Biomarker Validation Process

Utilizing the FFP strategy, various questions can be asked at the beginning of any biomarker research and development (R&D) project: For what reason are the biomarker(s) being identified? Is the clinical validation going to validate the biomarker for specificity, sensitivity, and reproducibility for diagnostic purposes, or to serve as a surrogate endpoint? What business-critical decisions will be made based on the biomarker data? These questions not only help determine the level of confidence required for the biomarker, but also help strategize regarding the phases of validation. For example, in the case of developing surrogate biomarkers to replace clinical endpoints, candidate bio-markers would, theoretically, evolve over time toward the point of surrogacy as the research project moves through different phases of validation. For the purpose of this chapter, the validation process from initial biomarker development to postmarket surveillance has been broken down into five major phased strategies (Figure 1). It is important to note that the overall process is a continuous loop driven by the intended purpose of the biomarker data, but the flow of the overall process may be subjected to change depending on the results generated at each phase [22].

In general, the process of biomarker validation can be described as a multifaceted process that includes determining sensitivity, specificity, and reproducibility of the assay and also clinical sensitivity and specificity [27]. This applies to both methodologic and clinical validation. Method validation pertains to the process by which the assay and its performance characteristics are assessed. This assessment is performed throughout biomarker translation and is based on several fundamental parameters: accuracy, precision, selectivity, sensitivity, reproducibility, and stability [16,22]. Method validation is not discussed in detail in this chapter.

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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