Why Sponsors Hesitate To Deploy New Clinical Trial Systems

In the past decade, the high-level way in which  sponsors manage their clinical trials has changed little.

Clinical operations teams at smaller biotech companies rely on spreadsheets (and/or spreadsheet outputs from their CRO) while those at mid-sized and large pharma rely on a combination of spreadsheets and their legacy Clinical Trial Management System (CTMS).

This traditional model persists despite the following continued trends:

• The increasing complexity of clinical trials
• The increasing time and cost of clinical trials
• The increasing size and complexity of clinical trial teams

So why do many sponsors (and CROs) hesitate to improve the status quo and deploy new clinical trial systems?

After all, they run the risk of not being able to compete in a constantly changing drug development and talent landscape.  Let’s visit some common reasons:

• Setup effort
  • EDC and IXRS are critical systems are are widely used across trials.  It is typically via these systems that clin ops people gain exposure to the setup process for clinical trial technology.
    • This means, in most peoples’ minds, system setup is comprised of a long and painful series of specification reviews, decision making meetings, and user authorized testing (UAT).
    • Seascape’s stance is that while specifications, meetings, and testing are key components of technology setup, this process can be made much shorter, and simpler, with much of the work being done by the system provider, especially for systems that don’t require the very high degree of configuration that EDC and IXRS systems do.
• Maintenance effort
  • New systems require new workflows and in many cases, create more workflows instead of streamlining existing ones.
    • For example, from a clin ops employee’s perspective (especially those working on large, complex trials), the deployment of a CTMS does not remove the need for detailed spreadsheet tracking, no matter what a provider’s marketing jargon may state.
      • This means that employees must now update data in the CTMS in addition to their spreadsheets.
      • Like CTMS, many systems ultimately become another data silo that employees need to maintain data in (frequently via manual entry) and navigate to, making their trial work even more inefficient.
  • Sometimes systems or their integrations are so complicated to use that sponsors must create system-specific SOPs and other training materials.
  • Many systems require detailed and lengthy recurring trainings.
  • Seascape’s stance is that deployed technologies should be not only provide new insights and information, but without increasing work.  In fact, we believe that insights should be delivered and be easy to use, while also lowering work to a needle moving degree. 

• Negligible ROI yet much higher job complexity
  
  • Many clin ops people have used CTMS and analytics software that provide analytics, but at the high cost of efficiency (i.e. the efforts noted above).
  • Another example is spending a lot of time setting up automated alerts in a cloud-based spreadsheet timeline only to have to manage it manually in case it accidentally fires during edge cases.
• Previous negative experiences with technology
  • As humans, we are designed to look for patterns to make decisions. Clinical operations employees who have experienced any of the above are likely to write off new technologies that, on the surface, seem similar.
  • Seasoned employees may be inclined to write off any new technologies altogether.

We at Seascape Clinical understand these concerns.  After all, many of us have worked in the field, have deep understanding of it, and have experienced different systems.

That’s why we’ve taken great effort to ensure that our Clinical Operations Oversight Solution, ClinOps Pro, addresses and solves these issues for good.