Enrollment

When clinical trial teams screen for "tech-savvy, engaged" participants, they're often running a second, unwritten eligibility criterion that systematically excludes the populations the study drug is actually meant to treat.

In this Q&A, Robert Hummel, chief operating officer at Suvoda, discusses how agentic AI is compressing RTSM build and deployment timelines, what safeguards are needed to maintain compliance and oversight at speed, and how intelligent automation will reshape the broader clinical trial technology stack over the next decade.

From rising costs and regulatory uncertainty to persistent vaccine hesitancy, sponsors face mounting pressure to standardize operations, build community trust, and develop the behavioral capabilities needed to run vaccine trials effectively in a rapidly shifting environment.

From planning one Phase III trial at a time to digital standardization on repeat.

In this Q&A, Del Smith, PhD, CEO and co-founder of Acclinate, discusses how structural and relational barriers continue to limit participation from underrepresented communities in clinical trials—and what it takes to build the kind of trust that translates into lasting research impact.

Despite political headwinds, life sciences leaders are holding their ground on DEI, but translating organizational commitment into representative enrollment requires structural changes to protocol design, site selection, and community engagement that most of the industry has yet to fully make.

In this Q&A, Adrelia Allen, executive director of clinical trial patient diversity at Merck, discusses how the company is embedding diversity into clinical trial execution—from protocol design and site selection to long-term community engagement that extends well beyond individual trial timelines.

Clinical development productivity improved in 2025, but gains remain fragile as end-to-end timelines lengthened again, signaling that future success depends less on individual trial execution and more on program-level orchestration, site engagement, and adaptive operating models.

Limited evidence surrounds direct-to-patient clinical trial site models, despite growing literature showing that decentralized approaches can improve patient access, enrollment performance, and operational efficiency while reducing participant burden.

The execution translation gap—the failure to convert identified problems into coordinated, timely action—costs millions per trial through delayed amendments, persistent deviations, and slow site activation, yet remains addressable through aligned accountability and proactive execution management.

In part 3 of this three-part series, behavioral science reveals that clinical trial diversity cannot be achieved through last-minute recruitment efforts, but requires designing protocols, sites, and enrollment strategies around the real barriers and needs of underrepresented communities from the outset.

In part 1 of this three-part series, behavioral science reveals how slow patient recruitment and enrollment challenges often stem from design and startup decisions made long before recruitment begins, but can be identified and resolved early when they still matter.

In this first part of a 2-part perspective, clinical trial recruitment failures are reframed as design outcomes, making the case for embedding enrollment feasibility into protocol governance from the start.

Sylviane de Viron, data and knowledge manager at CluePoints, shares new data highlighting regional variations in clinical trial risks—and how proactive risk planning based on up-to-date data is needed to overcome them.

By leveraging the Fresh Start Effect at site initiation and shifting from passive training to demonstrated readiness, sponsors and CROs can turn trial launch into a powerful multiplier for early performance, compliance, and execution quality.

Learn why combining AI-enabled trial matching with transportation, lodging, and financial assistance is essential to turning trial eligibility into actual participation—and why matching alone is not enough.

Examine how the American Cancer Society’s national ACTS expansion is designed to simplify trial discovery, reduce logistical barriers, and help patients, caregivers, and providers navigate cancer clinical trials through a centralized support model.

Persistent recruitment delays, high dropout rates, and missed timelines continue to slow global clinical trials, while data show that sub-Saharan Africa offers a largely untapped opportunity with established research capacity, large patient pools, and strong enrollment and retention performance.

Learn how organizing data assets, activating nonresearch HCPs, and building referral pathways with compliant remuneration can convert identified patients into enrolled participants.

Understand how combining proprietary and real-world datasets with tokenization enables accurate protocol matching while maintaining privacy and compliance.

Gain insight into how principal investigator scarcity, frequent protocol amendments, and uneven site performance undermine enrollment and extend timelines.

In a breakout session at the 2025 SCRS Global Site Solutions Summit, industry leaders from SCRS, QCR, and Syneos Health discussed how sites can prioritize patient empowerment, strengthen community outreach, and collaborate with CROs and sponsors to secure resources for engagement initiatives.

Modernizing Clinical Trials: A Site-Centered Roadmap for the Future Simplifying startup, empowering sites through networks, and adopting evidence-based site selection frameworks can address enrollment bottlenecks, reduce dropout, and strengthen trial efficiency across the research ecosystem.