Oncology Clinical Trials: Successful Design, Conduct, and Analysis

Oncology Clinical Trials

We wish to draw your attention on the publication of a valuable book Oncology Clinical Trials – 2nd edition edited by William Kevin Kelly, DO, Susan Halabi, PhD, FASCO in which IDDI has contributed a chapter on surrogate endpoints.
The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections, this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials.
Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology.

Highlights of Oncology Clinical Trials

oncology clinical trials • Outlines how to design clinical trials with and without biomarker testing- including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials
• Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in
investigational studies, establishing surrogate endpoints, practical issues with correlative studies, costeffectiveness analysis, and more
• Comprehensively covers all regulatory aspects in the pursuit of
global oncology trials.20% discount using the promo code KELLY20: Click here for more information to place an order 


Oncology is IDDI’s core therapeutic area, we have designed collected, analyzed clinical data and reported on oncology clinical research studies for more than 27 years and are currently collaborating with oncology cooperative groups all over the world. IDDI has been involved in 15 marketing approvals of anti-cancer therapies and has supported 630 oncology trials since inception. Should you require further information on our expert services please do not hesitate to contact us.