Protocol Design

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.

Optimization challenges spurring cultural, strategic, and organizational change.

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.

Participant adherence depends on readiness—a combination of knowledge, calibrated confidence, and real-world mastery—not simply on digital tools, reminders, or education, which are forms of exposure rather than preparation for sustained performance.

Pediatric trial participation shapes children's and caregivers' long-term psychological outcomes, yet protocol design often overlooks experience as a variable affecting recruitment, retention, and data integrity—a gap increasingly recognized by regulators and quality standards

In this Q&A, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, discusses how clinical trial design has become a strategic business decision—and why small and midsize companies bear the greatest consequences when those decisions go wrong.

In this Q&A, Mwango Kashoki, MD, MPH, SVP and global head of regulatory strategy at Parexel, breaks down the FDA's plausible mechanism framework and what it means for sponsors developing individualized therapies in ultra-rare disease settings.

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.

Insights from SCOPE 2026 highlight the industry’s shift toward connected, data-centric clinical trial ecosystems, where digital protocols, shared data, and renewed scientific rigor are driving more efficient, interoperable, and patient-focused research.

A look at how efficiency, access, platformization, AI, non-traditional players, and regulatory recovery are expected to reshape clinical operations in 2026.

Analyze the operational pressures driving longer activation timelines, from protocol complexity to site competition, and learn how earlier, more flexible site engagement can restore momentum.

The clinical trial ecosystem is entering a phase of consolidation and reinvention driven by the collapse of boundaries between functions, data, and even companies themselves.

Pharmacovigilance has advanced in detecting population-level safety signals, but a critical gap remains in translating those insights into transparent, defensible patient-level decisions.

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 how expanding clinical trials into community and nontraditional sites, simplifying protocols, and leveraging AI can broaden patient access and bridge the gap between real-world care and research.

See how combining human oversight with AI insights improves protocol authorship, site selection, and monitoring strategies, delivering better decisions than AI-only or human-only approaches.

Investigate how sponsors are responding to rapid growth in obesity drug development, including strategies for manufacturing, supply chain optimization, dosing innovations, and combination therapies to meet market and patient needs.

Gain insight into why sponsors are taking a larger role in site selection and CRO oversight using robust data to validate feasibility before launch.

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

Learn how incorporating real-world data at study design can improve feasibility, reduce amendments, and align eligibility with findable patients across geographies.

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

Learn how early regulatory engagement, validated digital systems, and robust protocol design enable biotechs to run parallel studies without compromising compliance or data integrity.