Looking for order in chaos

PLEASNTON, Calif.—It is a paradox. The benefits that are supposed to accompany increased availability of technology to capture data in the life-sciences realm are not materializing. In fact, the widespread use of technology in data collection and management has led to increased fragmentation of data processing and, in turn, slowed the entire clinical trial process. Two recent industry surveys conducted by Veeva Systems Inc. delve into the problems posed by using diffuse technologies throughout the clinical trial process and explore ways data professionals might reverse the trend of slowing science.

Study data used to be collected on paper, which was a slow and cumbersome method, but one that enabled a fairly seamless integration of many data points from different sources. The introduction of online electronic data capture (EDC) systems promised quicker access to data, greater data security, greater accuracy and organization and better compliance with regulatory requirement—all at a lower cost. The golden age of EDC systems has not been reached, however, due to a haphazard adoption of wildly divergent technology that paradoxically requires more time and human intervention in order to sync information.

Working with Veeva Systems, researchers from the Tufts Center for the Study of Drug Development surveyed data management executives to identify the root causes of delays and inefficiencies impacting clinical trials. Based on their 2017 survey of 257 organizations, and one-on-one interviews with 40 high-level executives, they found that protocol design changes, data management delays and the incompatibility of various technologies to be among the greatest contributing factors to slowing timelines.

“Protocol design is taking longer to finalize and undergoing more iterations, creating challenges in data management and overall trial efficiency,” explained Ken Getz, research associate professor and director at the Tufts Center for the Study of Drug Development. “Also, data volume supporting clinical endpoints is rapidly increasing. More data comes from sources other than eCRF and lab data, creating substantial integration and coordination difficulties for data management.”

The Trial Timeline Study was augmented by the 2018 iteration of Veeva’s Unified Clinical Operations Survey, which examines the life-sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 331 clinical operations professionals from around the globe. This research examines the drivers, barriers and benefits of a unified clinical operating model and tracks the industry’s progress in its move to streamline clinical systems and processes. Not surprisingly, given the rise in disjointed technology, the need to unify clinical trial operating environments emerged as a primary concern.

According to Richard Young, vice president of Veeva Vault EDC, today’s clinical trials have moved from one- or even two-dimensional exploration to a fast-paced three-dimensional environment, with studies changing focus, timelines or participants many times between design and outcome.

Respondents to the study demonstrated the urgency of the problems of technology and trial speed with three key metrics:

• 87 percent of clinical leaders reported they have already taken action, or intend to take action in the next 12 months to unify information systems
• 83 percent of respondents are taking, or intend to take within the next 12 months, concrete actions to reduce the start-up time for new studies and streamline the study launch process
• 77 percent intend to introduce stronger KPIs (key performance indicators) to pinpoint why a trial may not be working sooner, and allow for faster, less disruptive adjustments to a trial.

Jim Reilly, vice president of clinical market strategies at Veeva, cited Peter Drucker’s well-known adage: “If you can’t measure it, you can’t improve it.” Reilly feels that the combination of regulatory pressures catching up with clinical trials, coupled with promising platforms on the horizon to better synchronize data, will lead to improvements in clinical operations. When detailed metrics are applied and key markers can be found for why a trial isn’t working, trials can be altered and fixed quickly and cost effectively. “We see from the study there is a real catalyst to recognize the business optimization of a unified clinical landscape,” says Reilly. “It drives business efficiency, reduces timelines and lowers costs.”

Veeva has introduced a potential tool in data unification with its Vault EDC, which enables data management teams to integrate data from a variety of sources and systems via a single cloud-based application. Veeva’s Young likens the Vault EDC to a smartphone operating system, able to communicate between many different applications and translate various coding to a common, user-friendly interface to synthesize data.

“There is tremendous opportunity to address the limitations of traditional data collection to accelerate clinical trial timelines,” said Henry Levy, chief strategy officer at Veeva. “As the number of data sources continues to rise, data management teams will have a greater need to see all their clinical data, at all times. Veeva’s vision is to help organizations seamlessly bring their data together throughout the course of a trial and make the transition to risk-based trials where data is collected and analyzed for a current, holistic view of the patient.”