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CoDESIGNing the Clinical Trial Experience Together

Megan LakerProgress in any industry comes when a person or group truly and persistently believe in an idea. My colleague, Megan Laker, is a good example. Megan, an Advisor for Lilly's Patient Experience and Design Innovation team, played a key role in the development of our CoLAB capability, which is dedicated to bringing in perspectives from clinical research sites and patients. More than five years later, Megan is now helping lead the charge as we expand the program from CoLAB to CoDESIGN, aiming to incorporate these perspectives earlier in the clinical trial design process. I recently sat down with Megan to ask her a few questions about her experience with the CoDESIGN program and the impact it has had on our clinical trials thus far.

  1. What is Lilly's CoLAB, now CoDESIGN, program and what is your role in it? The original purpose of CoLAB was to bring everyone involved in clinical research together for a “dress rehearsal” of a clinical trial protocol. To do that, we invited patients and caregivers, study coordinators and principal investigators and people in various roles among the Lilly team to walk through key components of the research study, allowing our external partners to infuse their expertise into the clinical development process. The name CoLAB reflected our goal to run a lab of sorts, experimenting with ideas and trying different things. After attending the first-ever CoLAB simulation, I felt committed to making a difference and I knew I wanted to continue playing a larger role in this work. Today, I am responsible for expanding the program, which we now call CoDESIGN. 
  2. How did the original idea for CoLAB come to light? It started in our oncology division a little over 5 years ago.  The Lilly oncology team conducted a customer survey and learned that we needed to be easier to work with: we were inadvertently making things too hard for the nurses and physicians who were conducting our research. We realized the best way to make things better was to get direct input from the people most affected. There are a few key elements that were integral to the program's success: 1) include external partners at the table, 2) be comfortable with being vulnerable and sharing draft materials for external feedback and 3) take an iterative mindset. Ultimately, our goal was to create a collaborative environment that fostered partnerships in the discovery of protocol issues and potential solutions.
  3. How did Lilly's CoLAB program evolve to CoDESIGN? Until recently, we have focused on implementation aspects of the research study. Yet what we were finding during many of the simulations was that the issues identified by the participants were rooted further upstream in the process, and we were beyond the point of being able to make some of those changes. In order to do this program right, we knew we had to make a shift beyond just operational changes towards a focus on study design. We piloted this new approach in 2017 and, while there were areas for improvement, the consensus among internal and external participants was that the pilot was a success. Moving upstream meant that we had to diversify the participants beyond clinical sites, patients and caregivers to include payers and regulatory consults, as well. Because of this shift, we changed the name to CoDESIGN. The name change reflects a broadening and deepening of the collaborative approach across various stages of our clinical development process—from strategy to study design to implementation.
  4. What is the energy like in the room during CoDESIGN simulations? It can be really stimulating! For the Lilly participants, it’s a unique opportunity to bring our whole selves to work—the professional side and the patient or caregiver side. Many of the patients who participate have never been in a clinical trial, so it’s an opportunity for them to learn a bit about drug development. The research site staff generally appreciate the opportunity to provide input directly to us, the sponsor company. When people participate in a way that is open to learning, ready to both listen and contribute, the ah-ha moments can happen and real change becomes possible. 
  5. What is one thing you've learned from your CoDESIGN experiences? We often hear feedback from external participants that is so valuable, but it sometimes feels like we would need to move a mountain to implement it. Yet what I've learned is that finding solutions to this type of feedback makes the biggest impact. For example, a study coordinator shared a pain point around a specific type of report that was adding to site burden. After taking a deeper look into the issue, we learned that many research sites were having the same experience. While it took a year and half of site surveys, meetings and never letting it go, we were finally able to revise the form, removing the trouble spot for sites. The best part of this experience was that I got to go back to that study coordinator who raised the concern during the CoDESIGN session and say, "We made this change because YOU said something." This is one example where I was able to contribute to change, but I want to do more.