Exploring Type and Severity of Changes to Inclusion/Exclusion Criteria in ClinicalTrials.gov
This dataset was created for an Eli Lilly and Company employee information management training program. It was part of a project that explored the potential use of ClinicalTrials.gov (CT.gov) as a tool to evaluate the severity of changes to inclusion and exclusion criteria on clinical trial operations. CT.gov is a public clinical study registry that records summary data about clinical trials. The registry includes a historical record of changes (change history) to inclusion and exclusion criteria and other data that is accessible by users.
The dataset consists of a small sample of summarized data for Phase 1, 2, and 3 interventional diabetes studies. The change history was used to identify modifications to the summarized inclusion and exclusion criteria. The changes were categorized by type and severity for clinical trial operations. The contribution of this dataset is to demonstrate use of the change history as a tool to explore and assess potential consequences for clinical trial operations. The dataset was used for a training activity, and the results were not validated using other data.
The data of the database is represented using five tables: CTgovIE_Studies (26 attributes), CTgovIE_ExclusionCategories (5 attributes), CTgovIE_ExclusionSeverities (2 attributes), CTgovIE_InclusionCategories (5 attributes), CTgovIE_InclusionSeverities (2 attributes).
 Z. Luo, M. Yetisgen-Yildz, & C. Weng. “Dynamic categorization of clinical research eligibility criteria by hierarchical clustering,” Journal of Biomedical Informatics, vol. 44, no, 6, Dec, pp. 927-93, 2011.
 U.S. Institutes of Health, “ClinicalTrials.gov,” U.S. National Library of Medicine. [Online] Available: https://clinicaltrials.gov/ct2/home. [Accessed: April 3, 2021]
- CTgovIE_ExclusionCategories.csv (1.79 kB)
- CTgovIE_ExclusionSeverities.csv (66 bytes)
- CTgovIE_InclusionCategories.csv (1.79 kB)
- CTgovIE_InclusionSeverities.csv (66 bytes)
- CTgovIE_Studies.csv (511.72 kB)