Survey Spotlights Challenges of Handling EDC Properly

Hugo Cervantes, Vice President of Vault EDC, Veeva Systems

Hugo Cervantes, Vice President of Vault EDC, Veeva Systems

A new survey provides some interesting benchmark data that may help clinical study sites get a sense of how they’re performing.

Failure to adequately handle electronic data capture (EDC) at the front end continues to add time to trials downstream, said Hugo Cervantes, vice president for Vault EDC with Veeva Systems. His firm produced the study along with the Tufts Center for the Study of Drug Development. The study was completed by 257 clinical trial companies between May and July this year. Nearly 90% of respondents were located in the United States.

“We knew there was a problem, but the survey showed it was bigger than we expected,” Cervantes said. In some cases, EDC mismanagement adds up to a month for data retrieval later in the process. Here are some other interesting survey findings:

  • It took respondents on average nearly 69 days from beginning the time to build a study database and its release.
  • It took an average of just over eight days between the time of the first patient visit for the data to be entered in the EDC system.
  • Respondents reported it took more than 36 days from the study’s last patient visit to database lock.

Drilling down into different segments of respondents, the survey found:

  • Sponsors required just over 73 days for time to build and release a database, while contract research organizations (CROs) reported nearly 53 days.
  • Sponsors took an average of just over eight days to enter patient data, while CROs took nearly seven.

A few other data wrinkles arose from examining average time to lock a study database:

  • Taken as a group, sponsors clocked in at nearly 39 days for this task, while CROs eclipsed 27.
  • Low trial volume groups were slowest, clocking in at just over 42 days. By contrast, medium and high trial volume sites came in at a bit more than 33 days.

Protocol changes were the top culprit causing database build delays. More than 51% of CROs and more than 43% of sponsors cited that as the top cause of delay. User acceptance testing came in second, with about 12% of CROs calling it out, while nearly 19% of sponsors made the same claim.

Author: Michael Causey