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Session 6: Considerations for Publicly Funded Master Protocols with Research Objectives
Session Chair(s)
Lisa LaVange, PHD
Professor Emerita
University of North Carolina at Chapel Hill, United States
Rui (Sammi) Tang
Vice President, Global Head of Biometrics
Servier Pharmaceuticals, United States
In this session, we will explore the use of master protocols in research studies funded by government agencies such as the National Institutes of Health (NIH). The NIH has a long history of establishing trial networks to conduct one or more studies in a particular disease area. These networks often include trial infrastructure and foster innovative trial designs, making them a natural home for master protocols. At the same time, a number of differences may exist in publicly funded master protocols compared to their industry-funded counterparts that should be taken into consideration in study planning. A few examples are study objectives, stakeholder negotiations, data sharing, trial governance, and safety reporting. Other considerations will also be discussed during this session, and an NIH funded master protocol will be presented as a case study.
Learning Objective : - Identify key aspects of study design, conduct, and reporting that may require special consideration when planning a master protocol funded by a public agency
- Understand statistical aspects of trial design options that may be well-suited to meet the research objectives of a publicly funded master protocol
- Apply some of the lessons learned from a case study when planning a publicly funded research master protocol in the future
Speaker(s)
Publicly Funded Master Protocols Compared to Their Industry Counterparts
Lisa LaVange, PHD
University of North Carolina at Chapel Hill, United States
Professor Emerita
The Rationale for NHLBI Funded Master Protocols
Patricia Noel
NIH, United States
Project Officer for PrecISE, Lung Division, NHLBI
Statistical Innovation in Trial Design for Master Protocols
Anastasia Ivanova, PHD
University of North Carolina at Chapel Hill , United States
Professor, Department of Biostatistics