Application of the Fit for Purpose Strategy

The fit-for-purpose (FFP) strategy is a fluid concept that can be applied to any clinical trial to validate biomarkers of interest. As described earlier, the classification and validation of a biomarker is context-specific, and the validation criteria required are dependent on the intended use of the biomarker. The concept of fit-for-purpose validation is sensible, as biomarkers may be used to include or exclude patients from treatment and to determine dosing, toxic-ity, or safety. The consequence or risk of a false- negative or false- positive biomarker indication must be considered since even the most sensitive and specific assays are not perfect. A biomarker intended as a population screen must be very sensitive and extremely specific [25] . Any tests that are to be used in isolation for decision making require particularly stringent validation, whereas drug efficacy biomarkers that are typically used in groups or involve subsequent testing may require less stringency since the consequence of a false indication of efficacy is lower [26].

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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