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.
Photo by Standford Medicine X
On July 30, an article in the Wall Street Journal titled “Clincal Trials may be Compromised by Online Patient Chatter” prompted a lot of discussion among patients and researchers on Twitter. At the heart of the article is a concern shared by many sponsors and researchers: By discussing their participation in trials through blogs, social media, and online forums, patients may be unblinding themselves and compromising the scientific integrity of the studies.
While this is a legitimate concern,and something that should be addressed with input from patients and patient communities, it’s important to remember that open communication online can be just as much—if not more— of a value to clinical research than a threat.
That’s one of the reasons why I’m excited about the opportunity to present at Medicine X. I’ll be talking about about some of things my Lilly COI colleagues and I have learned through our journey into social media, connecting with people and engaging them in clinical research.
Click the image to view the infographic.
Tom Krohn recently wrote about our efforts to share more useful clinical trial site contact information with the public on ClinicalTrials.gov. Many of you—as a patients, caregivers, researchers, or curious citizen scientists—may have already visited ClinicalTrials.gov to explore clinical trials. But, for those who haven’t, or for those who would just like know more, we thought it might be helpful to look into the site’s origins and intentions with our latest infographic.
“Internet informed patient symposium” by Sebastiaan ter Burg is licensed under CC-BY-SA 2.0
Since Lilly COI’s inception, we’ve been fortunate to meet with many patients and caregivers, who generously took the time to share with us the knowledge and insights they’d gained through their efforts to find and participate in clinical trials.
When we’ve asked them to tell us about some of the biggest hurdles they’ve faced in finding and understanding clinical trials, many said they often came across information that was poorly organized and presented, or information that was incomplete, and lacking in the kinds of details that would truly be helpful to them in making a decision about participating.
At the heart of these challenges, is a past failure on the part of sponsors to fully understand what types of information are really most important to patients and how patients prefer to interact with and receive that information. It’s a multifacted issue, that will require a number of different approaches to address.
We’ve been thinking through several different possible approaches through our work here at Lilly COI. For example, we’ve encouraged innovation in patient and Health IT communities through challenges. We’ve continually worked on ways to enhance our API, which allows developers to work with data from ClinicalTrials.gov more easily. And, we’ve thought about ways we can improve the type of information we’re providing about our studies on ClinicalTrials.gov. More…