A risk-based paradigm of biomarkers in clinical trials

Jayson L. Parker, Elena Domazetoski, Matthew Bureau, Gilberto Lopes, Sebnem S. Kuzulugil, Nicholas Mitsakakis

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Biomarkers have many challenges in implementation that may not be fully appreciated given the multiple stakeholders involved in this undertaking. All of this is in the context of a treacherous landscape of risk that pervades clinical trial execution. The concept of risk is introduced here which creates the lens from which biomarkers can be understood. The high failure rates of new drugs in clinical testing may be improved by incorporating biomarkers. However, to date this has never been systematically demonstrated. Reducing the risk of new drug development can have concomitant effects on costs and time to market.

Original languageEnglish (US)
Title of host publicationCompanion and Complementary Diagnostics
Subtitle of host publicationFrom Biomarker Discovery to Clinical Implementation
PublisherElsevier
Pages399-412
Number of pages14
ISBN (Electronic)9780128135396
ISBN (Print)9780128135402
DOIs
StatePublished - Jan 1 2019

Keywords

  • Biomarker
  • Breast
  • Cancer
  • Clinical trial
  • Digital biomarker
  • Drug development
  • Lung
  • Markov
  • Melanoma
  • Risk

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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