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.
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, and sifted through data on trial activation.
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 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
Additional Links:
Read the Final Report shared with the executive team
