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A Practical Guide to Data Monitoring Committees in Adaptive Trials
Matilde Sanchez-Kam1, Paul Gallo2, John Loewy3
11 Biostatistics and Data Management, Arena Pharmaceuticals Inc, San Diego, CA, USA.
Therapeutic Innovation & Regulatory Science
|September 22, 2018
Summary
Data monitoring committees (DMCs) are crucial for adaptive clinical trials, ensuring participant safety and enabling trial modifications. Training for DMC members is vital for successfully managing these complex trials.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Drug Development
Background:
- Adaptive clinical trials allow for pre-specified modifications based on interim data.
- Data Monitoring Committees (DMCs) oversee trial data for participant safety and may implement adaptations.
Purpose of the Study:
- To summarize current practices and viewpoints on DMCs in adaptive trials.
- To provide guidance on evolving issues concerning DMCs in adaptive trial designs.
Main Methods:
- Review of common adaptive trial designs and unique DMC-related challenges.
- Inclusion of three practical examples of DMCs in late-stage adaptive trials.
Main Results:
- Identification of specific issues unique to DMCs in adaptive trial settings.
- Demonstration of practical DMC implementation in adaptive trials.
Conclusions:
- Qualified DMC members are fundamental to the successful execution of adaptive trial responsibilities.
- Advocacy for dedicated training opportunities for researchers serving on DMCs for adaptive trials.
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