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.