Biomarker Discovery: Study Design and Execution - Proteomic and Metabolomic Approaches to Biomarker Discovery - page 6

parameters include sample collection, handling
and storage conditions, sample preparation,
method of analysis, number of replicates, and
data analysis.

(urine, blood, or tissue) is taken from two groups:
diseased patients and healthy subjects. The spec-
imens are analyzed, the results are compared,
and the discriminating factors are determined.

Personnel and Instrumentation
A biomarker discovery study requires
a budget, an adequate number of patients and
healthy subjects (controls), clinicians (physi-
cians, surgeons, pathologists, and technicians),
modern instrumentation, competent analytical
chemists, biochemists, and bioinformaticists.

The Sample
Selection and preparation of the sample in
biomarker discovery is a crucial step in the
success of

finding a disease biomarker. There
are multiple decisions that should be consid-
ered prior to initiating the search because they
can affect the integrity of the results. These
include:
1.

E RRORS IN STUDY DESIGN

Cancer type and stage

2. Sample type

The current procedure for proteomic for metab-
olomic studies in search of biomarkers is depicted
in Figure 2 . As the

3. Selection of patients and controls

4. Number of patient and control samples

figure indicates, a specimen 5. Ethnicity, sex, and age of patients and controls

Biological Samples - Control

Biological Samples - Diseased

Sample Preparation

Metabolites or Proteins

HPLC-MS Analysis

Data

Statistical Analysis

Differentiating
Results

FIGURE 2 General procedure for biomarker discovery using HPLC/MS and statistical data analysis.