2026 Fall CTSA Program Annual Meeting

For meeting materials, please contact TINcoordination@ccos.ctsa.io. 

The National Clinical Cohort Collaborative (N3C) is evolving to provide CTSAs with new opportunities to accelerate translational science research through expanded access to real-world data and innovative approaches to evidence generation. This session will explore N3C’s value proposition, including planned access to CMS data and the opportunity to connect longitudinal claims data with electronic health record data to address research questions that may be difficult to answer using either source alone. Participants will also learn about the N3C Real-World Evidence Innovation Challenge, a Challenge Prize designed to advance reproducible, transportable analytic approaches and strengthen N3C as a national platform for generating reliable real-world evidence. Target audience: CTSA hub investigators, informaticians, data scientists, clinical researchers, and research/program leaders interested in leveraging N3C and real-world data. Learning objectives: Attendees will understand N3C’s emerging capabilities, identify potential applications of linked CMS/EHR data, and identify opportunities to engage in the N3C Challenge Prize.

The United States faces growing challenges in moving promising discoveries efficiently into early-stage clinical development. In this plenary, Karim Mikhail will examine barriers that can slow the path to first-in-human trials and emerging FDA approaches designed to make early clinical development faster, more predictable, and more collaborative. The session will explore the FDA’s Expedited IND Pilot, including clearer phase-appropriate requirements, iterative scientific engagement with qualified research institutions, and rolling review of IND components. Participants will hear how these approaches could reduce regulatory and operational delays while maintaining rigorous standards for patient safety and strengthen the U.S. clinical research ecosystem. Target audience: CTSA investigators, clinical research leaders, regulatory specialists, research operations professionals, and institutional leaders involved in translating discoveries into clinical studies. Learning objectives: Attendees will understand key barriers in early clinical development and how emerging FDA approaches could accelerate the transition from scientific discovery to first-in-human clinical trials.

This session brings together five investigators to share candid stories of AI implementation challenges they faced, from patient recruitment to real-world data/evidence generation, and how they adapted or overcame them. We're agnostic to the use case and are focused specifically on implementation challenges, lessons learned, and best practices moving forward. Rather than polished success stories, we're looking for honest accounts of what went wrong, what surprised folks, and what they'd do differently next time. A moderated panel and open discussion will follow, digging into the shared themes and practical takeaways across these experiences.

Developing a highly trained and competent workforce in clinical and translational science is essential to optimally serve our communities and remain at the cutting edge of discovery. Therefore, it is critical to develop a skilled workforce that also feels appreciated for their contributions to their teams, the institutions they work for, and the communities they serve. Promoting and retaining highly skilled research staff is critical for a vibrant healthcare community where the workforce feels their contributions to the clinical enterprise is appropriately valued. In this session, we will hear from three workforce development experts regarding how high quality staff training can be efficiently and effectively delivered and how competencies developed in their workforce ecosystems result in rewarding careers and increased promotion and retention. The speakers will address training, competencies, and assessments for clinical research professionals, workforce development in the rural setting, and retention of a workforce in the urban setting.

View all participating posters in the Poster Gallery.

Join NCATS Director Dr. Joni Rutter and NIH Director Dr. Jay Bhattacharya for a fireside chat exploring issues and opportunities shaping the future of clinical and translational science. Guided by questions submitted in advance by the CTSA community, the conversation will address topics of greatest interest to attendees, including the CTSA Program, NCATS, NIH priorities, and the broader clinical and translational research enterprise. Submitted questions will be grouped by common themes to help shape an engaging discussion and provide CTSA Program members with an opportunity to hear directly from NIH and NCATS leadership. Target audience: All CTSA Program meeting attendees.  Learning objectives: Attendees will gain insight into NIH and NCATS leadership perspectives on current priorities and issues affecting clinical and translational science and develop a greater understanding of how these priorities may inform the CTSA Program and the broader translational research enterprise.

This session will focus on newer, pragmatic clinical trial formats. Given time constraints, we will focus on optimization designs such as the Sequential Multiple Assignment Randomized Trial (SMART) and the factorial variant of Multiphase Optimization Strategy (MOST) trials. Examples from recent work will be offered. We will also discuss preference clinical trials, their indications, and certain methodologic and analytic considerations. Finally, we will discuss the study design services available from the Trial Innovation Network (TIN), and present data showing study designs used by CTSA-affiliated teams.  Target Audience: Learners, faculty, and research staff interested in learning more about state-of-the-art clinical trial design.  Learning Objectives: This session will provide attendees with an update on newer, pragmatic clinical trial designs that are suitable for use in late-stage translational research in clinical or community settings. Attendees will also better understand the design services available from the Trial Innovation Network.

The shared mission of the Consortium of Rural States (CORES) and CTSA institutions is to improve health in rural communities. Achieving that goal requires a coordinated strategy, not a single intervention. Rural communities have historically been less connected to research opportunities because of geography, transportation barriers, limited local infrastructure, technology gaps, and participant burden. This session will present a multi-component approach to advancing research in rural communities through community engagement, rural pharmacy partnerships, local phlebotomy infrastructure, telehealth-enabled participation, and hybrid trial models that maintain local connection while reducing burden. The session will begin with a brief history of CORES to frame the collaborative foundation for this work, followed by short presentations on specific strategies and resources. A moderated panel will then discuss how these approaches can be integrated into a coordinated model for rural research, followed by audience Q&A.