Why Single Pivotal Trials Make Patient Recruitment Far Less Forgiving

Full interview summary

In a recent video interview with Applied Clinical Trials, Gaynor Anders, chief delivery officer at Trialbee, discussed how the FDA's shift toward single pivotal trials is reshaping patient recruitment strategy, and why the industry's longstanding study-by-study approach to building patient pipelines is no longer fit for purpose. She opened by reflecting on sponsor reactions to the February 2025 announcement—largely mixed—noting that while the potential for faster approvals and lower overall costs is understood, the implications for recruitment are sobering. With only one shot at a pivotal study, the cost of getting recruitment wrong is dramatically higher, and Anders described a clear escalation in how seriously sponsors are treating feasibility, diversity, patient quality, and retention planning as a result.

She went on to explain why the model of rebuilding patient pipelines from scratch for each individual study has persisted for so long, tracing it to the historically protocol-centric nature of clinical research. The shift she is now seeing—and actively encouraging—is toward a more relationship-driven, programmatic approach: sponsors building ongoing connections with patient communities across therapeutic areas, keeping patients who don't qualify for one study engaged for the next, and putting the burden of patient matching on industry rather than on patients themselves.

On the operational requirements of program-level recruitment, Anders was candid that it demands organizational change as much as technological investment. Study teams need to break out of silos, budget structures need to support cross-study flexibility, and technology platforms need to be integrated end to end so that data flows from patient identification through to site enrollment and beyond. She identified mindset as one of the most persistent barriers to adoption, alongside the structural challenge of siloed budgets and teams that have limited visibility into what their colleagues are working on across the same therapeutic area.

She closed by framing success for CROs within this model as fundamentally about partnership—between the CRO, the sponsor, and the patient recruitment partner—supported by shared data, analytics visibility, and a common commitment to moving patients through the funnel rather than debating who owns the responsibility for doing so.