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.Biomarker discovery is a fundamental objective in the design of many clinical trials.
The discovery and assessment of biomarkers using cutting edge technologies across different clinical studies is a fundamental step in maximizing data generation.
Collaborative efforts to combine clinical trial samples and data will empower data analysis and the significance of any biomarkers identified.
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.
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.This white paper proposes the creation of a network to facilitate the sharing and coordinating of samples from clinical trials to enable more in-depth analyses of correlative biomarkers than is currently possible and to assess the feasibilities, logistics, and collated interests.We propose a high standard of sample collection and storage as well as exchange of samples and knowledge through collaboration, and envisage how this could move forward using banked samples from completed studies together with prospective planning for ongoing and future clinical trials.Despite success in a variety of malignancies, responses typically only occur in a small percentage of patients for any given histology or treatment regimen.There are also concerns that immunotherapies are associated with immune-related toxicity as well as high costs.Immunotherapies have emerged as one of the most promising approaches to treat patients with cancer.