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 foreign key
Details Type associated with API, can only be one of the following:api_type | description | parent_type |
---|---|---|
Allergen | Allergen | None |
Animal product | Animal product | None |
Biological | Biological | None |
Biologics | Biologics | None |
Botanical | Botanical | None |
Cell therapy | Cell therapy | None |
Gene therapy | Gene therapy | None |
mAb | mAb | Biologics |
Nucleic acid | Nucleic acid | Biologics |
Peptide | Peptide | Biologics |
Recombinant protein | Recombinant protein | Biologics |
Small molecule | Small molecule | None |
Vaccine | Vaccine | None |
Type foreign key
Details Type associated with API, can only be one of the following:api_type | description | parent_type |
---|---|---|
Allergen | Allergen | None |
Animal product | Animal product | None |
Biological | Biological | None |
Biologics | Biologics | None |
Botanical | Botanical | None |
Cell therapy | Cell therapy | None |
Gene therapy | Gene therapy | None |
mAb | mAb | Biologics |
Nucleic acid | Nucleic acid | Biologics |
Peptide | Peptide | Biologics |
Recombinant protein | Recombinant protein | Biologics |
Small molecule | Small molecule | None |
Vaccine | Vaccine | None |
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 Withdrawn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.Withdrawn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.trial_phase | description |
---|---|
Early Phase 1 | Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). |
N/A | Trials without FDA-defined phases, including trials of devices or behavioral interventions. |
Phase 1 | 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/Phase 2 | Trials that are a combination of phases 1 and 2. |
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/Phase 3 | Trials that are a combination of phases 2 and 3. |
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 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. |
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.trial_phase | description |
---|---|
Early Phase 1 | Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). |
N/A | Trials without FDA-defined phases, including trials of devices or behavioral interventions. |
Phase 1 | 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/Phase 2 | Trials that are a combination of phases 1 and 2. |
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/Phase 3 | Trials that are a combination of phases 2 and 3. |
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 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. |
Type foreign key
Details NoneType 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_type | description |
---|---|
Expanded Access | A 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. |
Interventional | A 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. |
Observational | A 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. |
Unregistered | A trial not sourced from ClinicalTrials.gov |
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_group | description |
---|---|
Active Comparator | An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers. |
Case | Group of individuals, initially defined and composed, with common characteristics (for example, condition, birth year), who are examined or traced over a given time period. |
Control | An 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. |
Experimental | An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial. |
No Intervention | An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial. |
Other | Details for arm type explained in the trial's "Detailed Description" section. |
Placebo Comparator | An arm type in which a group of participants receives a placebo during a clinical trial. |
Sham Comparator | An 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).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_type | description |
---|---|
Collaborator | Collaborator designation in aact.sponsors |
Lead sponsor | Lead sponsor designation in aact.sponsors |
Official | Empty designation in aact.overall_officials |
Overall official - principal investigator | Principal Investigator designation in aact.overall_officials |
Reponsible party - principal investigator | Principal Investigator designation in aact.responsible_parties |
Sponsor investigator | Sponsor-Investigator designation in aact.responsible_parties |
Study chair | Study Chair designation in aact.overall_officials |
Study director | Study Director designation in aact.overall_officials |
Sub investigator | Sub-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.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_type | description |
---|---|
Academic/Hospital | Academic institution or hospital |
For profit | For profit company |
Foundation | Foundations or non-profits |
Government | Government entity or institution |
Individual | Individual researcher |
Unknown | Provided 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 NoneType integer
Details NoneType integer
Details NoneType integer
Details None