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Session 4: DIA-ISPOR Session: Prospectively Planning Adaptive Endpoints and Involving All Stakeholders
Session Chair(s)
René Allard, PHD
Contractor, CTC, Germany
The FDA and EMA are encouraging clinical trials with adaptive features that may make studies more efficient. The IQWiG and other European Health Technology-bodies have been involved in a pilot project with the EMA to share scientific advice on clinical trials. One of the opportunities in the EU brings together HTA stakeholders to share early information about their clinical development plan to establish a consolidated view on trial designs and endpoints. The session will focus on the views of EU national regulators with regards to their assessment. Can cooperative projects such as the EUROPAIN consortium which studied the physiology of chronic pain, both from preclinical and clinical mechanistic perspectives, give insights on how adaptive designs can be best planned?
Speaker(s)
Richard J. Willke, PHD
Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR), United States
Session Co-Chair
Norbert Benda, PHD
Head of Biostatistics and Special Pharmacokinetics, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Regulatory Aspects of Adaptive Study Designs
François Meyer, MD
Advisor to the President, International Affairs, French National Authority for Health (HAS), France
Accelerated Regulatory Approval What is Needed to Convince the HTA-Body (Case Example)
Edmund Joseph Pezalla, MD, MPH
Chief Executive Officer, Enlightment Bioconsult, LLC, United States
Payer Issues with Adaptive Clinical Trial Designs
Marta Segerdahl, MD, PHD
Chief Medical Specialist, CRD Neurology, H. Lundbeck A/S, Belgium
Driving Innovation by Encouraging Cooperative Interactions
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