Clinical TrialsA proposed charter for clinical trial data monitoring committees: helping them to do their job well
Section snippets
Research strategy
The DAMOCLES study used several complementary strategies to study behavioural and organisational aspects of DMCs and procedural issues of interim analyses. These are described fully elsewhere.5 In brief, we used systematic reviews of published work on DMCs and on small group processes in decision-making; surveys of reports of RCTs, of recently completed and ongoing RCTs, and of the policies of major organisations connected with RCTs; detailed case studies of four DMCs in which difficult
The charter
Full details of the systematic review, the results of the surveys, and the systematic review of small group processes in decision making have been reported elsewhere.5, 6, 7, 8, 9 Here we present the proposed DMC charter (see end of article) with short summaries of the key points contributing to each of the charter's ten sections. From the review of published work and the cross-sectional surveys, we could see that various names and descriptors are used to describe the data monitoring process.
Comment
The DAMOCLES study used a combination of research strategies to consider the behavioural, procedural, and organisational aspects of data monitoring in RCTs. The study drew on a wide range of work, from publications directly addressing the working of DMCs to psychological research on processes that aid small group decision making. The surveys provided empirical evidence of previous and current DMC practices, and the interviews and case studies provided valuable insights into the factors
References (18)
- et al.
Terms of reference for Data and Safety Monitoring Committees
Am Heart J
(2001) - et al.
The agonising negative trend in monitoring of clinical trials
Lancet
(1999) - et al.
Under-reporting of clinical trials is unethical
Lancet
(2003) - et al.
The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
Lancet
(2001) - et al.
The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist
Control Clin Trials
(2002) - et al.
Data monitoring committees in clinical trials: a practical perspective
(2002) - et al.
The role of an independent statistical analysis center in the Industry-Modified National Institutes of Health Model
Drug Inf J
(2001) - Grant AM, Sydes M, McLeer S, et al. Issues in data monitoring and interim analysis of trials (the DAMOCLES study)....
- et al.
Systematic review of data monitoring committees in randomised controlled trials
Clin Trials
(2004)
Cited by (0)
Members listed at end of report