Can the Use of Biomarkers as Surrogate End Points Stimulate the Drug-Development Lull

Published by: Decision Resources

Published: Oct. 12, 2007 - 19 Pages

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

Abstract

• 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?

• 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.

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