Adverse Drug Reaction
An adverse drug reaction (ADR) is an unintended and harmful response to a medication that occurs at doses normally used for prophylaxis, diagnosis, or treatment.
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Research Glossary
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Benefit Risk Analysis
A benefit risk analysis is a systematic evaluation that compares the clinical benefits of a medical intervention (such as a drug, medical device, or procedure) with its associated risks and potential harms.
Biomarker
A biomarker, short for biological marker, is a measurable biological indicator used to assess a normal physiological process, a pathological process, or a pharmacological response to a therapeutic intervention.
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Clinical Data
Clinical data are information generated from the clinical use of a medical intervention, including data from formal clinical investigations, post market surveillance, published scientific literature, adverse event reports, and routine clinical practice.
Clinical Equipoise
Clinical equipoise is a state of genuine uncertainty within the expert medical community about the comparative therapeutic merits of each treatment arm in a clinical trial.
Comparative Effectiveness Research
Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of two or more prevention, diagnostic, or treatment options as they are used in routine clinical practice, with a focus on real world…
Composite Endpoint
A composite endpoint is a single outcome measure that combines multiple individual clinical endpoints into one, used in clinical trials to increase the statistical event rate and reduce the required sample size.
CONSORT (Consolidated Standards of Reporting Trials)
CONSORT stands for Consolidated Standards of Reporting Trials, a reporting guideline designed to improve the transparency and completeness of published reports of randomized controlled trials.
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Data Safety Monitoring Board (DSMB)
A Data Safety Monitoring Board, also known as a Data Monitoring Committee (DMC), is an independent group of experts that monitors participant safety and treatment efficacy during the conduct of a clinical trial.
Design Control
Design control is a systematic, structured approach to managing the design and development process for medical devices, required in the US by FDA's Quality Management System Regulation (21 CFR 820) and set out in ISO 13485, to ensure that a finished device…
Design Validation
Design validation is the process of confirming that a medical device, as a finished product, meets user needs and its intended uses under actual or simulated use conditions.
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Effectiveness
Effectiveness refers to the ability of an intervention to produce its intended results when applied under routine, real world conditions, with diverse patient populations, variable adherence, and the complexities of everyday clinical practice.
Efficacy
Efficacy is the ability of an intervention to produce its intended results under ideal or carefully controlled conditions, such as those of a well designed randomized controlled trial.
EUDAMED (European Database on Medical Devices)
EUDAMED (European Database on Medical Devices) is a centralized information technology system established by the European Union under the Medical Device Regulation (EU 2017/745) and the In Vitro Diagnostic Regulation (EU 2017/746).
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Intention to Treat (ITT)
Intention to treat (ITT) is an analysis strategy in clinical trials that includes all randomized participants in the groups to which they were originally assigned, regardless of whether they adhered to the treatment protocol, completed the study, or received…
Interim Analysis
An interim analysis is a planned examination of accumulating data conducted during the course of a clinical trial, before the study reaches its full enrollment or follow up target.
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Number Needed to Harm (NNH)
The number needed to harm (NNH) is the number of patients who need to be exposed to a risk factor, treatment, or intervention over a specific period before one additional patient experiences an adverse event that would not have occurred without the exposure.
Number Needed to Treat (NNT)
The number needed to treat (NNT) is the number of patients who need to be treated with a specific intervention for one additional patient to achieve a favorable outcome compared to the control or alternative treatment.
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Patient Reported Outcome (PRO)
A patient reported outcome (PRO) is any report of the status of a patient's health condition or treatment experience that comes directly from the patient, without interpretation by a clinician or anyone else.
Per Protocol Analysis
Per protocol analysis is a method of analyzing data from a clinical trial that includes only those participants who completed the study in full compliance with the protocol.
PMCF (Post Market Clinical Follow Up)
Post Market Clinical Follow up (PMCF) is the systematic and ongoing process of collecting and evaluating clinical data on a medical device after it has been placed on the market and is in routine clinical use.
Primary Outcome
The primary outcome is the main endpoint that a study is designed and statistically powered to evaluate, specified in the study protocol before data collection begins.
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Real World Data (RWD)
Real world data refers to health data collected outside of conventional clinical trials, drawn from sources that reflect routine clinical practice, patient behavior, and healthcare system operations.
Real World Evidence (RWE)
Real world evidence is clinical evidence about the usage and potential benefits or risks of a medical product or intervention derived from the analysis of real world data collected outside of conventional randomized controlled trials.
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Secondary Outcome
A secondary outcome is a prespecified endpoint that provides supplementary information about the effects of an intervention beyond what the primary outcome captures.
Subgroup Analysis
A subgroup analysis examines whether the effect of an intervention or exposure differs across specific subsets of participants, defined by baseline characteristics such as age, sex, disease severity, or comorbidities.
Surrogate Endpoint
A surrogate endpoint is a biomarker or intermediate outcome used in clinical trials as a substitute for a clinically meaningful final endpoint such as survival, disease progression, or functional status.