At the Global Genes Patient and Advocacy Summit, Rare Disease Report spoke with Kent Thoelke of PRA Health Sciences about how clinical trial organizations are changing the way patients are being involved in clinical trials.
As Thoelke explains, there is a paradigm shift in the way that the clinical trial community is starting to engage with patients.
Kent Thoelke: The paradigm shift, and this is not so much with rare patients but in general, nobody has ever really treated patients like consumers. We treat them completely differently now. Rare patients have less of a choice, but patients have a choice on where they get their healthcare delivered now. If you look at millennials, 25 or 30% of them don't have primary care physicians anymore. They get all their health care delivered in an ambulatory model so they go to urgent care clinics and they do it all through their iPhone. They schedule through their iPhone, they get their labs through their iPhone, they get all their notes through their iPhone.
So if the world doesn't keep pace with that, if patients in their everyday lives use their iPad, iPhone or web services to bank, to schedule their appointments, to get all their information services, etc, and then if you ask them to participate in a trial that is throwing them back 2 or 3 decades where you have to go to the doctor's office and fill out paper forms—there almost a cognitive dissonance there.
And it is not just millennials; parents have their own lives to lead. They have children that are sick and children that are healthy, and you have to give them a way to participate in a research that doesn't completely upend their world. With a mobile model, a virtual model, we lower that barrier to entry. We give those patients an opportunity to participate in research that they may not have had before because of the complexity of participating in the trial.
Healthcare providers also see this challenge so we can push that data directly to a healthcare provider and to the physician participating in the trial. We can create and engage with tele-visits. We can partner with a Bluetooth enabled device company so that we can collect all of that data in a real-time and push that data directly to the healthcare provider.
We can push the data to a healthcare provider in between visits so that the healthcare provider gets a much broader picture of what's happening in that patient's life.
There are all these people that are innovating and creating new technology and amazing new drugs and treatments for patients. And then we have this in-between world where we try to get to combine them—that has been a big challenge for people.
I totally get that we have a confined regulatory environment and we have to ensure patient safety and we have statistical methodology but when you get into the rare population, I think that we have to figure out a way to do what we've always done but in a way that actually makes it accessible for patients.
PRA Health Sciences is a global contract research organization. We basically are the arms and legs of getting clinical trials done. So we operate as an adjunct to pharmaceutical and biotech companies. A lot of those companies don't have the internal resources to conduct clinical research and so they outsource that to companies like ours. We've been doing this for a really long time, I think like 30 years now, and what we're finding, the status quo is not enough and so lots of people are looking at ways to broaden their scope, we're trying to focus on technology so how do we take all of the advances in technology in that innovation and use it to connect patients to trials and how do we switch the dialogue so that instead of making patients feel like they are lucky to participate in research that the patients are driving that dialogue with the physicians and with the pharmaceutical and the biotech companies.
We are trying to figure out how do we do that and how do we leverage that technology to make trials faster, quicker and more accessible. Lowering that barrier to entry is the first step.
We know that patients live their everyday lives through mobile devices and through mobile technology. A majority of millennials would rather lose their car than their phone— that is the environment that we live in now but we have a clinical trial industry that is still steeped in tradition. We are still doing the same things in clinical research we did 20 or 30 years ago and some of that is healthcare related but healthcare is actually moving quicker than the clinical trial space as well.
We are trying to fit ourselves into that paradigm and I don't know any other way to connect a rare community, that could span the globe, in a real-time environment without mobile technology.
That's our focus: we are trying to innovate through technology and insert our research into patients’ lives and make it easier for them to connect.
We collect lots of data around patient reported outcomes—How did the patient feel during the trial? How did their disease change during the trial? Etc.. We collect that in lots of ways. In a mobile model, in a bring your own device model, we deploy all of those scales through an App on your phone. Any patient can log into the app and collect that data and that's a simple methodology to show how it works. In a more complex mode, we can send a kit to a patient's home that has an entire suite of Bluetooth enabled devices, depending on what their disease is, it could be a Bluetooth scale for a blood-pressure cuff, pulse oximeter, glucometer, etc. Any medical grade device that is out there that can connect to a patient's phone or iPad through a Bluetooth connection, we can then have that patient do their own testing at home. This allows a patient that may be several hundred miles away, or a state or two away, or a country away, from a physician to still be able to provide that physician the key information.
We can also use the app to send home health care nurses to that patient to do blood draws or send out lab orders from the hospital directly to the patient, so they can take it to a nearby clinic and get their blood drawn and then send that data to the to the hospital. So there's lots of ways we can interact through the phone and what it does is it minimizes that need for the patient to make that long journey to wherever that trial site is. We're not going to totally replace those visits –Patients will still need to visit the clinical trial doctors but instead of 10 or 12 visits over 3 or 4 months it might be 2 or 3 visits.
The barrier to enter a clinical trial is so high for a lot of these patients, and while it's important that we give them therapy and we give them access to potential treatments that could change their lives, it shouldn't be the cost of up ending their entire life so they still have to have a quality of life and that's what we're trying to balance out.