Advertisement

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

  • Josephine Mary Glover
  • Richard KayEmail author
Regulatory Science

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.

Keywords

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

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

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.CrossRefGoogle Scholar
  4. 4.
    DeMets DL, Fleming TR. The independent statistician for data monitoring committees. Stat Med. 2004;23(10):1513–1517.CrossRefGoogle 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.CrossRefGoogle Scholar

Copyright information

© Drug Information Association, Inc 2012

Authors and Affiliations

  1. 1.Coephycient Pharmaceutical ConsultancyGuildfordUK
  2. 2.RK Statistics LtdGreat LongstoneUK
  3. 3.Cardiff School of Pharmacy & Pharmaceutical SciencesCardiff UniversityCardiffUK

Personalised recommendations