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Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
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Glossary

Ablation—the removal of a body part or the destruction of its function, as by a surgical procedure, morbid process, or noxious substance

Accelerated approval—regulatory mechanism by which new drugs meant to treat serious, life-threatening diseases or diseases for which there are no alternative treatments can be approved for marketing by the Food and Drug Administration using earlier clinical trial results than would be required for regular approvals; post-market surveillance and studies generally required

ACE inhibitor—see Angiotensin-converting enzyme (ACE) inhibitor

Adenomatous colon polyps—growths in the epithelial layers of the colon; can be flat, pedunculated, or sessile; result from multiple genetic mutations arising from environmental or inherited causes; can become cancerous

Adhesion molecules—molecules on cell surfaces that enable cells to stick to each other or other components of the extracellular matrix

Adjusted association—a measure of association between individual patients’ true endpoints and surrogate endpoints after controlling for treatment assignment; a statistical method for surrogate endpoint evaluation

Age-related macular degeneration—a disease occurring when the cells making up a central area of the retina, called the macula, break down or move away from their normal positions; causes blurriness and sometimes loss of the center of field of vision

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Analytical validation—“assessing [an] assay and its measurement performance characteristics, determining the range of conditions under which the assay will give reproducible and accurate data” (Wagner, 2002)

Angiotensin-converting enzyme (ACE) inhibitordrug used to treat blood pressure; prevents formation of a protein that causes constriction of blood vessels, thus lowering blood pressure

Angiotension receptor blocker—type of medication used to treat high blood pressure. Unlike ACE inhibitors, which prevent the formation of angiotensin II, angiotensin receptor blockers, while allowing the protein to form, prevent it from functioning. Thus, blood pressure is lowered by preventing constriction of the blood vessels.

Apolipoprotein—a protein component of lipoprotein complexes

Arrhythmia—loss of rhythm, denoting especially an irregularity of the heartbeat

Assay—a biochemical or other measurement developed to quantitate a biomarker

Atherogenic dyslipidemia—abnormal lipid levels (including abnormal cholesterol levels) having the capacity to initiate, increase, or accelerate the process of atherogenesis having the capacity to initiate, increase, or accelerate the process of atherogenesis

Atherosclerosis/arteriosclerosis—condition characterized by irregularly distributed lipid deposits in the intima of large and medium-sized arteries; such deposits are associated with fibrosis and calcification, and are nearly always present to some degree in middle aged and older individuals

Authorized health claim—voluntary statement that characterizes the relationship between a substance and its ability to reduce the risk of disease or a health-related condition (Schneeman, 2007) that meets the significant scientific agreement (SSA) standard

Autocrine signaling—hormonal signalling in which a cell produces an agent that then binds to receptors within the same cell; related to stimulation of T-cell growth and growth of some breast cancers

Beta-carotene (β-carotene)—pigment-producing molecule in the skin of several fruits and vegetables; after ingestion, some -carotene in blood-stream converts to two molecules of retinol (preformed vitamin A)

Bias—the systematic but unintentional erroneous association of some characteristic with a group in a way that distorts a comparison with another group (IOM, 2007)

Biological plausibility—data elucidating how the biological pathways leading from exposure to effect are useful

Biological products (biologics)a category of products regulated by the Food and Drug Administration, including vaccines, blood and blood

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

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 a[n]…intervention” (Biomarkers Definitions Working Group, 2001). Example: cholesterol level. The committee defines “objectively” to mean “reliably and accurately”

Bone mineral density (BMD)—may correlate with bone strength and a bone’s ability to bear weight; may be possible to predict fracture risk using BMD as a measure

Calcium channel blocker—drug used treat heart failure caused by high blood pressure; effects the movement of calcium in the cells of the heart and blood vessels to relax blood vessels and increase the supply of blood and oxygen to the heart

Calibration—the use of measurement standards and standard measurement protocols to ensure the precision and reproducibility of an instrument or other measurement method

Cardiotoxic—having a deleterious effect on the action of the heart, due to poisoning of the cardiac muscle or of its conducting system

Cardiovascular disease—a term encompassing diseases that affect the heart and blood vessels

CD4 cell (CD4+T-cells)—specialized cells that play a role in measuring immune response in individuals with HIV

Choi criteria—a measure used to assess tumor progression in gastrointestinal stromal tumor (GIST); incorporate tumor size and tumor density into a metric of tumor progression; demonstrated to more accurately predict overall survival in GIST than reduction in tumor size

Cholesterol—abundant steroid metabolite produced by animals and found in cell membranes and circulating in blood; excess cholesterol can lead to fatty deposits in blood vessels, a risk factor for cardiovascular disease

Chromium picolinate—biologically active chromium salt that is used as a dietary supplement

Chronic disease—a culmination of a series of pathogenic processes in response to internal or external stimuli over time that results in a clinical diagnosis/ailment and health outcomes

Clinical endpoint—a characteristic or variable that reflects how a patient feels, functions, or survives (Biomarkers Definitions Working Group, 2001)

Clinical triala formal study carried out according to a prospectively defined protocol that is intended to discover or verify the safety and effectiveness of procedures or interventions in humans (IOM, 2007)

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Clinical utility—see Utilization

Computed tomography (CT)—a special radiographic technique that uses a computer to assimilate multiple X-ray images into a two-dimensional, cross-sectional image, which also can be reconstructed into a three-dimensional image; can reveal many soft-tissue structures not shown by conventional radiography (IOM, 2007)

Congestive heart failure (CHF)—condition in which the heart is unable to maintain adequate circulation of blood in the tissues of the body or to pump out the venous blood returned to it by the venous circulation

Coronary artery disease (CAD)—see Coronary heart disease

Coronary heart disease (CHD)—refers to damage to the heart caused by atherosclerotic constriction of arteries supplying the heart; also known as coronary artery disease

C-reactive protein (CRP)—an acute-phase, non-specific, systemic marker of inflammation; in normal individuals, CRP is a trace plasma protein, but the serum concentration of CRP can increase upward of 1,000-fold upon exposure to a strong acute stimulus, such as sepsis or acute myocardial infarction

Cytostasis—the slowing of movement and accumulation of blood cells in the capillaries, as in a region of inflammation

Cytotoxic therapy—any agent or process that kills cells (e.g., chemotherapy and radiotherapy)

Diagnosis—a conclusion as to the presence of a disease

Diagnostic test—the investigative tools and techniques used in biological studies to identify or determine the presence of a disease or other condition. Any laboratory-based test that can be used in drug discovery and development as well as in patient care and clinical decision making (IOM, 2007)

Diastolic blood pressure—blood pressure as measured during the resting phase of the heart’s rhythm

Dietary guidance statement—a statement describing general dietary patterns, practices and recommendations that promote health; these make reference to categories of foods and not specific substances, and they do not describe relationships between a substance (specific food or food component) and a disease or health-related condition; these can be made without Food and Drug Administration review or authorization before use

Disease—damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., CHD), or a state of health leading to such dysfunctioning (e.g., hypertension)

Disease risk stratification—placement of an individual into a risk category based on the likelihood that a disease will develop or recur

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Diuretic—substance promoting loss of bodily fluids through increased production and elimination of urine

Drug—materials intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; materials (other than food) intended to affect the structure or any function of the body of humans or other animals

Early compound screening—the process of identifying compounds with the most promise for becoming efficacious and safe therapeutics

Efficacy—ability to produce a desired effect

Elliptoid model—method for estimating the volume of a cancer tumor using three different, preferably orthogonal, measurements of the tumor diameter

Epidemiologic studies—studies of the health of various human populations

Epitope—discrete site to which an antibody binds

Etiology—the science and study of the causes of disease and their mode of operation

Ex vivo—experimentation or measurements done in or on tissue in an artificial environment outside the organism

Familial hypercholesterolemia—metabolic disorder caused by defective or absent receptors for LDLs on cell surfaces; marked by an increase in blood plasma LDLs and by an accumulation of LDLs in the body resulting in xanthomas, atherosclerosis, and an increased risk of heart attack and coronary heart disease; inherited as an autosomal dominant trait

Fit-for-purpose—being guided by the principle that an evaluation process is tailored to the degree of certainty required for the use proposed

Folic acid—vitamin of the B complex that is required for normal production of red blood cells; used especially in the treatment of nutritional anemias

Food—articles used for food or drink for humans or other animals, chewing gum, and articles used for components of any such article; inclusive of foods consumed as part of meals and snacks, dietary supplements, and components contained in them (nutrients, other bioactive substances)

Friedewald formula—provides an estimate of LDL cholesterol for most fasting specimens, though its accuracy is lower at higher triglyceride concentrations.

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

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

genetic fingerprint is the pattern that stems from the variable expression of different genes in normal and cancer tissues (IOM, 2007)

Glycation—the uncontrolled, non-enzymatic reaction of sugars with proteins; important in the damage done to diabetics when their sugar levels rise above normal, and in damage done to critical proteins of long-lived nerve cells in aging

Glycosylated hemoglobin—hemoglobin to which glucose is bound; tested to monitor the long-term control of diabetes mellitus

Growth factor—a substance (e.g., vitamin B12 or an interleukin) that promotes cellular growth

Health claim—a claim that describes the relationship between a substance (food or food component) and a disease or health-related condition; limited to claims about disease risk reduction and cannot be claims about the cure, mitigation, treatment, or prevention of disease

Heart diseasesee Cardiovascular disease

Hemostasis regulator—biological chemical involved in the process of stopping blood flow, as from a broken blood vessel

High-density lipoprotein cholesterol (HDL-C)—a lipoprotein of blood plasma that is composed of a high proportion of protein with little triglyceride and cholesterol and that is associated with decreased probability of developing atherosclerosis

Hill criteria—criteria used to establish cause in the case of non-infectious or chronic disease by evaluating strength, consistency, specificity, temporality, biological gradient, plausibility, coherence, experiment, analogy; used in environmental health, toxicology, pharmacology, epidemiology, and medicine

Hyperlipidemia—the presence of abnormally high amount of lipids in the circulating blood

Hypertension—abnormally high arterial blood pressure that is usually indicated by an adult systolic blood pressure of 140 mm Hg or greater or a diastolic blood pressure of 90 mm Hg or greater; can result in thickening and inelasticity of arterial walls and damage to the heart; a risk factor for various pathological conditions or events (e.g., heart attack, heart failure, stroke, end-stage renal disease, or retinal hemorrhage)

Immune response—response of an organism to a foreign substance

Immunoassay—test measuring the immune response of an organism to an antigen

In vitro—outside the living body and in an artificial environment

In vivo—in the living body of a plant or animal

Incidence—occurrence of a disease or condition

Inflammatory biomarker—biological chemicals indicating tissue damage or irritation; C-reactive protein is an inflammatory biomarker

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Inflammatory response (inflammation)—a local response to cellular injury that is marked by capillary dilatation, leukocytic infiltration, redness, heat, pain, swelling, or loss of function and that serves as a mechanism initiating the elimination of elimination of foreign substances and for healing damaged tissue

Insulin resistance—an organism's inability to respond to and use the insulin it produces; this condition is related to the type 2 diabetes incidence

Intermediate endpoint—a biologic event or marker that is a precursor to a given health outcome (e.g., atherosclerosis for cardiovascular disease endpoints or blurred vision for macular degeneration)

Intervention—any drug, device, biologic, behavioral modification, nutritional modification, lifestyle modification, or other treatment intended to improve health

Intima-media thickness (IMT)—the thickness of the inner layers of an artery

Ischemic stroke—stroke caused by thrombosis or embolism; caused by an inadequate flow of blood to heart tissue due to a constriction or blockage to blood vessels supplying it

Lipoprotein—compounds containing lipid and protein; almost all lipids in plasma are lipoproteins

Low-density lipoprotein cholesterol (LDL-C)—a lipoprotein of blood plasma that is composed of a moderate proportion of protein with little triglyceride and a high proportion of cholesterol and that is associated with increased probability of developing atherosclerosis

Luminal structures—relating to the lumen of a blood vessel

Macromolecules—large molecules, often polymeric or with colloidal properties; examples include many proteins, nucleic acids, and polysaccharides

Magnetic resonance imaging (MRI)—method by which images are created by recording signals generated from the excitation (the gain and loss of energy) of such elements as the hydrogen of water in tissue when placed in a powerful magnetic field and pulsed with radiofrequencies (IOM, 2007)

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 (IOM, 2007)

Medical device—any instrument, apparatus, appliance, material, or other article intended to be used to affect the structure or any function of a human or animal body

Mendelian randomization—the random assignment of genetic material from parents to offspring; a tool used in epidemiology to help deter-

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

mine whether a health outcome is caused by genetic or environmental factors or to elucidate gene–gene or gene–environment interactions

Metabolomics—the systematic study of the unique chemical fingerprints that specific cellular processes leave behind, that is, small-molecule metabolites (IOM, 2007)

Microarray—a high-throughput biological assay in which different probes are deposited on a chip surface (glass or silicon) in a miniature arrangement; DNA microarrays most commonly used (IOM, 2007)

Myocardial infarction—an acute episode of heart disease marked by the death or damage of heart muscle due to insufficient blood supply to the heart muscle, usually as a result of a coronary thrombosis or a coronary occlusion and that is characterized especially by chest pain

Myxoid degeneration—a degenerative process in which the connective tissues are replaced by a gelatinous or mucoid substance

Neural tube effects—a group of birth defects that involve the central nervous system; result from failure of the neural tube to properly form

Normal sinus rhythm—normal heart rhythm

Null hypothesis—the hypothesis that an intervention has no effect (i.e., that there is no true difference in outcomes between a treatment group and a control group); typically, if statistical tests indicate that the P-value is at or above the specified a-level (e.g., 0.01 or 0.05), then any observed treatment effect is not statistically significant, and the null hypothesis cannot be rejected

Nutrient content claim—statements about the level of a nutrient or dietary substance in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite

Opportunity cost—for any decision, the loss of the benefits of the next best alternative decision

Oxidation—chemical reaction between a substance and oxygen. Fire and rust are examples of oxidative processes.

P-value—a measure of the probability that a subsequent measurement’s magnitude would be equal or greater to the measured magnitude if the null hypothesis is true—in other words, if there is no true difference between the control and experimental groups

Paracrine signal—referring to the release of locally acting substances from endocrine cells

Paraneoplastic—caused by or resulting from the presence of cancer in the body, but not the physical presence of cancerous tissue in the part or organ affected

Pathogenesis—the mode of origin or development of any disease or morbid process

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Pathophysiology—processes leading to the incidence or progression of disease or other health-related condition; alteration in function as distinguished from structural defects

Patient selection—in clinical trials, patient selection (inclusion/exclusion) by disease subset or probability of response/adverse events

Peripheral vascular disease—a type of cardiovascular disease caused by atherosclerosis of the arteries to the limbs, reducing the blood supply and therefore depriving the limb muscles of oxygen

Pharmacodynamic assay—a test used to determine a drug’s activity; can be used to select dose quantities and schedule

Pharmacologic response—the effect of a drug on an organism in relation to the concentration of the drug

Phase I trial—clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed (IOM, 2007)

Phase II trial—clinical trial in which the safety and preliminary efficacy of an intervention are assessed in patients (IOM, 2007)

Phase III trial—large-scale clinical trial in which the safety and efficacy of an intervention are assessed in a large number of patients. The Food and Drug Administration generally requires new drugs to be tested in phase III trials before they can be put on the market (IOM, 2007)

Phospholipid—any of numerous lipids in which phosphoric acid as well as a fatty acid is esterified to glycerol and which are found in all living cells and in the bilayers of cell membranes

Phytosterol—cholesterol-like compounds found in vegetable oils, nuts, and legumes; may reduce serum cholesterol

Plaque—a well-demarcated yellow area or swelling on the surface of the artery; produced by intimal lipid deposit

Plasma—the fluid portion of the circulating blood

Pleiotropic effects—having multiple phenotypic expressions; for example, the non-lipid effects of statins, including the anti-inflammatory and antithrombotic properties that contribute to an improvement in vascular function

Polymorphism—occurrence in the same population of two or more genotypes of such proportion that the most rare cannot be maintained by recurrent mutation alone; heritable variations in low-density lipoproteins; variant lipoproteins exhibit different antigenic and chemical properties compared with normal lipoproteins

Positive harm—something that is intended to do good is not only ineffective, but causes definite harm as an unintended side effect

Positive predictive value—the probability that an individual with a positive test has, or will develop, a particular disease, or characteristic, that the test is designed to detect; a measure of the ratio of true positives to (false + true positives) (IOM, 2007)

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Positron emission tomography (PET)—a highly sensitive technique that uses radioactive probes to image in vivo tumors, receptors, enzymes, DNA replication, gene expression, antibodies, hormones, drugs, and other compounds and processes (IOM, 2007)

Postmarket studies—may be mandated by the Food and Drug Administration for already approved drugs or devices to review potential risks

Precision—a measure of random error; inversely related to random error; confidence intervals are computed to demonstrate the precision of relative risk estimates

Predictive value—the ability to predict the change in the outcome of a disease given a particular intervention using a specified patient measurement

Prentice criteria—stringent requirements to be met before a biomarker can definitively substitute for a clinical endpoint for a given use; briefly, the criteria state that a biomarker must perfectly correlate with the clinical outcome it is meant to replace and capture the entire effect of the intervention used to bring about the effect on the clinical outcome

Prevalence (disease)—the number of existing cases of a disease in a given population at a specific time

Prevention—the use of medical and public health tools to prevent disease, injury, or other events injurious to health

Prognosis—an assessment of the probable course of a disease given the risk factors present in an individual; this assessment may affect treatment decisions

Prognostic value—the ability to predict disease outcome or course using a specified patient measurement

Protease—biological chemical that reacts with proteins, degrading them chemically and making them non-functional

Proteomics—the study of the structure, function, and interactions of the proteins produced by the genes of a particular cell, tissue, or organism. The application of proteomics in oncology may involve mass spectroscopy, two-dimensional polyacrylamide gel electrophoresis, protein chips, and other techniques to uncover the protein “fingerprint” of a tissue sample. This protein fingerprint is the pattern that stems from the various amounts and types of all the proteins in the sample (IOM, 2007)

Qualification—evidentiary process of linking a biomarker with biological processes and clinical endpoints

Qualified health claim—voluntary statement that characterizes the relationship between a substance and its ability to reduce the risk of disease or a health-related condition (Schneeman, 2007) that does not meet the significant scientific agreement (SSA) standard

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Randomized controlled trial (RCT)—a study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best

Relative effect—the effect of a treatment on the distribution of true endpoints versus surrogate endpoints; component of a statistical method for surrogate endpoint evaluation

Relative risk—the ratio of the risk of disease in exposed individuals to the risk of disease in non-exposed individuals

Risk–benefit analysis—the comparison of the risk of a situation to its benefits

Risk biomarker—biomarker that indicates a component of an individual’s level of risk for developing a disease or level of risk for developing complications of a disease

Risk stratification—the classification of patients into groups based on the likelihood of developing or suffering effects from a disease

Safety biomarker—a biomarker that can be used to identify patients at high risk for serious side effects, to monitor early signs of toxicity, or to predict the likelihood for severe toxicity

Sample biassee Bias

Saturated fat—fat having no double bonds; chemically the most stable type of fat; solid at room temperature; come chiefly from animal food products; tend to raise the level of cholesterol in the blood

Screening—the use of risk factor analysis and biomarker assays to detect early-stage disease in the asymptomatic population

Sensitivity (analytical)—the lowest concentration that can be distinguished from background noise; this concentration is termed an assay’s detection limit (IOM, 2007)

Sensitivity (clinical)—a measure of how often a test correctly identifies patients with a specific diagnosis. It is calculated as the number of true-positive results divided by the number of true-positive plus false-negative results (IOM, 2007).

Sepsis—the presence of various pathogenic organisms, or their toxins, in the blood or tissues

Serum—the fluid portion of the blood obtained after removal of fibrinogen, other clottting factors, and cells; a clear watery fluid, especially that moistening surface of serous membranes

Significant scientific agreement (SSA)—judgment that qualified experts would likely agree that the scientific evidence supports the substance– disease relationship that is the subject of a proposed health claim

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Specificity (analytical)—how well an assay detects only a specific substance and does not detect closely related substances (IOM, 2007)

Specificity (clinical)—a measure of how often a test correctly identifies the proportion of persons without a specific diagnosis; calculated as the number of true-negative results divided by the number of true-negative plus false-positive results (IOM, 2007)

Statin—any of a group of drugs (as lovastatin and simvastatin) that inhibit the synthesis of cholesterol and promote the production of LDL-binding receptors in the liver, resulting in a decrease in the level of LDL and a modest increase in the level of HDL circulating in blood plasma

Structure–function claim—statements describing the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans; may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function; may describe general well-being from consumption of a nutrient or dietary ingredient; manufacturer is responsible for ensuring the accuracy and truthfulness of the statement; FDA does not review these claims prior to manufacturer use

Substance—a specific food (tomato) or component of food (lycopene), whether in conventional food or dietary supplement form

Supplement—a product taken by mouth that contains a dietary ingredient intended to supplement the diet; dietary ingredients may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites; may be found in forms such as tablets, capsules, softgels, gelcaps, liquids, or powders

Surrogate endpoint—a biomarker that is intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict clinical benefit (or harm or lack of benefit or harm) based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence (IOM, 2007)

Surrogate threshold effect—the minimum treatment effect on the surrogate endpoint necessary to predict a non-zero effect on the true endpoint; provides information relevant to the practical use of a surrogate endpoint and can be interpreted from a clinical point of view

Surveillance—population-level monitoring for early detection and treatment of advancing disease or complications

Systolic blood pressure—the highest blood pressure that occurs during a beat of the heart, just after the left ventricle has contracted

Target validation—demonstration that a potential drug target plays a key role in the disease process

Therapeutic intervention—actions taken (through administration of a drug or other means) to treat a disease or other health-related condition

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×

Therapy monitoring—the process of determining whether a therapy is having the intended effect on a disease and whether adverse effects arise

Total cholesterol—total amount of cholesterol (both LDL and HDL) in the blood

Toxicology—the science of understanding the effects of chemicals on humans and other organisms

Triglyceride—any of a group of lipids that are esters formed from one molecule of glycerol and three molecules of one or more fatty acids, are widespread in adipose tissue, and commonly circulate in the blood in the form of lipoproteins

Troponin—protein of muscle that together with tropomyosin forms a regulatory protein complex controlling the interaction of actin and myosin and that when combined with calcium ions permits muscular contraction (e.g., of the heart)

True endpoint—the endpoint for which a surrogate endpoint is sought

Tumor response rates—in its most primitive form: tumor shrinkage; defined by a change in tumor bulk; commonly used for making decisions regarding approval of anticancer drugs in the 1970s

Tumor size—inconsistently defined biomarker often used for determining efficacy of cancer therapeutics

Type 2 diabetes—diabetes mellitus of a common form that develops especially in adults and most often in obese individuals and that is characterized by hyperglycemia resulting from impaired insulin utilization coupled with the body’s inability to compensate with increased insulin production

Ultracentrifuge—a high-speed centrifuge by means of which large molecules (proteins, nucleic acids) are caused to sediment at practicable rates; used for determination of molecular weights

Utilization—contextual analysis based on the specific use proposed and the applicability of available evidence to this use. This includes a determination of whether the validation and qualification conducted provide sufficient support for the use proposed

Validation—see Analytical validation

Vasodilator—an agent that causes dilation of the blood vessels

Ventricular tachycardia—relatively rapid heart action (whether physiological or pathological) that is associated with the generation of electrical impulses within the ventricles and is characterized by an electrocardiogram having a broad QRS complex. A QRS complex is a measurable characteristic of an electrocardiogram

Viral fitness—refers to the relative replication competence of a virus (e.g., HIV) under defined circumstances; generally assessed in tissue culture systems; its relevance to the clinical situation may be difficult to fully establish

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
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REFERENCES

Biomarkers Definitions Working Group. 2001. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics 69(3):89–95.

IOM (Institute of Medicine). 2007. Cancer biomarkers: The promises and challenges of improving detection and treatment. Washington, DC: The National Academies Press.

Schneeman, B. 2007. FDA's review of scientific evidence for health claims. Journal of Nutrition 137(2):493–494.

Wagner, J. A. 2002. Overview of biomarkers and surrogate endpoints in drug development. Disease Markers 18(2):41–46.

Suggested Citation:"Glossary." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
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Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

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