Who Advises the Data Monitoring Committee (DMC)? A Review of Regulatory Guidance for Sponsors on DMCs After 5 Years and Advice for DMC Members

Abstract

Regulatory authorities in the US and EU recommend that pharmaceutical companies employ data monitoring committees (DMCs) to protect the safety of patients taking part in large randomized trials involving diseases with high morbidity or mortality and have provided guidance as to how such committees should be used. This article, whose authors have considerable experience in DMC membership, reviews the applicability of guidance to sponsors after 5 years and suggests that regulatory support for DMC members would be valuable. Advice is offered to members, often very experienced clinicians but inexperienced in pharmaceutical data review, as to how standard DMC data packages should be reviewed, which aspects of trial validity should be addressed, and how communication with the trial sponsor should be handled. It is suggested that DMCs could be supported by regulatory authorities in managing ethical and legal dilemmas to make DMC membership less exposed and more inviting.

This is a preview of subscription content, access via your institution.

References

  1. 1.

    Committee for Medicinal Products for Human Use (CHMP). Guideline on data monitoring committees. July 2005. EMEA/CHMP/EWP/5872/03. https://doi.org/www.ema.europa.eu/pdfs/human/ewp/587203en.pdf. Accessed June 21, 2012.

  2. 2.

    US Food and Drug Administration, Department of Health and Human Services. Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees. March 2006. OMB control no. 0910-0581. https://doi.org/www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf. Accessed June 21, 2012.

  3. 3.

    DeMets DL, Fleming TR, Rockhold F, et al. Liability issues for data monitoring committee members. Clin Trials. 2004;1(6):525–531.

    Article  Google Scholar 

  4. 4.

    DeMets DL, Fleming TR. The independent statistician for data monitoring committees. Stat Med. 2004;23(10):1513–1517.

    Article  Google Scholar 

  5. 5.

    Amit O, Heiberger RM, Lane PW. Graphical approaches to the analysis of safety data from clinical trials. Pharm Stat. 2008;7:20–35.

    Article  Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Richard Kay PhD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Glover, J.M., Kay, R. Who Advises the Data Monitoring Committee (DMC)? A Review of Regulatory Guidance for Sponsors on DMCs After 5 Years and Advice for DMC Members. Ther Innov Regul Sci 46, 525–531 (2012). https://doi.org/10.1177/0092861512452123

Download citation

Keywords

  • data monitoring committees
  • regulatory guidance on DMCs
  • drug safety
  • interim analysis
  • indemnity