Yes
studies
character varying
-
Yes
studies
character varying
A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.
Last Known Status
Yes
studies
character varying
-
Yes
studies
character varying
-
Yes
studies
character varying
A (registered) organization (typically the Responsible Party) that sponsors the clinical trial (study)
Org Full Name
Yes
studies
character varying
-
Yes
studies
character varying
-
Yes
studies
boolean
For individual participants, including for emergency use, as specified in 21 CFR 312.310. Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
Exp Acc Type Individual
Yes
studies
boolean
For intermediate-size participant populations, as specified in 21 CFR 312.315. Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
Exp Acc Type Intermediate
Yes
studies
boolean
Under a treatment IND or treatment protocol, as specified in 21 CFR 312.320. Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
Exp Acc Type Treatment