Medical Research Abbreviations
94 abbreviations · part of Medical Abbreviations
Abbreviations used in clinical trials, epidemiology, biostatistics, evidence-based medicine, health economics and drug and device regulation, as they appear in journal articles, study protocols, consent forms and regulatory documents. Knowing terms such as RCT, NNT, ITT and QALY helps readers judge how strong a study's evidence is and what its results mean for patients. Regulatory entries mainly describe the US FDA framework, with European and UK counterparts noted where relevant.
| Abbreviation | Stands for | Description |
|---|---|---|
| 510(k) | Premarket notification (FDA section 510(k)) | FDA clearance pathway for most moderate-risk (class II) medical devices, in which the manufacturer shows the new device is substantially equivalent to a legally… |
| AHRQ | Agency for Healthcare Research and Quality | US Department of Health and Human Services agency that funds and conducts research on health care quality, safety, efficiency and effectiveness, and produces tools such… |
| ARR | Absolute risk reduction | Difference in outcome rates between control and treatment groups, such as 10 percent minus 8 percent giving a 2 percentage point reduction. |
| AUC | Area under the receiver operating characteristic curve | Summary of a test's or model's ability to discriminate between people with and without a condition, ranging from 0.5 (no better than chance) to 1.0 (perfect… |
| BTD | Breakthrough therapy designation | FDA designation for drugs intended to treat serious conditions when preliminary clinical evidence suggests substantial improvement over available therapy on a… |
| CBER | Center for Biologics Evaluation and Research | FDA center that regulates vaccines, blood and blood products, cellular and gene therapies, tissues and allergenic products. |
| CDER | Center for Drug Evaluation and Research | FDA center that regulates prescription and over-the-counter drugs, including generics and most therapeutic biologics such as monoclonal antibodies, overseeing clinical… |
| CEA | Cost-effectiveness analysis | Economic evaluation comparing the costs and health outcomes of two or more interventions, with outcomes in natural units such as life years gained, cases prevented or… |
| CI | Confidence interval | A range computed from sample data that would contain the true population value in a stated share of repeated samples, most commonly 95 percent. |
| CITI | Collaborative Institutional Training Initiative | Web-based training program widely required for researchers, students and staff before they work on human subjects research, covering research ethics, informed consent… |
| COI | Conflict of interest | Situation in which a researcher's or clinician's financial or personal interests, such as consulting fees, stock ownership or royalties, could compromise or appear to… |
| CONSORT | Consolidated Standards of Reporting Trials | Reporting guideline for randomized controlled trials, consisting of a checklist and a participant flow diagram that tracks enrollment, allocation, follow-up and analysis. |
| CPG | Clinical practice guideline | Systematically developed statements, based on evidence review and expert judgment, that recommend how clinicians should care for patients with specific conditions. |
| CRA | Clinical research associate | Professional, usually employed by a sponsor or CRO, who monitors clinical trial sites to verify that the study follows the protocol and GCP, that participants are… |
| CRC | Clinical research coordinator | Site-based professional who manages day-to-day trial activities under the principal investigator, including screening and enrolling participants, obtaining consent… |
| CRF | Case report form | Printed or electronic document designed to record all protocol-required information on each trial participant, such as eligibility, visit data, lab results, adverse… |
| CRO | Contract research organization | Company hired by pharmaceutical, biotechnology and device sponsors to run all or part of clinical development, such as trial design, site management, monitoring, data… |
| CTA | Clinical trial agreement | Contract between a sponsor and a research site, or between collaborating institutions, setting terms for conducting a clinical trial: budget, payment schedule… |
| DALY | Disability-adjusted life year | Measure of disease burden equal to one lost year of healthy life, calculated as years of life lost to premature death plus years lived with disability. |
| DSMB | Data and safety monitoring board | Independent group of experts, typically clinicians and a statistician unconnected to the trial, that periodically reviews accumulating unblinded data to protect… |
| EBM | Evidence-based medicine | Approach to clinical practice that integrates the best available research evidence with clinical expertise and patient values when making decisions about individual… |
| EDC | Electronic data capture | Software system that collects clinical trial data through electronic case report forms, with built-in edit checks, query management and audit trails. |
| EMA | European Medicines Agency | European Union agency responsible for the scientific evaluation, supervision and safety monitoring of medicines, issuing opinions on which the European Commission bases… |
| EUA | Emergency use authorization | FDA mechanism under section 564 of the Federal Food, Drug, and Cosmetic Act allowing unapproved medical products, or unapproved uses of approved products, during a… |
| FAERS | FDA Adverse Event Reporting System | FDA database of adverse event and medication error reports submitted by manufacturers, health professionals and consumers for drugs and therapeutic biologics. |
| FIH | First-in-human | First administration of a new drug, biologic or device to people, typically in a small phase 1 study of healthy volunteers or patients that focuses on safety… |
| FWA | Federalwide Assurance | Written commitment that a US or foreign institution files with the Office for Human Research Protections, pledging to follow federal regulations for protecting human… |
| GCP | Good Clinical Practice | International ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials involving human participants, set out in the… |
| GLP | Good Laboratory Practice | Quality system for planning, performing, monitoring, recording and reporting nonclinical laboratory studies, such as animal toxicology studies, submitted to regulators… |
| GRADE | Grading of Recommendations Assessment, Development and Evaluation | Widely used framework for rating the certainty of a body of evidence as high, moderate, low or very low, and for grading the strength of recommendations as strong or… |
| HR | Hazard ratio | Ratio of instantaneous event rates in two groups over time, estimated in survival analysis, usually with a Cox proportional hazards model. |
| HRQoL | Health-related quality of life | Aspects of quality of life affected by health and health care, such as physical functioning, pain, energy, emotional well-being and social roles. |
| HTA | Health technology assessment | Systematic evaluation of the clinical, economic, social and ethical implications of health technologies such as drugs, devices and procedures, carried out to inform… |
| IB | Investigator's brochure | Compilation of the clinical and nonclinical data on an investigational product that are relevant to its study in humans, including pharmacology, toxicology, earlier… |
| ICER | Incremental cost-effectiveness ratio | Extra cost of a health intervention divided by the extra health benefit it produces compared with an alternative, usually expressed as cost per QALY gained. |
| ICF | Informed consent form | Document that explains a study's purpose, procedures, risks, benefits, alternatives, confidentiality protections and voluntary nature, signed by a participant to record… |
| ICH | International Council for Harmonisation | Organization bringing together drug regulators and industry to develop harmonized technical guidelines on the quality, safety and efficacy of medicines, so that one set… |
| IDE | Investigational device exemption | FDA authorization allowing an unapproved medical device to be used in a clinical study to collect safety and effectiveness data, governed by 21 CFR Part 812. |
| IEC | Independent ethics committee | Body that reviews clinical research to safeguard participants, the term used in ICH guidelines and many countries outside the United States for the role an… |
| IIT | Investigator-initiated trial | Clinical study conceived, designed and run by an academic or clinician investigator rather than a company, although a manufacturer may supply the drug or partial funding. |
| IQR | Interquartile range | The spread of the middle half of a data set: the third quartile minus the first quartile (Q3 − Q1). |
| IRB | Institutional review board | Committee that reviews and monitors research involving human participants to protect their rights and welfare, approving protocols, consent forms and recruitment… |
| ITT | Intention-to-treat | Analysis principle in which every randomized participant is analyzed in the group to which they were assigned, whether or not they received or completed the treatment. |
| KM | Kaplan-Meier (estimator) | Statistical method for estimating survival over time from data in which some participants have not had the event when the study ends or leave early (censored data). |
| LOE | Level of evidence | Ranking of the strength of research supporting a statement, typically from systematic reviews and randomized trials at the top to expert opinion at the bottom. |
| LR | Likelihood ratio | Factor by which a test result changes the odds of disease: the positive likelihood ratio equals sensitivity divided by (1 minus specificity), and the negative… |
| LTFU | Lost to follow-up | Participants whose outcomes become unknown because they stop attending visits or cannot be contacted before a study ends. |
| MA | Meta-analysis | Statistical method that combines results from multiple studies addressing the same question to produce a pooled estimate with greater precision than any single study. |
| MedDRA | Medical Dictionary for Regulatory Activities | Standardized international medical terminology used to code adverse events, medical history and indications in clinical trials, safety reports and regulatory submissions. |
| MeSH | Medical Subject Headings | Controlled vocabulary of biomedical terms produced by the US National Library of Medicine and used to index articles in MEDLINE and PubMed. |
| MHRA | Medicines and Healthcare products Regulatory Agency | UK government agency that regulates medicines, medical devices and blood components, licensing products, inspecting manufacturers and monitoring safety. |
| NCT | National Clinical Trial (number) | Unique identifier assigned to studies registered on ClinicalTrials.gov, consisting of the letters NCT followed by eight digits. |
| NICE | National Institute for Health and Care Excellence | Body that decides which new medicines and treatments the NHS in England should fund, based on clinical and cost-effectiveness, and publishes clinical guidelines used… |
| NME | New molecular entity | Drug containing an active ingredient never before approved by the FDA in any form, as opposed to new formulations, combinations or uses of existing drugs. |
| NNH | Number needed to harm | Average number of patients who must receive a treatment for one additional patient to experience a specified harm compared with the control, calculated as 1 divided by… |
| NNT | Number needed to treat | Average number of patients who must receive a treatment over a stated period for one additional patient to benefit compared with the control, calculated as 1 divided by… |
| NPV | Negative predictive value | Probability that a person with a negative test result truly does not have the condition, calculated as true negatives divided by all negative results. |
| NS | Not significant (statistically) | Label used in tables and figures to show that a comparison did not reach the prespecified threshold for statistical significance, usually a p-value of 0.05 or more. |
| ODD | Orphan drug designation | FDA status for drugs intended to treat rare diseases, defined in the US as affecting fewer than 200,000 people. |
| OHRP | Office for Human Research Protections | Office within the US Department of Health and Human Services that oversees the protection of human subjects in HHS-funded research, interprets the Common Rule, approves… |
| OR | Odds ratio | Ratio of the odds of an outcome in one group to the odds in another, the standard effect measure in case-control studies and logistic regression. |
| PBO | Placebo | Inactive substance or sham procedure made to look identical to the active treatment, used in controlled trials to separate a treatment's specific effects from… |
| PCORI | Patient-Centered Outcomes Research Institute | Independent nonprofit created by the Affordable Care Act in 2010 to fund comparative effectiveness research that helps patients, clinicians and others choose among… |
| PDUFA | Prescription Drug User Fee Act | US law first passed in 1992 that lets the FDA collect fees from drug companies to fund the review of new drug and biologic applications, in exchange for commitments to… |
| PI | Principal investigator | Scientist or scholar who leads a research project and holds primary responsibility for its design, conduct, budget, compliance and reporting to the funding agency. |
| PICO | Population, Intervention, Comparison, Outcome | Framework for turning a clinical uncertainty into an answerable, searchable question by specifying the patients or population, the intervention or exposure, the… |
| PMA | Premarket approval | FDA's most stringent review pathway for medical devices, required for most high-risk class III devices such as implantable defibrillators, heart valves and some… |
| PMID | PubMed identifier | Unique number assigned to each citation in PubMed, the free database of biomedical literature run by the US National Library of Medicine. |
| PP | Per-protocol (analysis) | Analysis restricted to participants who completed the study largely as planned, receiving the assigned treatment and following the protocol. |
| PPV | Positive predictive value | The probability that a positive test result is truly positive: true positives divided by all positive results. |
| PRISMA | Preferred Reporting Items for Systematic Reviews and Meta-Analyses | Reporting guideline listing the items that systematic reviews and meta-analyses should include, from search strategy and selection criteria to risk-of-bias assessment… |
| PRO | Patient-reported outcome | Report of a patient's health status, symptoms, function or quality of life that comes directly from the patient without interpretation by a clinician. |
| PROM | Patient-reported outcome measure | Standardized, validated questionnaire that captures patient-reported outcomes such as pain, function, symptoms or quality of life in a scorable way. |
| QALY | Quality-adjusted life year | Measure combining length and quality of life, in which one year in perfect health equals one QALY and a year in a health state valued at 0.5 equals half a QALY. |
| QoL | Quality of life | A person's perception of their overall well-being, including physical, psychological, social and functional dimensions. |
| RCT | Randomized controlled trial | Study design in which participants are assigned by chance to receive an intervention or a comparison (placebo, usual care or another treatment) and are followed for… |
| ROC | Receiver operating characteristic | A curve plotting the true positive rate against the false positive rate of a classifier or diagnostic test across every possible threshold. |
| RR | Relative risk | Ratio of the risk of an outcome in an exposed or treated group to the risk in an unexposed or control group, used in cohort studies and trials. |
| RRR | Relative risk reduction | Proportion by which a treatment lowers risk relative to the control group, calculated as the absolute risk reduction divided by the control event rate, or 1 minus the… |
| RWD | Real-world data | Data on patient health status and care collected routinely outside conventional clinical trials, including electronic health records, insurance claims, disease… |
| RWE | Real-world evidence | Clinical evidence about the use, benefits and risks of medical products derived from analysis of real-world data, such as electronic health records, claims, registries… |
| SD | Standard deviation | A measure of how spread out values are around their mean, equal to the square root of the variance and expressed in the same units as the data. |
| SDV | Source data verification | Monitoring process that compares data recorded in case report forms with original source documents, such as medical records and lab reports, to confirm accuracy and… |
| SEM | Standard error of the mean | How much a sample mean would vary across repeated samples, estimated as the sample SD divided by the square root of the sample size. |
| SIV | Site initiation visit | Meeting held by the sponsor or CRO at a clinical trial site before enrollment opens, to train the investigator and staff on the protocol, procedures, investigational… |
| SOC | Standard of care | Treatment or process widely accepted by medical experts as appropriate for a given condition, used in trials as the comparator arm and in law as the benchmark for… |
| SPIRIT | Standard Protocol Items: Recommendations for Interventional Trials | Guideline listing the items a clinical trial protocol should contain, such as objectives, eligibility, interventions, outcomes, sample size, randomization, data… |
| SR | Systematic review | Review that answers a focused question by searching for all relevant studies with a predefined, reproducible method, assessing their quality and synthesizing the… |
| STROBE | Strengthening the Reporting of Observational Studies in Epidemiology | Reporting guideline with checklists for cohort, case-control and cross-sectional studies, describing what authors should report about design, setting, participants… |
| SUSAR | Suspected unexpected serious adverse reaction | Serious adverse event, possibly caused by the investigational product, whose nature or severity is not consistent with the reference safety information in the… |
| TEAE | Treatment-emergent adverse event | Adverse event that begins, or worsens, after the first dose of study treatment, as opposed to conditions already present before treatment. |
| TMF | Trial master file | Collection of essential documents that allows a clinical trial's conduct and data quality to be reconstructed and evaluated, including protocols, approvals, consent… |
| USPSTF | US Preventive Services Task Force | Independent panel of national experts in prevention and primary care that issues evidence-based recommendations on screening, counseling and preventive medications… |
| WTP | Willingness to pay | Maximum amount a person, payer or society is prepared to spend for a health benefit, used in health economics as the threshold against which cost-effectiveness ratios… |
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