Essentials of Clinical Trials and Cancer Drug Development

Essentials of Clinical Trials and Cancer Drug Development is a detailed guide designed for students, researchers, and emerging professionals exploring the fields of pharmaceutical science, data integrity, and patient safety. In an era where medical breakthroughs depend as much on robust data management as they do on biological innovation, this textbook provides a clear, structured roadmap through the entire clinical trial lifecycle. Focused specifically on the high-stakes field of oncology, the book explains about the unique challenges of cancer drug development from phase I dose-escalation and biomarker-driven trials to advanced survival analysis and regulatory submission. Readers will explore critical topics such as Good Clinical Practice (GCP), the role of Artificial Intelligence in data monitoring, and the ethical imperatives of the Declaration of Helsinki. Authors Dr. Sambasiva Rao Tummala and Dr. Naveena Gorrepati offer an indispensable resource for those dedicated to safeguarding public health and advancing the next generation of life-saving cancer therapies by blending rigorous statistical methodology with practical insights into pharmacovigilance and drug safety.