Designing a User-centered Clinical Trial Activation process

Designing a User-centered Clinical Trial Activation process

Client:

Penn Medicine, Office of the SVP & COO

Problem

Clinical Trials are necessary for drugs and devices to be tested in the health system before being broadly distributed. Physicians wanted to try promising therapeutics with their patients, but the health system’s process for on boarding new trials was extremely difficult and frustrating to navigate. 

The health system decided to hire an outside consulting firm to recommend changes. But first, they asked me and my team at the Innovation Center to apply a design-thinking approach to the problem. What recommendations would we make to improve the process through design?

 The current process was a frustrating web of approvals and boards. Physicians wanted nothing to do with it.

The current process was a frustrating web of approvals and boards. Physicians wanted nothing to do with it.

My Role

Innovation Experience Design Lead:

  • User research
  • Problem Definition
  • Inter-disciplinary discussions
  • Ideation of Solutions
  • Executive Presentations

PROCESS

I conducted user interviews with a variety of physicians on their experience in clinical trial on boarding. I also read past briefs on the problem, consulted with operational staff, sifted through data on trial activation, and conducted a landscape analysis of trial processes at other academic medical centers, like Duke.

 My deliverable: a report that detailed the many boards and regulatory systems, versus the recommended design

My deliverable: a report that detailed the many boards and regulatory systems, versus the recommended design

The summary observation from the engagement was that the clinical trials process at Penn had evolved into one that seems designed to prioritize the many committees that serve important internal and external regulatory needs. But there is much isolation and division of those processes. As a result, the system does not operate to serve the central user first; it creates an arduous process for the principal investigator and staff.
 

OUTCOME

My final report delivered to our Chief Medical and Operation Officers gave user-centered advice to address the problem. With creative analogies to Nintendo game design, leap-frog innovations with cell phones in the developing world, and scavenger hunts, the final report, written with my MD director, gave practical strategies for placing the physician, rather than the regulatory boards, at the center of the user experience.

 A user-centered process would have a few, clear steps for the principal investigator to walk through

A user-centered process would have a few, clear steps for the principal investigator to walk through

Additional Links:

Read the Final Report shared with the executive team

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