IDDI organized a webinar on Efficient Designs in Phase I oncology trials.
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.
KEY LEARNING OBJECTIVES:
- 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:
