Data monitoring committees

Fundamental healthcare issues may also be involved in the situation of policy-driven therapeutic research. The future investment of society in health may require a large-scale national clinical trial to answer questions relating to the prevention of disease or premature death. This type of clinical trial will not simply relate to one manufacturer s product. As such, it is preferable that the trial is organised on a national level, not necessarily with the exclusion of the company(s) involved. An independent data-monitoring committee (IDMC) should oversee the clinical trial with as much support from the pharmaceutical company(s) as possible. The clinical data collected belongs to the state and should be treated with the same quality standards as any pharmaceutical company sponsored study. 

CH14 INTERIM ANALYSIS AND DATA MONITORING COMMITTEES... 

FDA (2006) Establishment and Operation of Clinical Trial Data Monitoring Committees ... 

CHMP (2005) Guidance on Data Monitoring Committees/ FDA (2006) Establishment and Operation of Clinical Trial Data Monitoring Committees These documents provided guidance on the set up, operational and working procedures, and the roles and responsibilities of the DMC in a single clinical trial or collection of trials (see Section 14.4). 

Eggar M, Smith GD, Schneider M and Minder C (1997) Bias in meta-analysis detected by a simple, graphical test British Medical Journal, 315, 629-634 Ellenberg SS, Fleming TR and DeMets DF (2003) Data Monitoring Committees in Clinical Trials A Practical Perspective New York John WUey Sons, Inc. 

Trial Management, Data Handling, Record Keeping, and Independent Data Monitoring Committee Investigator Selection... 

Data monitoring committees face difficult ethical challenges, in particular deciding whether a clinical trial should be terminated early. 

Ellenbeig, S.S., Fleming, T.R., and DeMets, D.L., 2003, Data monitoring committees in clinical trials A practical perspective, John Wiley Sons. 

Ellenberg, Fleming and DeMets Data Monitoring Committees in Clinical Trials ... 

Use ofthe Independent Data-Monitoring Committee (IDMC)... 

Ellenberg SE, Fleming TR, DeMets DL (2003). Data Monitoring Committees in Clinical Trials A practical perspective. Chichester John Wiley Sons. 

In order to allow for efficient safety monitoring of the study, an independent data monitoring committee composed of international experts in movement disorder and stereotactic neurosurgery will analyze safety data at predefined intervals during the study. The first safety analysis will be performed when 1-month data from 12 patients is complete, the second will be with 1-month data from 36 patients, and the third and last when all patients have reached the 1-month time point after surgery. 

The following parameters will be listed and analyzed both for the final analysis and for the interim safety evaluations by the independent data monitoring committee ... 

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