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How Design Theory Is Building Better Trials



By Allison Proffitt

February 10, 2016 | Speakers at this year’s SCOPE meeting stepped out of the clinical space to borrow innovative thinking from design houses. Applying design thinking to the clinical trials process means spending more time with patients and sites and carefully identifying problems before moving forward with solutions.

Katherine Vandebelt, senior director for Clinical Innovation at Eli Lilly and Company presented Lilly’s new approach to trial design. Using the Design Thinking process outlined at the Stanford University Institute of Design, Lilly tackled a product delivery problem.

Design thinking, as Stanford presents it, first defines the problem and then implements the solutions, always with the needs of the user demographic at the core of concept development. The five-step process empathizes, defines, ideates, builds a prototype and tests a solution. At the core of this process is a bias toward action and creation: by creating and testing something, you can continue to learn and improve upon your initial ideas.

Lilly invested significant time in the first steps, Vandebelt explained. In some cases, team members have been observing Alzheimer’s patients for three months—even spending the night—to best identify their needs.

It worked. After lots of observation and prototype-building, the Lilly team designed a new pill shape that was easy for rheumatoid arthritis patients to pick up, but still easy to swallow.

At Novartis, Jeremy Sohn, head of digital business development & licensing, is working to design thinking as well, specifically using the Human-Centered Design Toolkit from IDEO to develop operational efficiencies, but he stressed that changes must be integrated with the work. Innovation teams must not sit outside of clinical operations, he said. It’s extremely hard to innovate from outside. We must bring innovation inside the team.

Of course innovation can be scary, he conceded, so change the conversation—present a well-form plan for efficiencies. For example, don’t ask regulatory if a particular change is going to be a problem, he advised. Present a complete plan, and let reviewers alert you to any concerns.

Sohn advocated for strong leadership to move innovation forward. Look at how you may optimize all phases of the trial process, not only recruitment and protocol feasibility, he said. What about informed consent? What about patient reported outcomes?

And when it’s time to kill an idea or project, do it quickly. Be willing to say, “That sounds cool, but is it a problem we really need to solve?” he said.

CoLAB simulates about 30% of Lilly trials, explained Megan Laker, a CoLAB consultant, and design thinking plays a role in CoLAB activities.

CoLAB simulates both the site and patient experience to ensure trials are thoughtfully supportive of the patients, and can be implemented effectively by the sites. CoLAB simulates trial pain points—first dose day, screening and baseline visits, dose modifications—internally first, then invites external partners for another simulation. Vendors have been excited to come to the table, Laker said.

CoLAB simulations do take time and effort, but Laker said that is improving with repetition. Now it takes a CoLAB consultant about 20 hours to set up the simulations, and study teams are actively simulating pain points for about two days.

The time investment has been well worth it, Laker says. CoLAB trials move faster, and avoid protocol amendments. 100% of patients involved in simulations felt Lilly genuinely valued their contributions, and 75% of CoLAB trials are meeting or exceeding enrollment timelines.

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