This glossary will help you understand words or phrases related to veterinary clinical studies listed on the AAHSD. For help with veterinary medical terms, see the petMD Glossary of Veterinary Terms.
A
ACCEPTS HEALTHY ANIMALS
Indicates that a clinical study is recruiting normal healthy animals either for genetic screening or to serve as healthy controls for comparison in the study.
ACTIVE COMPARATOR ARM
A group of participants that receives an intervention that is considered to be effective. One of several Arm Types.
ACTIVE, NOT RECRUITING
The clinical study is ongoing (that is, animals have been enrolled and are currently receiving an intervention or being examined), but new animals are not currently being recruited or enrolled. A type of Recruitment Status.
ADVERSE EVENT
An unfavorable change in the health of an animal enrolled in a study, which may include abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study is over. This may or may not be caused by the intervention being studied.
ALLOCATION
The assignment of enrolled animals to an arm of a study. Types of Allocation include Randomized, and Nonrandomized.
ARM
A group of animals within a clinical trial that receives a specific intervention, or no intervention, according to the study protocol. The arms of a study are decided before the trial begins.
ARM TYPE
A general description of the clinical study arm. It identifies the role of the intervention that participants will receive. Types of arms include Experimental, Active Comparator, Placebo Comparator, Sham Comparator, and No Intervention.
To Top
B
BASELINE CHARACTERISTICS
Data collected at the beginning of a clinical study for all enrolled animals in each arm or comparison group. These data include demographics, such as age and gender, and study-specific measures (for example, heart rate or prior treatments).
BLINDING (or Masking)
See Masking (or Blinding).
To Top
C
CERTAIN AGREEMENTS
As required by 801 of the Food and Drug Administration Amendments Act, in general, a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or to publish the study results in a scientific or academic journal after the trial is completed. (This does not apply if the PI is an employee of the sponsor.) (See also Certain Agreements results data element on ClinicalTrials.gov.)
CLINICAL STUDY
A research study in which animal patients will be used to evaluate biomedical or health-related outcomes. Two types of clinical studies are Interventional Studies (or clinical trials) and Observational Studies.
CLINICAL TRIAL (or Interventional Study)
See Interventional Study.
AAHSD IDENTIFIER NUMBER
A unique identification code is given to each clinical study registered on AAHSD, for example, AAHSD00128.
CLOSED STUDIES
Clinical studies that are no longer recruiting animals because they have enough enrolled already, because they are completed, or because they have been stopped for some reason. Recruitment statuses for closed studies in the AAHSD include:
- Pending
- Completed
- Completed with Results
- Terminated
- Suspended
COLLABORATOR
A collaborator is an organization other than the sponsor that provides support for a clinical study. This may include funding, design, implementation, data analysis, or reporting.
COMPLETED
The clinical study has ended normally, and animals are no longer being examined or treated (that is, the "last subject, last visit" has occurred). A type of Recruitment Status.
COMPLETED WITH RESULTS
The clinical study has ended normally and the final outcomes have been identified and posted on the AAHSD.
CONDITION
A disease, disorder, syndrome, illness, or injury that is being studied. There are also studies in the AAHSD for which no condition is being studied but rather healthy animals are needed to study the incidence of things like traits or genetic variations.
CONTROLLED TRIAL
A type of clinical trial in which observations made in the intervention group during the trial are compared to observations in a standard group (called the controls). The controls may be observations from a group of participants in the same trial, or observations from outside the trial (for example, from an earlier trial, called a historical control).
CROSSOVER DESIGN
Describes a clinical trial in which groups of participants receive two or more interventions in a particular order. For example, a two-by-two crossover design involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A during a later phase. So during the study, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the study, but in a different order, depending on the group to which they are assigned. One type of Intervention Model (Design).
To Top
D
DATA MONITORING COMMITTEE (DMC)
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, if it is causing harm to participants, or if it is not likely to serve its scientific purpose. Committee members are chosen based on the scientific skills and knowledge needed to monitor the particular study. Also referred to as a data safety and monitoring board (DSMB).
DMC
See Monitoring Committee (DMC).
DOUBLE BLIND MASKING
A type of masking in which both the owner and the investigators do not know which intervention that an animal is receiving.
To Top
E
ELIGIBILITY CRITERIA
The key standards that animals must meet or the characteristics they must have to participate in a specific study. These include inclusion criteria and exclusion criteria. For example, a study might only accept animals who are above a certain age, or come from the same breed group.
ENROLLING BY INVITATION
A clinical study that selects its participants from a population, or group of people, decided on in advance by the researchers. These studies are not open to everyone who meets the eligibility criteria, but only to people in that particular population, who are specifically invited to participate. A type of Recruitment Status.
ENROLLMENT
The number of animals that participated in a certain clinical study. The "estimated enrollment" is the number of participants that the researchers need for a certain study.
EXCLUSION CRITERIA
The factors (or reasons) that prevent an animal from qualifying for participation in a certain clinical study.
EXPANDED ACCESS
A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. One of several Study Types.
For more information on expanded access programs, visit the FDA Understanding Expanded Access/Compassionate Use Web site.
EXPERIMENTAL ARM
The group of animals that receives the intervention that is the focus of the study. One of several Arm Types.
To Top
F
FACTORIAL DESIGN
Describes a clinical study in which groups of participants receive one of several combinations of interventions. For example, a two-by-two factorial design involves four groups of participants. Each group receives one of the following pairs of interventions: 1) drug A and drug B, 2) drug A and a placebo, 3) a placebo and drug B, or 4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and placebos are given to different groups of participants. One type of Intervention Model (Design).
FDA
Food and Drug Administration. See also Food and Drug Administration (FDA).
FIRST RECEIVED DATE
The first received date is the date that a clinical study listing was first submitted to the AAHSD registry. There is typically a delay of a few days between the First Received date and when the study information is available on the AAHSD.
FOOD AND DRUG ADMINISTRATION (FDA)
An agency within the U.S. Department of Health and Human Services. FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure.
FUNDING SOURCE
Describes the type of organization that is providing funding or other support for the clinical study. Support may include providing facilities, expertise, or financial resources. There are four types of funding sources on the AAHSD:
- Federal Agency (eg., National Institutes of Health, USDA, etc)
- Industry (pharmaceutical and device companies)
- Charitable Foundation (eg., AVMF, Morris Animal Foundation, etc)
- Institution (ie, a University funding mechanism)
To Top
G
To Top
H
HAS DATA MONITORING COMMITTEE (DMC)
Indicates whether the clinical trial has a data monitoring committee (DMC) or data safety and monitoring board (DSMB).
HEALTH AUTHORITY
A national or international health organization that has authority over the clinical study. (See also Oversight Authorities data element on ClinicalTrials.gov.)
HUMAN SUBJECTS REVIEW BOARD
A group of people who review, approve, and monitor a clinical study protocol. Their role is to protect the rights and welfare of human research subjects participating in a study. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also known as an institutional review board (IRB) or ethics committee. Although the AAHSD is a database for veterinary clinical studies, some of those studies involve surveying the animal owners for which IRB approval is necessary in addition to animal welfare oversight mechanisms.
To Top
I
INCLUSION CRITERIA
The factors or characteristics that qualify an animal to participate in a clinical study.
INFORMED CONSENT
A process in which the study personnel communicate with individuals about their animals' potential participation in a certain clinical study. The study personnel will:
- Provide all the important information about the study, so that individuals can decide whether to enroll their animals (or, if they are already enrolled, to continue participating)
- Ensure that individuals understand the risks and potential benefits to their animals for participation in the study and the alternatives to the research being conducted
- Stress that enrolling in (and staying in) a clinical study is completely voluntary. Because giving consent to participate in research is not a contract, individuals can decide to remove their animals from a study at any time.
The goal of the informed consent process is to protect owners and their animals. It begins when an owner first asks for information about a study and continues throughout the study until the study ends. The researcher and the owner have discussions that include answering the owner's questions about the research. All important information about the study must also be given to interested individuals in a written document that is clear and easy to understand. This informed consent document is reviewed and approved by the human subjects review board for a study before it is given to potential participants. Generally, a person must sign an informed consent document to enroll their animal in a study.
INTERVENTION
A therapy that is the focus of a clinical study. This can include medications, medical devices, procedures, vaccines, and other products that are either investigational or already available.
INTERVENTION MODEL (Design)
The general design of the strategy for assigning interventions to animals enrolled in a clinical study. Types of intervention models include Single Group Design, Parallel Design, Crossover Design, and Factorial Design.
INTERVENTION NAME
The intervention being studied.
INTERVENTION TYPE
The general category of the intervention being studied. Intervention types include Diagnostic, Drug, Device, Biological/Vaccine, Surgery/Other Procedure, Radiation, Dietary/Neutraceuticals, Genetic (gene transfer, stem cell, recombinant DNA), Complementary/Alternative Medicine, Physical Therapy/Rehabilitation, and Other.
INTERVENTIONAL STUDY (or Clinical Trial)
A clinical study in which animals are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of those interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol.
INVESTIGATIONAL NEW DRUG
A drug, or biological product that is used in a clinical trial but has not been approved by the FDA (the drug is either not available for a veterinarian to prescribe or, is available, but not approved by the FDA for the use being studied).
INVESTIGATOR
An individual (usually a veterinarian) involved in the conduct of a clinical study.
To Top
J
To Top
K
To Top
L
LAST UPDATED DATE
The last updated date is the most recent date that changes to a study record were submitted to the AAHSD. There may be a delay between the Last Updated date and when the updated study information is available on the AAHSD.
LISTED LOCATION COUNTRIES
Countries in which research facilities for the study are located. A country is listed just once even if there is more than one facility in the country. The list of countries on the AAHSD presently is limited to the United States, Canada, and the United Kingdom.
To Top
M
MASKING (or Blinding)
A clinical trial design strategy in which one or more parties involved with the trial, such as the investigator or the owner, do not know which animals have been assigned to receive which interventions. This serves to remove any bias in the results that might be associated with a preconception of how the intervention being studied will perform. Types of Masking include None ("Open Label"), Single Blind Masking (in which either the investigator or the owner does not know the intervention that the animal is receiving), and Double Blind Masking (in which both the investigator and the owner do not know which intervention that the animal is receiving).
To Top
N
NO INTERVENTION ARM
A group of participants that does not receive any interventions during a clinical study. One of several Arm Types.
To Top
O
OBSERVATIONAL STUDY
A clinical study in which animals identified as belonging to study groups are assessed for biomedical or health outcomes. Animals may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign enrolled animals to specific interventions (as in an interventional study). A Study Type.
OBSERVATIONAL STUDY MODEL (Design)
The general design of the strategy for identifying and following up with animals during observational studies. Types of observational study models include Cohort, Case-Control, Case-Only, Case-Crossover, and Other.
OPEN LABEL
Describes a clinical trial in which masking is not used. This means that both the investigators and the owners in a trial know which animals have been assigned to receive which interventions.
OPEN STUDIES
Studies that are currently recruiting animals for enrollment or will be recruiting animals in the future. These include studies listed as having a recruitment status of 'Pending' or 'Recruiting'.
OUTCOME MEASURE
The variable described in the protocol that is measured to determine the effect of an intervention on the animals enrolled in an interventional clinical study. In observational studies, this might be a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include Primary Outcome Measure (the most important effect being studied) and Secondary Outcome Measure (one or more other effects being studied in addition to the primary outcome).
To Top
P
PARALLEL DESIGN
Describes a clinical trial in which two or more groups of animals receive different interventions. For example, a two-arm parallel design involves two groups of animals. One group receives drug A, and the other group receives drug B. So during the trial, animals in one group receive drug A "in parallel" to animals in the other group who receive drug B. One type of Intervention Model (Design).
PENDING
The clinical study has not started recruiting participants. A type of Recruitment Status.
PHASE
Food and Drug Administration (FDA) categories for describing the clinical trial of a drug based on the study's characteristics, such as the objective and number of participants. There are five phases:
- Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies)
- Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.
- Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
- Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
- Phase 4: Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.
PLACEBO
A substance that does not contain active ingredients and is made to be physically indistinguishable (that is, it looks and tastes identical) from the actual drug being studied.
PLACEBO COMPARATOR ARM
A group of animals that receives a placebo during a clinical study. One of several Arm Types.
PRIMARY COMPLETION DATE
The date that the last animal in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected. Whether the clinical study ended according to the protocol or was terminated does not affect this date. The "estimated primary completion date" is the date that the researchers think will be the primary completion date for the study.
PRIMARY OUTCOME MEASURE
The variable to be measured in the study that is the most important for evaluating the effect of an intervention. Most clinical studies have one primary outcome measure, but some may have more than one.
PRINCIPAL INVESTIGATOR (PI)
The person (usually a veterinarian) who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).
PROTOCOL
The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
PUBLICATIONS
Published scientific articles or abstracts about a clinical study. Investigators are encouraged to link published study results to AAHSD at any time.
To Top
Q
To Top
R
RANDOMIZED ALLOCATION
A strategy in which animals are assigned to arms of a clinical trial by chance. A type of Allocation.
RANK
Indicates the order in which studies appear in the Search Results list. The studies most relevant to your search terms appear higher in the list.
RECORD
See Study Record.
RECRUITING
The clinical study is currently recruiting animals. A type of Recruitment Status.
RECRUITMENT STATUS
Indicates the current stage of a clinical study and whether it is or will be open for enrollment. The possible recruitment statuses are:
| Open Studies |
Pending |
The study has not started recruiting animals. |
|
Recruiting |
The study is currently recruiting animals. |
|
Completed |
The study has ended normally, and is no longer recruiting animals. |
| Closed Studies |
Completed with Results |
The study has ended and the results have been finalized and posted on the AAHSD. |
|
Suspended |
The study has stopped recruiting or enrolling animals early, but may start again. |
REGISTRATION
The process of submitting and updating summary information about a clinical study protocol from its beginning to end, to a structured, Web-based registry that is accessible to the public, such as the AAHSD.
REGISTRY
A structured online system, such as the AAHSD, that provides the public with access to summary information about ongoing and completed clinical studies.
REPORTING (OR COMPARISON) GROUP
A grouping of participants in a clinical study that is used in summarizing the data collected during the study. This grouping may be the same as or different from a study arm.
RESULTS DATABASE
A structured online system, such as the AAHSD results database, that provides the public with access to summary results and registration information for completed or terminated clinical studies.
Note: The AAHSD results database was established in March 2016. It is unlikely that studies completed before the end of 2016 would have results in the database.
RESULTS SUBMISSION
The process of submitting and updating summary information about the results of a clinical study to a structured, public Web-based results database, such as the AAHSD results database. Investigators may post text of results, or links to results, from their studies on the AAHSD.
To Top
S
SECONDARY OUTCOME MEASURE
An additional variable to be measured in the study that is not as important as the primary outcome measure, but is still of interest in evaluating the effect of an intervention. Clinical studies may have more than one secondary outcome measure.
SHAM COMPARATOR ARM
A group of animals that receives a procedure or device that is made to be indistinguishable from the actual procedure or device being studied but does not contain active processes or components. One of several Arm Types.
SINGLE BLIND MASKING
A type of masking in which one party involved with the clinical trial, either the investigator or owner, does not know which animals have been assigned which interventions.
SINGLE GROUP DESIGN
Describes a clinical trial in which all participants receive the same intervention. One type of Intervention Model (Design).
SITE CONTACT
The individual who is responsible for submitting information about a clinical study to the AAHSD and updating that information, and receiving queries from individuals interested in enrolling an animal in that study. The site contact may, or may not be, the principal investigator for the study.
SPONSOR (LEAD)
The sponsor is the organization or person (see also Sponsor-Investigator) who oversees the clinical study and is responsible for analyzing the study data.
SPONSOR-INVESTIGATOR
The person who both initiates and conducts the clinical study.
STATUS
See Recruitment Status.
STUDY COMPLETION DATE
The date that the final data for a clinical study were collected because the last enrolled animal has made its' final visit to the study location. The "estimated study completion date" is the date that investigators think will be the completion date for the study.
STUDY DESIGN
The investigative methods used in the clinical study. For interventional studies, these include Primary Purpose, Intervention Model (Design) , Masking (or Blinding), and Allocation.
STUDY LISTING
An entry on the AAHSD that contains summary protocol information about a clinical study, such as recruitment status, eligibility criteria, contact information, and in some cases summary results. Each study listing is assigned a unique identifying number on the AAHSD.
STUDY START DATE
The date that the enrollment of animal patients for a clinical study begins.
STUDY TYPE
Describes the nature of a clinical study. Study types include Interventional Studies (or Clinical Trials), Observational Studies, and Epidemiologic/Survey Studies.
SUSPENDED
The clinical study has stopped recruiting or enrolling animals early, but it may start again. A type of Recruitment Status.
To Top
T
TERMINATED
The clinical study has stopped recruiting or enrolling animals early and will not start again. Animals that have been enrolled are no longer being examined or treated. A type of Recruitment Status.
TIME FRAME, OUTCOME MEASURE
The points in time at which the outcome measure is assessed. These are planned before the clinical study starts and listed in the protocol.
To Top
U
To Top
V
To Top
W
To Top
X
To Top
Y
To Top
Z
To Top