eClinical data volume and diversity pose increasing challenges and delays; report

The growing volume of data collected in clinical trials is contributing to longer development times and posing technical and integration challenges to clinical data management staff, according to a recently completed analysis by the Tufts Center for the Study of Drug Development.

Despite improvements and enhancements in data management technologies supporting clinical trials, during the past decade data management cycle times have gotten longer according to Tufts CSDD. The time from last patient, last visit to database lock, for example, has increased from an average of 33.4 days in 2007 to an average of 36.1 days in 2017.

"The volume of clinical data being collected from numerous and disparate data sources has grown dramatically in response to the rising scope and complexity of clinical trial protocols," noted Ken Getz, associate professor and director of sponsored research at Tufts CSDD, who led the analysis, "Drug development performance is heavily dependent on pharmaceutical and biotechnology companies, and contract research organizations (CROs), effectively and efficiently managing and integrating all of this data."

While all 257 drug developers surveyed by Tufts CSDD reported using electronic data applications in clinical trials, nearly one-third still use paper case report forms to support those investigations.