Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials

Learn how top pharmas and CROs plan to speed database build and data collection, as well as their top challenges and future priorities.

An extension of the Tufts eClinical Landscape Study, this report reveals underlying challenges impacting trial timelines and solutions to improve trial execution, through in-depth interviews with clinical data management leaders.

Volume and Diversity of Data Sources to Significantly Increase

97% of companies expect to use more clinical data from a wider variety of sources over the next three years, and 70% plan to use a data source in three years that they are not currently using today. However, the majority (77%) have challenges loading data into their EDC system, signaling an opportunity for companies to improve their data management processes in order to manage this data growth.

98% of Companies Are Facing System Challenges

Nearly all (98%) clinical data management professionals report challenges with their clinical data management applications. When asked about their single biggest challenges, cycle time – including time from last patient, last visit (LPLV) to database lock – is the biggest challenge cited (30%). The time it takes from LPLV to database lock is approximately 36 days, which, despite efforts to shorten, is longer than it was over 15 years ago (36 days vs. 33 days).

“The overall volume of data we collect is rising dramatically as we take advantage of mHealth to accumulate billions of data points per patient. Having a modern EDC system to bring this data together will be key to making accurate, real-time decisions and accelerating our clinical trials.”
- Scott Fisher, Ph.D., Executive Director of Emerging Therapies, Intrexon Corporation
Protocol Changes are Top Cause for Database Build Delays

45% of respondents say the most common cause for database build delays are protocol changes, underscoring the challenge data management professionals have in dealing with changes as they finalize the clinical trial database for the start of the trial. This highlights the need to optimize the database design process with standards and systems that support more flexible design and rapid development.

Delay in Releasing EDC Slows Clinical Trials

The up-front time it takes to build and release the clinical database has potentially significant impacts on downstream processes, including time to enter patient data in the EDC and time to final database lock after last patient last visit.

  • If the database is released before first patient first visit (FPFV) the time to input data into the EDC is 5 days and the database lock time is 31 days.
  • If the database is released after FPFV, data entry time is 10 days and time to database lock is 54 days.

“The study results indicate that companies face a growing number of challenges in building and managing clinical study databases. The results also show that the release of the clinical study database after sites have begun enrollment is associated with longer downstream cycle times at the investigative site and at study close out.”
— Ken Getz, Research Associate Professor and Director, Tufts Center for the Study of Drug Development