Lilly employee Coleman Gerstner presents a concept for improving adherence at the Adherence Summit.
The following post is by Ken Savin, Advisor, Clinical Innovation at Eli Lilly and Company. Ken received his Ph.D. from the University of Utah in 1996 and came to Lilly in 1998 from the Memorial Sloan Kettering Cancer Research Center as a senior organic chemist. He worked on several projects as a medicinal chemist in the areas of anxiety, depression and inflammatory disorders, and he has been involved in many cross-functional Lilly research collaborations. Some of Ken’s recent efforts include the NASA – Lilly collaboration, an outgrowth of the InnoCentive program and a recent Innovation Day event. Through these programs, he continues to reach out to other organizations internally and externally as part of a broader open innovation effort.
Every day we see some evidence that the culture of medicine is changing. Paternalistic approaches to providing healthcare are becoming less and less acceptable as patients have begun to make good use of the medical information and community support networks available on the Internet. If we, as drug developers, want to provide the best possible care and the best possible medicines, it just makes good sense for us to listen to people and carefully consider what works best from their standpoint.
Adherence, the idea of whether or not a patient is following a treatment regimen as directed, is one of many complex issues within drug development for which we could use more insights from patients and caregivers. It has been estimated that three out of four Americans do not take their medications as prescribed. Even in clinical trials, where adherence rates tend to be relatively high, investigators report average adherence rates of only 43 to 78 percent among patients receiving treatment for chronic conditions. This can lead to poor health outcomes for patients, and unreliable results in a clinical trial.
Joseph Kim serves as a Senior Advisor in Clinical Development Innovation at Lilly, focusing on developing and implementing innovative patient engagement solutions. He has spent over 15 years in the Pharma industry utilizing a unique approach that integrates his experiences working for Sponsors such as Shire and Merck, CROs, and technology vendors.
Joseph has a robust combination of experience that includes early and late phase clinical research, and a well known history of innovation in the clinical research industry, recognized as one of “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova. He can be reached at firstname.lastname@example.org and on Twitter.
Tell us a little bit about yourself and how you got started in clinical research.
For starters, you should know that I did not come to clinical research through any natural career path. In fact, I had two other careers as a social worker and high school science teacher before landing in clinical research. My first role was as an entry level data manager. Quite comfortable with trying things on and pivoting quickly, my instinct was, “This isn’t for me either.” Given that I worked for a large pharma company (Merck), I was able to quickly learn about other roles and try them on too. My next move was as a garden variety study manager in psychiatric research. This was the old model, where it was you and a medical monitor doing everything from writing the protocol, to selecting sites, to reviewing data, to paying grants.
The LVJJstudy.com website is a pilot project to improve how we inform patients about clinical trials.
At Lilly COI we spend plenty of time exploring the future of clinical trials. We continue to explore clinical trial matching, Internet-based studies, mobile health in trials, and other possibilities. Though we are excited by these possibilities, we also know that it will take some time for possibilities to fully morph into practicalities. Technologies need to improve, regulatory questions need to be answered, and clinical trial models need to evolve. Meanwhile, patients are in great need of an improved clinical trial experience today. We can’t ask patients to wait on a convergence of ideal conditions, especially when there are feasible improvements that we can make now.
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.