Strategies for Setting Up the Logistics in Early Phase Adaptive Design Clinical Trials

• Activity Number: 569
• Type: Topic Contributed
• Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Eva R. Miller*+
• Companies: ICON Clinical Research
• Keywords: Adaptive Designs ; Practical Considerations for Adaptive Designs ; Logistics of Adaptive Designs

Abstract

Logistical and operational considerations in designing and implementing adaptive designs have recently drawn greater attention because infrastructure for managing traditional double-blind, randomized, parallel group clinical trials does not lend itself to the challenges presented in implementation of flexible designs. Preserving the trial integrity of adaptive designs is more complex and requires more planning and teamwork than for traditional designs. Requirements for communication and firewalls must be pre-specified and standard operating procedures may need to be harmonized across several organizations (sponsors, CROs, and vendors). Benefits of employing adaptive designs include acceleration of the clinical trial process, enhancement of trial efficiency, and improvements in patient safety. We will explore several successful studies, how hurdles were tackled and what gains resulted.