BOSTON, March 17, 2020 (GLOBE NEWSWIRE) -- Rapid growth in data volume and the diversity of data sources are leading drug developers to plan and adopt data management strategies and tactics to help them improve clinical trial speed, efficiency, and quality, according to a newly completed analysis by the Tufts Center for the Study of Drug Development.
"Digital transformation continues to unfold across the drug development enterprise, with growing demand for larger and richer scientific and operating data," said Ken Getz, professor and deputy director of Tufts CSDD. "Sponsor companies are implementing data strategies and new data management mechanisms to align companywide demand, governance, and execution."
About one-third of sponsors have implemented a data strategy to date, according to the Tufts CSDD study, with half of all sponsors who responded to a global survey indicating they are considering or planning to implement a data strategy.
The presence of a formal data strategy—defined as high-level road maps guiding and aligning an organization's needs and use of clinical research data—is associated with faster time to lock a clinical trial database, Getz said.
Medium sized sponsors (those conducting six to 50 clinical trials annually) and large sponsors (51-350 clinical trials annually) are twice as likely to have implemented a formal data strategy, compared with small sponsors, according to Tufts CSDD.
Other key findings summarized in the March/April Tufts CSDD Impact Report, released today, include the following:
- More than two-thirds of all sponsors are using or piloting at least four different data sources to support the conduct of each clinical trial.
- Initiating external data vendor relationships is rated as the most time-consuming data management task; data integration is cited as least time consuming.
- Sponsors rely on a range of data tools and techniques to integrate and organize clinical trial data; clinical data hubs and repositories are the most widely used.
- Nearly three out of four sponsors are establishing data science disciplines or expanding the role of data scientists in their organizations.
ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Contacts: Tufts University
Geraldin Batista – 617-636-0840
Geraldin.Batista@tufts.edu
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Peter Lowy – 617-734-9980
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