The permanent Independent Data Monitoring Committee for EORTC studies (IDMC) was established in 2001. The committee is charged with the interim review of EORTC studies and Intergroup studies where the EORTC is the coordinating group (including studies done together with the pharmaceutical industry) as described in the EORTC POLICY 004.
The terms of reference of the IDMC include, as is relevant in regard to the study design:
- whether it is ethical to continue randomizing patients when there is compelling evidence that the risk/benefit ratio favors one of the arms over the other(s) or conversely, where there is compelling evidence of futility (i.e., that the study will never lead to concluding against the null hypothesis) following protocol defined stopping rules
- whether one should present or publish the results of all or some of the study endpoints earlier than anticipated, i.e., prior to study maturity
- whether a randomized phase II study should be continued (or possibly expanded) into a phase III study.
- whether a modification should be made to the study for safety reasons, for example, a modification of the eligibility criteria when the risk/benefit ratio seems unfavorable in specific subgroups of patients
- on modifications to the study sample size
- on study parameters that are planned according to an adaptive study design when the adaptions are effects based on an interim analysis of un-blinded results of the controlled study (generally involving comparative analyses of study endpoints or outcomes potentially correlated with these endpoints).
- n actions needed to manage identified issues related to patient compliance or study feasibility and/or quality
Chair: M. Mason, Cardiff (UK)
J-P. Armand, Bordeaux (FR)
H. Bartelink, Amsterdam (NL)
M. Gnant, Vienna (AT)
G. Griffiths, Southampton (GB)
A. Horwich, Sutton (GB)
The functioning of the permanent IDMC for EORTC studies is ruled by a Charter.
All communication with the IDMC should be addressed in writing and addressed to IDMCsec@eortc.be.