Abstract:
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While the development of digital diagnostic/prognostic algorithms (DDPA) for medical imaging has gained tremendous visibility, most DDPAs failed to be successfully deployed in clinical practice. We believe this could be improved if DDPA development followed the same evaluation process as other pharmacologic interventions through phased clinical trials. In this presentation, we will discuss analogies between the initial DDPA development and the discovery phase of drug development. Phase 0 studies assess the unmet medical need, explore intervention approaches and identify best candidates to advance to human trials. Similarly, DDPA development should assess the need for improved diagnostic/prognostic performance, investigate appropriate algorithms and data sources, and create the initial model. Phase 1 dose escalation and safety investigations are analogous to estimating model performance metrics and assessing the cost/benefit of true/false positives. We will give an example on the development of a cardiac MRI-based diagnostic algorithm for transthyretin amyloid cardiomyopathy to illustrate how these Phase 0/1 principles can be applied to improve DDPA development and implementation.
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