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A new survey of clinical data management professionals shows that the time it takes companies to design and release clinical study databases is having a negative impact on conducting and completing trials.
According to the 2017 eClinical Landscape Study from Tufts Center for the Study of Drug Development, it takes companies an average of 68 days to build and release a clinical study database. Delays in releasing the study database are associated with an increase of nearly a month downstream for other data management processes such as patient data entry and time to lock the database at the end of the study. Respondents that deliver the database after first patient, first visit (FPFV), take nearly twice as long to enter patient data throughout the study and about 75% longer to lock the study database when compared to those that deliver the final database before FPFV.
“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.”
EDC is the most widely adopted clinical application, used by all respondents (100%), followed by randomization and trial supply management (77%), electronic master file (70%), and safety (70%) systems. A majority (58%) of respondents use either Medidata Rave or Oracle Inform as their primary EDC system.
When asked about the type of data managed in their EDC, all (100%) CROs and sponsors cite electronic case report form (eCRF) data, followed by local lab and quality of life data (60% each). However, respondents say eCRF data is the highest volume of data they manage in their EDC system (at an average of 78% of the total data managed). The next highest data volumes reported are central lab data and local lab data at 5% each. Remaining data types reported are each 4% or less. This demonstrates the need for processes and systems to support the industry’s vision to have complete study data in their EDC.
More than three-quarters (77%) say they have issues loading data into their EDC application and most (66%) say EDC system or integration issues are the primary reasons they are unable to load study data.
The survey finds several common causes for clinical database build delays. Protocol changes is cited most by 45% of respondents, underscoring the challenge data management professionals have in dealing with changes as they are finalizing the clinical trial database for the start of the trial. This highlights the need to optimize the database design process with standards and systems that support more flexible design and rapid development.
Initial database delays also have significant downstream impacts on the time it takes sites to enter patient data in the EDC throughout the trial, as well as the final lock of the database once the study is complete. It takes on average five days from patient visit to when the data is entered into the EDC for companies that release the database before FPFV. When the database is released after FPFV, data entry time doubles to 10 days.
The impact of database build delays is even greater by the time companies get to database lock. Those who always release the database before FPFV get to database lock in an average of 31 days. Those who never release the database before FPFV take more than three weeks longer (54 days) to lock the database.
Sponsors take roughly 40% longer than CROs to build the database (73 vs. 53 days) and to get to database lock (39 vs. 28 days). Also, those using the two leading EDC systems report roughly 20% longer data cycle times (123 days) than those using other EDC systems (99 days), which includes time for database build (75 vs. 60 days), patient data entry (9 vs. 7 days), and database lock (39 vs. 32 days).
“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.”
Download the report at veeva.com/eu/EDCSurvey.