The time spent designing and implementing clinical study databases has a negative impact on conducting and completing trials, according to the 2017 eClinical Landscape Study from Tufts Center for the Study of Drug Development.
The delay in releasing a study database correlates with an increase of almost a month’s work of data management. This survey of clinical data management professionals reviewed current database measures including first patient, first visits (FPFV), electronic data capture (EDC) and system use.
“Database build processes have remained largely unchanged over the past 10 years, and the process will only get more complicated as CROs and sponsors manage an increasing variety of clinical trial data,” said Richard Young, vice president of Veeva Vault EDC. “Organizations compensate for technology limitations by reducing the volume of data they input. Our focus should be on improving EDC systems so sponsors and CROs are no longer limited, and instead can run the trial they want.”
- It takes an average of 68 days to build and release a clinical study database.
- Respondents that deliver the database after FPFV take twice as long to enter patient data and 75 percent longer to lock the study database when compared to those that deliver the final database before FPFV.
- EDC was the most used clinical application, used by all respondents, followed by randomization and trial supply management (77 percent), electronic master file (70 percent) and safety systems (70 percent).
- 58 percent of respondents used Medidata Rave or Oracle Inform as their primary EDC system.
- 100 percent of respondents used electronic case report form (eCRF) data as the type of data managed in their EDC, followed by local lab (60 percent) and quality of life data (60 percent), as the eCRF data is the highest volue of data managed in EDC systems.
- 77 percent reported having issues loading data into their EDC and 66 percent report integration issues are the reason.
- 45 percent of respondents cited protocol changes as the primary cause for clinical database build delays.
- Those who released the database before FPFV achieved a database lock in about 31 days; those who never realse the database before FPFV took 54 days to lock the database.
“The study results indicate that companies face a growing number of challenges in building and managing clinical study databases,” said Ken Getz, research associate professor and director at the Tufts Center for the Study of Drug Development. “The results also show that the release of the clinical study database after sites have begun enrollment is associated with longer downstream cycle times at the investigative site and at study close out.”