tailieunhanh - báo cáo hóa học:" Biomarkers in T cell therapy clinical trials"

Tuyển tập các báo cáo nghiên cứu về hóa học được đăng trên tạp chí sinh học đề tài : Biomarkers in T cell therapy clinical trials | Kalos Journal of Translational Medicine 2011 9 138 http content 9 1 138 JOURNAL OF TRANSLATIONAL MEDICINE REVIEW Open Access Biomarkers in T cell therapy clinical trials Michael Kalos Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers operationally defined as biological parameters measured from patients that provide information about treatment impact play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials and more specifically i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials. Review The central role for Biomarkers in clinical research The ultimate objective for clinical trials is to evaluate the safety and efficacy of novel therapeutic agents. Although the ability to evaluate safety is in general rather straightforward the ability to measure clinical efficacy is often compromised. The reasons for this are multiple and include the variable and often long times to progression the fact that direct measurements on target tumors are often not possible and also include patient- intrinsic effects related .