The following post is by Nicole Sheetz, Advisor of Clinical Development Innovation and Innovation Adoption at Eli Lilly and Company. Nicole is a 15-year pharmaceutical industry professional with broad clinical development experience. She has held leadership positions in clinical project management, data sciences, scientific communications, data disclosure, clinical operations, and competitor intelligence. Nicole currently leads clinical development innovation programs that span various functions, and she is specifically responsible for implementation of innovation projects that are ready for global production and scale-up at Lilly.
I’ve been working in and around clinical trials for most of my career, and I’ve learned that all voices – the patient, the site, and the sponsor – are vital when trying to improve how we conduct research.
Patients’ views are invaluable, as they help us to understand what makes participation in trials important and feasible for them. Clinical research site professionals (investigators, site directors, study coordinators, and pharmacists) are also critical, and they play a very important role in shaping the patients’ clinical trial experience. They serve as the primary bridge between the sponsor’s goals for a trial, the healthcare provider’s care for the patient, and the patient’s needs and wishes. As a result, site professionals are able to share plenty of great insights based on their day-to-day experiences interacting with patients and conducting trials.
I work on Lilly’s Clinical Development Innovation team, and we are focused on reducing the amount of time it takes to bring innovative medicines to patients while maintaining the highest standards of patient safety, ethical practice, and data quality. We know that we cannot reach this goal alone; we need input from the people involved in all facets of the clinical trial process in order to understand what we can improve upon and how. Hearing feedback and suggestions for improvement from site professionals who are “on the ground” every day will surely help us to develop the kinds of solutions that will make a real difference for patients and for the entire clinical development process.
Our Innovation Site Advocacy Group
That’s why Lilly’s Clinical Development Innovation team recently formed a partnership with the Society for Clinical Research Sites (SCRS) and created a Lilly Innovation Site Advocacy Group (SAG) with the sole objective of connecting Lilly (the sponsor) directly with site professionals for directed collaboration and insight sharing.
SCRS was founded in 2012 to help “unify and amplify the voice of the global clinical research site community for site sustainability.” SCRS currently represents approximately 10,000 investigators at more than 1,300 sites located in 22 countries.
Our Innovation SAG is bringing the voice of the site into our work on clinical development innovation. Members of the Innovation SAG are given the opportunity to exchange feedback on improving clinical trial experiences. It’s a win-win for sponsors like Lilly and for site professionals. It gives site professionals a platform from which to share their ideas, perspectives, and experiences, and it allows us to gather valuable input to do a better job in developing innovative processes, tools, and technologies.
Creating a Better Clinical Development Ecosystem
In late July, Lilly’s Innovation SAG members were invited to the Lilly COI offices and Lilly Corporate Center for two days of learning about innovation in clinical development. These meetings kicked off what will be a long-term engagement between SCRS, site professionals, and Lilly.
All of the meeting’s activities and presentations were centered on the following question: How can we collaborate to create a radically better clinical development ecosystem?
During a tour of the Lilly CDI innovation laboratory on day 1, everyone got to see first-hand how ideas turn into tangible applications at Lilly. The feedback and input from the SAG site professionals was incredibly valuable for us; their ideas will help us to take action in multiple projects to improve what we ask the site to do and for the patient who just wants to get better.
Lilly innovators and site professionals also had the opportunity to discuss on day 2 new and innovative ideas in clinical research. A few of things we discussed were…
- simulations to help create a practical protocol,
- simulations to improve the lab equipment, kit, and shipment experience for each research site, and
- how Lilly is exploring the use of patient-centered ‘conveniences’ for parts of the clinical trial.
Thoughts from the Innovation SAG Members
We surveyed our SAG member participants after the meetings, and were pleased to see that they felt that we are truly listening and providing opportunities for them to be heard. There are still some things we need to work on, of course, but we are grateful that so many were willing to share their thoughts and ideas openly with us.
One of the most important things about innovation is that it’s never done. In order to keep developing medicines that matter to patients, we have to keep an open dialogue with all of the people who have an important stake in our work.
So, in addition to the initial 2-day session, Lilly is making an ongoing effort to stay connected to the clinical research site through our Innovation SAG. If you are a clinical research professional and want to learn more, leave us a comment. We’re looking forward to uncovering more obstacles and working on ways to overcome them, together.