What does it take to make clinical trial innovation both effective and sustainable? That was the focus of AMRC’s latest webinar in our Network Advantage series, featuring David Burrow of the U.S. Food and Drug Administration (FDA).
Throughout the session, Burrow shared a regulatory perspective on quality by design, risk-based quality management, and the opportunities available through the CDER Center for Clinical Trial Innovation (C3TI). He also reflected on the agency’s growing engagement with artificial intelligence (AI), and why Sponsors should look to multisite research corporations (MCRCs) when seeking to implement new approaches.
Rethinking Quality and Risk
Burrow reminded the audience that clinical research is, at its core, an industry of hope, “addressing unmet medical need, curing things that were previously incurable.” But he stressed that innovation only works when it’s underpinned by quality. That starts with quality by design (QbD): deliberately building quality into protocols, operations, vendor management, and data systems from the very beginning. The aim, he said, isn’t flawless execution but “the absence of errors that matter.”
From there, he drew a line to risk-based approaches. Too often, he noted, the conversation stalls at risk-based monitoring; site visits, remote checks, and statistical reviews. Important, yes, but only “one small part of the story.” What is really needed is risk-based quality management (RBQM): an adaptive process that runs through the entire trial, constantly assessing and adjusting systems to preserve quality and efficiency.
For MCRCs, this is where their structure becomes a strategic advantage. With standardized oversight and interoperable systems, networks can put QbD principles into practice and sustain them through RBQM at scale. As Burrow put it, “A network of sites all under the same oversight structure, all using the same technologies… that’s a great opportunity to partner with sponsors as they develop their investigational plan.”
C3TI Opportunities
Much of the discussion focused on FDA’s C3TI program, which aims to accelerate innovation by providing a forum for demonstration projects. These allow sponsors to work with the FDA early in protocol development, reducing uncertainty in the development and review process by:
- Engaging early with sponsors: C3TI demonstration projects let sponsors bring innovative trial designs or methods to the FDA before the trial starts.
- Sharing lessons learned: The program collects and publishes insights from innovative trials so the whole industry benefits, rather than innovations being siloed.
- Building regulatory confidence: By clarifying expectations around new approaches, among them Bayesian statistics, selective safety data collection, and embedded trials, C3TI makes it less likely that a trial will run into problems at the submission stage.
“The goal,” Burrow explained, “is to decrease the chance that things go sideways downstream, to ensure that when a marketing application comes in for review, the compliance assessment is as clean as possible.”
Artificial Intelligence and FDA’s ‘Intern’
Burrow also addressed the FDA’s exploration of AI, including its generative AI tool, Elsa. While headlines have speculated about Elsa’s role, he was quick to set expectations: “Right now, it’s like an intern at the FDA. We’re assessing how she might be able to make life easier, but rest assured, it’s still people with beating hearts doing the review.”
Draft guidance on AI in drug development has already been issued, and Burrow noted this will be an ongoing area of collaboration between the FDA and industry.
Why MCRCs Matter
In closing, Burrow highlighted the alignment between FDA priorities and the strengths of MCRCs. Their centralized oversight, standardized operations, and ability to deploy innovations consistently across networks make them natural partners for sponsors.
“One of the very best value propositions for multisite research corporations is that you have the ability to ensure that all of your sites are operationalizing a trial the same way,” he said. “That consistency is exactly what sponsors are looking for.”
Watch the full webinar on demand.
