Guidance for Phase II Cancer Trials
Author Information
Author(s): Brown S R, Gregory W M, Twelves C J, Buyse M, Collinson F, Parmar M, Seymour M T, Brown J M
Primary Institution: University of Leeds
Hypothesis
A systematic review of phase II trial designs is necessary to improve the design and implementation of oncology trials.
Conclusion
The guidance offers researchers a structured and systematic approach to identifying phase II trial designs, highlighting key issues to be considered by both clinicians and statisticians.
Supporting Evidence
- A total of 122 papers describing new or adapted phase II trial designs were obtained.
- 96 of the 122 papers were classed as being easy to implement.
- The guidance manual is freely available to researchers upon request.
Takeaway
This study helps doctors and researchers choose the best way to test new cancer treatments by providing a guide on how to design their trials.
Methodology
A systematic literature review was performed to identify phase II trial designs applicable to oncology trials, resulting in a library of designs and a guidance document.
Potential Biases
The assessment of ease of implementation of designs is subjective.
Limitations
The review did not address reporting requirements and may be dated as trial designs continue to evolve.
Digital Object Identifier (DOI)
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