anaesth. 1997;78:642–651
  25. Wallace AE, Neily J, Weeks WB, Friedman MJ. A cumulative meta-analysis of selective serotonin reuptake inhibitors in pediatric depression: did unpublished studies influence the efficacy/safety debate?. J Child Adolesc Psychopharmacol. 2006;16:37–58
  26. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363:1341
  27. MacLean C, Morton S, Straus W, Ofman J, Roth E, Shekelle P, editors. Unpublished data from United States Food and Drug Administration New Drug Application Reviews: how do they compare to published data when assessing Nonsteroidal Antiinflammatory Drug (NSAm) associated dyspepsia? 7th Annual Cochrane Colloquium Abstracts; October 1999; Rome, Italy.
  28. Golder S, Loke Y, McIntosh HM. Poor reporting and inadequate searches were apparent in systematic reviews of adverse effects. J Clin Epidemiol. 2008;61:440–448
  29. Barbui C, Furukawa TA, Cipriani A. Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials. CMAJ. 2008;178:296–305
  30. Bohlius J, Weingart O, Trelle S, Engert A. Disentangling the data: variations in data submissions from different players and their potential impact on a systematic review [abstract]. XIII Cochrane Colloquium; Oct 22–26, 2005; Melbourne, Australia. 2005:60.
  31. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356:2457–2471
  32. 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
  33. Steinberg KK, Smith SJ, Stroup DF, Olkin I, Lee NC, Williamson GD, et al. Comparison of effect estimates from a meta-analysis of summary data from published studies and from a meta-analysis using individual patient data for ovarian cancer studies. Am J Epidemiol. 1997;145:917–925
  34. Hemminki E. Quality of reports of clinical trials submitted by the drug industry to the Finnish and Swedish control authorities. Eur J Clin Pharmacol. 1981;19:157–165
  35. Bennett DA, Jull A. FDA: untapped source of unpublished trials. Lancet. 2003;361:1402–1403
  36. LaValley M, Lo G, Hunter D, Felson D. Use of the USA Food and Drug Administration web site for clinical trial information from approved therapies [abstract]. 12th Cochrane Colloquium: Bridging the Gaps; Oct 2–6, 2004; Ottawa, ON. 2004.
  37. Bilker W, Gogolak V, Goldsmith D, Hauben M, Herrera G, Hochberg A, et al. Accelerating statistical research in drug safety. [letter] Pharmacoepidemiol Drug Saf. 2006;15:687–688
  38. Hauben M, Reich L, DeMicco J, Kim K. ‘Extreme duplication’ in the US FDA Adverse Events Reporting System database. Drug Saf. 2007;30:551–554
  39. Rennie D. Fair conduct and fair reporting of clinical trials. JAMA. 1999;282:1766–1768
  40. Mittmann N, Knowles SR. Repetitive publication, meta-analysis, and adverse events. J Clin Psychopharmacol. 1996;16:77
  41. Ioannidis JP, Chew P, Lau J. Standardized retrieval of side effects data for meta-analysis of safety outcomes. A feasibility study in acute sinusitis. J Clin Epidemiol. 2002;55:619–626
  42. Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005;330:753
  43. Dubben H, Beck-Bornholdt H. Systematic review of publication bias in studies on publication bias. BMJ. 2005;331:433–434

 Conflict of interest: No conflicts of interest have been declared.

 Funding/Support: This research was undertaken by Su Golder as part of an MRC fellowship. The views expressed in this presentation are those of the authors and not necessarily those of the Medical Research Council.

PII: S0895-4356(10)00094-6

doi: 10.1016/j.jclinepi.2010.02.009

Journal of Clinical Epidemiology
Volume 63, Issue 10 , Pages 1071-1081 , October 2010

Article Tools

* Image Usage & Resolution