Trial Design

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

As highly effective anti-obesity therapies emerge and regulatory expectations evolve, sponsors are adopting innovative trial designs, addressing long-term weight maintenance, monitoring lean mass preservation, and preparing for expanded safety and demographic requirements that will define the next era of obesity R&D.

Explore how AI can optimize study design, speed patient recruitment, and streamline operational workflows to shorten development timelines and enhance trial efficiency.

Twelve former FDA leaders have publicly challenged the agency’s proposed overhaul of vaccine approvals, sparked by an internal memo linking child deaths to COVID-19 vaccination, arguing the changes threaten evidence-based standards, weaken immunobridging practices, and risk eroding public trust.

Examine the rise of personalized and biomarker-driven therapies, the logistical challenges of rare patient populations, and how historical controls and real-world evidence are supporting strategy-driven trial designs.

Novel trial designs are reshaping clinical development by improving efficiency, reducing redundancies, and accelerating timelines toward a new era of precision medicine.

Exploring how large-scale patient databases and AI analytics can accelerate site activation, strengthen recruitment, and improve trial design from the start.

Revisit top insights from SCOPE Summit 2025, where industry leaders explored how artificial intelligence is reshaping trial risk management and how pragmatic study designs are bridging the gap between clinical research and real-world care.

See how early patient inclusion, integrated regulatory planning, and seamless CRO partnerships can help biotechs accelerate progression from Phase I to Phase II.

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.

By adopting structured practices today, clinical trials can deliver diagnostics that are reliable, impactful, and ready for tomorrow’s healthcare needs.

In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, highlights how clinical operations teams must enhance patient tracking, engage data monitoring committees earlier, and plan subgroup analyses to meet FDA’s overall survival guidance.

Pharma R&D faces rising trial complexity, high costs, and patient and investigator shortages, driving the need for adaptive models and data-driven strategies to speed therapies to market.

In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, explains how integrating real-world evidence and predictive modeling early in development can streamline OS-focused trials while meeting regulatory and payer expectations.

In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, discusses how model-informed drug development can help sponsors predict efficacy and safety outcomes to align shorter trials with FDA expectations for overall survival.

In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, explains how emphasizing overall survival ties trial success to both efficacy and safety while also shaping payer and access considerations post-approval.

In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, outlines how FDA’s emphasis on overall survival in oncology trials requires stronger safety monitoring, subgroup planning, and patient tracking.

In an era of constant policy change, timely real-world data is emerging as pharma’s most critical tool to track patient access, anticipate shifts in treatment utilization, and improve outcomes in real time.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, describes how double-blind double-dummy design, site reminders, and patient engagement measures ensured high adherence with quarterly subcutaneous dosing in the NIMBLE trial.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, explains how large sample size and stratification by immunosuppressant use ensured balance and consistent efficacy assessments in the NIMBLE study.

Clinical trial enrollment and retention challenges, coupled with limited site resources, highlight the need for stronger site support, collaboration, and patient-centered trial models.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, describes how double-blind double-dummy dosing, standardized assessments, and site training ensured protocol adherence and data integrity in the NIMBLE trial.

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.