“Too much cost. Too much time. Too much uncertainty,” were themes heard over and over at 2019’s DPharm: Disruptive Innovations Conference in Boston. The two-day gathering highlights the promises and challenges of bringing innovation to drug development, so therapeutics get to patients faster.
We also heard that Pharma has had enough. And it’s time to inspire belief that things can change. Dialoguing with patients and creating greater awareness of clinical trials as a path for care is one change. And an exciting convergence—between science, medicine, and technology—can help make meaningful patient collaboration a reality.
Former FDA Commissioner Scott Gottlieb, M.D. noted this inflection point as he opened DPharm and talked about how to modernize clinical trials. He discussed work done to help academic medical centers bring their innovations to the FDA and streamline the process by pooling individual researchers to submit applications. He noted the benefits of basket trials and master protocols to test multiple drugs in a small defined patient population for diseases such as cancer and Alzheimer’s Disease.
One highlight was his vision about a standardized research template, or as he put it, “Google Docs for the FDA.” While he did note it would require structural reform to the review process as well as a shift in management style and culture, such transformation could enhance collaboration on one set of data rather the siloed, disconnected data review shared via memos and sub memos for discussion.
He also saw opportunity to consolidate data from EMRs for post-market data safety and efficacy reviews. And he wanted the FDA to be more embedded and embrace Pharma’s use of real-world evidence (RWE) and leverage it similarly as with the FDA’s Sentinel database. With such changes and reforms, the FDA and the industry can better innovate and develop therapies for primary disease prevention, which is on the rise. These developments, if realized, could bring about the study of larger patient populations for longer periods of time at lower costs.
While “disrupting” the clinical trial process is a good start, Gottlieb observed it will take an additional 5-7 million physicians to participate in clinical trials, and right now there are only thousands of them. But never mind the number of primary care physicians needed. It will take millions of patients. And how do you find the patients—and then keep them involved, engaged, and retained in studies?
At the end of the day, all of the technology, Google Docs, and data are pointless if we don’t find the right patients for the right trials. A September PharmaVOICE piece by Cynthia Verst, Ph.D. notes that “big data, analytics, technology and domain expertise can help change the paradigm.” She also states that for such a disruptive change to happen and have an impact on accelerating recruitment and improve retention, we must “rethink the entire trial experience through the eyes of the patient.”
Water On an Ice Block: Structure Eats Culture
One presentation by PA Consulting’s Kelsey Jakee discussed what happens to an innovative idea: think of it as a drop of water meeting the “block-of-corporate-ice” way of doing things. It quickly becomes part of the block and gets absorbed—and dies through a chilly inertia. She believes it is partly why clinical trials remain costly, time-consuming, and uncertain after all these years.
Pharma’s structure is eating the culture of innovation for lunch. We need to get away from doing things the way we’ve always done things and start to go “further, faster, and together.” One idea? Involving patient from Day One and use technology to stay connected to them. For a long time, the work has been focused inwardly, and now it is time to look outward and involve patient populations like never before.
Technology can do that; it can be the enabler, but we must ask the right questions. We have to make it easy for patients to interact and dialog with Pharma, which can lead to more trust and confidence. We need to change the way patients think about clinical trials—if they think about clinical trials at all—so they have more confidence and incentive for participating in trials when they find them.
That is what is exciting for us—data have always been there, and we now have the technology to find the right data and use it in a more meaningful, disruptive manner. It’s what Debra Kientop, MBA Debra Kientop, MBA, our Vice President of Life Sciences, noted during her talk “Increasing Patient Recruitment to Trials: Innovation in Predictive Analytics and Digitization Brings Clinical Trials into Clinical Care.” We find patients by bringing clarity to clinical trials (from design to identifying patients), and providing the technology, data, and insight to help Pharma, CROs, and providers not only think differently, but also think better.
We can pull data from the point of care—from EMRs/EHRs to billing to LIMS to physician’s notes and cancer registries. We normalize and standardize more data, more formats, including unstructured data and notes into a single repository. We make it easy for sites by screening every patient every night for every trial. With such specific information, clinical sites can see how well a specific patient matches to their open trials. For clinical sites that we work with, the process has removed 70% of ineligible patients (based on trial inclusion/exclusion criteria), while increasing patient enrollment by 40%. We work to get patients enrolled by accelerating identity, screening, and enrollment. We put patients on watch lists; if they’re not eligible for a trial today, they could be tomorrow, so we watch them and highlight them as soon as they become eligible.
The Year Ahead for Us
We believe we must make the next year the year of bringing clarity to the process of finding the right patients. We must first find the patients and then we can educate and show them how clinical trials can be a viable part of their clinical care. If we can do a better job identifying these patients, it makes it easier for clinical sites to engage and educate patients.
When you find the right patients and educate them, they become the right kind of partners we need to affect change and make a difference. This is what patient-centric trials are for us.
What are you doing over the next year to get to patients first? And move the needle toward “Patient Centricity?”
HOW NEW THERAPIES REACH PATIENTS FASTER