Oncology Trials: Development Strategy

Authored by: Zhaoyang Teng , Yi Liu , Jing Yang , Zhaowei Hua , Mark Chang

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-140000052

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Abstract

Clinical development of new therapies is a complex process that requires considerable time and resources. The phase 3 trial failure rate is particularly high in oncology (oncology new drug application (NDA) approval rate is only 40%). In order to streamline and expedite the drug development for oncology and more efficiently identify the right population with right regimen for the patients around the world, innovated study designs should be implemented for drug developments including oncology trials. Adaptive design provides a more flexible framework for clinical development that can help increase the efficiency for use of available resources. Increasingly, drug makers are interested in using adaptive design trials to accelerate clinical development and speed new medicines to patients in need. Clinical trials using a biomarker strategy may result in smaller study sizes and higher probability of trial success with the right target patient population which in turn reduces development risk and generates higher return on investment. Multi-Regional Clinical Trials (MRCT) is a more efficient strategy to expedite global clinical development and facilitate drug registration globally. We provide some commonly used design strategies for oncology drug development, with main focus on adaptive design, biomarker-driven study design, and study design considerations for MRCT. We believe that adaptive design, biomarker utilization, and MRCT are three integral parts of a clinical development strategy for oncology drug.

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