Reference

Clinical Research Glossary

Thirty plain-language definitions to help patients, partners, and the curious read clinical trial materials with confidence.

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Adverse Event: Any untoward medical occurrence in a clinical trial participant, regardless of whether it is considered related to the investigational therapy.
Ambulatory Surgery Center: A licensed outpatient facility where same-day procedures are performed under sterile conditions, often as an alternative to the hospital setting.
Arrhythmia: An abnormal heart rhythm — too fast, too slow, or irregular. Examples include atrial fibrillation and ventricular tachycardia.
Atherectomy: A catheter-based procedure that removes or modifies plaque from inside an artery, often used in calcified peripheral artery disease.

Chronic Venous Insufficiency: A condition in which the leg veins do not return blood to the heart efficiently, causing swelling, skin changes, and venous ulcers.
ClinicalTrials.gov: A U.S. government registry and results database of publicly and privately supported clinical studies conducted around the world.
Coronary Artery Disease: Atherosclerotic narrowing of the arteries that supply the heart muscle, which can cause angina, myocardial infarction, or heart failure.
CRO: Contract Research Organization — a company that supports sponsors with trial monitoring, data management, regulatory submissions, and other operational tasks.

Double-Blind: A trial design in which neither participants nor the treating team know which treatment a participant is receiving, to reduce bias.

Endpoint: A pre-specified outcome measured during a trial to evaluate the safety or efficacy of an intervention.
Exclusion Criteria: Conditions or situations that make a person ineligible for a specific clinical trial, typically for safety or scientific reasons.

First-in-Human Study: The first time an investigational drug, biologic, or device is administered to human participants, after extensive preclinical testing and regulatory review.

GCP: Good Clinical Practice — an international ethical and scientific quality standard for designing, conducting, and reporting clinical trials in human participants.

ICH-GCP: The International Council for Harmonisation Good Clinical Practice guidelines (currently E6 R3), the global standard for clinical trial conduct and quality.
Inclusion Criteria: The clinical and demographic characteristics a person must have to be eligible for a specific clinical trial.
Informed Consent: A written and verbal process in which a participant learns the purpose, procedures, risks, benefits, and alternatives of a study before deciding whether to take part.
Intent-to-Treat: An analysis approach that includes all randomized participants in the groups to which they were originally assigned, preserving the benefits of randomization.
IRB: Institutional Review Board — an independent ethics committee that reviews and approves clinical research protocols and consent documents to protect human participants.

NCT Number: A unique 8-digit identifier (e.g., NCT01234567) assigned to a study registered on ClinicalTrials.gov.

Peripheral Artery Disease: Atherosclerotic narrowing of arteries outside the heart, most often in the legs, that can cause claudication, non-healing wounds, or critical limb ischemia.
Placebo: An inactive comparator used in some trials. Placebo arms are used only when ethically appropriate and typically combined with background standard of care.
Primary Endpoint: The principal outcome a trial is designed to measure, used to determine whether the therapy meets its main objective.
Principal Investigator: The physician-scientist responsible for the conduct of a clinical trial at a given site, including participant safety and protocol compliance.

Randomized Controlled Trial: A study in which participants are assigned by chance to one or more treatment groups, considered the gold standard for evaluating clinical interventions.

SAE: Serious Adverse Event — an adverse event that is fatal, life-threatening, requires or prolongs hospitalization, causes lasting disability, or is otherwise medically important.
Secondary Endpoint: Additional outcomes measured to provide supportive information beyond the primary endpoint.
Sham Control: A control group that undergoes a procedure mimicking an investigational intervention without the active component, used to isolate the true effect of the therapy.
Sponsor: The organization (often a pharmaceutical or device company, or an academic group) that initiates, manages, and funds a clinical trial.
Structural Heart Disease: Disease of the heart's valves, walls, or chambers, often treated with transcatheter or surgical procedures such as TAVR, mitral repair, or septal closure.

TAVR: Transcatheter aortic valve replacement — a minimally invasive procedure that replaces a diseased aortic valve through a catheter, most often via the femoral artery.