8:00 - 8:15 am: Registration and Continental Breakfast
8:15 - 8:30 am: SOCRA Welcome
8:30- 9:30 am: Decentralized Clinical Trials: An Evolving Landscape
Barbara Bierer, MD, Professor, Brigham and Women’s Hospital
Decentralized Clinical Trials: An Evolving Landscape will review the regulatory, ethical, and operational challenges in the planning and execution of such trials. While DCTs hold great promise for decreased participant burden and cost and increased speed and reach, there are also significant unresolved issues that limit their implementation. The roles and responsibilities of PIs and other members of the research and clinical team will be discussed, as these differ from traditional site-based trials. Considerations for IRBs and institutional human research protection programs (HRPPs) will be reviewed.
9:30 – 11:00 am: Food and Drug Administration Perspective
CDR Nicole Bell, MS, Regulatory Officer, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, FDA
This presentation will provide an overview of decentralized clinical trials (DCTs) along with the FDA’s current regulations and guidance. The presentation will address the perceived and/or actual benefits and challenges of decentralized clinical trials. The speaker will discuss the oversight of DCTs and key issues to consider.
11:00 – 11:15 am: Break
11:15 am – 12:15 pm: Two Roads Diverged: A Comparative Analysis of Quality Oversight and Management in a $25M Decentralized Clinical Trial In Two African Countries
Leslie Sam, BA, CSSBB, President, Leslie Sam and Associates, LLC
Ms. Sam will discuss the journey of designing, developing, and implementing Risk-Based Quality Management (RBQM) in a decentralized clinical trial (DCT) funded at $25 million using an approved IP that has a well-established safety profile (30+ years). Conducted in two African countries, first in Mozambique and then in Kenya, with inexperienced research site teams in both locations, the study navigated the challenges of vulnerable populations - children and illiterate individuals. The lessons learned from the traditional approaches in Mozambique led to an innovative strategy in Kenya, emphasizing, participant safety, data reliability and GCP quality.
12:15 - 1:15 pm: Lunch
1:15 – 2:15 pm: Preparing for DCTs: What Study Team Members Need to Know
Megan Singleton, JD, MBE, CIP, Assistant Dean, Human Research Protections, Johns Hopkins University School of Medicine
This session is designed to help study team members best identify and prepare for the unique challenges raised when supporting a study that includes de-centralized trial components. Ms. Singleton will discuss how potential study team members identify if and how a trial includes a decentralized component, what considerations are triggered when a study involves a decentralized component and how a team may proactively develop a plan for conduct of a de-centralized trial.
2:15 – 3:15 pm: Decentralizing Clinical Trials: The Site Perspective
Christina Wiess, BA, EMT, CCRP, Assistant Director, Clinical Operations, Yale University
Ms. Wiess will highlight key operational considerations of implementing decentralized clinical trials at the institutional level, including a hybrid approach for early phase trials where this has historically been limited. Throughout this discussion, the challenges and benefits of utilizing this model will be highlighted.
3:15 pm - 4:30 pm: Moderated Panel/ Q & A
Wendy Lloyd, BA, CCRP, LPN, Senior Clinical Research Quality Analyst-Education, Vanderbilt University Medical Center
Join conference speakers and fellow attendees for the panel discussion each day. Take advantage of this opportunity to engage with the speakers and delve deeper into the topics of the day. The speakers will facilitate discussions and field participate questions.
8:00 to 8:30 am: Registration and Continental Breakfast
8:30 – 10:15 am: Role of the HRPP in the Assessment of Decentralized Clinical Trials
Linda Coleman, JD, CIP, CHC, CHRC, CCEP-I, Director, Human Research Protection Program, Yale University
Ms. Coleman will discuss the role of the human research protection program to assist in the assessment of Decentralized Trials. The presentation will share possible models for leveraging the HRPP for assessing DCTs and discuss case studies and lessons learned regarding the role of the HRPP in the review of DCTs.
10:15 – 11:30 am: Ethics Review of Decentralized Clinical Trials
Barbara Bierer, MD, Professor, Brigham and Women’s Hospital
Dr. Bierer will discuss the ethics of conducting decentralized clinical trials. This presentation will review the ethical and regulatory responsibilities of sponsors, investigators, institutional review boards, and other stakeholders when planning and implementing DCTs.
11:00 – 11:15 am: Break
11:15 am - 12:15 pm: Post Approval Monitoring
Jessica Rowe, MA, MS, CIP, CCRP, Director for Quality and Education, Yale Cancer Center, Clinical Trials Office
Ms. Rowe will discuss the significance of post-approval monitoring within a human subject protection program. The presentation will explore the role of quality in post-approval monitoring and discuss different approaches to PAM design and implementation taken by institutions. Gain insights into the proactive measures taken in response to noncompliance findings during quality reviews. Ms. Rowe will address the challenges in PAM for DCTs and present potential solutions and options for implementation of a quality PAM program for DCTs.
12:15 - 1:15 pm: Lunch
1:15 - 3:00 pm: Moderated Panel/ Q & A
Wendy Lloyd, BA, CCRP, LPN, Senior Clinical Research Quality Analyst-Education, Vanderbilt University Medical Center
Join conference speakers and fellow attendees for the panel discussion each day. Take advantage of this opportunity to engage with the speakers and delve deeper into the topics of the day. The speakers will facilitate discussions and field participate questions.