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Designing Smarter and More Cost-Effective Phase 1 Protocols
Session Chair(s)
Gary L. Steinman, MS
President, Medexetech LLC, United States
In this session, experienced phase 1 clinical and preclinical investigators will present realistic protocols, identify and evaluate the impact of unnecessary, costly and time-consuming requirements that can drive up conduct costs and/or impede timely study completion, offer protocol design recommendations that can improve study conduct efficiency and, by incorporating translational methodologies, more effectively discern the viability of drug candidates in early clinical development.
Learning Objective : Identify and evaluate protocol features that drive up study conduct costs and/or impede timely study completion while adding little value to test article development; Design protocols that avoid such unnecessarily costly and challenging features and specifications; Consider the potential value of incorporating translational medicine methodologies in early phase 1 protocols.
Speaker(s)
Gary L. Steinman, MS
President, Medexetech LLC, United States
Jazz, Tetris and CPUs: An Introduction
William B. Smith, MD
CEO, Alliance for Multispecialty Research, LLC , United States
Designing and Executing Efficient Phase 1 Protocols: Clinical Aspects
Mary L. Westrick, PHD
Adjunct Professor, University of Wisconsin, United States
Designing and Executing Efficient Phase 1 Protocols: Operations Aspects
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