Practical Guidance for Implementing Predictive Biomarkers into Early Phase Clinical Studies
Joint Authors
Marton, Matthew J.
Weiner, Russell
Source
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-10-22
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
The recent U.S.
Food and Drug Administration (FDA) coapprovals of several therapeutic compounds and their companion diagnostic devices (FDA News Release, 2011, 2013) to identify patients who would benefit from treatment have led to considerable interest in incorporating predictive biomarkers in clinical studies.
Yet, the translation of predictive biomarkers poses unique technical, logistic, and regulatory challenges that need to be addressed by a multidisciplinary team including discovery scientists, clinicians, biomarker experts, regulatory personnel, and assay developers.
These issues can be placed into four broad categories: sample collection, assay validation, sample analysis, and regulatory requirements.
In this paper, we provide a primer for drug development teams who are eager to implement a predictive patient segmentation marker into an early clinical trial in a way that facilitates subsequent development of a companion diagnostic.
Using examples of nucleic acid-based assays, we briefly review common issues encountered when translating a biomarker to the clinic but focus primarily on key practical issues that should be considered by clinical teams when planning to use a biomarker to balance arms of a study or to determine eligibility for a clinical study.
American Psychological Association (APA)
Marton, Matthew J.& Weiner, Russell. 2013. Practical Guidance for Implementing Predictive Biomarkers into Early Phase Clinical Studies. BioMed Research International،Vol. 2013, no. 2013, pp.1-9.
https://search.emarefa.net/detail/BIM-1005338
Modern Language Association (MLA)
Marton, Matthew J.& Weiner, Russell. Practical Guidance for Implementing Predictive Biomarkers into Early Phase Clinical Studies. BioMed Research International No. 2013 (2013), pp.1-9.
https://search.emarefa.net/detail/BIM-1005338
American Medical Association (AMA)
Marton, Matthew J.& Weiner, Russell. Practical Guidance for Implementing Predictive Biomarkers into Early Phase Clinical Studies. BioMed Research International. 2013. Vol. 2013, no. 2013, pp.1-9.
https://search.emarefa.net/detail/BIM-1005338
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1005338