Preparing for Phase II: Finding the Right Dose, Schedule, and Combination from your Phase I/II Oncology Trial

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Determining the optimal dose, dosing regimen and, in a growing number of trials, the right combination treatment partner for a key Phase II clinical trial, is essential to developing an oncology therapeutic. Phase I/II oncology clinical trial designs must take into account the latest information about emerging therapies, biomarkers, and clinical trial methodology, along with evolving regulations, to achieve the optimal design to determine dose, schedule, and combination treatment regimen.

This webinar will review these and other factors important to planning and executing early-phase oncology clinical trials in preparation for a decision-making Phase II trial. This is important since most failures of oncology therapeutics result from poor outcomes in Phase II studies.

Beginning with the end in mind, we will:

  • Identify what is meant by the “right” dose, regimen, and potential combination treatment for a Phase II clinical trial
  • Describe current regulatory and scientific/clinical factors impacting dose and regimen selection
  • Consider how to define starting dose, regimen, combination, and potential biomarkers and pharmacodynamic measurements from nonclinical and clinical data on your compound or those with a similar mechanism of action
  • Describe early-phase trial designs, such as 3+3, the continual reassessment method, and Bayesian designs, that determine the minimum effective dose and/or maximum tolerated dose
  • Explore use of adaptive design approaches in phase I/II trials

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Title: Medical Device Regulation: Finding Your Path to Success

Date: Tuesday, November 7, 2017

Time: 11am – 12pm EST (4pm GMT / 5pm CET EU-Central)

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