Dinner Short Course

Building an Investigational Program to Establish the Clinical Value of a Test  

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 SchnabelCatherine Schnabel, Ph.D., Vice President, Medical, Clinical & Regulatory Affairs, bioTheranostics, Inc. 







Brock SchroederBrock 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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