*All times in Eastern Time Daylight Zone
1:00-1:30 - Introduction to Emergency Research Conference
Silas Bussmann MPH, MBA, Lecturer III/Associate Director for Research in Emergency Medicine, University of New Mexico, Department of Emergency Medicine
Mr. Bussmann will provide an introduction and overview to the Emergency Research Conference. During this time there will be discussion to assist the faculty in getting to know our attendees and their learning objectives.
1:30-2:30 - KEYNOTE SPEAKER: The impact of COVID-19 on Conducting Emergency Medicine Clinical Research
Adel Elkbuli, MD, MPH, Director of Clinical Research, Department of Surgery, Kendall Regional Medical Center
COVID-19 presents incredible opportunities and challenges for researchers. Many of the changes required to adapt to the pandemic, such as working virtually, adapting to e-consent and increased emphasis on safe practices may be here to stay. Dr. Elkbuli will discuss these changes and their impact on our research operations.
2:30-2:45 - Break - Opportunity for Networking - Q&A
2:45 - 3:45 - Program Management in Emergency Medicine
David T. Huang, MD, MPH, Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science, Director, MACRO (Multidisciplinary Acute Care Research Organization), University of Pittsburgh and UPMC Health System
Dr. Huang will present the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial including: it’s unique operational philosophical and statistical approach, how it was implemented in the US, results that have changed clinical practice, and the future of REMAP type trials and learning health systems.
3:45 - 4:45 - Management of a U.S. Multi-Center Emergency Department Study Network – EMERGEncy ID NET
Anusha Krishnadasan, PhD, Project Director of Research, Olive View-UCLA Education and Research Institute
Dr. Krishnadasan will be presenting a brief history of EMERGEncy ID NET and its successful research conducted over the last 25 years. She will present the operations and logistics of managing the network’s set up, collaborations, and study activities on a limited federal budget.
4:45 – 5:00 - Wrap-up - Discussion - Q&A
1:00 – 1:15 - Welcome Day 2
1:15 – 2:30 - Managing Clinical Research Trials that Enroll Pediatric Participants in Emergency Settings
Brenda Barton, RN, BSN, CCRP, Nurse Project Manager
Ashley Kuniholm, Regulatory Affairs Specialist, Boston Children’s Hospital
Ms. Barton and Ms. Kuniholm will present lessons learned to aid research staff involved in coordinating trials in an emergency setting that enroll pediatric participants or who are interested in learning key elements involved for enrolling this vulnerable population in clinical research trials. This session will review regulatory considerations to be addressed prior to initiation of clinical trial and the need for precise planning to ensure that study safety and study integrity is maintained while in the emergency setting.
2:30 – 2:45 - Break - Opportunity for Networking - Q&A
2:45 - 3:45 - Practical Knowledge and Experience for the Implementation of EFIC Studies
Peter Adams, MBA, MHA, Acting Staff Director, Multidisciplinary Acute Care Research Organization (MACRO)
Mr. Adams will share best practices for implementation of Exception from Informed Consent (EFIC) research. He will offer insight from past experiences and include tips and tricks for performing and compiling information from public disclosure and community consultation.
3:45 - 4:30 - Emergency Research Regulations
Elizabeth Mendelsohn, CIP, Research Compliance Analyst/IRB Committee Coordinator, Human Research Protection Program, University of California
Ms. Mendelsohn will review current regulations related to emergency research.
4:30 – 5:00 - Wrap-up - Discussion, Q&A
1:00 – 1:15 - Welcome Day 3
1:15 - 2:15 - Industry-Sponsored Studies – Keeping Relationships Efficient and Effective
Barbara Powers, MSN, PhD, President, Expedite Research, LLC
Industry-sponsored studies can bring both funding opportunities as well as the opportunity to be part of developing the cutting-edge devices and drugs of tomorrow. But these studies come at a price – these Sponsors expect results! You will hear perspectives from the Sponsor side regarding how to successfully establish and maintain effective and efficient Sponsor-Clinical Site relationships.
2:15 - 3:15 - Emergency Access to Investigational Products
April Lehman, MPPM, Regulatory Specialist, University of Pittsburgh
An overview of the FDA Expanded Access/Compassionate Use Program will be presented. Detailed information will be presented on the process for submitting Emergency Use Requests to the FDA to gain access to investigational drug products and investigational medical devices. A brief overview of requests made for emergency access to investigational drug products for the treatment of COVID19 will also be shared.
3:15 - 3:30 - Break - Opportunity for Networking - Q&A
3:30 - 4:30 - Operating a Research Associate Program in Emergency Medicine
Silas Bussmann MPH, MBA, Lecturer III/ Associate Director for Research in Emergency Medicine, University of New Mexico, Department of Emergency Medicine
Opportunities for students, even in clinical education tracks, to gain exposure to hospital-based research, are very limited. Mr. Bussmann will present the structure and function of a Course-Based Undergraduate Research Experience (CURE) in Emergency Medicine, discuss needs and strategies for program start-up and why the emergency department is an ideal setting for learners new to clinical research.
4:30 - 5:00 - Close - Group Discussion - Q & A