Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Advanced Clinical Trial Design: From Randomization to Real-World Evidence

Advanced Clinical Trial Design: From Randomization to Real-World Evidence

Fernández López, Juan Manuel

Paperback

Medical Reference

Currently unavailable to order

ISBN13: 9798296736697
Publisher: Independently Published
Pages: 514
Weight: 1.35
Height: 1.28 Width: 6.00 Depth: 9.00
Language: English
Clinical trials are evolving at an unprecedented pace. The rigid protocols of the past no longer suffice in an era shaped by genomics, artificial intelligence, digital health, and real-world data. Regulatory agencies are embracing innovation, and sponsors are being challenged to deliver not only faster, but smarter.

Advanced Clinical Trial Design: From Randomization to Real-World Evidence is a comprehensive and forward-looking guide for clinical research professionals, regulatory strategists, data scientists, and all those shaping the future of clinical development.

This book takes you beyond the fundamentals of randomized controlled trials (RCTs), offering a deep dive into the flexible, adaptive, and technology-driven approaches now transforming clinical research. It blends theoretical rigor with practical insights drawn from real-world implementation, and it is designed to equip you with the tools and vision needed to lead in a fast-changing landscape.

Inside this book, you'll explore:

  • The evolution from classical RCTs to adaptive, Bayesian, platform, basket, and umbrella designs.
  • The increasing role of real-world data (RWD), synthetic control arms, and external comparators in evidence generation.
  • Strategies for integrating AI and machine learning into trial operations and analytics.
  • The rise of decentralized and hybrid trials, including regulatory, technological, and ethical considerations.
  • Risk-based quality management (RBQM), remote monitoring, and data governance under ICH E6(R3).
  • Operational, infrastructural, and financial aspects of complex trial execution.
  • Patient engagement and co-design strategies that improve retention, diversity, and relevance.
  • Case studies of successful trials across oncology, rare diseases, and global multi-center studies.
Whether you're designing your first master protocol, leading a multinational adaptive trial, building a digital infrastructure for remote participation, or seeking to navigate regulatory expectations across regions, this book provides strategic frameworks, actionable guidance, and real-world perspectives.

About the Author

Juan Manuel Fernández is a Clinical Project Manager and Clinical Research Consultant with over a decade of experience managing global clinical trials across Europe and the United States. His expertise spans oncology, hematology, rare diseases, and medical devices, with a strong focus on early-phase and complex multinational studies.

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