Beyond Thrombolysis and Thrombectomy:
Designing and Conducting Successful Stroke Clinical Trials

Thrombolysis and thrombectomy have transformed acute ischemic stroke care, yet the need for therapies that improve recovery and reduce disability remains. For small and mid-sized biotech companies developing new treatments, a critical challenge is translating a compelling mechanism of action into a trial that can demonstrate meaningful clinical benefit.

This webinar will explore how therapeutic rationale, patient selection, treatment timing and operational execution come together to shape successful stroke clinical development. Cytoprotective therapies offer a potential approach to complement reperfusion, but advancing these candidates requires reproducible evidence across independent laboratories, activity against relevant components of the ischemic cascade and administration within a biologically appropriate window. These considerations provide the foundation for decisions about whom to enroll, when to treat and how to measure benefit.

Building on this foundation, the featured speaker will examine how time from onset, stroke severity and advanced imaging can inform patient selection and treatment timing relative to reperfusion. The discussion will address the balance between identifying patients most likely to benefit while maintaining enrollment feasibility and generalizability. It will also consider how to align endpoints with the expected biological effect and regulatory expectations, including the role of the modified Rankin Scale at 90 days.

Translating these design choices into a feasible study requires flexibility and practical planning. Adaptive and platform designs may support sample-size re-estimation, arm dropping or subgroup enrichment, while preserving trial integrity. Their value depends on execution within the urgency of acute stroke care, supported by appropriate consent procedures, prepared sites, robust staff training, workflow integration and realistic recruitment targets.

By connecting these scientific and operational considerations, this webinar will offer attendees a clearer framework for moving from therapeutic promise to interpretable clinical evidence. The focus will be on designing feasible, scientifically rigorous trials that can demonstrate meaningful improvements in recovery and reduce the lasting burden of stroke.

Register for this webinar to learn how to address scientific, clinical and operational challenges in stroke clinical trials to support more effective trial design and execution.