Virtual Clinical Trials
Hello, I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars With Researchers. Today we are going to continue our conversation on virtual clinical trials.
What Trials Look Like Today
Almost all trials today occur in what I call brick and mortar buildings. I ask you, as a patient, to come to me; that’s how most healthcare is today. If you go see your doctor, you get in your car, you go to a doctor’s office, and you are seen at that location. The doctor doesn’t come to you nor do you interact with your doctor through a web-based portal. But it’s starting to happen more and more in healthcare… it’s called telemedicine. It’s been happening for decades now, but it is accelerating, and it is gaining more traction. In research, it’s called virtual clinical trials because the trial is moving from brick and mortar to web-based platforms. Today, in research, almost everything is traditional brick and mortar.
What Do Virtual Trials Look Like?
Virtual allows you and I to be able to talk to each other in a real time. Virtual is where I’m able to see you through a web-based platform, which is no different than FaceTime, Skype, or Webex, but is HIPAA secure. I’m able to see you and interact with you and we can discuss the informed consent document for a research trial. I can review your medical history and your medical records. I can answer all of your questions about that informed consent and about the details of the trial. If you’re interested and it’s appropriate, you and I can both electronically sign the informed consent document together, live! It is as interactive as if you had come to my office. Then we can proceed with the study visits: where I interview you, interact with you, and I can send a nurse to your home who can help with the physical exam, drawing blood, and help with the EKG.
An EKG, as you know, is where they put leads on your chest to take a look at your heart rhythm. Today, we have Bluetooth enabled devices where a patient can put their fingertips on a couple of sensors and an EKG can be done through your fingertips. I can see the results from my office without you needing to come to me just to have an EKG done. All of your research visits could be done in the comfort of your own home.
Now, there’s also a step in-between. We’ve have traditional brick and mortar, virtual, and the step in-between is called ‘hybrid’. It’s a combination of the two, where some of the visits would be brick and mortar, and some of the visits would be virtual.
Now what’s driving this? Why are we driving toward virtual? Two main reasons:
1) it’s hard to find local patients that meet criteria, or
2) when they do meet criteria, there is a greater likelihood that they say no because we are asking too much of their time.
Finding Patients that Meet the Criteria
Inclusion and exclusion criteria are increasing largely because we are entering an era of personalized health care, personalized medicine, and genetic health care. We have research trials occurring in all specialties where we are targeting patients with a very specific genetic profile. Our therapies are becoming that precise, which is a wonderful thing! It is so beneficial that we’re not treating all congestive heart failure patients the same; treating all breast cancer patient the same. Rather, we are treating patients based upon their specific genetics, which is revolutionary for healthcare. But what it means is: target patients are rare.
If you have a physician practice with a database of 1,500 patients, you don’t have enough patients in your practice to be successful on most of those trials. You need access to more patients to find ones who meet all the inclusion and exclusion criteria, and additionally have the right genetics. You need a population of hundreds of thousands… or millions… of patients to be successful. How do we achieve access to that many patients? Virtual clinical trials mean I could enroll patients from across my entire state. I’m in the state of Georgia right now and Georgia has a population of over 12 million people. That’s not 1,500, that’s not 100,000, that’s 12 million patients who could be considered for one of my research trials. Why is that the case? Most patients aren’t going to travel any long distance. Typically, most patients in my research trials will travel a maximum of five miles to my office. There are occasions where patients will travel hundreds of miles for the opportunity to enter a research trial, but that’s the exception, not the rule. With virtual trials: No driving! That gives me access to the 12 million Georgia patients. So virtual clinical trials help fix the issue of proximity.
Asking Patients for Too Much Time
And then the second was, I ask so much of patients. There are many office visits, so patients are more likely to say no to a trial. Well, now I’m going to come to you….virtually! You can be in your bunny slippers, in your living room, and we will facilitate your ability to be in a research trial. In fact, you could do a virtual study visit while you’re at work, whereas if I’m asking you to come see me, you must take time off work to do so.
The Hybrid Model
Virtual clinical trials are a wonderful solution to those two critical issues, and that’s why virtual is coming. Now hybrid (the spot in between) is good, but not great. The industry is saying, “let’s put a toe in the water by starting with hybrid trials.” While that may seem sensible, it’s not an accurate experiment to show how revolutionary virtual could be. Hybrid still improves the patient experience, as most of your visits could be at home, but you’d still need to be in my office. It doesn’t alleviate the geography issue and that’s huge. If I’m asking you to come to my office at all, in that hybrid model, only patients who have the ability to travel to my office can enter the trial. I immediately shrink the geography back down to something similar to brick and mortar. There’s a huge decrease in success in the hybrid model over the virtual model.
Virtual Trials are Coming
They’re going to be fantastic with a dramatic ability to enroll patients in research trials, faster. You can’t ignore the massive benefit of being able to pull from huge geographies and dramatically improve the patient experience. Look up virtual clinical trials, they’re very exciting! And participate! Help our industry move forward. I’m a consultant with numerous companies on virtual clinical trials. I’ve been speaking and writing on virtual trials, and I will continue to do so because this is the research of the future.
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