Biomarkers have gained importance and interest over the last couple of decades. They are critical tools in various scenarios including drug development, prognosis, and diagnosis. This is still a relatively new discipline, so definitions can vary.
However, biomarkers can be seen as measurable indicators related to a biological state or condition. These indicators often represent biological processes in normal and pathological conditions, or as a response to pharmacological intervention.
For drug development, biomarker testing has emerged as a useful area. Biomarker testing services are often used for all phases, ranging from candidate selection to non-clinical and clinical trials, and post-market studies. Clinical researchers lead academic trials, but it is the laboratory experts and researchers who excel in biomarker validation and test development. The testing service should provide skill, coordination, and excellence. Let’s consider some factors involved.
1. Defining Role and a Fit-for-purpose Biomarker Test
Defining the role of a biomarker is necessary for choosing a fit-for-purpose biomarker. The definition generally forms the first step and determines the role it will play. Choosing between exploratory, integral, and integrated biomarkers depends on the scope and need of the study.
After defining the role, a biomarker fit for that role is chosen. This is, of course, easier said than done and several tests will proceed with the aim of identifying the biomarker. The distinction appears binary but remains dependent on the sensitivity and should be seen as a scale.
2. Describing and Implementing Test Procedures
A description of the biomarker test and the laboratory procedures required to perform it are necessary. This depends on the stage and specific requirements. For example, there is a difference between choosing procedures for developing pharmacodynamic (PD), pharmacokinetic (PK) assays, and tests for patient eligibility. In any case, a clinical protocol with instructions for handling and processing samples and assays is necessary.
3. Biomarker Assay and Sample
Collecting and processing samples and assays is of critical importance in biomarker testing. The process must ensure sample quality and prevent contamination and degradation of plasma. The trial and limitations of the assay should be clear, as should be the risks involved in the collection of the samples/specimens.
4. Method Validation and Analytical Validation
Analytical validation establishes parameters for the performance of the biomarker test. In an early phase, this can define biomarker validation to justify the accuracy and reliability of the test. This also verifies the earlier process of defining the role of a biomarker and choosing a fit-for-purpose biomarker. Reproducibility, repeatability, and linearity may also be considered.
After biomarker validation, it can be incorporated into testing and trial as necessary. At this point, it is also useful to maintain a collection of specimens and samples for future or further analysis.
6. Communication between Teams
The importance of robust and clear communication between teams cannot be overstated. It is often the biggest challenge to overcome. The laboratory team or biomarker testing services and the clinical team often have different perspectives and structures. That may lead to missed or simply improper communication. Factors and processes to mitigate these should be established.
7. Future Development
After a trial, the future and possible use of the biomarker should be assessed. Ideally, this should be done whether or not the trial was able to confirm the hypothesis. There are chances of using the same biomarker in a future trial or a different role. Thus, inadequately developed biomarker tests are best avoided.