Translating Promising Biomarkers into Oncology Clinical Practice

There is a clear need for biomarker assays that can assist in the choice of the best treatment for individual cancer patients. Many manuscripts can be found in the literature that describe promising correlations of molecular features with cancer outcomes, but few of these ever translate to assays that come into common clinical use. Some reasons for this lack of development are the failure to define a clear and compelling intended use for the biomarker assay, as well as the paucity of necessary and careful validation studies: the analytical and clinical validation of a given assay, optimization for clinical use, and demonstration of the clinical utility of the assay. These steps often require resources beyond those of the original laboratory that defined the correlation of the biomarker result to clinical outcome. This manuscript details some of the matters that are faced by assay developers, as well as some solutions for improved assay development and validation.

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Clinical assay development program.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.30_suppl.98 ◽

2012 ◽

Vol 30 (30_suppl) ◽

pp. 98-98

Author(s):

Barbara A. Conley ◽

Margaret M. Cavenagh ◽

JoyAnn Phillips Rohan ◽

Tracy G. Lively ◽

Chih-Jian Lih ◽

...

Keyword(s):

Development Strategy ◽

National Laboratory ◽

Development Program ◽

Assay Development ◽

Clinical Use ◽

Molecular Features ◽

Clinical Assay ◽

Continued Education ◽

Definition Of ◽

Intended Use

98 Background: Discoverers of predictive or prognostic molecular features often do not have the resources to analytically validate findings into a “locked down” assay. Methods: The Clinical Assay Development Program (CADP) was created to provide resources to transition promising markers/signatures into validated assays for use in clinical trials. The CADP is composed of the Clinical Assay Development Network of 8 contracted CLIA-accredited labs and research lab soon to be CLIA accredited (at Frederick National Laboratory for Clinical Research), and Tissue Resources. Applicants from industry, academia, and government are eligible to apply. Applicants must specify one intended clinical use, a prototype assay that performs in human tissues, and relevant prevalence information. Applicants must also describe the clinical need, the current state of the assay and future plans for assay development (such as use in clinical trial) and request the services required for analytical validation (e.g. platform migration, etc.). The applications are evaluated by outside experts. Recommended applications are reviewed internally to ensure availability of appropriate resources and consistency of the application with NCI strategic directions. The successful application is then overseen by a project management team: project manager, subject matter experts from NCI, expertise from contracted resources, and the assay submitter. Intellectual Property remains with the submitter. After validation, the specifics of assay performance and standard operating procedures are returned to the assay submitter. Results: Of 16 applications in year 1, 2 projects are near completion and 2 are beginning. Common problems of the applications were lack of definition of single intended use, specimen availability, and marker still in discovery. Several applicants have used the advice of the CADP team to improve development strategy. Conclusions: Continued education on assay development strategy, particularly intended use and clinical context, is necessary to encourage development of potential molecular assays from the research lab into clinical use. Creativity is needed in finding appropriate specimens. Initial results of CADP are promising; interest from potential applicants is increasing. http://cadp.cancer.gov .

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Measurement in Occupational Therapy: Scientific Criteria for Evaluation

Canadian Journal of Occupational Therapy ◽

10.1177/000841748705400308 ◽

1987 ◽

Vol 54 (3) ◽

pp. 133-138 ◽

Cited By ~ 102

Author(s):

Mary Law

Keyword(s):

Clinical Practice ◽

Occupational Therapy ◽

Treatment Effect ◽

Clinical Utility ◽

Occupational Therapists ◽

Measurement Instruments ◽

Measurement Tools ◽

Criteria For Evaluation ◽

Intended Use

Measurement Instruments are used by occupational therapists to describe patients, predict recovery and evaluate immediate treatment effect within their clinical practice. An instrument's development and methodological properties are guided by the purpose of the instrument. In this paper, criteria are proposed for evaluating the utility of measurement tools used by occupational therapists. These criteria are discussed within the framework of the intended use of the instrument. The criteria include the instrument's purpose, clinical utility, construction and scaling, standardization, reliability, validity and responsiveness. An algorithm to guide therapists' appraisal of measurement instruments is included.

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The FDA's perspective on the evaluation of tumor marker tests

Clinical Chemistry ◽

10.1093/clinchem/39.11.2439 ◽

1993 ◽

Vol 39 (11) ◽

pp. 2439-2443 ◽

Cited By ~ 5

Author(s):

K J Aziz ◽

P E Maxim

Keyword(s):

Cancer Diagnosis ◽

Clinical Utility ◽

Claims Data ◽

Performance Characteristics ◽

Clinical Use ◽

Cancer Marker ◽

Cancer Markers ◽

Marker Test ◽

The Us ◽

Intended Use

Abstract Cancer marker tests are often proposed for three intended uses: screening, diagnosis, and monitoring. For each intended use, performance characteristics need to be well defined. The utility of a marker in a given setting depends heavily on two predominant performance characteristics--sensitivity and specificity. These parameters must be established with respect to the intended clinical use of the marker. The value of the marker in a particular situation also depends on the effectiveness of therapy for the malignancy. In reviewing a cancer marker test, the US Food and Drug Administration focuses on both the proposed intended use statement and the clinical utility of the marker. The sponsor is expected to provide specific claims data in support of the safety and effectiveness of the device through well-designed and -executed clinical studies. Several cancer markers are already available. In the future, new markers are anticipated that may greatly expand the range of usefulness in cancer diagnosis screening and monitoring.

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