Enrollment

Phase III oncology setbacks often reflect incomplete biological understanding rather than target failures, but robust biomarker strategy and multi-dimensional patient selection developed early in development can strengthen pivotal trial design and increase success.

As the FDA's single-trial standard raises the cost of recruitment failure and diversity expectations intensify, sponsors are under pressure to move beyond study-by-study outreach toward programmatic, relationship-based approaches that treat patient engagement as a long-term strategic capability rather than a per-study operational task.

The evolving role of medical affairs in connecting patients, physicians, and evidence generation.

Eligibility criteria alone rarely predict enrollment, which depends more on trust, hope, and fear, requiring relationship-based community engagement paired with behavioral readiness assessments rather than transactional outreach.

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.

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.

Behavioral science reveals how recruitment failures, site disengagement, and underrepresentation in clinical trials are rooted in early design decisions, and what sponsors can do to address them before they become costly problems.

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.

Assess the industry-level changes needed to ensure cancer clinical trial populations better reflect disease demographics, improve US-based enrollment, and support regulatory confidence in trial outcomes.

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.

Explore early data from the ACTS program that reveal the volume and types of patient-reported barriers to cancer care and clinical trial participation, highlighting the critical role of support services in sustaining enrollment.

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.