Clinical Trial Data Sources Poised for Spike

New Report Predicts Massive Increase in Volume, Diversity of Data Sources Used in Clinical Trials

The volume and diversity of data sources used in clinical trials are expected to skyrocket for the rest of the decade, according to new research from Tufts Center for the Study of Drug Development. In the second report from the 2017 eClinical Landscape Study, 97% of companies say they will increase their use of at least one clinical data source to make faster, more accurate decisions during trials.

Regardless, 98% 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, the study surmises.

According to the study, life sciences companies use an average of four data sources in clinical trials today. That figure will nearly double in the next three years, with 70% of companies planning to use a new data source that they are not leveraging today. The survey was sponsored by Veeva Systems.

The survey also found nearly 93% of respondents expect to use eInformed consent data, up from 62% today. A majority of companies also plan to use mHealth and smart phone data, with each increasing 47%, and eSource data rising 46%.

Contract research organizations (CROs) report they plan to use more data sources than sponsors, and 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, companies in 2017 are primarily managing electronic case report form (eCRF) data in their primary electronic data capture (EDC) system. Over the next three years, 93% of respondents aim to use electronic patient reported outcomes (ePROs) and electronic clinical outcomes assessment (eCOA) as sources, but today such data make up only 4% of the total data managed in EDC. Similarly, 76% plan to use mHealth data as a source, but only 10% are currently managing such data in their primary EDC application and it represents just 0.3% of the total data managed in EDC.

About 30% of respondents cited cycle time, including time from protocol completion to first patient, first visit (FPFV) and time from last patient, last visit (LPLV) to database lock as the biggest budget challenges with clinical data management systems today.

Loading data into the primary EDC application is an issue for 77% of sponsors and CROs, and 66% of those point to EDC system or integration issues as the main cause.

Author: Michael Causey