Biomarkers in imaging: realizing radiology's future

Area of Science:

• Biomedical Imaging
• Pharmaceutical Development
• Medical Device Evaluation

Background:

• Pharmaceuticals and medical devices offer significant patient benefits but incur high and increasing development costs.
• Typical drug development takes 12 years and hundreds of millions of dollars, requiring U.S. Food and Drug Administration approval.
• Imaging biomarkers are key parameters for disease detection and severity assessment.

Purpose of the Study:

• To explore the potential of imaging biomarkers in streamlining preclinical studies and clinical trials.
• To outline the scientific criteria for the successful application of imaging biomarkers.
• To position the radiology community as a leader in evaluating new medical treatments.

Main Methods:

• Defining imaging biomarkers as detectable parameters (anatomic, physiologic, biochemical, molecular) for disease assessment.
• Establishing criteria for successful biomarker use: close link to disease, accurate/reproducible detection, and correlation with therapeutic effects.
• Applying these criteria across various imaging modalities.

Main Results:

• Imaging biomarkers promise smaller, less expensive, and more efficient preclinical and clinical studies.
• Recognition of biomarker potential by scientists, regulators, and industry.
• A paradigm for rigorous scientific application is proposed for biomarker success.

Conclusions:

• The rigorous application of science to imaging biomarkers is crucial for realizing their full potential.
• Biomarker success hinges on close disease correlation, reliable measurement, and linkage to therapeutic outcomes.
• The radiology community can significantly influence preclinical and clinical evaluations through strategic biomarker use.