19: The STEP Platform with Dr. Eva Mistry and Dr. Jordan Elm

This episode of "In the Interim..." features an in-depth discussion of the StrokeNet Thrombectomy Endovascular Platform (STEP), a multi-domain, multi-factorial, adaptive platform trial for acute stroke, anchored in the NIH StrokeNet network. Guests Dr. Eva Mistry (University of Cincinnati) and Dr. Jordan Elm (Medical University of South Carolina) join us to explain how STEP enables simultaneous investigation of multiple treatment strategies in patients with acute ischemic stroke. The conversation details the use of a master protocol, the integration of industry partners through the Other Transactional Authority (OTA) NIH mechanism, and innovative statistical designs to efficiently identify improved treatment strategies.

Key Highlights:

• STEP utilizes a master protocol within NIH StrokeNet, unifying eligibility, procedures, and data collection across all study domains.

• The platform supports multiple research questions.

• In an initial domain STEP applies a statistical change-point model to empirically estimate the thresholds where EVT is effective, neutral, or potentially deleterious based on medium vessel occlusions and baseline clinical status.

• Protocols may be adapted in response to new external data, including pausing and revising enrollment in specific subpopulations when emerging science warrants.

• Shared control groups are used wherever applicable, improving trial efficiency by reducing the number of patients allocated to control arms and allowing eligible patients to contribute to multiple domains when protocol and scientific rationale permit.