Tufts CSDD Study Reveals Increased External Data Sources Contributing to Delays in Trial Completion

With the increased number of data sources being used in clinical trials, life sciences organizations are exploring new ways to gain better insight, early access and greater control over their clinical data. According to The Tufts-eClinical Solutions Data Strategies & Transformation Study, conducted in 2019 by eClinical Solutions LLC and the Tufts Center for the Study of Drug Development (Tufts CSDD), the increasing volume and diversity of external data sources is contributing to longer database lock cycle times. Large pharmaceutical companies are experiencing the greatest delays, showing a 32 percent increase in time from the Last Patient Last Visit (LPLV) Database Lock since the last study done in 2017. Overall cycle times for this metric have increased by an average of six days over the last two years and current trends only indicate further increase, if unresolved. 

The time-consuming and labor-intensive nature of handling more diverse data sources has highlighted the need for the industry to adopt new technologies and methods for organizing and managing data. 

"While new types and sources of data have created tremendous opportunities to gain deeper insights in clinical research, this study clearly illustrates the challenges and resulting chaos that life sciences organizations face today in dealing with this inundation of data," said Raj Indupuri, CEO of eClinical Solutions. "The findings also demonstrate the positive impact a robust end-to-end data strategy coupled with modern technology infrastructure have on decreasing cycle times and advancing analytics capabilities for data-driven decision making. Companies that are defining their data strategies and utilizing clinical data hubs are faring better than those that do not have these capabilities in place.”

“The results of this study show that sponsor companies are in transition with regards to managing rapid growth in the volume and diversity of scientific and operating data,” said Ken Getz, Deputy Director and Professor at Tufts CSDD, Tufts University School of Medicine. “All organizations are adjusting and adapting to better leverage this data with larger companies generally farther along in implementing data strategies, new mechanisms and infrastructure.”

Other key findings from The Tufts-eClinical Solutions Data Strategies & Transformation Study include:

• Over two-thirds of all sponsors are using or piloting at least four types of data in clinical trials.

• Only one-third of sponsors have implemented a formal data strategy.

• Approximately a quarter of sponsors overall have formal data governance policies and processes in place.

• The vast majority (87-93 percent) of sponsor companies understand the benefits of a formal data strategy. Those that have implemented a data strategy have seen a six-day improvement from the LPLV Database Lock, compared to companies with no formal strategy (36.1 days vs. 41.8 days).

• Sponsors rely on various data tools and techniques to integrate and organize clinical trial data, but clinical data hubs and repositories are the most widely used.

• Nearly three out of four sponsors are establishing a data sciences discipline or expanding the role of the data scientists in their organizations.

Clinical data are among the most valued assets of life sciences companies and are the fuel for digital transformation. As this study indicates, industry leaders are adopting definitive data strategies along with modern technologies to increase control over the research process and leverage new data streams to shape the future of research.