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  • Daniel J. Sargent & Qian Shi: Statistics in Oncology Clinical Trials Column /
  • Phase II design: history and evolution

Phase II design: history and evolution

Posted On 2015-05-12 17:15:28

Historically, phase II trials in oncology generally had a single-arm design, constructed to distinguish between a tumor response rate felt to indicate a lack of promise (often 5%) and a rate that would indicate potential benefit (often 20%), with a one-sided type I error rate of 5% to 10% and a type II error rate of 10% to 20%. We have reviewed the history and evolution of the phase II trial over the past 50 years, in particular, in oncology trials.

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Daniel J. Sargent & Qian Shi: Statistics in Oncology Clinical Trials Column

  • Findings from the Adjuvant Colon Cancer End Points (ACCENT) Collaborative Group: the power of pooled individual patient data from multiple clinical trials
  • Statistical aspect of translational and correlative studies in clinical trials
  • Phase III design: principles
  • Phase II design: history and evolution
  • Adaptive clinical trial designs in oncology
  • Biomarker based clinical trial design
  • On independent data monitoring committees in oncology clinical trials
  • Overview: biostatistician’s role in oncology clinical trials—strive for sound, efficient and practical studies
  • The current design of oncology phase I clinical trials: progressing from algorithms to statistical models
  • Adaptive randomized phase II design for biomarker threshold selection and independent evaluation

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Aims and ScopeThe Chinese Clinical Oncology (CCO; Chin Clin Oncol; Print ISSN 2304-3865; Online ISSN 2304-3873) is an Open Access, peer-reviewed, bimonthly journal (quarterly published from Sep 2012-D...

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