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Monday, June 20 • 1:15pm - 2:15pm
#110: Adaptive Designs Save Time and Money: Regulatory Agencies Accept Them - Why Aren’t They Used More?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-513-L04-P ; CME 1.00; RN 1.00

Adaptive designs are accepted by regulatory agencies so why aren't more sponsors using them? These trials enable sponsors to fail faster and focus effort on where they succeed. We will cover the process from protocol design to interim analysis and communication to key stakeholders for adaptations. There are too many reasons why adaptive designs should be used on more clinical trials. This session will explore those reasons and benefits.

Learning Objectives

Identify the types of adaptive trials; Describe best practices and recommendations for the protocol design phase as well as pre-study planning; Identify what communication is needed to conduct the interim analysis; Assess which stakeholders should be part of this process; Discuss how success should be defined.

Chair

Marc Kaufman

Speaker

Using Trial Simulations to Provide Tailored Adaptive Design in Early Stage Clinical Trials
Song Wang, PhD, MS

Impact of Adaptive Trials to Global Clinical Supply Plans
Haneen S Mazahreh, MS

Adaptive Designs: CRO Perspective
Russell Reeve


Speakers
avatar for Marc Kaufman

Marc Kaufman

Director, Product Management, RTSM Customer Adoption and Value Realization, Medidata, a Dassault Systèmes company, United States
Marc Kaufman has been in the Life Sciences Industry for close to 20 years, specializing in IRT/RTSM technology for the past 15 years. Marc is a Director - RTSM Customer Adoption and Value Realization at Medidata Solutions. Marc has been at Medidata Solutions for 5 years. Marc is a... Read More →
HM

Haneen Mazahreh

Chief Executive Officer, Pivot Consulting and Services, United States
Haneen Mazahreh-Boivert is a global clinical supply expert and end to end supply chain advocate. Throughout her 15+ year career, she has worked and consulted for numerous companies of varying footprints including British Petroleum, Schering-Plough, Merck, Celgene, KMPG, and OptiNose... Read More →
RR

Russell Reeve

Vice President, Biostatistics, IQVIA, United States
SW

Song Wang

Senior Statistical Science Director, PPD, Part of Thermo Fisher Scientific, United States
Song Wang got his Master and PhD degree from University of Utah. He worked as a statistician in PPD for 18 years. He has comprehensive experience in study design and data analysis in clinical trials across phases and indications. His passion is to use innovative study design and analysis... Read More →

Monday June 20, 2022 1:15pm - 2:15pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   11: Statistics, Session