According to a survey recently released by Tufts Center for the Study of Drug Development, ‘2017 eClinical Landscape Study’, the length of time it takes companies to build and release a clinical study database (68 days on average) is having a negative effect on trial completion.
Survey
“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 enrolment is associated with longer downstream cycle times at the investigative site and at study close out.”
The aim of the research was to understand current clinical data management practices and assess the performance and challenges of electronic data capture (EDC) systems. It includes the insights and opinions of 250 clinical data management professionals, making it one of the largest clinical data management studies to date.
All respondents stated that they employed EDC systems, followed by randomization and trial supply management (77%), electronic master file (70%) and safety (70%) systems. Just more than half (58%) of respondents specified that they used Medidata Rave or Oracle Inform as their primary EDC system.
The type of data managed in the EDC systems was specified as electronic case report form (eCRF) data (100%), followed by local lab and quality of life data (60% each). However, respondents also revealed that 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 with remaining data types reported at 4% or less. These figures demonstrate 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%) cited that they have issues loading data into their EDC application and most (66%) claimed that EDC system or integration issues are the primary reasons they are unable to load study data.
Additionally, the survey revealed several common causes for clinical database build delays: Protocol changes were cited by the largest proportion of respondents (45%); which highlights the need to optimise the database design process with standards and systems.
“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. “Organisations 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.”
The ‘2017 eClinical Landscape Study’ from Tufts Center for the Study of Drug Development was sponsored by Veeva Systems.