“On Target” by ViZZZual.com is licensed under CC-BY-2.0
Last November, Tom Krohn announced that we would begin collaborating with Novartis and Pfizer to build a consistent framework for clinical trial eligibility criteria by developing target profiles and implementing them in our API. Our shared mission was to make it easier for people to find clinical trials that are right for them or their loved ones.
Not long after that announcement, I was thrilled to be given the task of helping to lead such an important project. And, right now, I’m excited to share with you that some great strides have been made. In the last six months we’ve consulted with our partners from Pfizer and Novartis, along with other outside experts, to determine the best possibilities for presenting clinical trial eligibility criteria in a way that’s clear and consistent. From these discussions, we were able to form our first target profiles, which were made available to the public in late July through a major update to the LCOI-API. And, we’ve only just begun…
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.