Genomics—the study of all of the nucleotide sequences, including structural genes, regulatory sequences, and noncoding DNA segments, in the chromosomes of an organism or tissue sample. One example of the application of genomics in oncology is the use of microarray or other techniques to uncover the genetic “fingerprint” of a tissue sample. This genetic fingerprint is the pattern that stems from the variable expression of different genes in normal and cancer tissues.

Global outsourcing—conducting a clinical trial outside the United States in an effort to save money.

High-throughput system—any approach using robotics, automated machines, and computers to process many samples at once.

Human epidermal growth factor receptor 2 (HER-2/neu)—a growth factor receptor that is used as a breast cancer biomarker for prognosis and treatment with the drug trastuzumab (Herceptin), which targets the protein. The HER-2/neu protein is overexpressed in approximately 25 percent of breast cancer patients, due to amplification of the gene.

Magnetic resonance imaging (MRI)—a method by which images are created by recording signals generated from the excitation (the gain and loss of energy) of hydrogen atoms in tissue when placed within a powerful magnetic field and pulsed with radio frequencies.

Mass spectrometry—a method for separating ionized molecular particles according to mass by applying a combination of electrical and magnetic fields to deflect ions passing in a beam through the instrument.

Microarray—a high-throughput tool for biological assays in which many different probes (sometimes 10,000 or more) are deposited on a chip surface (glass or silicon) for analysis. DNA microarrays are the most commonly used microarrays.

Microdose study—a study employed in phase 0 clinical trials that uses imaging or other means to assess where in the body a compound is distributed and for how long it remains in these sites. A microdose is defined as less than 1/100th of the dose predicted to yield pharmacological effects, and less than 100 micrograms. A microdose study is designed not to induce pharmacologic effects; rather, it can indicate whether an experimental drug reaches its target.

Off-label use—the doctor-prescribed use of a drug for a condition or dis-

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