“Clinical trial complexity and operational fragility are not necessarily the same thing,” says Tia Warrick, DHSc, MPH, CCRA, ACRP-PM. “A trial can be highly complex but operationally resilient if appropriate resources, redundancy, contingency planning, and communication pathways are in place.”
On the other hand, she notes, a seemingly straightforward trial may be highly fragile if successful execution depends on a small number of assumptions or operational dependencies that have little tolerance for disruption.
In her upcoming ACRP 2027 presentation on “Operational Fragility in Clinical Trials: A Framework for Identifying Risk Before Enrollment Begins” in San Diego (April 30–May 3), Warrick, Chief Executive Officer of Lesous Consulting LLC, will untangle the Gordian knot of recognizing when a trial is on shaky ground while there’s still time to address the issues at hand or, better yet, prevent them from becoming problematic in the first place.
Warrick says that she will introduce an Operational Fragility Framework that examines vulnerabilities related to such factors as staffing and specialized resource dependencies; participant access, visit burden, caregiver involvement, and retention demands; and scheduling requirements and protocol execution constraints.
“This framework also addresses things like vendor, technology, and supply dependencies; budget and reimbursement assumptions; endpoint execution and data collection requirements; and communication, escalation, and cross-functional coordination pathways,” Warrick adds.
A key component of the framework is what she refers to as the Dependency, Redundancy, and Recoverability (DRR) assessment, during which, for each operational area, teams consider three questions:
- Dependency: How dependent is successful trial execution on this particular resource, process, person, vendor, or assumption?
- Redundancy: If that component becomes unavailable or fails, is there a realistic alternative or backup?
- Recoverability: If a disruption occurs, how quickly and effectively can the study recover without significant effects on enrollment, protocol execution, participant retention, budget, or data quality?
“The purpose of the DRR assessment is to move beyond identifying individual risks and instead evaluate how vulnerable the overall operational system may be to disruption,” Warrick explains. “For example, a specialized assessment may not appear particularly problematic during traditional feasibility review. However, if only one trained individual at the site can perform it, no backup is available, recertification requires several weeks, and the assessment must occur within a narrow visit window, that operational dependency becomes much more fragile.”
Operational Fragility in Clinical Trials: A Framework for Identifying Risk Before Enrollment Begins
Join Tia at ACRP 2027 [April 30-May 3; San Diego, Calif.] as she will introduce an Operational Fragility Framework for identifying clinical trial risk before enrollment begins. View complete schedule.
The framework also examines how seemingly minor disruptions or vulnerabilities can interact, she says, such as what might happen when a narrow visit window which may not independently create substantial risk produces disproportionate downstream consequences when combined with limited staffing, participant transportation barriers, a specialized assessment, or vendor-dependent procedures.
“I will discuss how teams can apply the framework and DRR assessment during feasibility, site selection, budget review, study start-up, and operational planning to distinguish normal trial complexity from vulnerabilities that may warrant upfront mitigation,” promises Warrick, who will also present a session at ACRP 2027 on “The Impacts of AI-Enabled Coverage Analysis on Trial Budgeting, Site Reimbursement, and Sponsor-Site Alignment.”
Edited by Gary Cramer
