Practical Guidance for Implementing Predictive Biomarkers into Early Phase Clinical Studies

Figure 1

Schematic diagram of assay development activities. Development begins with defining the intended use, which is documented along with assay requirements. After platform selection, a validation plan is developed and executed according to CLSI guidelines. The validation summary is sent to the regulatory agencies prior to the initiation of the clinical study. Reminders discussed in the text are shown to the right. The relative timing of when steps that require advance planning should start is shown to the left.