EORTC-IDMC

A permanent Independent Data Monitoring Committee (IDMC) was established in 2001 to review the status of EORTC clinical trials and make recommendations to the Groups concerning trial continuation, modification, and/or publication.

Members

Chair R. Kaplan, Leeds (UK)

A. Awada, Brussels (BE)
M. Gnant, VIenna (AT)
G. Griffiths, Cardiff (UK)
A. Horwich, Sutton (UK)
K. Pritchard, Toronto (CA)
P. Scalliet, Brussels (BE)
S. Stenning, London (UK)
R. Sylvester, Brussels (BE) (Ex-officio member)

In accordance with EORTC POL 004, external study specific experts provide advice to the committee on a confidential basis.

The committee meets on a quarterly basis or according to need. In 2009, seven different trials were reviewed.

IDMC review is mandatory for phase III trials where formal interim analyses and early stopping rules are foreseen and is recommended in the following situations:
• Intergroup trials coordinated by the EORTC;
• All trials requiring the randomization of more than 1000 patients or more than four years of patient accrual;
• Trials with highly toxic regimens or particular safety concerns;
• Trials encountering major strategic dilemmas (for instance, problematic issues arising from similar studies elsewhere) ;
• Pivotal phase III trials which will be used for drug registration;
• Randomized phase II trials that may be continued as a phase III trial without clear rules in the protocol.

The IDMC also reviews requests for the early release of data prior to trial maturity.

The Committee’s recommendations are forwarded to the trial management group and to the EORTC Executive Committee when further action is required.

In 2010, the EORTC Data and Safety Monitoring Board (DSMB) was formed as a subcommittee of the EORTC IDMC. Chaired by C. Twelves (Leeds, UK), the DSMB has early trials/drug development expertise and provides a separate review process, having no access to outcome data. It reviews safety problems identified by the EORTC HQ for which advice is sought, primarily for phase I and non randomized phase II studies, but also as an initial step in phase III trials to advise if the study should then go to the full IDMC.

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EORTC Independent Data Monitoring Committee (IDMC)

Members