FAQ

Citing TrialsAnnotator

We ask that users who download significant portions of the database cite the TrialsAnnotator paper in any resulting publications.

Data Sources

All clinical trial data is currently extracted from the Clinical Trials Transformation Initiative AACT database which is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov.

Data Filtering

Currently, the Trials Annotator site only lists clinical trials matching certain criteria:

Annotation Categories

Several categories have been defined for the annotation effort:

Clinical Trial Terms

Recruitment

Recruitment, a component of the consent process, is the process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment.

Enrollment

Occurs when an eligible, informed potential participant undergoes the initial informed consent process and voluntarily agrees to participate in a research project. Example: You enroll 100 to accrue 25. See also Accrual.

Screen failures

Subjects who consented to participate in research but who were disqualified during screening procedures.

Accrual

The number of subjects who have completed or are actively in the process of completing a study [...]. This does not include screen failures. It does include withdrawals. Example: You enroll 100 to accrue 25.

Withdrawals

Subjects who were accrued but later withdrew from the study, either before or after receiving a study drug, device or intervention. This does not include screen failures.

IND

Investigational New Drug Application

PI

Principal Investigator

DSMB

Data and Safety Monitoring Board

IRB

Institutional Review Board

IEC

Independent Ethics Committee

SAEs

Serious Adverse Events

Dose-Limiting Toxicity (DLT)

Describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

Disclaimer

All data are exclusively aimed at medical professionals and researchers. No guarantee can be undertaken for the accuracy, up-to-date nature or completeness of data. Moreover, the individual situation of the patient and the latest relevant product information for the drug to be employed shall be taken into consideration when taking a decision on therapy. Any liability claims related to damage of a material or non-material nature, which was caused by the use or non-use of the presented information or by the use of inaccurate or incomplete information, are essentially excluded, except in the event of verifiable intentional or gross negligence.