Selecting and Qualifying Imaging Sites

Selecting imaging sites for a clinical trial is a complex matter. Important considerations include (1) the type and quality of imaging equipment available at the site and its compatibility with the equipment at the other sites, (2) the competence, motivation, reliability, and clinical-trials experience of the imaging technologists at the sites, (3) proximity to desirable clinical investigators, (4) patient convenience, (5) availability and ease of scheduling, as trial imaging competes with...

Development Of A Genetic Biomarker Assay The Herceptin Story

An example of the widespread use of genetic biomarkers in general practice is the example of the marker used to identify breast cancer patients eligible for treatment with Herceptin. HER2 is the protein product of the oncogene erbB-2, a member of the growth factor oncogene family of receptors 50 . The overexpression of HER2 on the surface of some breast cancers is closely linked to amplification of the erbB-2 DNA and contributes to the growth characteristics of these tumors. HER2 overexpression...

References

Biomarkers and surrogate endpoints in clinical research definitions and conceptual model. In Biomarkers and Surrogate Endpoints Clinical Research and Applications Downing, G.J., Ed. Elsevier Amsterdam, 2000 1-9. 2. Biomarker Definitions Working Group. Biomarkers and surrogate endpoints preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 2001, 69, 89-95. 3. Mildvan, D. Landay, A. De Gruttola, V. Machado, S.G. Kagan, J. An approach to the...

Meeting The Objectives Of Nonclincal Studies

Data from animal toxicology and safety pharmacology studies are needed from drug developers to demonstrate for regulatory agencies a safe strategy for initiating human clinical trials. A thorough assessment from nonclinical studies should (1) identify the dose-limiting and associated toxicities and whether the toxicities seen are reversible, (2) identify safety pharmacology risks of the drug (and its metabolites) to function of the central nervous system, cardiovascular system, gastrointestinal...