The mission of the CADP is to improve patient outcomes by enabling the use of molecular features of malignancies to guide treatment.
Significant advances in our understanding of the biology of cancer and in the technologies that allow the characterization of individual tumors promise to change the practice of medicine. The ability to improve patient outcomes will depend on the availability of tests that permit treatments to be optimized and tailored to an individual’s needs. A major challenge to realizing this goal lies in optimizing the analytical performance of the proposed tests and evaluating their clinical utility. To date few tests have met the standards needed to convince the clinical community that they can be used to make treatment decisions that will improve outcomes.
Analytical performance (analytical validity): how accurately the test detects the analyte(s) of interest.
Clinical validity: how well the test relates to the clinical outcome of interest, e.g., response to therapy, survival, etc.
Clinical utility: whether the results of the test provide information that can contribute to and improve current optimal management of the patient’s disease.
The NCI currently has a large portfolio of grants that support the identification of promising biomarkers and technologies, early development of assays for detection, and preliminary evaluation of clinical relevance. A large number of markers have been reported but few have been translated to clinical tools. Clinical trial protocols often include markers that will be used to determine eligibility, to stratify patients, or to assign patients to treatment arms (integral markers), but the assays to measure these markers do not always meet required standards for assays to be used for clinical decision-making.
The NCI’s new Clinical Assay Development Program (CADP) has been designed to identify promising tests, assess the needs for further development, and provide services to facilitate optimization of analytical performance and to establish clinical validity so that the clinical utility of the assay can be evaluated in well-designed clinical studies. The overall goal of the CADP is to create an efficient process to develop diagnostic tests that will address clinical needs, including co-development of targeted agents and predictive markers.
A reasonable development plan is presented in the figure below. Assays may require some or all of the resources for CADP analytical and clinical validation.