Agenda

Hot Topics and Practical Considerations for Protecting Human Research Participants

2024 AGENDA

Day One - Thursday

8:00 - 8:15 Registration and Continental Breakfast

8:15 - 8:30 Welcome and Introduction

8:30 am – 9:30 am IRB Considerations in Todays Research
Jessica Rowe, MA, MS, CIP, CCRP, Director for Quality and Education, Yale Cancer Center, Clinical Trials Office
As the clinical research landscape continues to change Human Research Protection Programs (HRPPs) and Institutional Review Boards (IRBs) considerations need to evolve ensure continue projection of human subjects. Ms. Rowe will discuss the changing research landscape, highlighting hot topic areas such as AI-driven research and DCTs, and the impact on IRB considerations.

9:30 am - 10:30am Research in a Virtual World
Michelle Brignac, MPA, CIP, CCRP, Manager-Clinical Research Operations - Hematology, St. Jude Children’s Research Hospital

Sustaining research needs to adapt to changing and evolving technology and embracing new partners. By advancing to a de-centralization of clinical trials and using virtual tools, research can thrive. Does the current regulatory landscape support research in a virtual world?

10:30 – 10:45 Break

10:45 am - 11:45 am Decentralized Clinical Trials: What They Are, FDA Regulations, Benefits and Challenges, Oversight and Execution, FDA Guidance

Sherri N. Rohlf, M.D., Certified Clinical Bioresearch Monitoring Investigator, Bioresearch Monitoring, West, Office of Regulatory Affairs (ORA), 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.

11:45 – 12:45 Lunch

12:45 pm - 1:45 pm Challenges decentralized clinical trials face involving biologics
Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Director of BioSafety Services, Advarra
Research involving engineered genetic materials is booming. The technology is coming to the forefront regardless of whether we’re looking at infectious disease vaccines, CAR T cells in oncology or correcting mutations that cause rare diseases. Dr. Eisenman will provide an introduction to the field of gene therapy and the science behind it as well as provide an overview of the regulatory requirements and how to prepare to conduct a gene therapy study.

1:45 pm - 2:45 pm Using Telemedicine Compliantly When Conducting Decentralized Clinical Trials
Kyle Faget, JD, Partner, Co-Chair Health Care Practice Group, Foley & Lardner, LLP

Ms. Faget will entail how to use telemedicine, most specifically, doing so compliantly, during decentralized clinical trials. Any risks associated with not being compliant, will also be addressed.

2:45 - 3:00 Break

3:00 pm - 4:00 pm Choose Your Own Adventure: A Unique Use of REDCap to Train Research Staff
Natalie Dilts, MPH, Senior Research Strategy & Program Specialist, Vanderbilt University Medical Center

This presentation will educate attendees on the use of an interactive REDCap module to train study coordinators on how to enroll only qualified participants into their study. The engaging tool features a narrative story with the reader assuming the role of a Research Coordinator and making choices to determine whether an imaginary participant meets study inclusion/exclusion criteria. In addition to training study staff, the tool allows the PI to determine what additional staff education is needed to safely and successfully enroll study participants into the trial.

4:00 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.

Day Two

8:00 - 8:15 Registration and Continental Breakfast

8:15 - 8:30 Welcome

8:30 - 9:30 Post Approval Monitoring Using a Risk-Based Approach
Jessica Rowe, MA, MS, CIP, CCRP, Director for Quality and Education, Yale Cancer Center, Clinical Trials Office

This presentation will discuss current trends of post-approval monitoring programs. Ms. Rowe will discuss different Post-Approval Monitoring program structures, risk-based approaches, and present tools and tips for effectiveness.

9:30 - 10:45 Clinical Research Administration in an Academic Setting
Jessica Collins, BA, ACRP-CP, Director, Vanderbilt Coordinating Center, Vanderbilt University Medical Center

The Vanderbilt Coordinating Center was re-established in 2016. The speaker will explain the structure of our coordinating center. The vision of what the department would look like changed from challenges encountered. The lesson learned during the challenges allowed best practices to be established along the way.

10:30 – 10:45 Break

11:00 - 12:00 Understanding the Role of Health Disparities in Clinical Research and the Importance of Diverse Study Participants.
Dea Papajorgji-Taylor, MPH, MA, CCRP, Research Associate, Kaiser Permanente Center for Health Research

This presentation will explore the critical role that health disparities play within the landscape of clinical research. By exploring the intersection of demographics, socioeconomic factors, and access to healthcare, I will underscore the necessity of diverse study participants in ensuring equitable and comprehensive research outcomes. Through examples of clinical trials and evidence-based insights, attendees will gain a deeper understanding of how considering health disparities when engaging study participants can enhance the validity, generalizability, and ultimately the impact of clinical research findings.

12:00 – 1:00 Lunch

1:00 - 2:00 Mitigating Health Literacy Barriers to Enhance Clinical Trials Recruitment
Cynthia Jean-Baptiste, DRPH, MPH, MA. CPH, Research Epidemiologist; Associate Professor, Veterans Health Affairs; Shenadoah

Ms. Jean-Baptiste will discuss health literacy challenges especially impacting recruitment of disparate and underserved participants. This presentation will ascertain impacts of non-representation in clinical trials and to integrate health literacy best practices into participant-facing communication.

2:00 – 2:15

2:15 – 3:15 Discuss the registration and results entry process in ClinicalTrials.gov
Cristina Ferrazzano Yaussy, MPH, CCRP, Research Regulatory Affairs Specialist, Dartmouth-Hitchcock Medical Center

Ms. Ferrazzano Yaussy will provide guidance for managing trials, in addition to reviewing the registration and results entry process in CLinicalTrials.gov. Best practices and helpful tips for both Administrators and users will be provided. Attendees are invited to bring their own scenarios for group discussion and should leave the workshop with skills to successfully manage trials within ClinicalTrials.gov.

3:15 – 3:45 - Q & A / Wrap up

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

Agenda

Hot Topics and Practical Considerations for Protecting Human Research Participants

Day One - Thursday

Day Two

Protecting Human Research Participants: Legal, Ethical, and Practical Considerations