Reducing Risk in Decentralized Trials: Part 2 - Practice Makes Perfect

Reducing Risk in Decentralized Trials: Part 2 - Practice Makes Perfect

In Part 1 of this series on Reducing Risk in Decentralized Trials, we covered 7 key issues that Sponsors need to consider when designing a #DCT. In this installment, let's talk about how best to mitigate and even eliminate that risk through self-serve, Digital Design...and practice.

Let’s first define self-serve Digital Design.  In a nutshell it means you as the Sponsor have unlimited capability to design a wide variety of real and technical UX/UI to make your study a reality.  Remember, a DCT means more people are involved while not being colocated.  As such the UX needs to be tightly orchestrated between and amongst people who are not in earshot of each other.  They can’t rely on real-time verbal/nonverbal communication or brick and mortar business processes.  When these ways of collaborating and communicating are gone, designing a trial “on paper” and then handing it off to a tech enabled service will have little chance of succeeding.

Designing digitally, yourself, means you can tightly orchestrate and practice the real workflow and graphical user interface that each person in the study will need to faithfully execute their activities, whether it be a blood draw, ePRO, or a physical exam. It also relieves pain points you only thought you had to live with. Imagine being able to:

  • Design and practice subsections of the study UX/UI and get them right in an agile method
  • Work more closely with patients during design to optimize their experience beyond reading words and bullet points, using the real UI
  • Pressure test key 3rd party tech and personnel collaborations well before going live
  • Design alternatives so you are ready for any potential, testable failure modes, as well as regulatory/executive management decisions that may affect the study design
  • Having all your designs in a library for future use, increasing your efficiency exponentially

Conversely, relying on a tech enabled service typically means Sponsors must have all their ducks in a row and the study completely finalized on paper before engaging.  Each study has a net new cost and engaging early and often is hardly ever free.  Certainly, preliminary and iterative 3rd party UI builds and revisions will incur costs. This sequential waterfall method of operational study design is old hat, wasting both time and money.  

There is a better way to get DCTs right. Indeed, practice can make perfect.

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