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Considerations for Designing and Implementing Phase II Oncology Clinical Trials

Author

Listed:
  • Lai Wei
  • Xueliang Pan
  • Soledad Fernandez

    (Department of Biomedical Informatics, Ohio State University, Columbus)

Abstract

Oncology Phase II trials’ main objective is to collect preliminary efficacy data of an oncology treatment, that will be used to inform and decide whether to further investigate the treatment. Choosing a proper design is an important but not easy task in the treatment evaluation/FDA approval process. The objectives of this short article are to briefly summarize the different type of phase II clinical trial designs, including the traditional designs and the more recently developed adaptive designs; discuss the practical considerations in the selection of proper designs; provide recommendations for the implementation, especially some aspects to be considered for the adaptive designs.

Suggested Citation

  • Lai Wei & Xueliang Pan & Soledad Fernandez, 2019. "Considerations for Designing and Implementing Phase II Oncology Clinical Trials," Biostatistics and Biometrics Open Access Journal, Juniper Publishers Inc., vol. 10(1), pages 1-4, October.
    • Handle: RePEc:adp:jbboaj:v:10:y:2019:i:1:p:1-4
    DOI: 10.19080/BBOAJ.2019.10.555776
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