Mike's Blog

The 2026 Fall CTSA Program Annual meeting took place in Washington, DC, centered on the theme “From Discovery to Impact: Advancing the Translational Pathway.” More than 550 participants attended sessions from September 23-25, discussing ways to move discovery toward meaningful, real-world impact.

Across plenaries, panels, posters, and breakout sessions, one common thread emerged. Discovery alone is not enough. Translation also depends on infrastructure, a skilled workforce, trusted relationships with participants and communities, and research methods designed with implementation in mind.

These invigorating ideas were evident at the inaugural All-EC Plenary and EC meetings, which brought together the CTSA Enterprise Committees (ECs) to examine opportunities and challenges at the intersection of artificial intelligence, research innovation, community engagement, and trust. Perspectives from the private sector, academia, and communities underscored a theme that would recur throughout the meeting: Innovation works best when paired with responsible use of data and maintaining human connections that drive meaningful research impact.

Building a stronger pathway for evidence

Several sessions, including the Trial Innovation Network (TIN) meeting examined how shared and innovative infrastructure can make research faster, more reliable, and more useful.

The NCATS session on the National Clinical Cohort Collaborative (N3C) Unlocking Real-World Data to Accelerate Translational Impact showed how N3C is evolving into a broader platform for real-world research. N3C brings harmonized electronic health record data together in a secure, governed environment and can connect those records with other data sources. Developed during the pandemic, N3C is becoming a disease-agnostic ecosystem that combines harmonized electronic health records with claims, mortality, geospatial, and environmental data in a secure, governed environment. The Real-World Evidence Innovation Challenge was also announced. The challenge is designed to assess reproducibility, transportability, and stability across multiple health systems.  This is a national prize competition designed to establish validated benchmarks for analytic methods operating on real-world clinical data.

Following the N3C discussion, the meeting’s Keynote Address was delivered by Karim Mikhail, director of the FDA’s Center for Biologics Evaluation and Research, who also approached research efficiency, though from another angle. He discussed efforts to modernize early clinical development, and FDA’s Expedited Investigational New Drug Pilot Program.

The pilot pairs sponsors with qualified research institutions, or QRIs, that can provide scientific expertise during preparation of first-in-human IND submissions. The FDA can then review individual submission components on a rolling basis rather than waiting for a complete package. The FDA retains regulatory authority and responsibility for IND review. The model is intended to identify and resolve scientific and regulatory issues earlier and make early-stage development more collaborative and efficient. The FDA is looking for about 10 institutions to take part in the pilot and help shape the program. Karim views the expertise and capabilities of CTSAs as an essential component of this pilot.

Technology still depends on people

Discussion about AI was everywhere at the meeting, and so was an important qualification: better tools do not eliminate the need for people, judgment, and relationships. During the AI in Practice: Barriers, Blind Spots, and Breakthroughs session, topics included consent chatbots, researcher expertise matching, digital twins, automated clinical-data queries, and secure research environments — all aimed at reducing bottlenecks in the research process.

Responsible AI adoption requires more than warnings about risk. Researchers also need useful tools, appropriate expertise, secure infrastructure, and clear institutional pathways. Speakers emphasized human review of AI-assisted work, continued validation, AI literacy, and collaboration between clinical and technical experts.

The panel on Workforce Development: Career Training and Pathways for Research Staff Retention and Promotion made the case that supporting clinical research professionals cannot be ad hoc. A stable, skilled workforce requires deliberate investment in onboarding, competency development, mentoring, and career pathways.

Megan Hoffman illustrated the point through the University of Minnesota’s experience, which evolved over 15 years from fragmented support prior to 2011 to a more mature and structured system. This success is anchored by its Foundations for Research Professionals program, a two-week onboarding to 837 staff, and a personalized training roadmap has been used by more than 1,000 professionals.

The example of the career of “Liz,” who progressed from research coordinator to Senior Clinical Research Regulatory Manager in about six years, illustrated what those structures can mean for individual advancement. This matters for the CTSA Program because it suggests retention and research quality are directly tied to investment in staff, not just in PIs, and that institutions across the consortium stand to benefit from sharing what works. As Hoffman put it, “A well-trained workforce drives translational science.”

The discussion also raised broader questions: Should training expectations extend to principal investigators? Should clinical research professionals have a formal Department of Labor classification? And how can hubs share successful tools and curricula rather than duplicating work?

In the session entitled Design, Execute, & Scale Clinical & Translational Research: State of Participant Recruitment and Retention, speakers explored how innovative recruitment strategies, emerging technologies, and trusted relationships can help reach, recruit, and retain the participants essential to clinical and translational research.

“You need two things to have an effective clinical trial or study … you need a PI … and you need participants. And as far as I’m aware, LLM and AI can’t do that alone,” observed Rey Panettieri. That sentiment captured the tension at the heart of a lively discussion about the future of participant recruitment and retention: technology may help in finding potential participants, but successful clinical research still depends on human involvement and interaction.

Speakers described increasingly sophisticated ways to identify potential participants, from digital advertising targeted to particular populations and geographies to using AI and data to find the proverbial “needles in the haystack.”

Researchers must also understand barriers to participation, reduce burdens on sites and participants, and build relationships that sustain engagement.

Consuelo Wilkins pointed to what may be the CTSA Program’s “special sauce”: connections among researchers, healthcare providers, and communities. The Trial Innovation Network’s success, she noted, is rooted in the CTSAs. Those relationships make it possible not only to reach potential participants but also to listen to them, return things they value, and “demonstrate why we are trustworthy.” The opportunity, then, is not to choose between technology and human connection. It is to use technology in ways that strengthen that connection. For the CTSA Program, the opportunity is to make responsible AI innovation and implementation a shared capability rather than a challenge that institutions must solve independently.

The Poster session: 20 Years of CTSA Impact offered many more perspectives and evidence of the health outcomes. More than 50 posters demonstrated ways CTSA hubs have helped move discoveries beyond research settings to produce clinical, community, economic, and policy benefits. PDFs of the entire set of posters are viewable online in the poster gallery.

A Tufts CTSI poster traced how support for research on newborns experiencing opioid withdrawal contributed to evidence that informed treatment guidance and neonatal research. UC Irvine’s poster reported that its pilot awards supported 107 projects and generated $26.88 in related extramural funding for every dollar invested. And Oregon Clinical and Translational Research Institute's poster described community research facilitators who sustain local partnerships beyond individual studies and help communities shape research from the outset.

This whirlwind of CTSA activities continued into the final day of events. A Fireside Chat was a novel format for the CTSA program meeting with NIH Director Jay Bhattacharya and NCATS Director Joni Rutter. And we learned several things about Jay, especially his affinity for baseball analogies, and that he is a WWE fan! He shared some reflections on his experience reviewing CTSA applications (which can be quite lengthy) and reiterated his belief that the CTSAs are critical to the overall NIH success and with CTSAs activities responsive to NIH and HHS priorities.

Designing research for what comes next

A session on Innovations in Clinical Trial Design discussed how clinical care is inherently adaptive. Clinicians try an approach, assess how a patient responds, and decide what to do next. Why shouldn’t clinical trials better reflect that reality?

Steven Bernstein described the Multiphase Optimization Strategy, or MOST, as an approach for determining which components of a complex intervention contribute value while considering effectiveness, cost, feasibility, and acceptability. Jennifer Edelman discussed Sequential Multiple Assignment Randomized Trials, or SMART, which allow treatment pathways to change based on participant response. Jonathan Casey brought the concept directly into clinical care through embedded pragmatic trials. His team conducted a 1,301-patient emergency intubation trial in approximately 18 months by incorporating trial procedures into existing clinical workflows instead of creating a separate research infrastructure.

What happens when translational science moves beyond academic centers and closer to the communities it is intended to serve? The Accelerating Rural Research to Improve Health session focused on multi-component strategies for rural communities.

Highlights included the Consortium for Rural States’ multi-site pilots (merging dental and medical EHRs to study periodontitis–diabetes links; community implementation studios; justice-system research platforms), Dr. Meghan Breckling’s pharmacist-led train-the-trainer naloxone program to reach underserved towns, Dr. Jennie Hill’s “Building Healthy Families” digital train-the-trainer platform for pediatric obesity delivered through local implementation teams, and Dr. Rob Singleton’s Rural Research Phlebotomy Collective that cut average round-trip visit time from about 7.5 hours to roughly 1.1 hours by using a 46-site network. Bringing research closer to people can dramatically change the landscape. “We have to lower the bar for participation for our clinicians … as well as our patient populations and communities,” Dr. Pat Winokur said.

These approaches also raise questions about sustainability and scale. How can successful programs continue after grants end? How far can decentralized research services expand without overburdening local sites? And how can practice-based networks and state rural health initiatives help effective models reach more communities?

For real-world settings, the translational pathway in practice must reduce burdens on researchers, participants, clinicians, and communities. Invest in the people who make research possible. And anticipate: Can it work in real-world care? Can it adapt? Can it scale? And ultimately, can it improve health?

In summary, the CTSA Annual Program meeting was a roaring success. The energy and engagement were high and sustained throughout the week. With the increasing focus across HHS on activities that have been long standing CTSA efforts, CTSAs have the opportunity to impact health care research and overall health care in a big way of particular relevance to our various stakeholders.

The independence and liberty you possess are the work of joint counsels, and joint efforts of common dangers, sufferings, and successes.
-  George Washington, Farewell Address 1796

Note: ChatGPT was utilized to assist in merging the various components of this blog developed independently of one another.