Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials

Therapeutic Innovation & Regulatory Science
Zoran AntonijevicMatilde Sanchez

Abstract

In this paper, the authors express their views on a range of topics related to data monitoring committees (DMCs) for adaptive trials that have emerged recently. The topics pertain to DMC roles and responsibilities, membership, training, and communication. DMCs have been monitoring trials using the group sequential design (GSD) for over 30 years. While decisions may be more complicated with novel adaptive designs, the fundamental roles and responsibilities of a DMC will remain the same, namely, to protect patient safety and ensure the scientific integrity of the trial. It will be the DMC's responsibility to recommend changes to the trial within the scope of a prespecified adaptation plan or decision criteria and not to otherwise recommend changes to the study design except for serious safety-related concerns. Nevertheless, compared with traditional data monitoring, some additional considerations are necessary when convening DMCs for novel adaptive designs. They include the need to identify DMC members who are familiar with adaptive design and to consider possible sponsor involvement in unique situations. The need for additional expertise in DMC members has prompted some researchers to propose alternative DMC models or alternativ...Continue Reading

References

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Citations

Jan 8, 2020·Pharmaceutical Statistics·Hui QuanGautier Paux
Mar 18, 2015·Statistics in Medicine·Peter BauerGernot Wassmer
Sep 1, 2014·Therapeutic Innovation & Regulatory Science·Oleksandr Sverdlov, Weng Kee Wong
May 1, 2014·Therapeutic Innovation & Regulatory Science·Matilde Sanchez-KamThomas Laage
Nov 10, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·W Charles HuskinsScott Evans

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