Parallel Paths to Predictive Biomarkers in Oncology: Uncoupling of Emergent Biomarker Development and Phase III Trial Execution

Author:

Sikorski Robert1,Yao Bin1

Affiliation:

1. Amgen, Thousand Oaks, CA 91320, USA.

Abstract

Predictive biomarkers can be integrated into phase III clinical trials by several approaches, including one that anticipates that a new biomarker will emerge during the course of the trial.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

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2. Clinical Application of Molecular Features in Therapeutic Selection and Drug Development;Statistical Methods in Biomarker and Early Clinical Development;2019

3. Biomarker-Defined Subgroup Selection Adaptive Design for Phase III Confirmatory Trial with Time-to-Event Data: Comparing Group Sequential and Various Adaptive Enrichment Designs;Statistics in Biosciences;2017-06-12

4. The Importance of Biopsy in the Era of Molecular Medicine;The Cancer Journal;2016-11

5. Biomarker Applications in the Pharmaceutical Industry;The Path from Biomarker Discovery to Regulatory Qualification;2013

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