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Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry
1AbbVie, North Chicago, IL, USA.
Clinical Trials (London, England)
|March 7, 2022
Summary
Cluster randomized controlled trials (cluster RCTs) use group randomization and require consideration of the intraclass correlation coefficient (ICC). Understanding ICC is crucial for effective design, analysis, and reporting in biopharmaceutical research.
Area of Science:
- Biostatistics
- Clinical Trials
- Public Health Research
Background:
- Cluster randomized controlled trials (cluster RCTs) randomize groups, not individuals, and are used in public health.
- Growing use of real-world data in regulatory settings may increase industry adoption of cluster RCTs.
- The intraclass correlation coefficient (ICC) is a key differentiator from traditional RCTs.
Purpose of the Study:
- To discuss practical considerations related to the ICC in cluster RCTs.
- To improve the translation of research findings from cluster RCTs into biopharmaceutical industry practices.
Main Methods:
- Discussion of practical considerations for ICC in cluster RCT design.
- Consideration of ICC in cluster RCT conduct.
- Addressing ICC in cluster RCT analysis and reporting.
Main Results:
- Key considerations for ICC in cluster RCTs were identified.
- Practical implications for the biopharmaceutical industry were discussed.
Conclusions:
- Addressing ICC is vital for successful cluster RCT implementation.
- Improved understanding of ICC can enhance the application of cluster RCTs in the biopharmaceutical sector.
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