Most Trial Companies Satisfied with Their EDC Solutions and Providers, Survey Shows
Despite no improvement for the past three years in the amount of time it takes to complete certain key processes in a clinical trial, most organizations are satisfied with their electronic data capture (EDC) solutions and providers, according to a global survey by the Tufts Center for the Study of Drug Development (CSDD), with collaboration and funding from IBM Watson Health.
More than 12 different EDC solutions were identified by the survey’s 194 respondents. Most organizations (73.9 percent) reported using two or more solutions, while the remaining 26.1 percent reported using only one. The typical respondent noted 3.3 different pain points associated with their primary EDC solution. Planned (56.5 percent) and unplanned (48.4 percent) mid-study updates and their associated delays topped the list of pain points, followed by flexibility and customization challenges (43.6 percent).
Although 32.3 percent of respondents cited database go-live delays as a key challenge, the survey found that the cycle time between final protocol approval and the database go-live milestone both increased slightly the past three years. First protocol approval to database go-live was 69.4 days in the new survey, compared to 68.3 days in a survey conducted in 2017. Last patient, last visit (LPLV) to database lock also grew to 36.8 days, up from 36.3 days.
The survey found that managing a mid-study update requires about half of the total time needed to achieve the initial go-live release of the database, which explains why such updates are listed among the top pain points. But the survey also revealed that smaller organizations, which were classified as organizations that performed fewer than 50 trials a year, were faster at early-stage data management processes, while larger organizations were faster in late-stage processes.
Despite the challenges, 98.3 percent of respondents said they were satisfied with data collection from their EDC solution. Database design (92.9 percent), database closeout (89.5 percent), the overall end-to-end process (88.1 percent), and database processing and cleaning abilities (83.3 percent) also received high satisfaction marks. Managing mid-study updates was at the bottom of the list, with a satisfaction rate of 67.2 percent.
EDC solutions received high satisfaction marks for their ability to reduce the number of manual errors (84.1 percent) and to avoid costs in managing mid-study updates (82.3 percent), while fewer respondents (75.8 percent) said they were satisfied with their solution’s ability to reduce delays in managing mid-study updates. All respondents said they were satisfied with how their EDC systems handled data capture, randomization and endpoint adjudication, and more than 90 percent of respondents said they were satisfied with their data integration, inventory management, query management, medical coding and electronic consent capabilities.
The survey, conducted between September and October 2020, can be viewed here: http://bit.ly/3qz5XVR.