What is Precision Enrollment?
I am Dr. Jeff Kingsley and this is another edition of Riding in Cars With Researchers! Today we are going to talk about precision enrollment. I’ve talked in past episodes about the immense waste associated with research. That it costs on average $2.8 billion dollars to get one FDA approval, and that it’s the biggest driver for what drugs and hospitalization cost what they do. You go to the pharmacy to get a very simple antibiotic and you get sticker shock. It shouldn’t cost that much. We’ve talked about the timelines and how long it takes to run research trials and how difficult it is to find patients for research trials. Trials end up taking twice as long to find patients than anyone could predict. We’ve talked about the criteria to get into a trial and how they are getting harder, for good and bad reasons. So increasingly you are doing a lot of work as a research site to find very few patients for a research trial.
What Does It Mean For The Industry?
What does all of that mean? There is a lot of drivers for the waste, costs, and delays in getting new innovative therapies to the patients that need them. What is precision enrollment or “just in time” startup? Traditionally, organizations pick sites from across the nation or around the world to run a given research trial. And our industry is really very bad at choosing sites who are going to perform in a given research trial. They are very bad at choosing who is going to produce high-quality enrollment and data. The industry finds research sites, they fly people around the world, open and train research sites, ship manuals, drugs and kits to those research sites, and those sites may never enroll the number of patients they said they would. They may never enroll a single patient but those sites have drugs sitting on their shelves going to waste. That’s a huge driver of that R&D cost.
In precision enrollment we start a conversation with a biotechnology company, we review their protocol and decide that we like them, that this is good science, good medicine and makes good medical sense to us. We like the study design and think we can find patients for the trial; that it’s a good trial for our community and think we have the capacity to do this trial. So we start working with all the vendors that are necessary to conduct a clinical trial. We take that conversation just far enough to be ready and we…stop! We stop and go find patients and prove we have the patients that are appropriate for this trial. Then the moment you find the patients necessary, you trigger the study start-up. The drug is shipped to the site, lab kits are sent, and whatever else is necessary, and in a rapid fashion the site is opened up and you already have patients ready to engage in the trial.
Brilliant Evolutionary Change
This is brilliant evolutionary change. Just last week we did this at IACT Health. Under precision enrollment, we opened up a trial for lymphoma. Increasingly in the age of genetic medicine, especially oncology, trials are getting more difficult because we are smarter, because we are tailoring very specific therapies to very specific patients with very specific genetic make-ups. We opened the lymphoma protocol just far enough, and then we began looking for patients. We found a patient who was very appropriate for the trial, who wanted to go into the trial, and we triggered the rest of the study start-up and opened the trial in 13 days. That lymphoma patient is now being treated under the research protocol. That’s what precision enrollment is. It will reduce R&D costs and enhance efficiency for our industry. As our industry gets smarter and trials get harder, this is a great evolutionary change for us to embrace to help combat normal alterations to how we do research trials.
You’re going to see more of precision enrollment. It is a good thing and reduces a lot of waste throughout the industry.
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