Efficient Designs in Phase I Trials in Oncology

September 19, 2013

IDDI organized a webinar on Efficient Designs in Phase I oncology trials.

  • The key learning objectives of this webinar were :
    • To understand the role of phase I trials in the drug-development process in oncology
    • To identify key concepts commonly used in the design and analysis of phase I trials
    • To assess the benefits and limitations of various phase I designs

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Efficient Designs in Phase I Trials in Oncology

To access the presentation of this on-demand webinar, register to the right

Contents:

  • Historical developments, ethical aspects, some definitions (e.g., difference between first-in-human and subsequent trials; phase I/II trials; DLT; MTD), usual endpoints, potential differences between chemotherapy and targeted therapy, regulatory guidelines. Potential benefits and limitations of various classical and novel designs: 3+3 design and its modifications, continual reassessment method (CRM), toxicity probability interval (TPI) design, PK assessment as one of the objectives of phase I.
  • The Key learning objectives were :
    • To understand the role of phase I trials in the drug-development process in oncology
    • To identify key concepts commonly used in the design and analysis of phase I trials
    • To assess the benefits and limitations of various phase I designs

Speakers:

  • Tomasz Burzykowski, VP Research, IDDI
  • Everardo Saad, CEO Dendrix, Oncology Consultant IDDI
Presentation of the Webinar: Efficient Designs in Phase I Trials in Oncology

To access the presentation of this on-demand webinar, please fill out this form.

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