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Widespread functional and molecular imaging in drug development.

Edward A Ashton¹

¹VirtualScopics, Inc., 500 Linden Oaks, Rochester, NY 14625, USA +1 585 249 6231 ; +1 585 218 7350 ; ashton@virtualscopics.com.

Expert Opinion on Drug Discovery

|March 15, 2013

Summary

New drug development methods are crucial due to high failure rates. Functional imaging offers sensitive, reproducible evidence of treatment effects in early-phase trials, improving drug efficacy assessment.

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Area of Science:

Pharmaceutical Sciences
Biomedical Imaging
Drug Development

Background:

Increasing numbers of drug candidates contrast with persistent high failure rates (80% overall, 50% late-stage).
Rising R&D expenditures necessitate novel approaches for early-stage efficacy assessment.
Clinical endpoints in early-phase trials often lack sufficient statistical power.

Purpose of the Study:

To evaluate the utility of functional and molecular imaging in early drug development.
To explore the benefits and challenges of integrating imaging into clinical trials.
To identify methods for improving the assessment of drug efficacy.

Main Methods:

Review of functional and molecular imaging techniques.
Analysis of their application in early-phase clinical trials.
Examination of sensitivity, reproducibility, and statistical power.

Main Results:

Functional imaging provides sensitive and reproducible detection of treatment effects.
Imaging can yield statistically supportable evidence even in small Phase I trials.
These techniques offer a viable alternative to underpowered clinical endpoints.

Conclusions:

Functional and molecular imaging present significant advantages for early drug development.
Careful consideration of benefits and potential pitfalls is essential for successful implementation.
Imaging can enhance the efficiency and success rate of bringing new drugs to market.