Protocol Design

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.

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.

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.

As pharma wrestles with whether to trust fully autonomous AI, semi-autonomous agents are emerging as a safer middle ground that reduces manual work, eliminates white space in clinical development, and accelerates trial timelines without compromising patient safety.

An analysis of primary Phase II protocols paired with their Phase III pivotal trials spotlights the need to balance scientific curiosity with participant and site burden.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, explains how NIMBLE showed cemdisiran achieved strong efficacy with partial complement inhibition and reduced disease worsening compared to combination therapy.

In this Q&A, Randa Wahid of Indero, and Lyn Mursalo, a freelance clinical research professional, share how sponsors and CROs can build collaborative partnerships, navigate global trial complexities, and apply practical strategies to deliver studies on time and with quality.

How decentralized clinical trial designs and smart data integration are transforming the patient experience.

A 2025 survey highlights growing momentum for multi-indication drug development, with opportunities in innovative trial design, targeted patient selection, and real-world evidence to speed label expansion.