Agenda
This track is designed for individuals interested in learning about clinical research from an investigator’s perspective.
Investigator Sessions
12:00-1:00pm PDT
Physician vs. the Physician-Investigator: Is there a Difference?
This session will explore the similarities and differences between the role of the physician and the role of the physician investigator, comparing responsibilities in the areas of patient care decisions, treatment interventions, legal accountability, documentation, and collaborators.
Speaker: Paul Martin, MD
Paul J. Martin, MD, a co-Principal Investigator of ITHS, served as the Medical Director of Clinical Research Support, the Fred Hutch Clinical Trials Office, from 2011 to 2017. He is a Member of the Fred Hutch and a Professor of Medicine at the UW. Dr. Martin has more than 40 years of experience with hematopoietic cell transplantation at Fred Hutch, focusing on acute and chronic graft-versus-host disease (GVHD).
12:00-1:00pm PDT
Protocol Design
This session will summarize considerations for the four key questions that investigators should address when designing a prospective interventional clinical trial. The key questions will be linked to criteria that make clinical trials ethical.
Session Materials
Speaker: Paul Martin, MD
Paul J. Martin, MD, a co-Principal Investigator of ITHS, served as the Medical Director of Clinical Research Support, the Fred Hutch Clinical Trials Office, from 2011 to 2017. He is a Member of the Fred Hutch and a Professor of Medicine at the UW. Dr. Martin has more than 40 years of experience with hematopoietic cell transplantation at Fred Hutch, focusing on acute and chronic graft-versus-host disease (GVHD).
Note: Dr. Martin is replacing Andrei Shustov as presenter of the Protocol Design session.
12:00-1:00pm PDT
Responsibilities and Oversight Obligations:
The Critical Role of the Principal Investigator
This is a deep dive into the critical leadership role of the Principal Investigator for a clinical trial. You will work through case studies that highlight important compliance responsibilities, quality assurance, and methods to manage the clinical research team.
Speaker: Ann Melvin, MD, MPH
Ann J. Melvin, MD, MPH, is Professor of Pediatrics, Division of Pediatric Infectious Diseases. Dr. Melvin received her MD and MPH from Tulane University School of Medicine and completed her Pediatric residency and Pediatric Infectious Disease fellowship training at the University of Washington.
Dr. Melvin is the director of the clinical HIV program at Seattle Children’s Hospital where she provides primary care services for HIV-exposed and infected children and adolescents. Her research effort focuses on clinical trials in HIV‐infected children and adolescents to investigate optimal management strategies for initial and long‐term treatment for these children. Through the NIH-funded International Maternal Pediatric Adolescent AIDS Clinical Trials Group, she has been chair or co‐chair of several national and international clinical trials. Dr. Melvin has been the co‐chair of the Regulatory Support and Bioethics Core of the University of Washington Institute for Translational Health Sciences and is now the faculty lead for the ITHS Recruitment Support Service.
12:00-1:00pm PDT
Building An Interdisciplinary Team
In this session, we will discuss the fundamental concepts and features associated with teamwork and will describe strategies for building interdisciplinary research teams.
Session Materials
9 MBPRESENTATION – Building an Interdisciplinary Team (BC2020 IT4)
Speaker: Brenda Zierler, PhD, RN, FAAN
Brenda K. Zierler, PhD, RN, FAAN is a Professor of Biobehavioral Nursing and Health Informatics in the University of Washington School of Nursing. Dr. Zierler’s research explores the relationships between the delivery of health care and outcomes—at both the patient and system level. Her primary appointment is in the School of Nursing at the University of Washington (UW), but she holds three adjunct appointments – two in the School of Medicine (Division of Vascular Surgery and Biomedical Informatics and Medical Education) and one in the School of Public Health (Department of Health Services).
Dr. Zierler currently leads a HRSA training grant focused on an education-practice partnership between UW School of Nursing and Kaiser Permanente-Washington designed to recruit and train nursing students and current RNs to practice at the full scope of their license in interprofessional ambulatory care teams. Dr. Zierler is co-lead of the Team Science Core for UW’s Institute for Translational Health Sciences (CTSA). She is the Director of Research and Training for the UW Center for Health Sciences Interprofessional Education, Practice and Research. Dr. Zierler is a past member of the Institute of Medicine’s Global Forum on Innovation in Health Professions Education. She teaches “Leadership and Team Science” for the Master’s of Science in Clinical Translational Science program in the School of Public Health and in the PhD program in the UW School of Nursing. She also teaches “Quality Improvement, Patient Safety and Informatics” in the UW School of Nursing’s BSN program and teaches “Proposal and Project Development” in the jointly offered Clinical Informatics and Patient Centered Technologies master’s in Science Program (School of Medicine and School of Nursing).
12:00-1:00pm PDT
Best Practices and Resources for Engagement of Diverse Communities in Clinical and Translational Research
This presentation will provide an introduction to best practices and share ITHS-supported resources for partnering with diverse communities in clinical and translational research. We will discuss benefits and drawbacks to different levels of community engagement so that attendees can learn how to tailor engagement to their research.
Speaker: Laura-Mae Baldwin, MD, MPH
Laura-Mae Baldwin, MD, MPH is a Professor of Family Medicine at the University of Washington and a seasoned researcher with a focus on implementation of evidence-based interventions into diverse primary care clinical settings. As either Principal Investigator or Co-Investigator on grants funded by federal agencies, foundations, and non-profit organizations, she has developed and applied her quantitative and qualitative research skills in diverse projects involving partnerships with community-based clinicians and clinical organizations. She currently serves as Senior Advisor for the Community Engagement Program within the Institute of Translational Health Sciences, and is currently co-leading the development of the Implementation Laboratory for the Optimizing Implementation in Cancer Control Center at the University of Washington.
