Beyond The Benchmark: How Innovative Trial Designs Are Transforming Clinical Research

By Meg Hooton, President, IQVIA Biotech, Murray Aitken, Executive Director, IQVIA Institute for Human Data Science, and Keith McDonald, Head of Drug Development Strategy, Regulatory Affairs & Drug Development Solutions, IQVIA

Clinical research is undergoing a major transformation as biotech companies face funding volatility, evolving regulations, and mounting pressure to accelerate development. Innovative trial designs are emerging as a critical solution, offering flexibility and efficiency in an increasingly complex environment.

Adaptive trials enable real-time modifications based on participant data, improving statistical power and ethical standards while reducing timelines. Decentralized models, supported by telemedicine and digital data collection, enhance patient engagement and can speed enrollment by up to 78%. External control arms and real-world evidence are also gaining traction, strengthening regulatory submissions and reimbursement strategies. Meanwhile, generative AI is streamlining operations and data management, though its adoption requires careful oversight to ensure transparency and compliance.

These advancements, combined with global regulatory initiatives promoting diversity and faster approvals, are reshaping how therapies move from concept to market. Access the full resource to explore how innovative trial designs and technology-driven strategies can optimize development and deliver treatments faster.