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Adaptive Clinical Trials - ADAPT Congress 2011

Day 1  |  Day 2

THURSDAY, SEPTEMBER 8

8:30 am Sponsored Breakfast Presentation (Opportunity Available)

 

IMPLEMENTING ADAPTIVE CLINICAL TRIALS

9:15 Chairperson’s Remarks

Vlad Dragalin, Senior Vice President, Innovation Center, Aptiv Solutions

9:25 Implementing Adaptive Clinical Trials: Challenges and Solutions

Vlad Dragalin, Senior Vice President, Innovation Center, Aptiv Solutions

Adaptive designs represent a totally new technology in drug development. A prerequisite for their successful implementation is an understanding of the underlying methodology and their impact on the logistics of the trial, such as data management and monitoring procedures, EDC/IVRS, drug supply management, and DMC operating procedures. These designs have an impact on drug development strategies, trial protocols, informed consent forms, data analysis, and reporting plans. Adaptive design will also change enrollment, randomization, and data capturing process, monitoring, and data cleaning systems. We will discuss all these challenges and will outline some solutions.

9:55 Randomization Challenges and Solutions in Adaptive Design Trials

Olga Kuznetsova, Ph.D., Director, Scientific Staff, Clinical Biostatistics, Merck Sharp & Dohme Corp.

Adaptive designs bring to the forefront methodological and implementation challenges in the randomization area. Advanced randomization techniques help efficiently manage limited or expensive drug supplies in multi-center adaptive design studies, deal with an inconvenient allocation ratio common to dose-ranging studies or multi-arm studies with sample-size re-estimation, and provide balance in baseline covariates in small interim analysis samples. In this session, we will review examples of challenging randomization issues that arise in adaptive design trials and go over the solutions to those. Critical points in implementation of the randomization techniques in adaptive design trials will be discussed.

10:25 Networking Coffee Break in the Exhibit Hall with Poster Viewing

11:05 Key Data Considerations For Successful Adaptive Trial Implementations

Walter Boyle, Advanced Analytics Strategist, Health and Life Sciences Global Practice, SAS Institute

Adaptive trials are a critical component in accelerating the drug development process. While advanced analytics and agile operations are certainly critical factors in the successful implementation of adaptive approaches, these core capabilities cannot be successful without a strong data management strategy. Biopharmaceutical companies continue to aggregate research data as each clinical trial is completed, but that data is minimally used beyond the primary goals of proving the hypothesis for a single trial and, where necessary, supporting the submission of a marketing application. Only recently have companies begun to manage their legacy clinical trials data so it can be used to drive advanced scientific and business decisions, such as those identified through modeling and simulation.

11:35 Implementing Adaptive Designs: Better Technology to Protect Trial Integrity, Reduce Operational Bias and Build Regulatory Confidence
Eric Silva, Enterprise and Hosted Solutions Manager, Cytel Inc.
With the growing acceptance of adaptive trial designs, both sponsors and regulators are increasingly challenged to routinely manage and monitor trials incorporating interim analyses.  This session will focus on identifying the challenges and the technology now being used to specifically address the demands inherent particularly with adaptive studies.  We’ll examine new processes and online systems designed to preserve the integrity of the trial by securely managing access to the blinded data, supporting DMC procedures, facilitating audits and automating analyses and reporting.

12:05 Drug Supply Challenges and Strategy for Adaptive Dose Response Clinical Trials

Gayle Flynn, Head of Global Ramos & Supply Chain Analytic, GlaxoSmithKline

Clinical IVR/IWR systems are essential to effectively conduct adaptive trials.  In addition to controlling randomization, they can also be used to optimize the quantities of clinical supplies required to support the study.  In addition to pointing out potential pitfalls in designing your clinical IVR/IWR system, this presentation will explore the unique drug supply challenges faced in adaptive trials.  This includes effective strategies for supply optimization such as forecasting demand, maintaining the blind in shipments and supply pooling.

12:35 pm Close of Conference

 

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