Allergan Research & Development: Clinical Trials. Insight for Life

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Terminology Definitions

Adverse Events (AEs): Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product. While AEs may be associated with the temporal use of the drug, there may not be a causal relationship.

Blinding: A procedure in which one or more parties to the clinical trial (i.e., the subject/patient, investigator, and/or sponsor medical personnel) are kept unaware of the treatment assignment(s) of the clinical study participants.

Clinical Trial Registry (CTR): A publicly available on-line registry that will provide physicians and patients with information regarding Allergan’s clinical studies. Although publicly available, in order to access the CTR, the individual users must agree to certain terms and conditions.

Comparator Drug: A marketed drug (i.e., active control) or placebo used as a reference in a clinical trial.

Dosing Regimen: The number of times each day a medication is given. QD= once a day; BID= twice a day; TID= three times a day; QID= four times a day.

Double-Blind Study: A clinical trial in which neither the investigator, the sponsor nor the subject/patient is aware of the treatment received.

Efficacy: The ability to produce a desired favorable effect in treating or preventing the studied disease or condition.

Allergan Drug: A prescription pharmaceutical product that Allergan is selling for human consumption in the United States following FDA approval (including a Allergan Investigational product once it receives FDA approval and is sold by Allergan), for which Allergan has both the clinical development responsibility and the legal right to use or disclose such product’s clinical study data.

Allergan-Sponsored Clinical Studies: Clinical studies of a Allergan Drug or a Allergan investigational agent where Allergan is ultimately responsible for regulatory approvals, site selection, protocol development, initiation, monitoring, safety reporting, and data analysis, even if some or all of these activities are transferred to another party (e.g., Contract Research Organization).

Indication: The efficacy claims that are approved by the FDA for the Allergan Drug on the basis of the key registration studies. The indication is contained in the product labeling, also called the prescribing information. An indication may involve the use of a drug to treat a particular disease state, or a particular type of medical symptom (e.g. relief of pain).

Allergan Investigational Drug: A Allergan Drug that is being studied in a clinical trial and has not been approved by the FDA for marketing in the U.S.

Off-Label Use: Use of a prescription drug product for a purpose outside the scope of the approved package insert. This can include use of a drug for an indication, dosage form, dosing regimen, patient population, or any other parameter not defined in the product's FDA approved labeling.

On-Label Use: Use of a Allergan Drug to treat a condition, disease, or population approved as an indication in the U.S. Prescribing Information (labeling) for the Allergan Drug.

Open-Label Trial: A clinical trial in which the identity of the treatment being administered to each person is known by the investigator, subject/patient and sponsor.

Pharmacokinetics: The disposition of a drug in the human body over a period of time, including absorption, distribution, metabolism, and excretion of the drug.

Phase 1: A Phase 1 trial is the first step in testing a new investigational drug in humans. Initial Phase 1 studies are mainly concerned with evaluating a drug’s safety profile, including the safe dosage range and the potential for adverse events in association with its administration. These studies may also determine how the drug is absorbed and broken down by the body (i.e. the drug’s disposition); what is the best way to give the drug to a patient, as well as its duration of action. Later Phase 1 trials may include assessments of the disposition of the drug after administration of different formulations or in special populations of individuals. Phase 1 clinical trials are usually conducted in healthy individuals and are not intended to treat disease or illness.

Phase 2: Phase 2 clinical trials involve patients who have the disease or condition to be treated. These trials are usually conducted in smaller groups of patients to gain preliminary information about the safety of the investigational drug and to give an indication of the effect of the investigational drug on the targeted disease or condition. Several different doses of the drug may be studied.

Phase 3: Phase 3 clinical trials are conducted in larger groups of patients to confirm efficacy and to provide substantial safety and tolerability data. A Phase 3 trial frequently determines how well the study drug works compared with an inactive placebo and/or another approved drug under a double-blind study design.

Phase 4: Phase 4 clinical trials, sometimes called "post-marketing" trials, begin after the drug has been approved by the FDA. These studies may be done to determine if the drug is effective in other disease states, or to test different ways of taking the drug according to different dosage regimens or routes, or to observe for adverse events in larger populations over longer periods of time.

Placebo: An inactive substance or “sugar pill” used in comparative studies. In clinical trials, experimental treatments are often compared with placebo to assess the treatment's effectiveness.

Protocol: The investigational plan used to conduct a clinical study.

Serious Adverse Event: Any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In addition, any event not meeting the above criteria may still be deemed serious by the investigator if, with appropriate medical judgment, such an event jeopardizes the patient and may require medical or surgical intervention to prevent one of the outcomes listed above.

Statistical Significance: A finding resulting from application of statistical procedures that a difference between a sample value and another value (either a constant or another statistic) is large enough to conclude that the two values being tested are different, that is, that the difference is not due to chance or random error. The most commonly used confidence level for finding statistical significance is a probability (often referred to as a p-value) of less then 0.05, meaning that there is a 5 percent or less probability that the difference observed was caused by “chance.”

Study Completion Date: The date that the last observation is made at the time of the last study visit of the last patient who remains enrolled in the clinical study (Last Patient Last Visit, LPLV) at the planned completion of the trial, or following a decision to terminate the clinical study early, whichever happens first.

Summary of Clinical Study Report (SCSR): A detailed summary of a clinical study, describing a) the study title, rationale, objectives and design (including the planned statistical methods) and b) the clinically relevant findings or results of the study, including the answers to the questions posed at the outset of the study and the results of the protocol-defined outcomes.