SOURCE: Xtalks

Xtalks Webinars

October 19, 2017 07:00 ET

Preparing for Phase II: Finding the Right Dose, Schedule, and Combination from your Phase I/II Oncology Clinical Trial, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - October 19, 2017) - In a complimentary webinar, experts from Premier Research Paul Hallenbeck, Ph.D., Executive Director of Strategic Development, Oncology, Peter Larson, M.D., Senior Medical Director of Hematology-Oncology and Gabriele Accetta, Principal Biostatistician discuss important factors for planning and executing early-phase oncology clinical trials in preparation for a decision-making Phase II trial. The live event takes place on Tuesday, November 7, 2017 at 11am EST (4pm GMT).

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 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

To learn more about this event visit: Preparing for Phase II: Finding the Right Dose, Schedule, and Combination from your Phase I/II Oncology Clinical Trial

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, oncology, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

To learn more about Premier Research visit:


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