Let’s talk about moving research into the patient’s home. I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers.

There has been a movement going on for 28 years now to move research into the patient’s home making it easier for patients to participate in research. The hardest thing we do is find patients who can meet the stringent criteria for research, and who have the time and the willingness to participate. If it’s the hardest thing we do, we need to remove as many barriers as possible, and make it as easy as possible for patients to be able to participate. The direct-to-patient movement is aimed at that.

These trials go by a number of different names, but it is all the same thing. You’ll hear people talk about virtual clinical trials, which used to be the preferred name. You’ll hear direct-to-patient, decentralized clinical trials, and hybrid trials but, again, it’s all really the same thing. My preferred term is direct-to-patient because that’s the entire point.  I am not really a big fan of calling it virtual, because it makes it sound like it’s not a real trial.  All of our trials are decentralized today. If we have 12 vendors per trial, they’re all in different locations. Decentralized isn’t the purpose, the entire purpose is to move the research to the patient rather than making the patient come to us. So, direct-to-patient makes a lot of sense to me, and that’s what you’ll hear me call it.  

Direct-to-patient research has economic pitfalls as it will not likely be cheaper for the industry because there is a cost shift. What happens is you’ll pay the Principal Investigator and the research site less per-patient, because the site is not being paid to draw blood, but the site is still being paid to interpret the labs. The site is not being paid to do an EKG, but it is still being paid to interpret the EKG. So, the site budget goes down, but that Sponsor company is now having to pay home health agencies to pay others to drive to that patient’s home and draw the blood, or do the EKG, or maybe Bluetooth-enabled blood pressure and vital signs.

There will be a cost shift that will probably be net neutral to the Sponsor, but for the site, the per-patient budget will go down. The only way the economic model makes sense for Principal Investigators to start doing direct-to-patient research is if they can enroll larger volumes of patients. In which case, doing that work still becomes profitable work for an Investigator and for a research site. If the per-patient budget goes down and the Investigator can still only enroll the same number of patients that they would have in a brick-and-mortar model, then, in fact, their business probably becomes unprofitable. If that happens, they are going to start turning down direct-to-patient trials, so our industry is going to have a hard time finding Investigators who say yes to direct-to-patient work, and we’re not going to gain the traction necessary to be able to move this initiative forward.  

We have to remain cognizant of the economics of direct-to-patient work. That’s why I’m not a big fan of hybrid trials, where some of the visits are in the patient’s home, and some of the visits have to be in my office because by default, I won’t be enrolling an entire state or states. I’ll still only be enrolling a small geography of patients who are willing to drive to my office.

There are some quick thoughts on the direct-to-patient movement. I’m going to do more on this topic because it’s incredibly hot right now, and it’s only going to increase. It is the direction we should be going as an industry, making trials easier on the patient, is a patient centric model and that’s the way we should be moving.