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SUMMARY
Introduction
Biopharmaceutical companies are exploring ways to bring their products to
market as quickly and as effi ciently as possible. The use of biomarkers that
function as surrogate end points in clinical trials may allow product
developers to design more-effi cient and shorter trials while offering the
opportunity to diagnose preclinical disease In this report, we examine the
ways in which biomarkers and innovative trial designs that optimize the use of
biomarkers promise to provide biopharmaceutical developers with a competitive
advantage.
Get the Answers You Need to Shape Your Strategy
- The use of surrogate end points in clinical trials can reduce trial time
and expedite the launch of effective medicines to market. However, before any
type of biomarker is used as a surrogate end point in the drug development
process, it must be validated to ensure the confi dence of regulatory bodies.
What steps must be taken to validate a biomarker? What potential pitfalls are
inherent in the validation process?
- Regulatory bodies are showing a great interest in accelerating the drug
development and approval process. How are the FDA and the European Medicines
Agency (EMEA) encouraging the use of biomarkers in clinical trials, and how
are these agencies moving to accommodate the infl ux of trials based on
biomarkers and surrogate end points?
- Given the lack of time and funding needed to study biomarkers extensively,
there has been a strong push among biopharmaceutical industry players to
explore innovative study designs that optimize the use of biomarkers as
surrogate end points. Which study designs are poised to be most valuable, and
how do these designs promise to identify patients that are most appropriate
for a given drug? Which novel technologies do these groundbreaking designs
employ?
Scope
- The role of biomarkers in drug discovery: overview of what defi nes
a biomarker and how biomarkers can act as surrogate end points in clinical
trials.
- The biomarker validation process: the process that deems a
biomarker fi t to act as a surrogate end point in clinical trials.
- Stakeholder actions: key initiatives and partnerships among
regulatory and industry players that aim to accelerate the drug development
and approval process.
- Optimizing the use of biomarkers in clinical study: biomarker-based
innovative study designs that promise to fulfi ll the need for more-effi cient
clinical trials.
- Outlook: discussion of the promises and pitfalls presented by the
use of biomarkers as surrogate end points.
TABLE OF CONTENTS
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Biomarkers for Drug Discovery and Development
- The Search for Surrogate End Points
- Validated Biomarkers as Surrogate End Points
- Characteristics of Validated Surrogate End Points
- The Validation of a Biomarker
- Sources of Error
- Variability
- Sample Size and Multiple Comparisons
- Stakeholder Interest in Biomarkers
- Regulatory Bodies
- The Diagnostics and Biopharmaceutical Industries
- Oncology
- Cardiovascular Disease
- Optimizing the Use of Biomarkers Through Innovative Study Designs
- Adaptive Signature Design
- Biomarker-Adaptive Threshold Design
- Other Designs
- Outlook for Biomarkers as Surrogate End Points
Tables
- 1. Select U.S. FDA Critical Path Opportunities Initiated in 2006
- 2. Select Validated Genomic Biomarkers Cited in FDA-Approved Drug Labels
- 3. Key Alliances in Biomarker Discovery, Development, and Commercialization
Figures
- 1. Biomarker Continuum
- 2. Codevelopment Timelines of Drug, Biomarker, and Diagnostic Test
- 3. Multifactorial Drug/Disease Pathway
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