Glossary

All the table columns available in the query tool are defined in the panels below; click on any of the titles to reveal the definition.

Type integer

Details Unique identifier for the Active Pharmaceutical Ingredient (API); e.g. 22983.

Type foreign key

Details Type associated with API, can only be one of the following:
api_typedescription
AllergenAllergen
Animal productAnimal product
BiologicalBiological
BiologicsBiologics
BotanicalBotanical
Cell therapyCell therapy
Gene therapyGene therapy
Small moleculeSmall molecule
VaccineVaccine

Type string

Details The common, preferred name for an API.

Type foreign key

Details Status of an API-trial-indication pairing or of an API overall. In the case of an API, the cronological order goes as: Experimental -> Approved -> Withdrawn. Any API that has an associated trial number will be considered Experimental.

NOTE: the Withdrawn status is not yet implemented.

Type boolean

Details Has ever been approved by the US FDA.

Type integer

Details Earliest year with evidence of US FDA approval.

Type boolean

Details Has ever been marketed in the United States.

Type integer

Details Earliest year with evidence of US FDA approval.

Type foreign key

Details Phase of clinical trial, must be one of phases listed in the table below; see clinicaltrials.gov or PRS for more information.
descriptiontrial_phase
Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies).Early Phase 1
Trials without FDA-defined phases, including trials of devices or behavioral interventions.N/A
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.Phase 1
Trials that are a combination of phases 1 and 2.Phase 1/Phase 2
Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.Phase 2
Trials that are a combination of phases 2 and 3.Phase 2/Phase 3
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. Phase 3
Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.Phase 4

Type foreign key

Details ID that uniquely identifies the clinical study.

Type foreign key

Details Phase of clinical trial, must be one of phases listed in the table below; see clinicaltrials.gov or PRS for more information.
descriptiontrial_phase
Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies).Early Phase 1
Trials without FDA-defined phases, including trials of devices or behavioral interventions.N/A
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.Phase 1
Trials that are a combination of phases 1 and 2.Phase 1/Phase 2
Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.Phase 2
Trials that are a combination of phases 2 and 3.Phase 2/Phase 3
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. Phase 3
Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.Phase 4

Type foreign key

Details None

Type foreign key

Details The type of clinical trial, must be one of the types listed in the table below; see clinicaltrials.gov orPRS for more information.
trial_typedescription
Expanded AccessA way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
InterventionalA type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
ObservationalA type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment.
Observational [Patient Registry]An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.

Type foreign key

Details A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol. Must be one of groups listed in the table below; see clinicaltrials.gov or PRS for more information.
treatment_groupdescription
Active ComparatorAn arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.
CaseGroup of individuals, initially defined and composed, with common characteristics (for example, condition, birth year), who are examined or traced over a given time period.
ControlAn arm type in which a group of individuals, involved in the clinical trial, do not receive the treatment, in order to determine the effectiveness of the drug, supplement or treatment being tested.
ExperimentalAn arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial.
No InterventionAn arm type in which a group of participants does not receive any intervention/treatment during the clinical trial.
OtherDetails for arm type explained in the trial's "Detailed Description" section.
Placebo ComparatorAn arm type in which a group of participants receives a placebo during a clinical trial.
Sham ComparatorAn arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components.

Type date

Details The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit).

NOTE: this is not the Primary Completion Date field found on clinicaltrials.gov.

Type integer

Details The number of participants in a clinical study.

Type date

Details The actual date on which the first participant was enrolled in a clinical study.

Type foreign key

Details Type of relationship between trial and organization; parsed from AACT database tables: sponsors, overall_officials and responsible_parties. Must be one of the following:
relationship_typedescription
CollaboratorCollaborator designation in aact.sponsors
Lead sponsorLead sponsor designation in aact.sponsors
OfficialEmpty designation in aact.overall_officials
Overall official - principal investigatorPrincipal Investigator designation in aact.overall_officials
Reponsible party - principal investigatorPrincipal Investigator designation in aact.responsible_parties
Sponsor investigatorSponsor-Investigator designation in aact.responsible_parties
Study chairStudy Chair designation in aact.overall_officials
Study directorStudy Director designation in aact.overall_officials
Sub investigatorSub-Investigator designation in aact.overall_officials

Type string

Details The name of the organization/affiliation linked to the clinical study.; these data were parsed from AACT database tables: sponsors, overall_officials and responsible_parties. See Relationship type for more information regarding the provenance of these data.

NOTE: this can also be the name of an individual.

Type string

Details The name of the all parent organizations for the organization/affiliation linked to the clinical study. This includes parents of parent organizations, up to the present parent organization.

Type foreign key

Details The type of organization, must be one of the following:
org_typedescription
Academic/HospitalAcademic institution or hospital
For profitFor profit company
FoundationFoundations or non-profits
GovernmentGovernment entity or institution
IndividualIndividual researcher
UnknownProvided information is too vague to assertain organization type

Type boolean

Details An organization has contributed to an NME if they are listed as the IND or NDA organization on any drug, or if they were involved in a drug trial that started before the drug was approved by the FDA.

Type string

Details The status of the organization, Acquired, Renamed, Defunct, or Independent (never been acquired).

Type string

Details Existence of trial involvement: Trial Sponsor if Lead sponsor on any trials, Other Invovlement if otherwise involved in any trials, No Trials if not involved in any trials.

Type integer

Details None

Type integer

Details None

Type integer

Details None

Type integer

Details None