Industry Taking Action to Unify Clinical Operations

Clinical Researcher—September 2018 (Volume 32, Issue 8)

CLIN OPS INSIGHTS

Jim Reilly, MBA

New life sciences industry research reveals there has been significant momentum toward streamlining clinical systems and processes over the past year. More than 300 clinical operations professionals from around the globe were surveyed for the Veeva 2018 Unified Clinical Operations Survey, which annually tracks the industry’s progress in improving clinical operations. Nearly all (99%) clinical leaders recognize the need to unify their clinical operating environments, and most (87%) have plans in place to get there. Here’s what we learned.

Need for Better Visibility and Faster Trial Execution

The widespread move to unify clinical environments is being driven by application and process silos that have resulted from the steady adoption of function-specific clinical technologies over the past decade. Standalone e-clinical applications, including those designed for electronic data capture (EDC), electronic trial master files (eTMFs), randomization and trial supply management (RTSM), and clinical trial management systems (CTMSs), are now the norm. Further, newer, purpose-built applications for purposes such as study start-up are gaining traction.{1}

Faced with a landscape of disparate systems and processes, more than three-quarters (77%) of those surveyed find better visibility across their clinical trial processes a top driver for unifying clinical applications. Other primary drivers include faster study execution (67%), improved study quality (62%), and increased productivity (51%) (see Figure 1).

 


Figure 1: Top Drivers for Unified Clinical Operations

 

On average, companies use four applications to manage their clinical studies, and more than one-third (38%) use at least five applications. While such applications have been critical to modernizing clinical processes in key areas, they have also created common operational challenges with application and system silos. Integrating multiple applications (74%) is the top challenge reported by both sponsors and contract research organizations (CROs), followed by reporting across multiple applications (57%) and managing content and data across them (56%).

However, the survey shows that organizations extensively using standardized operational metrics and key performance indicators (KPIs) to measure trial performance have fewer challenges than their peers across key trial processes, most notably study performance metrics and reporting (44% versus 66%, respectively), as well as visibility into TMF status (32% versus 45%, respectively). In addition, organizations using metrics are four times more likely to have programs in place to unify their clinical applications than those not using metrics (47% versus 12%, respectively).

Increased Shift to eTMF Applications to Optimize TMF Processes

With the focus to improve clinical operations, companies are looking for more advanced, purpose-built systems to impact visibility, collaboration, and compliance. The survey reveals that adoption of eTMF has grown significantly, and it is now the second-most commonly used clinical system at 66%. In fact, the number of organizations now using eTMF applications has quadrupled since 2014, with 50% of sponsors using purpose-built eTMF applications, versus 13% in 2014 and 31% in 2017.

This increase is matched by a sharp decline in the use of content management systems and file shares. This signals a shift away from general-purpose methods—typically used in “passive” TMFs—toward a mature, active TMF operating model in which TMF processes and information are managed in real time. These active TMF solutions have a positive impact on inspection readiness and trial performance. Automated document exchange and tracking replace iterative, paper-based processes, study progress is made visible to all stakeholders, and centralized oversight and use of metrics enable a constant state of inspection readiness.{2}

This new model, and the emergence of modern systems to support it, are helping to drive change in the industry. Sponsors and CROs are now looking to optimize TMF processes in order to improve inspection readiness (70%), visibility (61%), and automated tracking and reporting (57%).

Streamlining Study Start-Up Now a Major Priority

Organizations are also looking at upstream processes as an area of significant potential, focusing on study start-up and leveraging study start-up applications as major priorities. It is estimated that 70% of studies run more than one month behind schedule, costing sponsors between $600,000 and $8 million per day of delay.{3} With as many as 11% of sites failing to enroll a single patient, and another 37% failing to meet enrollment targets, poor site selection can increase the cost of trials by at least 20%.{4}

Consequently, 83% of organizations say they have initiatives under way, or will within the next year or so, to improve study start-up processes. Top drivers for improving study start-up include faster study start-up times (63%), improved site feasibility and site selection outcomes (48%), and better visibility into site performance (44%).

Opportunity to Improve Clinical Trial Performance with CTMS

With the amendments in 2016 to International Council for Harmonization E6(R2) Good Clinical Practice guidelines, companies are now required to document the rationales for their chosen trial strategies, including the use of systems and processes.{5} This may have contributed to survey respondents’ desire to improve the use of CTMS in their trial operations.

Nearly all respondents (99%) have challenges with core trial management processes, such as study performance metrics and reporting (51%), study and site management (49%), and resource management (45%). The majority (84%) also report significant deficiencies with their current CTMS applications; most have applications that cannot fully support a range of key functions, including governance and oversight (89%), resource management (88%), and issue and task management (86%). They see improving the CTMS as a way to gain greater visibility (70%), more proactive risk identification and mitigation (65%), and improved study analytics and reporting (61%).

Key Findings of Veeva 2018 Unified Clinical Operations Survey

  • Nearly all (99%) respondents report the need to unify clinical operations, and 87% say their organizations have, or plan to have, initiatives in place to do so.
  • All respondents say they want to improve the use of CTMS in study operations. Drivers are greater visibility (70%), more proactive risk mitigation (65%), and better study analytics and reporting (61%).
  • Organizations have made progress in modernizing trial processes with purpose-built applications such as eTMF, ensuring a constant state of inspection readiness (70%), increased visibility and oversight (61%), and improved collaboration (42%).
  • Consistent with the aim to improve study execution, study start-up is a priority focus. Most (83%) organizations have programs to speed study start-up (63%), streamline contract approval cycles (48%), and improve site selection (44%).
  • Organizations that use metrics (77%) report fewer challenges with clinical operations, and are four times more likely to have programs in place to unify their clinical applications than those not using metrics.
  • Those that have programs in place to unify their clinical landscapes are also more likely to use operational metrics to measure performance, manage risk, and implement process improvements.

Industry Moving Toward Unified Clinical Landscape

There is universal recognition of the importance of a unified clinical landscape in improving trial performance, and most companies are now working toward this goal. The industry sees a significant opportunity to run more efficient and effective trials by increasing visibility, quality, and speed of execution.

The majority of challenges faced by sponsors today in managing clinical trials still stem from the siloed nature of processes and applications, which makes visibility across the end-to-end trial life cycle difficult. Adoption of newer, more advanced, cloud-based applications is already having a measurable impact on visibility, collaboration, and compliance. Rationalizing systems, eliminating silos and manual processes, and having best-in-class applications on a single clinical platform are now critical steps toward unifying clinical operations.

With the growing complexity of trials and the ongoing need to improve compliance and leverage insight across the full trial life cycle in order to accelerate time to market, the industry sees unifying clinical environments as key to transforming operations – and major change is well under way.

References

  1. Markets and Markets: eClinical Solutions Market—Global Forecast to 2020 (released 2016).
  2. Veeva 2017 Clinical Operations Survey: Benefits of an eTMF by Type of eTMF.
  3. Temkar P. 2017. Accelerating study start-up: the key to avoiding trial delays. Clin Res 31(1):40–5. https://acrpnet.org/2017/02/01/accelerating-study-start-up-the-key-to-avoiding-trial-delays/
  4. Lamberti MJ, Wilkinson M, Harper B, Morgan C, Getz KA. Assessing study start-up practices, performance, and perceptions among sponsors and contract research organizations. Thrptc Innov Reg Sci. [doi:10.1177/2168479017751403] tirs.sagepub.com
  5. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (released 2016).

Jim Reilly, MBA, (jim.reilly@veeva.com) is vice president of Clinical Market Strategy at Veeva Systems.