In the News: An Overview

IRT Essentials

At three recent clinical trial conferences,  industry thought-leaders laid out their current prospectus for revolutionary redesigns of traditional clinical trials processes – in many cases (but not all), leveraging technological advances in the interest of new concepts and efficiencies.

Here’s a brief rundown of many of the ideas that were on the table, some of which applied to IRT (IVR/IWR), and others that addressed broader issues. Per assorted opinion leaders the industry will:

  • Move from thinking about platform ‘integrations’ to thinking about interoperability, centralization, and platform-agnostic solutions
  • Revolutionize system development to utilize ‘beyond agile’ approaches that move development prior to specification –- by this method, for example, achieve 1-2 week rapid deployment of IRT (IVR/IWR) and other systems
  • Adopt a ‘user centric’ perspective, and accommodate ‘Millennial’ user-experience demands in all systems
  • Have vendors in multiple areas of clinical trials able to provide both SaaS (self-service) and customized system options to sponsors
  • Focus on patient engagement and a ‘patient centric’ perspective, including accommodating patient advocacy groups and utilizing social media for recruitment, communications, and training
  • Set population diversity as a scientific goal for most trials
  • Achieve single sign-on within and across projects and vendors
  • Solve the problem of having multiple versions of the same software at a site
  • Move all clinical trial operations to the cloud to facilitate sharing
  • Unify data store to identify one ‘golden source’ for cooperative data mining and ensuring data integrity via ‘chain of custody’ tools
  • Unify operational analytics in line with FDA preferences
  • Increase adoption of Risk-Based Monitoring techniques and data analysis
  • Move toward ‘site-less trials’ (or ‘virtual trials’, ‘digital trials’, ‘visit-less trials’) which involve direct-to-and from-patient orientation
  • Move from controlled trials to the integration of more Real World Evidence
  • Merge Electronic Health Records (EHR) and e-source platforms with one-stop EDC
  • Achieve a variety of mobile solutions for trial conduct and BYOD capabilities
  • Leverage Artificial Intelligence in new ways to permit entirely remote management of trials
  • Utilize robotics in new ways – e.g., as patient-care nurses
  • Do away with limitations of the classic pharmacy concept – e.g., have drones deliver drugs right to patient homes!

Sound wild? Maybe… And then again…maybe not.

Look for hot topics on many of these concepts on this website in the coming weeks.

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