# Making Acute Stroke Trials Succeed: Challenges and Potential Solutions

> **NIH NIH U01** · UNIVERSITY OF CINCINNATI · 2024 · $56,700

## Abstract

As a part of the US-Japan Brain Research Cooperative Program (BRCP), in collaboration
with the stroke investigators of the NINDS StrokeNet and the National Cardiovascular Center
(NCVC) and other stroke centers in Japan, we plan to organize and conduct a workshop entitled
“Making Acute Stroke Trials Succeed: Challenges and Potential Solutions.” The intent for this
workshop is to build upon the knowledge gained from the previous workshops and the
collaboration on the ATACH-2 (Antihypertensive Treatment of Acute Cerebral Hemorrhage II)
and FASTEST(rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time) Trials. The
workshop has two goals: 1) To exchange information about the opportunities and barriers to
conduct collaborative stroke clinical trials that are innovative in design, patient-centered, and
pragmatic whenever possible. Such trials must consider differences in cultures, the patient care
management and regulatory systems, and financial issues. 2) To explore the use of emergency
consent procedures, and other innovative methods to facilitate enrollment in acute stroke trials
in Japan and the U.S.
 In this seminar, two main topics will be discussed. One is innovative clinical trial
methodology, the other is about emergency consenting procedures. The first day will be
dedicated to discussions on the topic of clinical trial methodology. Several biostatisticians and
trialists from the US and Japan will discuss innovative clinical trial methodology including
pragmatic trial designs, platform trials, adaptive designs, and patient-centered outcomes.
These presentations will be followed by in-depth discussion by all participants. The participants
will identify ongoing or proposed trials that have potential for collaboration.
 The second day is dedicated to discussions on the topics of exception of informed content
and emergency consenting procedures. The US Researchers will present the EFIC (Exception
from informed consent) approach and its advantages and weaknesses as well as current state
of emergency consent in other countries. Japanese researchers will discuss the results of an
international survey on the regulatory status of emergency consent. Opportunities and next
steps for emergency consent in Japan will be identified.
 These collaborative discussions will enhance the mutual understanding of acute stroke
treatments in general, as well as the design, implementation and financing of future clinical trials
of acute stroke. The workshop can be viewed as an accelerator of patient-centered global
collaborative trials and a facilitator of enrollment using emergency consent procedures in Japan.

## Key facts

- **NIH application ID:** 10930336
- **Project number:** 3U01NS110772-03S1
- **Recipient organization:** UNIVERSITY OF CINCINNATI
- **Principal Investigator:** Joseph Paul Broderick
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $56,700
- **Award type:** 3
- **Project period:** 2020-03-01 → 2026-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10930336

## Citation

> US National Institutes of Health, RePORTER application 10930336, Making Acute Stroke Trials Succeed: Challenges and Potential Solutions (3U01NS110772-03S1). Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/grant/nih/10930336. Licensed CC0.

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