Clinical research is an invaluable part of making life better for people across the globe. While incredible strides have been made in what researchers are able to discover, there's still room for improvement. Lilly Trials pushes the boundaries of clinical research, making it more connected, engaging, and accessible than ever before. We believe that in order to advance and accelerate the development of new medicines, we have to have open and honest conversations with patients, caregivers, researchers, innovators. The more we share ideas and knowledge, the bigger the difference we can make. Join us in transforming clinical research, together.
The Lilly COI API and TrialReach: A Story of Innovation
The following blog post is by Tom Krohn. Tom is the Chief Development Officer for TrialReach and is responsible for business development including clinical trial sponsor relationships, patient advocacy groups and research institutions. He has 25 years of experience across different sectors in health including large pharma, hospital & retail pharmacy, and the developing world. Most recently, Tom led the Clinical Open Innovation team at Eli Lilly with a focus on patient engagement, open data and business transformation. Tom is passionate about serving patients from their point-of-view while building sustainable and highly effective organizations.
Everyone Has a Story
Everyone has a story. You. Me. Innovation.
About four years ago, a small group of Lilly employees started work on open innovation with a focus on improving public information to accelerate medical innovation. Barry Crist and I wrote a whitepaper that outlined a vision for clinical knowledge generation becoming participatory for all in the clinical research ecosystem, especially patients. Participatory—that is the essence of an open network. It is at the core of open innovation.
With executive sponsorship and a case for action, we took these ideas and developed an open API which launched in 2012. We put Creative Commons copyleft licensing on the API to remove the friction that is the norm of the life-science industry. Then, open innovation happened.
People started using the API. Patient organizations. Data service providers. Even our competitors. We ran an in-house hackathon that generated some cool apps, a codeathon with central Indiana talent and a Clinical Trial Redesign challenge. We learned and evolved with the emerging marketplace. But the data was insufficient. While the API made things easier, an API is only as good as its content.
We shifted our focus and did the hard thing—listening—to patients and those serving patients. We challenged all of Lilly to listen and engage patients differently: in trial design processes, in trial execution and through post-study results sharing and continuity of care. Our Patients at the Center of Clinical Trials Workshop was a powerful onsite gathering of open sharing and creative solutions with patients and disease advocacy leaders the first of its kind for Lilly, and perhaps all of pharma). One of the areas in which patients spoke very loudly, was helping patients find, understand and match to clinical trials. Clinicaltrials.gov receives 112 million page views per month. A good portion of those views come from patients and their caregivers, yet it is far from meeting patients’ needs.
This was a challenge we had to take on.
Patients 2 Trials
We in the pharma industry are our worst enemies, because we make it difficult for patients to connect to our studies. Information is hard to find, is written from a scientific-only point-of-view, and is often only available at the investigator site where distance and logistics can be a big barrier to patients. We also focus on our single study while from a patient point-of-view, the perspective is “which clinical trial might help me?” regardless of the sponsor. With this background and understanding, we moved this initiative beyond Lilly to a small consortium of the willing. This was the birth of the Patients 2 Trials Consortium.
Using our API as a base platform for augmented content, we took on the task of structuring eligibility criteria in a consistent and machine readable manner. Pfizer and Novartis, through their innovation teams, recognized the potential and joined us. Soon we were structuring trials from each of the consortium's partners. At the same time, the U.S. government had put the Blue Button initiative into play with Meaningful Use stages and incentives, and we now had a patient record format against which to test our approach. We successfully tested it and shared the outcome at the 2014 Partnerships in Clinical Trials conference. The Patients 2 Trials consortium then moved on to market pilots and finding a long-term home for the API and the trial matching approach. The primary goal of finding a long-term home was to maximize impact for patients, drive to sustainable scale, and ultimately to help transform the industry.
Lilly chose TrialReach to be the long-term home for its API platform and trial matching work, and completed the agreement late last year. TrialReach’s strong patient focus, large network of partners and freemium business model made it a great home for the initiative. Lilly and TrialReach completed the technical transfer of the API in the first quarter of this year. And, at the 2015 Partnerships in Clinical Trials, representatives from Lilly, Pfizer and Novartis announced the transfer of leadership to TrialReach.
So what is next? First of all, three of the Lilly COI team members (Tyler Trueg, Dean Sellis and myself) have chosen to join TrialReach to see this innovation through to full success. It was a tough decision for each of us. We truly enjoyed the innovation work at Lilly and the collegial environment that allowed us to make a difference. We are excited to bring our knowledge and experience in clinical trials and the API platform and combine them with the patient-engagement insights of the TrialReach team to help this become an industry game changer.
TrialReach is committed to structuring ALL recruiting clinical trials and making this information ubiquitous on the internet. We’ve started with diabetes studies and plan in place to roll out more by therapeutic areas. Our goal is to complete all therapeutic areas in one year. It is a big goal, but also one that patients are waiting for.
We are also committed to partnering with sponsors in bringing easier-to-understand study information to the internet. As I’ve shared before, we need to separate informed from consent. Patients need to be informed to consent, but don’t need to consent (at site) to be informed. Instead, patients need and deserve clear information so they can compare studies, determine which ones they may be eligible for, and deeply understand the implications of participation in a study—all before they have to make the journey to the nearest investigator site for the full screening and participation.
Time for Change
The time for this change is now. The industry needs to look at its trial accrual challenge through new lenses. Patients have wanted this improvement for a long time. And, it is personal to us and to me. About two years ago, I lost my brother-in-law to esophageal cancer. Unfortunately, by the time a clinical trial was considered, it was too late. As my sister-in-law said, “I believe most patients who want to fight their cancer will be very interested in clinical trials if they could find them and understand them and didn’t have to depend solely on our doctor." This is exactly what we are trying to do.
And so the story continues, both my story and this innovation story. I’m not sure how the story ends— we never quite know. But we’ve made it this far through perseverance and commitment. I know we’ll be faithful to patients and the vision to serve them well. And in the process, write another chapter in the innovation book and changing the life science industry.