chapter  2
20 Pages

The Clinical Laboratory and Collection of Biomarker Data

The clinical laboratory is an important research tool, providing a broad scope of

biochemical, cellular, and morphological safety and efficacy biomarkers. While

much of the biomarker testing is performed in the clinical laboratory, the

processes provided by many laboratory facilities are well suited to support data

generation performed at clinical study sites and other specialized testing

facilities. When the biomarker measurements are performed on biological

specimens, the consistent processes provided by the clinical laboratory help

ensure an acceptably stable and appropriately identified sample for biomarker

testing. A centralized clinical trial laboratory can minimize a broad spectrum of

variables. Timely transportation and delivery of biological samples is just one

example. These processes have become highly refined so as to provide for

collection and analysis of specimens from most of our global geography. The

audit trail available from a number of centralized laboratories can track collection

and disposition of specimens and the availability of required laboratory and other

biomarker data. By working with a central laboratory, clinical trial sponsors gain

great expertise and efficiency in sample collection and specimen handling.

Analytically robust testing is the hallmark for centralized facilities and, when

based on consistent method principle and calibration, provides data that can be

combined across time and geographies. The centralized clinical laboratory also

employs a spectrum of operational processes designed for efficient collection,

verification, and presentation of biomarker-related data. Timely access to clean,

combinable biomarker data is a key component in efficient translation of data to

information and knowledge. This chapter examines key preanalytical, analytical,

and postanalytical biomarker-related requirements and central laboratory

capabilities to address these requirements.