The FDA guidance on clinical trials during COVID-19 advised sponsors to evaluate alternative methods for safety assessments to protect patients, where necessary and feasible.
Sponsors had already started to explore the benefits of decentralised and hybrid trials and the current conditions have heightened the need to consider this approach to reduce patient burden and increase retention to minimise disruption.
Join our experts to hear more about this approach and the value it brings to patients and sponsors.
Topics covered include:
- The benefits of In-home visits
- Patient populations and study type considerations
- The scope of services and tests feasible in the home setting
- Best practice in planning and execution
- Regulatory guidance and steps required to integrate this option into studies
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Donna Mackey
Donna Mackey has over 25 years of clinical research experience and has spent the last 15+ years focused on developing treatments for patients with rare medical conditions. She is currently Senior Director of Clinical Operations at Alnylam Pharmaceuticals where she is responsible for clinical oversight of several rare disease programs utilizing a new class of therapies based on RNA interference. Previously she was with Synageva BioPharma and Genzyme Corporation as the Therapeutic Clinical Leader for lysosomal storage disease programs well as a Global Team Leader. Prior to joining Genzyme, Donna was with Quintiles and directed the local Cardiovascular Therapeutics group. She is a graduate of McGill University with a degree in Physiology and has also received a Master of Science degree in Management.
David Morse
David provides operational oversight and strategic planning for ICON’s Global Regulatory Affairs services group. He has over 30 years of experience in Regulatory Affairs, including over a decade in the clinical research services industry and nearly two decades at the US FDA. David’s experience covers all phases of product development, from discovery and translational development through to marketing application preparation and post-marketing product life-cycle management. Much of David’s experience has emphasised products for serious and life-threatening disease indications, accelerated development strategies in international trials, and the use of expedited programs in product review. He has multiple publications and presentations regarding product review, the development of new regulations, and the communication of risk to special populations. David has dual Baccalaureates in Biology and Psychology, and a PhD in Neuroscience.