Validating protein biomarkers november
At present, several research institutes around the world, including many at which the authors of this article are based, are collecting tumor, blood, serum and faecal samples to investigate prognostic and predictive biomarkers and to better understand the complex immunobiology of patients and their cancers.
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There is a need for an international joint effort to maximize data, information and knowledge generation from existing and completed clinical trials and to design clinical trials that will better address these important issues.
The proposal of this white paper is to encourage the creation of a network to facilitate the sharing and coordinating of samples from clinical trials in order to allow more in-depth analyses of correlative biomarkers than is currently possible.
Therefore, the incorporation of correlative biomarker studies using state-of-the-art technologies within clinical trials in order to maximize data generation is required.
The challenge at this stage is that most completed or ongoing clinical trials have not sufficiently incorporated biomarker assessment into their design.
A biomarker with clinical relevance requires rigorous validation which can be separated into several sequential steps: assessment of basic assay performance (analytical validation); characterization of the assay performance with regard to its intended use (clinical validation); validation in clinical trials that ensures that the assay performs robustly according to predefined specifications (fit-for-purpose) and the establishment of definitive acceptance criteria for clinical use (validation of clinical utility).
The fit-for purpose approach (an umbrella term used to describe distinct stages of the validation process) for biomarker development and validation addresses the proper assay tailored to meet the intended purpose of the biomarker.
The opportunity to design parallel biomarkers studies that are integrated within key randomized clinical trials could be the ideal solution.
Sample collection (fresh and/or archival tissue, PBMC, serum, plasma, stool, etc.) at specific points of treatment is important for evaluating possible biomarkers and studying the mechanisms of responsiveness, resistance, toxicity and relapse.
The feasibility, logistics, and various stakeholder interests in such a network are also considered.
A high standard of sample collection and storage as well as the exchange of samples and knowledge through collaboration is proposed, and we envisage how this could move forward with banked samples from completed studies as well as with the prospective planning of ongoing and future clinical trials.
The Society for Immunotherapy of Cancer (SITC) Immune Biomarkers Task Force convened to address this need in this two-volume series; pre-analytical and analytical (Volume I) as well as clinical and regulatory (Volume II) aspects of the validation process as applied to predictive biomarkers for cancer immunotherapy .