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Design issues in randomized phase II/III trials.

Edward L Korn¹, Boris Freidlin, Jeffrey S Abrams

¹Biometric Research Branch, EPN-8129, National Cancer Institute, Bethesda, MD 20852, USA. korne@ctep.nci.nih.gov

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology

|January 25, 2012

Summary

This summary is machine-generated.

Phase II/III trials combine early and definitive treatment testing, improving efficiency. Key design choices involve data accrual suspension and selecting the phase II target effect for optimal clinical trial outcomes.

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Area of Science:

Clinical Trials Methodology
Biostatistics
Drug Development

Background:

Phase II trials assess preliminary treatment activity or select among options.
Phase III trials definitively test prioritized treatments against controls.
Current methods often involve sequential, distinct trial phases.

Purpose of the Study:

To explore the design of integrated randomized phase II/III trials.
To identify key parameters influencing the efficiency of combined trial designs.
To provide recommendations for optimizing phase II/III trial strategies.

Main Methods:

Discussion of adaptive trial designs integrating phase II and phase III.
Analysis of critical design parameters: data accrual suspension and phase II target effect.
Review of example phase II/III trials to illustrate design principles.

Main Results:

Randomized phase II/III trials offer potential time savings and reduced patient numbers.
Strategic decisions on data maturity and target effect significantly impact trial efficiency.
Integrated designs can streamline the drug development pathway.

Conclusions:

Optimizing phase II/III design parameters is crucial for efficient clinical research.
Adaptive integrated designs represent a promising approach for drug evaluation.
Recommendations are provided for the efficient design of future phase II/III trials.