BOSTON & PLEASANTON, Calif.—The volume and diversity of data sources used in clinical trials are expected to increase significantly over the next three years, according to new research from the Tufts Center for the Study of Drug Development, bringing complications as well as potential advantages.
In the “2017 eClinical Landscape Study: Assessing Data Management Practices, Performance, and Challenges” survey report, one of the largest, most in-depth surveys of clinical data management professionals, 97 percent of companies say they will increase use of at least one clinical data source to make faster, more accurate decisions during trials. However, 98 percent of respondents currently report challenges with their clinical data management systems, indicating that companies will need to be better prepared to collect and analyze the growing volume of real-world patient data available from a variety of sources.
“Clinical trial complexity is challenging scientific, operating and technology solution domains,” said Ken Getz, research associate professor and director at the Tufts Center for the Study of Drug Development. “At the same time that clinical teams are managing traditional data from case report forms and local and central labs, they are being forced to step out of their comfort zone to manage, integrate and analyze data from more diverse and less compatible sources, including smartphone and wearable devices, real-world evidence and social media.”
According to Tufts, life-sciences companies use an average of four data sources in clinical trials today. In three years, the number of data sources utilized is projected to increase to six, with 70 percent of companies planning to use a new data source that they are not leveraging today.
The survey also showed very significant changes in the range of clinical information organizations plan to use in the next three years. Nearly all (93 percent) respondents expect to use electronic informed consent data (up 62 percentage points from today). A majority of companies also plan to use mobile health and smart phone data (each increasing 47 percentage points) and e-source data (increasing 46 percentage points).
Significant differences were also observed when comparing company type and size. CROs report they plan to use more data sources than sponsors. Similarly, those with the highest trial volumes (greater than 15 trials per year) say they will use more sources of clinical data within the next three years compared to those with lower trial volumes.
While the industry expects to leverage a greater range of patient data in clinical trials, today companies are primarily managing electronic case report form (eCRF) data in their primary electronic data capture (EDC) system. In three years, 93 percent of respondents aim to use electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) as sources, but today that data makes up only 4 percent of the total data managed in EDC. Similarly, 76 percent plan to use mobile health data as a source, but only 10 percent are currently managing it in their primary EDC application, and it represents just 0.3 percent of the total data managed in EDC.
The majority of data in EDC (78 percent) is eCRF, which only provides one dimension of data into a patient’s overall health. Moving forward, to collect and analyze a higher volume and variety of electronic data beyond just eCRF, there will be a greater need for EDC applications to better access and centralize clinical information.
When asked about the single biggest challenge with their clinical data management systems today, most respondents cite cycle time (30 percent). Cost was the second most prevalent challenge among respondents (29 percent), followed by the number of clinical systems (18 percent). The amount of companies that cite “number of systems” as their single biggest challenge rises to 28 percent as trial volume increases. Respondents with high trial volumes have seven applications versus four for those with low trial volume. As companies manage more trials, the ability to unify applications and processes will become increasingly important in improving trial efficiency.
Specific to EDC, loading data into the primary EDC application is an issue for the majority (77 percent) of sponsors and CROs, and 66 percent of those point to EDC system or integration issues as the main cause. Data loading challenges risk becoming a larger problem as companies utilize more data from more sources over the next three years.
