The American Journal of Medicine
Volume 117, Issue 8 , Pages 582-589 , 15 October 2004

Availability of large-scale evidence on specific harms from systematic reviews of randomized trials

  • Panagiotis N. Papanikolaou, MD
  • ,
  • John P.A. Ioannidis, MD

      Affiliations

    • Corresponding Author InformationRequests for reprints should be addressed to John P. A. Ioannidis, MD, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina 45110, Greece

Received 20 January 2004 ,Accepted 15 April 2004.

References 

  1. Ioannidis JP , Lau J . Improving safety reporting from randomised trials . Drug Saf . 2002;25:77–84
  2. Ioannidis JP , Lau J . Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas . JAMA . 2001;285:437–443
  3. Jick H . The discovery of drug-induced illness . N Engl J Med . 1977;296:481–485
  4. Berlin JA , Colditz GA . The role of meta-analysis in the regulatory process for foods, drugs, and devices . JAMA . 1999;281:830–834
  5. Jadad AR , Moher M , Browman GP , et al.  Systematic reviews and meta-analyses on treatment of asthma: critical evaluation . BMJ . 2000;320:537–540
  6. Jadad AR , Cook DJ , Jones A , et al.  Methodology and reports of systematic reviews and meta-analyses: a comparison of Cochrane reviews with articles published in paper-based journals . JAMA . 1998;280:278–280
  7. Gøtzsche PC . Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal, antiinflammatory drugs in rheumatoid arthritis [published correction in Control Clin Trials. 1989;10:356] . Control Clin Trials . 1989;10:31–56
  8. Loke YK , Derry S . Reporting of adverse drug reactions in randomised controlled trials - a systematic survey . BMC Clin Pharmacol . 2001;1:3
  9. Edwards JE , McQuay HJ , Moore RA , Collins SL . Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain . J Pain Symptom Manage . 1999;18:427–437
  10. Hayashi K , Walker AM . Japanese and American reports of randomized trials: differences in the reporting of adverse effects . Control Clin Trials . 1996;7:99–9110
  11. Martin RCG , Brennan MF , Jaques DP . Quality of complication reporting in the surgical literature . Ann Surg . 2002;235:803–812
  12. Ernst E , Pittler MH . Systematic reviews neglect safety issues . Arch Intern Med . 2001;161:125–126
  13. Writing Group for the Women's Health Initiative Investigators . Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial . JAMA . 2002;288:321–333
  14. Million Women Study Collaborators . Breast cancer and hormone-replacement therapy in the Million Women Study . Lancet . 2003;362:419–427
  15. Jick H , Derby LE , Myers MW , et al.  Risk of hospital admission for idiopathic venous thromboembolism among users of postmenopausal oestrogens . Lancet . 1996;348:981–983
  16. Skegg DC , Doll R . The case for recording events in clinical trials . BMJ . 1977;2:1523–1524
  17. McPherson K , Hemminki E . Synthesising licensing data to assess drug safety . BMJ . 2004;328:518–520

PII: S0002-9343(04)00494-2

doi: 10.1016/j.amjmed.2004.04.026

The American Journal of Medicine
Volume 117, Issue 8 , Pages 582-589 , 15 October 2004