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Clinical trials have a high failure rate, even for those compounds that have demonstrated efficacy in Phase 2 in the target population. CNS trials are associated with some of the highest failure rates and pose unique challenges. Clinical trials in CNS/Neuroscience are complex and prone to producing uninterpretable or ambiguous results. This can have grave effects on the development of potentially effective treatments- leading to program delay or cancellation, as well as company failure. Measures that help to increase the likelihood of a clear, interpretable signal, and avoid unnecessary trial failure are therefore of great potential value.
The enrollment of unsuitable subjects has the potential to have a significant financial cost to sponsors as well as risk signal detection.
Join experts from Syneos Health and Karuna Pharmaceuticals as they discuss their strategy—implemented by Syneos Health Clinical Surveillance and Training (CST)—to help sites identify suitable subjects, minimize noise, protect study investment and help obtain clearer results.
In this webinar you will:
- UNDERSTAND how to define unsuitable subjects and their impact on trial outcomes.
- LEARN the benefit and outcomes of CST’s approach to Eligibility Review.
- EXPLORE how eligiblity review is perceived by sites and sponsors
Presenters
Beth Eisenberg
Director, BU Ops Clinical Surveillance & Training,
Neurosciences, Syneos Health
Zelma Gandy-Don Sing
Lead Clinical Scientist, Clinical Surveillance & Training, Syneos Health
VP, Med & Scientific Strategy,
Medical Management, Syneos Health
Chief Medical Officer, Karuna Therapeutics
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