Veeva Systems, Inc. Release: Industry Survey Reveals Clinical Data Management Delays Are Slowing Trial Completion

Published: Sep 22, 2017

83% of life sciences organizations release the clinical database after first patient, first visit, which is associated with downstream delays of up to a month in key data management activities

BOSTON and PLEASANTON, CA — Sept. 21, 2017 — One of the largest, most in-depth surveys of clinical data management professionals shows that the time it takes companies to design and release clinical study databases is having a negative impact on conducting and completing trials.

According to the 2017 eClinical Landscape Study from Tufts Center for the Study of Drug Development, it takes companies an average of 68 days to build and release a clinical study database. Delays in releasing the study database are associated with an increase of nearly a month downstream for other data management processes such as patient data entry and time to lock the database at the end of the study. Respondents that deliver the database after first patient, first visit (FPFV), take nearly twice as long to enter patient data throughout the study and about 75% longer to lock the study database when compared to those that deliver the final database before FPFV.

“The study results indicate that companies face a growing number of challenges in building and managing clinical study databases,” said Ken Getz, research associate professor and director at the Tufts Center for the Study of Drug Development. “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."

Electronic Data Capture (EDC) Providers and System Use

EDC is the most widely adopted clinical application, used by all respondents (100%), followed by randomization and trial supply management (77%), electronic master file (70%), and safety (70%) systems. A majority (58%) of respondents use either Medidata Rave or Oracle Inform as their primary EDC system.

When asked about the type of data managed in their EDC, all (100%) CROs and sponsors cite electronic case report form (eCRF) data, followed by local lab and quality of life data (60% each). However, respondents say eCRF data is the highest volume of data they manage in their EDC system (at an average of 78% of the total data managed). The next highest data volumes reported are central lab data and local lab data at 5% each. Remaining data types reported are each 4% or less. This demonstrates the need for processes and systems to support the industry’s vision to have complete study data in their EDC.

More than three-quarters (77%) say they have issues loading data into their EDC application and most (66%) say EDC system or integration issues are the primary reasons they are unable to load study data.

Impact of Database Build Delays on Trial Cycle Times

The survey finds several common causes for clinical database build delays. Protocol changes is cited most by 45% of respondents, underscoring the challenge data management professionals have in dealing with changes as they are finalizing 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.

Initial database delays also have significant downstream impacts on the time it takes sites to enter patient data in the EDC throughout the trial, as well as the final lock of the database once the study is complete. It takes on average five days from patient visit to when the data is entered into the EDC for companies that release the database before FPFV. When the database is released after FPFV, data entry time doubles to 10 days.

The impact of database build delays is even greater by the time companies get to database lock. Those who always release the database before FPFV get to database lock in an average of 31 days. Those who never release the database before FPFV take more than three weeks longer (54 days) to lock the database.

Sponsors take roughly 40% longer than CROs to build the database (73 vs. 53 days) and to get to database lock (39 vs. 28 days). Also, those using the two leading EDC systems report roughly 20% longer data cycle times (123 days) than those using other EDC systems (99 days), which includes time for database build (75 vs. 60 days), patient data entry (9 vs. 7 days), and database lock (39 vs. 32 days).

“Database build processes have remained largely unchanged over the past 10 years, and the process will only get more complicated as CROs and sponsors manage an increasing variety of clinical trial data,” said Richard Young, vice president of Veeva Vault EDC. “Organizations compensate for technology limitations by reducing the volume of data they input. Our focus should be on improving EDC systems so sponsors and CROs are no longer limited, and instead can run the trial they want.”

The 2017 eClinical Landscape Study: Assessing Data Management Practices, Performance, and Challenges from Tufts Center for the Study of Drug Development, sponsored by Veeva Systems (NYSE: VEEV), reviews the state of data management in life sciences with an in-depth look at the insights and opinions of clinical data management professionals at more than 250 companies, including sponsors and CROs, with an average of 17 years of experience in clinical data management. Download the report at veeva.com/EDCSurvey.

To learn more about the findings, see the presentation from Ken Getz, research associate professor and director at the Tufts Center for the Study of Drug Development, and Richard Young, vice president of Veeva Vault EDC, at the SCDM 2017 Annual Conference on Monday, Sept. 25 at 3:00 p.m. in the exhibit hall.

About the Tufts Center for the Study of Drug Development

The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. 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. For more information, visit csdd.tufts.edu.

About Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 550 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit veeva.com.

Roger Villareal
Veeva Systems
925-264-8885
roger.villareal@veeva.com

Rachel Stanton
Tufts Center for the Study of Drug Development
617-636-2170
rachel.stanton@tufts.edu

Lisa Barbadora
Veeva Systems
610-420-3413
pr@veeva.com

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