Clinical Terms (29)

A clinical trial design that allows pre-planned modifications to aspects of the trial based on accumulating data, while maintaining trial integrity and validity.

A clinical trial design that tests one investigational therapy across multiple indications or tumor types sharing a common molecular target or biomarker.

The absence of a significant difference in the rate and extent to which the active ingredient in two pharmaceutically equivalent products becomes available at the site of drug action.

A clinical trial design technique where participants, investigators, or both are prevented from knowing which treatment each subject is receiving.

A clinical study conducted to allow extrapolation of efficacy and safety data from one region or population to another.

An FDA order to a sponsor to delay a proposed or suspend an ongoing clinical investigation due to safety concerns or deficiencies.

A company that provides outsourced research services to pharmaceutical and biotechnology companies.

An independent group of experts that periodically reviews accumulating clinical trial data to monitor participant safety and trial integrity.

A clinical trial where some or all trial activities take place at locations other than traditional research sites, often including patient homes.

The first clinical trial in which an investigational product is administered to human subjects, typically as a Phase 1 study.

International ethical and scientific quality standards for designing, conducting, and reporting clinical trials.

The nonclinical studies a sponsor conducts to support the safety and feasibility of initiating human clinical trials under an IND.

The process by which a research participant learns about and agrees to participate in a clinical trial after understanding the risks, benefits, and alternatives.

An independent committee that reviews and approves research involving human subjects to ensure ethical standards and participant protection.

A comprehensive document summarizing clinical and nonclinical data on an investigational product for clinical trial investigators.

A single overarching clinical trial protocol designed to evaluate multiple therapies, multiple indications, or multiple populations in a coordinated framework.

The lowest dose at which a biologic is anticipated to produce any pharmacologically meaningful effect in humans, used as the basis for first-in-human starting dose for high-risk products.

The highest dose in a toxicology study that does not produce a statistically or biologically significant adverse effect compared to controls.

A structured clinical narrative describing the adverse event experience of an individual trial subject, required in clinical study reports.

An outcome measure that comes directly from the patient about their health condition without interpretation by a clinician or anyone else.

The study of a drug's biochemical and physiological effects on the body and the mechanisms underlying those effects.

The study of how a drug moves through the body: absorption, distribution, metabolism, and excretion over time.

The first stage of clinical testing in humans, primarily assessing safety, tolerability, and pharmacokinetics.

Clinical trials evaluating a drug's efficacy and optimal dosing in patients with the target disease.

Large-scale pivotal trials that confirm a drug's efficacy and safety to support regulatory approval.

The main outcome measure of a clinical trial, selected before the trial begins and used as the primary basis for the trial's conclusion about efficacy.

A formal modification to an approved clinical trial protocol requiring documentation, IRB approval, and where applicable regulatory notification or approval.

Clinical evidence about the use, potential benefits, or risks of a medical product derived from analysis of real-world data.

A clinical trial design that tests multiple investigational therapies against a single disease, typically with biomarker-driven patient assignment to treatment arms.