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Emerging Wellness Science Glossary

Plain-language definitions of 18 research terms used across the Emerging Wellness Science library, from translational research and biomarkers to absolute risk and regulatory approval.

Content last updated . This page has not been medically reviewed.

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How to use this glossary

These are the terms that come up again and again in emerging health research. Each entry is short and in plain words. Where a term is used differently by different groups, the entry says whose definition we follow. Terms are in alphabetical order. A definition is not a judgment about any product.

Biomarker

A measurable sign in the body, found in blood, other fluids or tissues, that points to a normal or abnormal process or to a condition. [3] FDA describes it as a defined characteristic that is objectively measured as an indicator of normal biological processes, pathologic processes, or responses. [4] A biomarker is not the same as how a person feels or lives. See Biomarkers vs Clinical Outcomes.

Blinding

A design in which participants, or participants and their doctors, do not know which treatment is being given. [5] It limits the way expectations can shape results. See Randomization, Blinding and Placebo.

Clinical endpoint

An event or outcome measured objectively to decide whether the intervention being studied is beneficial. [6] Clinical outcomes directly measure whether people in a trial feel or function better, or live longer. [4] Compare with surrogate endpoint.

Clinical utility

Whether using a test leads, through an action taken because of the result, to a better health outcome. In the NCI genetics dictionary it is the likelihood that a test will, by prompting an intervention, result in an improved health outcome. [7] A test can be accurate and still lack clinical utility.

Confidence interval

A range that shows how uncertain an estimate is. [2] A narrow interval means the effect size is known fairly precisely, a wide one means more uncertainty. [2]

Effect size

How big a difference is. The point estimate is the best estimate of the magnitude and direction of an intervention's effect compared with the comparator. [2] Different scales can be combined into a standardized mean difference. [2] Always read the effect size with its confidence interval.

Investigational

A drug or procedure being tested in people. It may be approved for one condition and still be investigational for another. [8] Investigational does not mean safe or effective, and it does not mean unapproved everywhere.

Mechanism

How a drug or other substance produces an effect in the body, such as acting on a particular target in a cell. [9] A plausible mechanism is a reason to run a study. It is not a result. See The Translational Pipeline From Laboratory to Approval.

Off-label

Use of an approved drug in a way it is not approved for, such as a different condition. [10] Prescribers generally may do this when they judge it medically appropriate, but FDA has not determined that the drug is safe and effective for the unapproved use. [10]

Placebo

An inactive substance or other intervention that looks the same as, and is given the same way as, the treatment being tested. [11] It lets researchers compare the real treatment with something that feels the same.

Preprint

A complete and public draft of a scientific document that is not yet certified by peer review. [12] Results and conclusions may change after review. [12]

Randomization

Assigning participants by chance to separate groups given different treatments, so that neither researcher nor participant chooses. [13] This makes the comparison fairer.

Replication

Repeating a study to see whether the finding holds. Replication effects can be smaller: in one large project in psychology, they were half the magnitude of the original effects. [17] One result is a starting point, not a settled fact.

Surrogate endpoint

A stand-in for a direct measure of how a patient feels, functions or survives. [4] Surrogate endpoints are not always true indicators of how well a treatment works. [18] Candidate surrogate endpoints are still under evaluation for their ability to predict clinical benefit. [4]

Translational research

The process by which laboratory results are used to develop new ways to diagnose and treat disease. [19] NCATS describes translation as turning observations in the laboratory, clinic and community into interventions that improve health. [20]

Where to read more

For how we use these terms in summaries, see How We Write Study Explainers and Research Updates. For the labels we attach to evidence, see How We Label Evidence in Specialty Topics.

Frequently asked questions

Is a surrogate endpoint the same as a biomarker?

Not exactly. FDA describes some surrogate endpoints as a small subclass of biomarkers, so the two overlap but are not the same. [4]

Which matters more, relative risk or absolute risk?

Both. A 25% relative reduction and a 1 percentage point absolute reduction can describe the same change, from 4% to 3%. [2]

Does "investigational" mean a treatment is unsafe?

No. It means it is being studied for a use. It also does not mean it works. [8]

Does "off-label" mean illegal?

No. FDA says providers generally may prescribe an approved drug for an unapproved use when they judge it medically appropriate. [10]

Does a placebo mean the control group gets nothing?

No. A placebo looks the same and is given the same way as the real treatment. [11]

More details: evidence, limits and cautions

The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.

Absolute risk
How likely an event is, on its own. [1] If a risk falls from 4% to 3%, that is a 1 percentage point absolute reduction. [2] Absolute effects depend on baseline risk, so the same relative change can mean very different things for different people. [2] See also relative risk.
Regulatory approval
A regulator's decision that a particular product met its standard for a stated use. In the United States, a company must demonstrate that its drug or biological product is safe and effective for its intended use. [14] In the EU, EMA's committee recommends and the European Commission grants the authorization. [15] Approval is specific to a product, use and country.
Relative risk
A comparison of the risk of an event in one group with the risk in another; also called risk ratio. [16] A risk ratio of 0.75 equals a relative risk reduction of 25%. [2] Without the absolute numbers, a relative figure can make a small change sound large.
References
  1. National Cancer Institute, NCI Dictionary of Cancer Terms: absolute risk. Read 2026-10-22.
  2. Cochrane Handbook for Systematic Reviews of Interventions, Chapter 15: Interpreting results and drawing conclusions. Read 2026-10-22.
  3. National Cancer Institute, NCI Dictionary of Cancer Terms: biomarker. Read 2026-10-22.
  4. FDA, Surrogate Endpoint Resources for Drug and Biologic Development. Read 2026-10-22.
  5. National Cancer Institute, NCI Dictionary of Cancer Terms: blinded study. Read 2026-10-22.
  6. National Cancer Institute, NCI Dictionary of Cancer Terms: endpoint. Read 2026-10-22.
  7. National Cancer Institute, NCI Dictionary of Genetics Terms: clinical utility. Read 2026-10-22.
  8. National Cancer Institute, NCI Dictionary of Cancer Terms: investigational. Read 2026-10-22.
  9. National Cancer Institute, NCI Dictionary of Cancer Terms: mechanism of action. Read 2026-10-22.
  10. FDA, Understanding Unapproved Use of Approved Drugs "Off Label". Read 2026-10-22.
  11. National Cancer Institute, NCI Dictionary of Cancer Terms: placebo. Read 2026-10-22.
  12. NLM, NIH Preprint Pilot. Read 2026-10-22.
  13. National Cancer Institute, NCI Dictionary of Cancer Terms: randomization. Read 2026-10-22.
  14. FDA, Is It Really "FDA Approved"?. Read 2026-10-22.
  15. EMA, Authorisation of medicines. Read 2026-10-22.
  16. National Cancer Institute, NCI Dictionary of Cancer Terms: relative risk. Read 2026-10-22.
  17. Open Science Collaboration, Estimating the reproducibility of psychological science (Science 2015). Read 2026-10-22.
  18. National Cancer Institute, NCI Dictionary of Cancer Terms: surrogate endpoint. Read 2026-10-22.
  19. National Cancer Institute, NCI Dictionary of Cancer Terms: translational research. Read 2026-10-22.
  20. NCATS, About Translational Science. Read 2026-10-22.
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.