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.