Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials

Sydes, Matthew R; Spiegelhalter, David J; Altman, Douglas G; Babiker, Abdel B; Parmar, Mahesh KB; DAMOCLES Group

doi:10.1191/1740774504cn004rr

Cited by 76Statistical Methods in Clinical TrialsEthics in Clinical ResearchPharmaceutical industry and healthcare

Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials

Sydes, Matthew R, Spiegelhalter, David J, Altman, Douglas G, Babiker, Abdel B, Parmar, Mahesh KB, DAMOCLES Group·2004·Clinical Trials

DOI 10.1191/1740774504cn004rr

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Abstract

Aims To systematically review the published literature on data monitoring committees (DMCs) for randomized controlled trials (RCT) and summarize information and opinions on best practice. This was part of the DAMOCLES project. Methods A systematic and comprehensive search of five online bibliographic databases was performed, identifying 4007 potentially relevant articles. These were assessed in two stages by the authors. The 84 most relevant articles were agreed and were supplemented with extracts from 16 books: ultimately, 100 sources were reviewed. A series of 23 questions plus subquestions were developed to structure the data extraction and interpretation process. Results Much has been written about DMCs but by a rather small community of authors. The papers included some results of surveys, but were mainly opinion pieces based on the authors' beliefs, practices and experiences. There is a lack of empirical evidence for many aspects of DMCs. There was a great range of detail in the literature relating to the prespecified questions. It was generally agreed that interim monitoring of accumulating data was necessary in some form for most trials. Questions such as membership of the DMC featured widely in the literature with opinions and practice ranging from 3–20 members, of whom between none and all should be independent. There was a consensus that formal statistical methods should be used as tools to guide decision making rather than as hard rules. Conversely, topics such as the training and experience required for DMC membership were discussed in very few papers. Conclusions There is a consensus in the published literature in a number of areas, although there are many different models for structure and functions of a DMC. While uncertainty remains about some issues, it is strongly recommended that an explicit set of guidelines (Charter) is prepared for each DMC prior to the start of the trial specifying clearly how it will operate.

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Data monitoring committees may not be needed for trials that are of short duration, have known minimal risks, are designed to demonstrate principles, or are on behavioural or administrative issues.
“DMCs may not be needed: 1) for trials that are of short duration (where it may not be feasible to convene a DMC in a timely fashion to review the data); 2) for trials with known risks that are minimal; 3) for trials in which the objective is to demonstrate principles (such as in early-phase clinical trials); or 4) for trials on behavioural or administrative issues.”
From Coping with Uncertainty in Everyday Situations (CUES©) to address intolerance of uncertainty in autistic children: Study protocol for an intervention feasibility trial (2019) · cites this paper as [48]

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Authors: Sydes, M. R., Spiegelhalter, D. J., Altman, D. G., Babiker, A. B., Parmar, M. K., & DAMOCLES Group
Affiliations: MRC Clinical Trials Unit at UCL (GB)
MRC Biostatistics Unit (GB)
Cancer Research UK (GB)
ORCID: Sydes, Matthew R
Spiegelhalter, David J
Altman, Douglas G
Parmar, Mahesh KB
Venue: Clinical Trials
Publisher: SAGE Publications
Published: 2004-02
Volume: 1
Issue: 1
Pages: 60-79
ISSN: 1740-7745 (ISSN-L)
1740-7753
DOI: 10.1191/1740774504cn004rr
OpenAlex: W2026423245
Cited by: 76
References: 111
Citations by year: 2026: 3 · 2025: 1 · 2024: 5 · 2023: 3 · 2022: 4 · 2021: 7 · 2020: 3 · 2019: 5 · 2018: 1 · 2017: 1 · 2016: 1 · 2015: 6 · 2014: 2 · 2013: 1 · 2012: 2
FWCI: 0.72
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Clinical Trials (publishedVersion)
PubMed (publishedVersion)
UCL Discovery (University College London) (submittedVersion)
DigitalGeorgetown (Georgetown University Library) (submittedVersion)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (submittedVersion)
Funders: National Cancer Institute
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords: data monitoring committees, randomized controlled trials, interim analysis, best practice guidelines
MeSH terms: Humans, Randomized Controlled Trials as Topic, Clinical Trials Data Monitoring Committees

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Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials

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