Evolution of Translational Omics Lessons Learned and the Path Forward (2012) / Chapter Skim
Currently Skimming:
Glossary
Glossary
Pages 327-338
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 327... ...
Adjuvant therapy -- additional cancer treatment given after the primary treatment to lower the risk that the cancer will return. May include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.
|
From page 328... ...
Bioinformatics -- a field of study focused on developing fast, efficient computational procedures for data reduction, data mining, and literature search techniques and developing biologically informative annotations related to DNA/RNA sequence, gene/protein expression, or the interaction of pathways, networks, phenotypes, and druggable targets. Biological plausibility -- data elucidating the biological pathways underpinning a causal association.
|
From page 329... ...
, including vaccines, blood and blood components, allergenic compounds, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biomarker -- a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to an intervention.
|
From page 330... ...
Clinical utility -- evidence of improved measurable clinical outcomes, and a test's usefulness and added value to patient management decision making compared with current management without omics testing. Completely randomized trial design -- in this report, a test result is not used in the randomization of patients to different therapies, nor is patient accrual stratified according to the test results.
|
From page 331... ...
-- damage to the heart caused by atherosclerotic constriction of arteries that supply blood to the heart. Cross-validation -- a statistical method for preliminary confirmation of a model's performance using a single dataset, by dividing the data into multiple segments, and iteratively fitting the model to all but one segment and then evaluating its performance on the remaining segment.
|
From page 332... ...
Formalin-fixed, paraffin-embedded tissue -- a tissue sample that has been preserved to enable pathological or molecular analysis. Fully specified computational procedure -- all component steps of the procedure -- namely, all data processing steps, normalization techniques, weights, parameters, and other aspects of the model, as well as the precisely defined mathematical formula or formulas used to convert the data into a prediction of the phenotype of interest -- are completely formulated in writing.
|
From page 333... ...
-- an FDA designation that allows an investigational device to be used in a clinical study to collect safety and effectiveness data supporting a premarket approval application or a premarket notification submission. Laboratory-developed tests (LDTs)
|
From page 334... ...
Metabolome -- the complete set of small molecule metabolites found with a biological sample (including metabolic intermediates in carbohydrate, lipid, amino acid, nucleic acid, and other biochemical pathways, along with hormones and other signaling molecules, as well as exogenous substances such as drugs and their metabolites)
|
From page 335... ...
Omics-based test -- an assay composed of or derived from many molecular measurements and interpreted by a fully specified computational model to produce a clinically actionable result. Overfitting -- occurs when the model-fitting process unintentionally exploits characteristics of the data that are due to noise, experimental artifacts, or other chance effects that are not shared between datasets, rather than to the underlying biology that is shared between datasets.
|
From page 336... ...
Prospective–retrospective clinical study -- an analysis using archived specimens from previously conducted prospective clinical trials that addressed the intended clinical use of the test. Proteome -- the complete set of proteins expressed by a cell, tissue, or organism.
|
From page 337... ...
-- a measure of how often a test correctly identifies patients with a specific diagnosis. It is calculated as the number of truepositive results divided by the number of true-positive plus false-negative results.
|
From page 338... ...
Tamoxifen -- a drug that interferes with activity of the hormone estrogen; it is used to treat or reduce the risk of breast cancer. Test validation phase -- the second phase in the omics-based test development process where the clinical test method is defined, and analytical and clinical/biological validation are performed in a CLIA-certified laboratory.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.