Skip to main content

Advertisement

SpringerLink
Log in

A primer on data safety monitoring boards: mission, methods, and controversies

  • Legal and Ethical issues in clinical research
  • Published:
Intensive Care Medicine Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Heart Special Project Committee (1988) A report from the heart special project committee to the national advisory heart council, May 1967. Controlled Clin Trials 9:137–148

    Article  Google Scholar 

  2. Meduri GU, Headley AS, Golden E, Carson SJ, Umberger RA, Kelso T, Tolley EA (1998) Effect of prolonged methylprednisolone therapy in unresolving acute respiratory distress syndrome: a randomized controlled trial JAMA 280:159–165

    Article  PubMed  CAS  Google Scholar 

  3. Steinbrook R (2003) Trial design and patient safety—the debate continues. N Engl J Med 349:629–630

    Article  PubMed  Google Scholar 

  4. EMEA Committee for Medicinal Products for Human Use (2005) Guideline on data monitoring committees. Available at: http://www.emea.eu.int/pdfs/human/ewp/587203en.pdf, accessed 16 April 2007

  5. Grant AM, Altman DG, Babiker AB, Campbel MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MKB, Pocock SJ, Spiegelhalter DJ, Sydes MR, Walker AF, Wallace SA, the DAMOCLES study group (2005) Issues in data monitoring and interim analysis of trials. Health Technol Assess 9:1–235

    CAS  Google Scholar 

  6. United States Department of Health and Human Services, Food and Drug Administration (2006) Guidance for clinical trial sponsors. Establishment and operation of clinical trial data monitoring committees. Available at: http://www.fda.gov/CBER/gdlns/clintrialdmc.pdf, accessed 16 April 2007

  7. United States Department of Health and Human Services, Food and Drug Administration (2006) Guidance for clinical trial sponsors. Establishment and operation of clinical trial data monitoring committees. http://www.fda.gov/CBER/gdlns/clintrialdmc.pdf, p 1, accessed 16 April 2007

  8. Goss PE, Ingle JF, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL (2003) A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med 39:1793–1802

    Article  Google Scholar 

  9. Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, Bucher HC, Schunemann HJ, Meade MO, Cook DJ, Erwin PJ, Sood A, Sood R, Lo B, Thompson CA, Zhou Q, Mills E, Guyatt GH (2005) Randomized trials stopped early for benefit: a systematic review JAMA 294:2203–2209

    Article  PubMed  CAS  Google Scholar 

  10. Pocock SJ (2004) A major trial needs three statisticians: why, how and who? Stat Med 23:1535–1539

    Article  PubMed  Google Scholar 

  11. Snapinn S, Cook T, Shapiro D, Snavely D (2004) The role of the unblinded sponsor statistician. Stat Med 23:1531–1533

    Article  PubMed  Google Scholar 

  12. Grant AM, Altman DG, Babiker AG, Campbell MK, the DAMOCLES Study Group (2005) A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 365:711–722

    Google Scholar 

  13. Slovic P (1987) Perception of risk. Science 236:280–285

    Article  PubMed  CAS  Google Scholar 

  14. Whitehead J (2004) Stopping clinical trials by design. Nat Rev Drug Discov 3:973–977

    Article  PubMed  CAS  Google Scholar 

  15. Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bev M, Shearer W, Jacobson RL et al (1994) Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med 331:1173–1180

    Article  PubMed  CAS  Google Scholar 

  16. Bresalier RS, Sandler RS, Quan H, Bolognese JA, Stat M, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA, for the Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 352:1092–1102

    Article  PubMed  CAS  Google Scholar 

  17. Solomon SD, McMurray JJ, Pfeffer MA, Whittes J, Fowler R, Finn P, Anderson WF, Zauber A, Hawk E, Bertagnolli M for the Adenoma Prevention with Celecoxib (APC) Study Investigators (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352:1071–1080

    Article  PubMed  CAS  Google Scholar 

  18. Arber N, Eagle CJ, Spicak J, Raez I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonal K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B, for the PreSAP Trial Investigators (2006) Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med 355:885–895

    Article  PubMed  CAS  Google Scholar 

  19. Fleming TR, Ellenberg S, DeMets DL (2002) Monitoring clinical trials: issues and controversies regarding confidentiality. Stat Med 21:2843–2851

    Article  PubMed  Google Scholar 

  20. Lilford RJ, Braunholtz D, Edwards S, Stevens A (2001) Monitoring clinical trials—interim data should be publicly available. BMJ 323:441–442

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Medicine, Division of Oncology/Hematology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada

    Lisa K. Hicks

  2. Keenan Research Centre, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Canada

    Lisa K. Hicks, Andreas Laupacis & Arthur S. Slutsky

  3. Faculty of Medicine, University of Toronto, Toronto, Canada

    Lisa K. Hicks & Arthur S. Slutsky

Authors
  1. Lisa K. Hicks
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Andreas Laupacis
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Arthur S. Slutsky
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Lisa K. Hicks.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Hicks, L.K., Laupacis, A. & Slutsky, A.S. A primer on data safety monitoring boards: mission, methods, and controversies. Intensive Care Med 33, 1815–1818 (2007). https://doi.org/10.1007/s00134-007-0794-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00134-007-0794-9

Keywords

Search

Navigation