Dinner Short Course
Sunday, February 9, 2014 | 2:30 - 5:30 pm | Moscone North Convention Center | San Fransisco, CA
Building an Investigational Program to Establish the Clinical Value of a Test
Catherine Schnabel, Ph.D., Vice President, Medical, Clinical & Regulatory Affairs, bioTheranostics, Inc.
Brock Schroeder, Ph.D., Director, Medical & Scientific Affairs, bioTheranostics Inc.
Development of a strong clinical program for diagnostic tests requires consideration and integration of key strategic drivers such as clinical adoption, reimbursement, & regulatory filing based on a proposed indication for use. In considering the appropriate use of new tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient’s clinical status (clinical validity), the risks and benefits resulting from test use (clinical utility), and the medical value of the test (health economics/outcomes).
This workshop will provide a basic framework for establishing comprehensive clinical evidence based on analytical validity, clinical validity, clinical utility, and health economics and effectiveness, and utilize a case study of the 92-gene assay, CancerTYPE ID to build these points.
- Clinical study designs for biomarker research/Levels of evidence
- Formulating clinical endpoints
- Framework for clinical evidence
- Data requirements for various stakeholders
- Case study
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