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Adaptive designs in clinical trials: a systematic review-part I
Mohamed Ben-Eltriki1,2,3, Aisha Rafiq4, Arun Paul4
1Department of Pharmacology and Therapeutics, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada. mbeneltriki@alumni.ubc.ca.
BMC Medical Research Methodology
|October 4, 2024
Summary
Adaptive designs (ADs) enhance clinical trial flexibility and efficiency. This review details their use, highlighting challenges in reporting and the need for better guidelines and education for wider adoption.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Drug Development
Background:
- Adaptive designs (ADs) offer flexibility, efficiency, and cost savings in clinical trials.
- Widespread understanding of AD characteristics, benefits, and limitations remains limited in the research community.
- This systematic review (Part I) examines the application of ADs in published clinical trials.
Purpose of the Study:
- To provide a comprehensive overview of the methodological features of adaptive clinical trials.
- To identify common adaptations, statistical methods, and reporting practices in adaptive trials.
- To lay the groundwork for future comparisons and recommendations, particularly for pediatric studies.
Main Methods:
- Systematic literature search of MEDLINE, Embase, and International Pharmaceutical Abstracts (2010-April 2020).
- Inclusion of clinical trial protocols, reports, and secondary analyses using ADs for drugs or vaccines.
- Extraction and summarization of data on study characteristics, adaptations, statistical analyses, and operational considerations.
Main Results:
- 317 adaptive trials were included, predominantly in oncology (53%) and early-phase development (87%).
- Dose-finding designs (38.2%) and adaptive randomization (16.7%) were most common; frequentist methods (64%) were more prevalent than Bayesian (24%).
- Adaptation details were inconsistently reported, impacting interpretation and generalizability.
Conclusions:
- Adaptive clinical trials show promise for efficiency but require standardized reporting.
- Improved reporting guidelines and educational strategies are crucial for effective implementation.
- Addressing scientific, operational, and ethical challenges will facilitate wider adoption of ADs.
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