Fitforpurpose Strategy

Despite the lack of universal guidelines or agreement on the specific requirements for biomarker assay development and validation, there is a general consensus in the biomarker research community that the foundation of validation efforts is to ensure that the biomarker(s), or the assay, is "reliable for its intended use" [20] - This principle is now commonly referred to as the fit-for-purpose validation strategy or guideline. This approach embraces the notion that depending on the intended purpose of the biomarker, the objectives and processes or types of validation will probably be different [21,22]. Dose selection, early efficacy assessment or candidate selection, and surrogacy development are all examples of biomarker clinical purposes, each of which have differing levels of validation requirement. The risk and consequence may be different depending on the purpose, even when the same biomarker is used [4].

Further, the degree of stringency and phase of the validation, both of which are discussed later in the chapter, should be commensurate with the intended application of the validation data (Figure 1) [22]. In that sense, the term validity should be thought of as a continuum—an evaluation of the degree of validity—rather than an all-or-none state [14,23]. Therefore, biomarker utility is not measured dichotomously and should not be classified as simply good or bad. The level of a biomarker' s worth is gauged on a continuous scale, with some being much more valuable than others, depending on what they indicate and how they can be applied [24]. Validation of biomarkers and establishment of their "worth" or "value" is a continually evolving and often iterative process (Figure 1 ).

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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