Clinical trials are generating more data than ever and researchers need systems capable of recording, storing and managing the additional information, says tech firm Medidata.
The Dassault Systèmes-owned trial software systems developer made the comments to coincide with the launch of enhancements to its monitoring and study management platforms it says will help sponsors and CROs handle larger data volumes.
“Today’s clinical trials are faster and have vastly more data than ever before, creating opportunities for quicker development of new therapies and improved patient experiences," said Lisa Moneymaker, senior vice president R&D, Clinical Operations Technologies at Medidata. “All of this requires a seismic shift in how clinical operations teams can—and should—monitor and report on those data to derive actionable insight."
The enhancements consist of role-based data access, site performance review and protocol risk monitoring system and a visual analytics module.
Medidata’s comments about increasing data volume are in keeping with the findings of a study by the Tufts Center for the Study of Drug Development. The research, which was based on 220 recently completed protocols, suggests that phase 3 clinical trials generate an average of 3.6 million data points, roughly three times the volume of data collected by late-stage studies a decade ago. The study also showed that phase 2 and 3 protocols currently involve an average of 263 procedures per patient, supporting approximately 20 endpoints, which is an increase of 44% since 2009. In addition, the average number of investigative sites conducting phase 2 and 3 protocols increased 33% from 2009-2012 to 2017-2020.
The Tufts team attributed the data surge to increasing protocol complexity with industry’s focus on rare diseases as well as greater use of biomarkers and patient stratification being major drivers.
Other tech firms have also recognized the increase in data being generated during drug clinical trials. Earlier this month Arkivum said the drug industry must invest in more effective management and preservation technologies to ensure the integrity of clinical data. And just last week, Florence Healthcare said $27 million raised through a recently completed fundraising round would support the expansion of its tech platform to meet growing demand for digital trial management technologies.