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Clinical Trials in Oncology: Design, Execution, and Challenges is a comprehensive guide for clinical research teams involved in cancer trials. It covers the foundations of oncology research, including trial phases and innovative study designs like biomarker-driven, basket, and platform trials. The book explores methodologies, key clinical endpoints, and the role of biomarkers in precision oncology.
Practical aspects of trial execution, such as patient recruitment, regulatory approvals (FDA, EMA), ethical considerations, and safety monitoring, are thoroughly discussed. It also highlights emerging trends, including immunotherapy, CAR-T cell therapy, AI-driven research, and decentralized trials.
The book concludes with case studies of trial failures, challenges in low-resource settings, and future advancements in AI, CRISPR, and gene therapy. Designed for clinical researchers, oncologists, and trial professionals, this book provides a roadmap for conducting successful oncology trials and advancing cancer treatment.
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