Clinical Operations Professionals Vexed by Industry Fragmentation

New Report Details 'Unification' Initiatives in Clinical Research

New Report Details 'Unification' Initiatives in Clinical Research (Img: Veeva Systems)

Practically everyone’s pursuing the Holy Grail of “unity” in research, according to the Veeva 2018 “Unified Clinical Operations Survey” unveiled today (June 25) at the DIA 2018 conference in Boston. More than 90% of the 331 clinical operations professionals surveyed worldwide said their organizations have a plan in place to get there.

The top drivers for unification are to improve visibility and oversight (77%), enable faster study execution (67%), and improve study quality (62%). Other interesting survey findings include:

  • An average of four applications are used to manage the respondents’ clinical studies, and more than one-third (38%) use at least five applications.
  • Integrating multiple applications (74%) is the top challenge resulting from application and process silos, followed by reporting across multiple applications (57%) and managing content and data across applications (56%).
  • Clinical applications are common today, with those designed for electronic data capture (90%), electronic trial master file (eTMF) (66%), randomization and trial supply management (61%), and clinical trial management system (60%) purposes being the most commonly used.
  • Those extensively using standardized operational metrics and key performance indicators to measure clinical trial performance, manage risks, and implement process improvements report fewer challenges across key trial processes, including study performance metrics and reporting (44% versus 66%, respectively) and visibility into TMF status (32% versus 45%, respectively).
  • Organizations using metrics are four times more likely to have programs under way to unify their clinical applications than those not using metrics (47% versus 12%, respectively).
  • The concept of streamlining study start-up processes is gaining traction, according to the survey, with 83% of respondents reporting their organizations have a study start-up improvement initiative under way.
  • More than half of respondents (53%) report site contract and budgeting among the most challenging study start-up processes that limit their organization’s ability to speed clinical trials, followed by institutional review board and ethics committee planning and approval (45%) and site identification and selection (41%).
  • More than half of respondents (63%) cite faster study start-up times as the primary driver for improving study start-up processes, followed by streamlining site contract and budgeting approval cycles (49%) and improving site feasibility and site selection outcomes (48%).

The life sciences industry is at a tipping point, says Dr. Jeff Kingsley, founder and CEO of IACT Health. The complexity of trials with multiple primary endpoints, large number of outsourced partners, and data-sharing challenges amongst investigators and other stakeholders have contributed to the current state of the industry.

“Too many technology barriers, layers of participants, and endpoints in clinical trials hinder collaboration and communications,” Kingsley says. “We’re at a breaking point where people, processes, and technology must change [for the industry] to continue to innovate.”

Author: Michael Causey