News Note: New NCI Program Will Help Aid Development and Validation of Tests Used in Cancer Clinical Trials
Posted Jun 20 2010 9:00pm
News Note: New NCI Program Will Help Aid Development and Validation of Tests Used in Cancer Clinical Trials
In order to conduct rigorous and robust clinical trials, the tests, or assays, used in those trials must meet optimum standards. To bring those assays and standards in line with 21st century technology, NCI's Division of Cancer Treatment and Diagnosis has started a new program called the Clinical Assay Development Program (CADP) to facilitate development and validation of clinical assays. These assays are often integral components of phase III and large phase II clinical trials. NCI has issued a request for proposals (RFP) to find laboratories that can help in the development of these assays.
The laboratories that enroll in this program will need to have expertise in one or more of the following technologies: immunohistochemistry, ELISA, in situ hybridization, quantitative Reverse Transcriptase-Polymerase Chain Reaction, quantitative PCR, and DNA sequencing. Additional technologies may be required in the future. Using reference sets of specimens, the labs that will comprise the clinical assay development network will assess reproducibility, robustness, inter- and intra-laboratory variability, and other relevant measures of assay performance and utility. NCI’s Program for the Assessment of Clinical Cancer Tests initiatives over the past several years have contributed significantly to progress in the field of biomarker development and clinical application. To find out more about this program and to access the request for proposals, which closes on July 23, 2010, please go to https://www.fbo.gov/spg/HHS/NIH/FCRF/ST10-1078/listing.html
In order to conduct rigorous and robust clinical trials, the tests, or assays, used in those trials must meet optimum standards. To bring those assays and standards in line with 21st century technology, NCI's Division of Cancer Treatment and Diagnosis has started a new program called the Clinical Assay Development Program (CADP) to facilitate development and validation of clinical assays. These assays are often integral components of phase III and large phase II clinical trials. NCI has issued a request for proposals (RFP) to find laboratories that can help in the development of these assays.
The laboratories that enroll in this program will need to have expertise in one or more of the following technologies: immunohistochemistry, ELISA, in situ hybridization, quantitative Reverse Transcriptase-Polymerase Chain Reaction, quantitative PCR, and DNA sequencing. Additional technologies may be required in the future. Using reference sets of specimens, the labs that will comprise the clinical assay development network will assess reproducibility, robustness, inter- and intra-laboratory variability, and other relevant measures of assay performance and utility. NCI’s Program for the Assessment of Clinical Cancer Tests initiatives over the past several years have contributed significantly to progress in the field of biomarker development and clinical application. To find out more about this program and to access the request for proposals, which closes on July 23, 2010, please go to https://www.fbo.gov/spg/HHS/NIH/FCRF/ST10-1078/listing.html