Articoli correlati a Clinical Trials in the Era of Real-World Evidence

Clinical Trials in the Era of Real-World Evidence - Brossura

Chen, Jie; Ting, Naitee; Lu, Feinan

 
9781394369652: Clinical Trials in the Era of Real-World Evidence
Brossura
ISBN 10: 1394369654 ISBN 13: 9781394369652
Casa editrice: John Wiley & Sons Inc, 2026

Sinossi

Integrate RCTs and real-world evidence for stronger regulatory submissions

Since the passage of the 21st Century Cures Act, the landscape of clinical research has transformed dramatically. Today, the integration of real-world data (RWD) and real-world evidence (RWE) with traditional randomized controlled trials (RCTs) is not just innovative - it is essential for modern drug development and regulatory decision-making.

This comprehensive volume bridges the methodologies of conventional RCTs and emerging RWE studies, offering systematic approaches for leveraging diverse data sources throughout the clinical development lifecycle. Grounded in regulatory statistics yet forward-looking in scope, the book explores Stein's continuum of study designs - from traditional RCTs to pragmatic trials and observational studies - and demonstrates how RWD can enhance trial feasibility, inform outcome selection, provide external controls for single-arm trials, and strengthen post-approval safety monitoring.

Readers will find detailed explorations of:

  • A history of clinical trials, evidence-based medicine, and the regulatory frameworks governing drug approval
  • Treatment switching and estimands in RWE studies
  • Advanced analytical considerations including precision medicine, vaccine effectiveness, safety evaluation, and sensitivity analysis
  • Practical roadmaps for designing robust RWE studies
  • Artificial intelligence and machine learning in clinical research

Designed as both a reference and a graduate-level textbook, this book serves clinical researchers such as clinicians and biostatisticians, regulatory professionals, public health scientists, and industry practitioners seeking to harness the power of RWD and RWE to generate credible, actionable evidence for modern medicine.

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Editore
John Wiley & Sons Inc
Data di pubblicazione
2026
Lingua
Inglese
ISBN 10 
1394369654
ISBN 13 
9781394369652
Rilegatura
Copertina flessibile
Numero di pagine
464
Contatto del produttore
Easy Access System Europe Oü, 16879218
gpsr.requests@easproject.com

Mustamäe tee 50, 10621, Tallinn, Estonia
Tallinn
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Estonia