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By John Bloom, Richard A. Dean

Offering functions in medical improvement, pharmacokinetic/ pharmacodynamic modelling and medical trial simulation, this reference experiences the position of biomarkers in winning drug formula and improvement.

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Examples include radiographic vertebral morphometry in osteoporosis; radiographic OARSI (Osteoarthritis Research Society, International) scoring [1] or whole organ MRI scoring (WORMS) [2,3] in osteoarthritis, 38 Peterfy and Maley radiographic Sharp scoring of bone erosions and joint-space narrowing in rheumatoid arthritis [4,5]; sonographic measurement of carotid intima-media thickness; MRI measurements of entorhinal cortex and hippocampal volume in Alzheimer’s disease [6]; and dimensional measurements of tumor size in cancer.

By generating biomarker data continuously one can assess site and lab performance. If one waits until the end of the study, one may find specimens have been collected in a manner that does not permit generation of valid analytical data. Coagulation biomarkers are a good example. Coagulation samples are very sensitive to collection artifacts such as coagulation pathway activation in the collection process and therefore fibrin generation before freezing. Laboratories will cancel coagulation samples containing detectable fibrin clots [5].

The laboratory processes also should have backup strategies to cope with the lack of a response by the investigator. 26 Kapke and Dean This may involve engagement of the laboratory director and key personnel from the study sponsor. Sharing of data with the investigator is a critical element in patient care and safety. The laboratory can generate, organize, and communicate much of the data needed by the investigator. The laboratory also can identify and “flag” laboratory and other biomarker findings that are notable and may require a specific response on the part of the investigator site.

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