Monitoring Committee Structure and Function
The investigator’s ethical responsibility to the study participants demands that safety and clinical benefit be monitored during trials. If data partway through the trial indicate that the intervention is harmful to the participants, early termination of
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Monitoring Committee Structure and Function
The investigator’s ethical responsibility to the study participants demands that safety and clinical benefit be monitored during trials. If data partway through the trial indicate that the intervention is harmful to the participants, early termination of the trial should be considered. If these data demonstrate a clear definitive benefit from the intervention, the trial may also be stopped early because continuing would be unethical to the participants in the control group. In addition, if differences in primary and possibly secondary response variables are so unimpressive that the prospect of a clear result is extremely unlikely, it may not be justifiable in terms of time, money, and effort to continue the trial. Also, monitoring of response variables can identify the need to collect additional data to clarify questions of benefit or toxicity that may arise during the trial. Finally, monitoring may reveal logistical problems or issues involving data quality that need to be promptly addressed. Thus, there are ethical, scientific, and economic reasons for interim evaluation of a trial [1–3]. In order to fulfill the monitoring function, the data must be collected and processed in a timely fashion as the trial progresses. Data monitoring would be of limited value if conducted only at a time when all or most of the data had been collected. The specific issues related to monitoring of recruitment, adherence, and quality control are covered in other chapters and will not be discussed here. The monitoring committee process has been described in detail [4] as have case studies representing trials, which were terminated for benefit, harm, or futility [5]. One of the earliest discussions of the basic rationale for data monitoring was included in a report of a committee initiated at the request of the council advisory to the then National Heart Institute and chaired by Bernard Greenberg [3]. This report outlined a clinical trial model depicted in Fig. 16.1, variations of which have been implemented widely by institutes at the National Institutes of Health (NIH). The key components are the Steering Committee, the Statistical and Data Coordinating Center, the Clinics, and the Data Monitoring Committee. Later the pharmaceutical and device industries [6] adopted a modified version of this NIH model, depicted in Fig. 16.2. The main modification was to separate the Statistical Data Coordinating Center into a Statistical Data Analysis Center and a Data Coordinating Center. © Springer International Publishing Switzerland 2015 L.M. Friedman et al., Fundamentals of Clinical Trials, DOI 10.1007/978-3-319-18539-2_16
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Steering Committee
Monitoring Committee Structure and Function
NIH
Policy Board Data Monitoring Committee
Coordinating Center
Clinical Centers
Central Units (Labs, …) Institutional Review Board
Patients
Fig. 16.1 The NIH Clinical Trial Model
Steering Committee
Pharmaceutical Sponsor
Regulatory Agencies
Independent Data Monitoring Committee (IDMC) Statist
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