Tom Rhoads gave a keynote presentation at eyeforpharma that challenged the clinical trials industry to be open to new patient expectations based on COVID-19.
Tom Rhoads (00:00):
It’s my privilege to be here today with these esteemed speakers to deliver the keynote for the eyeforpharma 2020 virtual conference. My name is Tom Rhoads and I’m the CEO of Spencer Health Solutions. Today I’d like to address the expectations your patients and subjects will have post-pandemic COVID-19 has brought the biggest change to healthcare in decades. How often have you heard the term “the new normal” in the past month? The idea of patient-centricity is a journey or an ambitious goal is no more. Instead, we’re living the day to day urgency of keeping high-risk patients including those participating in clinical trials safe and on therapy and I don’t believe things will go back to the way they were. I thought we’d start by looking at what the patient reality is. How will expectations change about healthcare engagement going forward? How should digital health be a key element of the strategy to address those expectations?
Tom Rhoads (00:53):
We’ll also take a look at telemedicine and be aware of the complexity that might arise with an avalanche of different digital technologies entering the home. I’ve got data on adherence and patient engagement and to look at how the depth of data the digital tools can provide allows for actionable clinical decision making. And finally, we’ll look at an outcomes-based contracts and how those might also benefit premier enhanced digital strategy. COVID-19 has turned the world upside down as we know it. This conference in fact is an example of the new normal as we’ve gone totally virtual this presentation, will you meet your patients? Post pandemic expectation, a bit of a tongue twister, but you know, it challenges us to look forward because patients are experiencing healthcare in many new ways and they may not want to go back. So how do we assess the changes that have positive effects for our patients and ourselves with the addition of potentially immense quantities of digital data?
Tom Rhoads (01:49):
How do we make it actionable and employer not only clinical trials but provide commercial lift while supporting value-based contracts? No. As we move forward, I think we’re learning a lot and a position to bring digital technology and med-tech into a major role to address these issues. We’ve talked about patient-centricity for several years now and it’s gaining tremendous momentum. Well, there’s nothing like COVID-19 to come in and say, there is no more evaluation time for implementation. We have reached the goal line and we have to implement many of the strategies intended for better outcomes, lower costs, and increasingly focused on the patient. Whether you’re looking at clinical trials, a commercial brand launch, or even constructing value-based contracts with payers. Everyone has to take a closer look at the new normal. A study just released when the performance research group in March found that 49 to 56% of the population will take months to begin re-engaging with their communities, and many of those in that study suggested their social outreach will be limited forever.
Tom Rhoads (02:49):
That’s a pretty challenging time and patient perspective, but I believe the efforts over the years to evaluate patient needs, their safety and security with technologies that are now supporting, in some cases, hybrid studies and value-based contracts has positioned the market to make a dramatic and beneficial long-term shift. In other words, COVID-19 is intersected. The healthcare community’s attempts to deliver patient-centricity real-time data and evidence for efficacy and value-based contracts with the patient community. It’s now seeking greater opportunities for remote engagement and care. So the very technology that you’ve been studying offers the opportunity to satisfy the patient expectations of increased remote care but also benefits from their willingness to engage with technologies to help keep them remote. We might finally raise the bar on real-time longitudinal data access, connected care, insights, and compliance, all from the safety of their home.
Tom Rhoads (03:46):
So what about pharma specifically in this pandemic age, to say the least, it has had a big impact. In fact, a survey by continuum clinical in late March showed the unwillingness of people to participate in a clinical study jumped 88% in just four days. Not terribly surprising given the environment we’re in, but it has been reported that almost 47% of people are unwilling to continue in the trial that they’re already enrolled in. In fact, ACRP reported that over one-third of clinical trial sites have a fear of total shutdown and that 80% say that at least some ongoing research will be put on hold or canceled in another study. 56% of patients indicated they were less willing to participate in trials due to COVID and that 80% of patients are unwilling to visit the site for study appointments. This is a significant disruption to the current clinical operations.
Tom Rhoads (04:39):
There are significant ramifications for the current and future of trials and we need to address them with patient-centric strategies as the technologies and the new normal patients are going to be calling more of the shots. They’ve experienced a whole new world of technology. Many for the first time they’ve done it without leaving the safety of their homes. They’ve connected via telehealth, biometric devices, medication dispensers in a whole host of other products. That’s also aligning them with our clinicians or pharmacist and their family caregivers. In the new world order, I can assure you they aren’t going to go back and sign up for unnecessary risk of visiting hospitals, clinics, and trial sites when they know alternatives exist. As we’ve seen, the pairs have responded aggressively to the covert crisis. Physicians can actually receive full billing for telehealth appointments just as if they were meeting face to face.
Tom Rhoads (05:29):
As we’ve seen, payers have responded aggressively to the COVID crisis. Physicians can finally receive full billing for a telehealth appointment just as if they were meeting face to face just a few months ago. We thought this might take years to reach this milestone and I don’t think we’ll go back quickly. As we look at clinical trials, I think you’re going to be asked, why do I need to come to the clinic? Can’t we do this over video? And I think if the answer is going to be, well, I’d prefer you to come into the clinic even though we’re not drawing blood, et cetera. Patients might respond, look, if you want me to be a trial participant, you’re going to have to do this over video from the safety of my home. Now, the good news is that studies have shown that behavior actually increases subject retention and allows sites to serve more subjects.
Tom Rhoads (06:13):
So the benefits here can be mutual. There’s an old saying that you may have heard of. The secret of change is to focus all of your energy, not on fighting the old, but on building the new. That is 2,500-year-old wisdom from Socrates, and as we look at the healthcare landscape, digital tech is here to stay. It’s been tested, it’s been evaluated for many years, and it’s in a position to help address the problem. So let’s address now the mindset of the middle folks separating the patients from the technology and fully embraced the future. I think looking down that road, the thing that can comfort us as a change will bring remarkable insights, efficiencies, and opportunities to apply things like artificial intelligence to the reams of data spanning patient-reported outcomes, biometrics, surveys, and compliance. He’s high access longitudinal. Yep. Low impact engagements will ultimately redefine trial costs, timing and determination of the efficacy of the drugs for faster development platforms.
Tom Rhoads (07:15):
These high access longitudinal. Low-impact engagements. Will ultimately redefine trial costs, the timing of drugs and determination of the efficacy of the drugs for faster developmental pathways. You know, there a lot of technologies out there that have been working hard for years to make sure that their platforms are patient-centric, safe and provide robust data align with the industry’s needs. Spencer is direct to patient platform. It takes on the task of distributing meds, asking surveys and quality of life questions during every dispense while also capturing biometrics in the home. Plus, Spencer has a telehealth interface. The platform itself has been used by patients for about 30 months. Our population ranges in age from 22 to 99 years old, averaging around 64 years old, 58% are female and on average are taken about seven meds per day. You know what we’ve seen that’s pretty interesting in the data is that regardless of disease type, we see similar compliance and engagement results across all the populations and we don’t necessarily see better adherence, for instance, with a Beaver health population versus the Parkinson’s population.
Tom Rhoads (08:25):
And that’s been a very exciting find for us because we spent 18 months trying to understand their needs and went through numerous FDA formative studies in our IRB studies. So when we look at the data from our digital health platform, we can see that there in many cases can be over 7,000 unique data points per patient. Lots of insights and complexity to correlate data and we need to make sure and work with our community partners that all of that is actionable. In the medication adherence sphere, we see the general population often mirroring the clinical trial population. So you’ll see adherence ranging typically between 38 and 57% which is surprisingly low and can have a dramatic impact on outcomes as we’ve seen firsthand lately. So in the case of technology and Spencer, our users demonstrate a greater than 97% adherence as measured by taken during the time prescribed.
Tom Rhoads (09:19):
The granularity of the data is very important because even when someone is 100% adherent, it may still have some concerning habits that need to be addressed by their clinician. In addition, we see an engagement rate that’s about 80% now this is an important access point for the care community and the clinical trial sites to know that they can consistently engage those folks in their home while still receiving timely feedback is a really critical factor. On this next chart, I wanted to take a step closer to some of the data and show you what we collect on a single patient over the course of 30 days. In this case, this patient is taking three different medications. As you can see on the left-hand side of the chart, administration hours are 6:00 AM-noon and 7:00 PM and what you see here is they’re actually surprisingly consistent in taking their medications during the hour of 6:00 AM and the hour of 7:00 PM it’s the middle part that we see a lot of variabilities.
Tom Rhoads (10:13):
That noon dose for a patient that’s 99% adherent. Having only missed a couple of doses over the course of 30 days. We actually see that almost 30% of the doses taken in the middle of the day are taken within two hours of their final evening dose. Now, depending on the medication that could present a problem. So this is an example of just how exciting some of the data that we’re beginning to get with these ongoing longitudinal engagement platforms can be and allow us to explore this and see what the impact might be on studies with this insight. Teams need to step back and begin to determine how are they going to react to this type of data. What should be the protocols for engaging the patient and explaining the challenges with taking medications too closely together and what the impact might be on side effects or adverse events? I believe some of the exciting next steps are when you have data like this presented to you, now the clinical teams can do an even better job engaging their patients with data like this.
Tom Rhoads (11:15):
Clinical teams can now do an even more thorough job engaging their patients with these types of data insights. Clinical teams can now better engage their patients. They might have deeper explanations for adverse events across a certain population. They might have opportunities to educate around what taking medications, who closely together could affect. From a side effect standpoint. There’s a lot of engagement, education, and outreach that can occur. Now that we have this type of insight. Well, we would hope to see is that these insights lead to not only better outcomes for trials but also a much more significant improvement as becoming approved and go to market into the commercial space. Well, we like to see is that this type of data not only improves outcomes but also positions those drugs better for commercial launch. You know, in the past a 5% improvement over standard of care was pretty acceptable and a new path as we look forward can reframe that expectation and look once again at dramatic improvements, which may be very critical for drug launches, especially when you start considering the pairs reactions to your therapy.
Tom Rhoads (12:22):
You know, they’re already asking to be more involved in the development, to better understand whether these drugs are coming down the pipeline or they must have drugs, may have drugs to the formulary or in worst case do not add drugs to my formulary. And a lot of these drugs are very crowded spaces. So moving from five to 10% could be the difference and you being on formulary and another one being moved off. And as we look at big-ticket therapies, pairs need a more structured way to review the value and impact across their patient base and the therapeutic errors they’re serving. The missing link here, of course, is the evidence and the data to support those claims. So as we look at new digital technologies to better engage patients and keep them at a safe distance, those same technologies may be the missing link and creating the evidence needed to better position you for brand success.
Tom Rhoads (13:15):
The result of all of this is that we can finally fully meet patient expectations and needs, especially moving forward. Well also position ourselves to have a much richer experience and insight leading to lower costs, faster development. And greater success in the market, which all, of course, improve the livelihoods of our moms, our sisters, our fathers, and our friends. And that’s why we’re here and that’s why we’re doing what we’re doing. So we all want the same thing. We have to have better patient outcomes and better insights to not only build the trust but the evidence for better decision making. I think we’re on the cusp of that. I appreciate your time today and stay safe.
Tom Rhoads, MBA, has been leading the development and launch of healthcare technology for 25 years. As founder and CEO of Spencer Health Solutions, he led the development of the direct-to-patient spencer® medication dispensing, telehealth, and in-home monitoring platform. Prior to his current role, Rhoads was CEO of Parata Systems pharmacy automation company and previously held leadership roles at Baxter Healthcare and Cardinal Health Corporation. He is a member of the Advisory Panel Member for the Centers for Medicare and Medicaid Innovation (CMMI) Services, Payment and Program Evaluation grant in North Carolina.