Put Patients First

Clinical trials haven’t changed much in decades. These industry leaders show us why it’s time for disruption – and how to make it happen. Spencer Health Solutions is proud to present the Voice of Disruption.


Tom Rhoads:                   00:00                   Clinical trials are ripe for disruption. The process is expensive, unwieldy, complicated, lengthy, inhospitable and more likely to fail than to succeed. I’m Tom Rhoads, CEO Spencer Health Solutions. As I have traveled to conferences, business meetings and clinical trials sites across the US, Canada and Europe, I’ve had the pleasure to meet and connect with some exceptional professionals and thought leaders who are committed to changing the clinical trials process through disruption, transformation and innovation. We have asked some of them to share their ideas with us on the People Always, Patients Sometimes podcast. We asked them to tell us what is holding back the industry or what could propel it forward with a little push. I hope you enjoy hearing these ideas and will join me to bring innovation to clinical research. Here are the Voices of Disruption.

Janet Kennedy:                00:52                   Hi, this is Janet Kennedy. I’m a member of the marketing team at Spencer Health Solutions and also the host for the “People Always, Patients Sometimes” podcast. I had the honor of interviewing everyone for the Voices of Disruption eBook and this podcast and I was so impressed with their thoughts and suggestions to improve clinical trials. We did find an interesting trend reflected in all of their comments. It’s all about the patients. So much so that we were able to group their ideas into three different topics. The first topic category is titled Put Patients First. The second topic combines ideas about training the staff to be more patient-centric, and the third category revolves around ideas to make the clinical trial process much more patient-friendly. We’ve had so many good comments that we wanted to give them to you in their entirety, so we’re breaking this podcast into three episodes. Welcome to the first episode, Put Patients First.

Gayle McCracken:           01:55                   Hi, I’m Gayle McCracken, vice president of market innovation at Spencer Health Solutions. Remember ePatient Dave and his 2012 TED MED cry for inclusion with the “gimme my damn data” video and how the next year the pharmaceutical industry began inching toward the patient, with it’s “Beyond the Pill” movement? Meanwhile, payers turn their attention to value-based care delivery in pursuit of better treatment outcomes at lower costs. Yet we find ourselves on the threshold of the next decade with a continuing dialogue about how to bring people to the center of their care and to the center of treatment development. There is no disagreement that when people are informed and are active participants in their health and in clinical research, the outcomes are better for everyone. The patient, the payer, the research community and yes, the drug company. How do we walk the talk, especially when it comes to bringing the patient voice to clinical research and eventually to research as a treatment option for every person.

Gayle McCracken:           03:11                   As Spencer Health Solutions, all that we do from design to manufacturing to introducing intuitive digital technology to the home starts and stops with the individual wherever they may be on their health journey. That’s exactly why we launched our podcast. People Always, Patient Sometimes. Host Janet Kennedy, senior digital brand manager at Spencer health Invites leaders of change in health medicine and clinical research to exchange ideas on how we can work together to accelerate research, reform and inclusion. This podcast presents a collection of excerpts from hours of discussion among patients and pharmacy industry leaders about obstacles to change, the critical need for innovation, and what single action today might propel us toward better outcomes for all. I hope that in listening to Voices of Disruption, you’ll find both a sense of urgency and inspiration to see new opportunities for bringing patients to the heart of care delivery and to clinical research.

Janet Kennedy:                04:28                   There’s a lot of agreement these days about the need to disrupt clinical trials. The lengthy, costly and complex process of evaluating therapies hasn’t changed much in several decades. What’s more, the process is simply not designed with the patients in mind. Many industry leaders want to change that, but how? What should they focus on? Where are the opportunities to bring in more patients and ensure a better experience? In this podcast, Spencer Health Solutions brings you the perspectives of thought leaders, including patients, who are providing some answers. We call it Voices of Disruption because that’s exactly what they’re advocating. Clinical research isn’t going to embrace patient-centeredness, real-world data and evidence, or digital technologies without some upheaval. Incremental change is no longer enough. We asked more than a dozen industry leaders and patients what one thing they would do or change about clinical trials. No surprise that we got a variety of responses, but almost everyone kept coming back to an overriding theme. How to make clinical research better for patients. Eva Mae is a patient community partnership creator and a cancer survivor. Her advice is very simple. Give participants a voice. Higher patient engagement has been demonstrated to help participants complete clinical trials.  For Ava engagement means greater communication between researchers and patients.

Eva May:                           06:09                   Hi, I’m Eva May, a patient-powered research advocate and a patient community partnerships creator. If I could change one thing about clinical trials, I would ensure that researchers develop and implement a bi-directional engagement program with the real patient or consumer community.  If done properly, this would improve recruitment and retention of a truly representative participant group. It would reduce the disparities of typically underrepresented participant cohorts. It would improve the relevance and robustness of patient-reported data and it would give participants the opportunity to become partners in meaningful research.

Janet Kennedy:                06:53                   We asked podcast guest, Darcy Forman, who’s the CEO of Centricity Clinical and formerly with Forma Clinical Trials, what she would recommend and boy she went right to the crux of the matter. Innovate faster. Innovation is a word that pops up frequently when discussing improvements in clinical research. Darcy, who consults with clinical trial sponsors, sees that current innovation efforts are occurring too slowly.

Darcy Forman:                 07:21                   It would really be that the sponsors and the sites and everybody adopt the changes faster. Take a little bit more risk and do it with high quality, but we need to innovate at a faster pace.

Janet Kennedy:                07:36                   It’s one of the most common refrains in healthcare today. Let’s make sure patients are truly in charge of their own health. But how and what does this really mean? Our Voices of Disruption have given the concept of patient-centeredness a lot of thought and while there’s much work to be done to put patients first, most are optimistic about the prospect for making it happen, including patient-centered clinical trials. We asked Craig Lipset, a clinical trials innovator and consultant, what he thought about changing clinical trials and he felt it was imperative to aggregate patient health data for the patient.

Craig Lipset:                     08:19                   So one thing that’s already changing, that will continue to change and have a tremendous impact on how we’re running our clinical trials and developing our medicines is the power that patients have to access and control their health data. The ability for patients to aggregate their own health data sparked by different apps and patient portals and the proliferation of FHIR as a new data standard, this is creating the future where patients are the ideal aggregator of health data. That if I go to one data provider or one health system and try to get data on a patient, I’m really only going to get one slice about that patient. But if I go directly to the source, the patient themselves, they are now in the unique position to aggregate all of this diverse health data from different pharmacies they may go to, from different doctors or hospitals or health systems where they may go. Now that patients are in control and have that diverse health data together, they now become the place that I can turn to when I want deep data on patient journeys to answer research questions and that includes for prospective clinical trials where so many of the questions that we’re asking of investigators and study coordinators are to enter data that already exists in an electronic health record somewhere else, but we don’t have access to it.

Craig Lipset:                     09:38                   The other awesome aspect about what happens when patients are in control over their data, is we don’t have HIPAA excuses standing in the way any longer. HIPAA doesn’t block a patient from sharing data wherever they want to. And so a disruptive force that’s going to change and streamline how studies are run in the future, that’s going to be the data empowered patient.

Janet Kennedy:                     10:01                   Let me put my patient hat on though and say that I’m fortunate. I only have maybe two or three physicians that I work with on a regular basis, but every one of them has a different portal. I even have two different portals at my current physician depending on whether I use Google to log in or an email to login. So that all sounds wonderful, but if we’re not dealing with a universal standard, how does that work?

Craig Lipset:                     10:27                   It is an unfortunate reality that even when patients in the United States have access to their health data, it’s through a cacophony of different patient portals or different logins for what look and feel like the same portal. For example, many of my providers are using Epic, but I have five different logins for Epic’s My Chart app for each of the providers’ instances of My Chart. Now, third party apps are emerging that are streamlining some of this and we see new products like Hugo Health, like Seekstr, like Citizen and others that are helping patients to not only access the data in these diverse places where they may live, but bring that data together to give patients and those with whom they choose to share their data an integrated view. So agnostic to whether this lab test was run at Provider A or Provider B, pull it all together so I could just see my labs rather than view it in the artificial silos that healthcare boundaries have created. So again, I think that it’s a challenge today, but I believe that many of the emerging products that are being built to leverage FHIR and pull that data together are creating awesome new views that are great for patients and researchers and providers.

Janet Kennedy:                11:48                   Clinical trial participants tend to feel that the benefit is for someone else, other patients, or perhaps even the drug companies sponsoring the trial. Jennifer Byrne of Javara Research wants to change that perception. The lack of knowledge about the purpose, process and benefits of clinical trials can be addressed by changing how to discuss clinical trial participation with patients. She says if you could change one thing about clinical trials, what would it be?

Jennifer Byrne:                12:20                   The lack of general knowledge about what being in a clinical trial for an individual patient participant actually means.

Janet Kennedy:  How would you solve that?

Jennifer Byrne: Well, first of all, I probably would use different terminology. I would be thinking about positioning clinical trial participation as an innovative care option.

Janet Kennedy:                12:46                   Oh, I like that idea. Is there a problem in clinical trial participation in that people only assume you have to be really sick to be in one?

Jennifer Byrne:                12:55                   I don’t know that it’s so much assumed that you have to be really sick, but I do think that on the patient, the general public side, there is still a connotation of Guinea pig. So it’s, “I am part of a scientific experiment and that scientific experiment is not about benefiting me. It is about benefiting a company or potentially benefiting other people to come”.

Janet Kennedy:                13:26                   So do you feel that if you participate in a clinical trial you should feel better or do better when it’s over?

Jennifer Byrne:                13:35                   I think that you should expect to have some benefit and I don’t know that that expectation should be that you have treatment or condition benefit, but I think that you should expect to be better informed about your medical condition. I think you should expect to be able to leave that clinical trial being better informed in terms of what other options for care or research or treatment you might have access to. I think that you should expect to have an exceptional care delivery experience.

Janet Kennedy:                14:11                   All right, so now you are officially the genie who has to answer that wish and solve the problem of getting more people involved. How do we solve that problem?

Jennifer Byrne:                14:21                   I think we have to bring better alignment with health care. This conference is terrific, but I think this conference and other conferences in the clinical research space focus heavily on pharma and CRS and then the workforce with respect to clinical research coordinators. I think that we need more health care leaders. Those people who are leading organizations and that are charged every day in their job to find better ways to deliver or reducing cost of care, improving outcomes for the patients for whom that organization or institution serves. And finding ways to bring about more satisfying patient experiences. Because I think that clinical research can be a tool in that toolbox to help accomplish that. So in that way, it’s not about clinical research being a means to an end for pharma companies to get a drug approved, but that clinical trial access is actually beneficial to that individual in their care at that moment.

Jennifer Byrne:                15:42                   And it is beneficial to that health system to better understand is an active participant and as part of an active learning health system that in real-time is also bringing benefit. It’s a tremendous shared value opportunity.

Janet Kennedy:  We talk a lot about we need to have patients at more conferences. I’m wondering if we need to also have at every American Academy of Pediatrics or the Academy of Family Physicians at every one of those general practice types of conferences, panels on clinical trials and how to translate them for your patients.

Jennifer Byrne: Absolutely and I think we also need to be including people who are opposed to clinical trials. I think it’d be a great learning experience to hear from a physician who has refused to participate in clinical research, which is different from a physician who hasn’t participated because they haven’t had the opportunity or they don’t have the infrastructure to support that, but I would like to hear from physicians who perhaps participated in research, those “one and done” physicians that we talk about, I’d like to hear why, what we can learn from them to make that better.

Janet Kennedy:                17:06                   We invited patient advocates to also be a part of the Voices of Disruption. Carly Flumer, a scientific data analyst, patient advocate and cancer survivor goes right to the gist of it. Use plain language.

Carly Flumer:                   17:23                   I’m Carly Flumer. I’m a scientific data analyst, a patient advocate and a cancer survivor. If I could change one thing about clinical trials, it would be the language that they’re written in. Health literacy is such an important component of healthcare, yet it’s not recognized to it’s fullest potential. Clinical trial enrollment numbers are pretty low and I believe one of the causes of this is some of the language that’s used, specifically medical terms that patients aren’t able to understand on their own. Rather they need a doctor or a nurse or other healthcare provider to explain the trial to them and that’s only if one, the patient brings up the trial during an appointment and the provider has enough time to discuss it, which is another issue or two, the provider recommends the trial to the patient as a form of care. Without this guidance, the majority of patients may have a hard time understanding what they’re reading and if they don’t understand it, they’re less likely to take an interest in it.

Janet Kennedy:                18:26                   To fully engage patients, it’s essential that clinical trials accurately represent the population of patients who are intended to benefit from the therapy under a study. We asked Julius Wilder, assistant professor at Duke University School of Medicine and the Duke Clinical Research Institute, what he thought, he explained that with clinical trials historically under-representing certain types of patients. There’s work to be done.

Julius Wilder:                   18:54                   My name is Julius Wilder. I am an assistant professor in the Duke School of Medicine within the Division of Gastroenterology as well as the Duke Clinical Research Institute. As I reflect on how we can improve clinical trial research, I believe a key component to that will be ensuring that clinical trials reflect the diversity of the population of people with the diseases that are being studied. Historically, minority populations including blacks and Latinx as well as women have been underrepresented in clinical trials. This has significance for many reasons, including the potential creation of therapies that may be dangerous or not efficacious in these populations. This historically has been a problem for decades and we have been able to address it. I believe the solution for this problem includes a mixture of policies including policies around ensuring that the clinical trials report participation of minorities and women in clinical trials – incentives. These could be financial or related to FDA approval to provide motivation for pharma to invest in diversity and research on what are the barriers and to identify potential interventions to increase diversity within clinical trials.

Janet Kennedy:                20:08                   Tom Rhoads, CEO of Spencer Health Solutions and the founder of the company brings the conversation right back to the essential element of what Voices of Disruption is all about. That clinical trials should start and end with the patient.

Tom Rhoads:                   20:25                   I think to be patient-centric really means that we begin with the patient and work out. Today a lot of the approaches I see are attempting to modify decades-old processes and make them patient-centric and I don’t see that as a winning strategy. I think you have to rethink what are the endpoints you’re trying to accomplish here and if you’re that, then you really begin with what does the patient need, what do they expect, what kind of feedback and support will enable them to provide adequate insights to the protocol or the molecule or whatever you might be testing. And I think a lot of the approaches today miss that point. It seems like a simple point, but it’s actually complex if you really dig in to try to understand how to best engage someone in their home environment ideally. As an example, family –  patients have a rather significant, in many cases, family support system in place and those don’t go away just because they’re in a trial.

Tom Rhoads:                   21:26                   Oftentimes the family needs to drive them to the clinic. They need to help them answering questions; they need to help them with their daily living activities. There are a lot of aspects of that that are already happening on a day to day basis, but oftentimes we don’t see any engagement with the family and I think that’s an example of an area that we need to get better at, which starts with the person. And I say person because we acknowledge that there are always people in their patients at times and often too often, whether it’s in clinical trials or in the healthcare system, those systems are set up to treat them as a patient, which means that they’re going to do the processes they need to do to reach the endpoints they need to get to and that may or may not include informing those individuals of what’s going on, why it’s going on, what the feedback is, what the prognosis is, all of those aspects that any normal person may wonder, especially if they’re suffering from either a chronic or life threatening disease.

Tom Rhoads:                   22:19                   So as we think about platforms and innovation, they really need to start contemplating how might a patient use, integrate all the tools, we talk about wearables. There’s lots of wearables coming to the market, which means there are lots of wearables coming into the home. The medications are using, the titration schedules that might follow those, the telehealth aspects. How can I talk to someone when I feel like I’m having an adverse event? The ability for them to be mobile. A lot of these people still have lives, are working in many cases and, and how can I carry this with me, but still participating in a meaningful way while getting feedback. I think right now there’s so many good ideas that are creating a bit of a technology avalanche.

Tom Rhoads:                   23:13                   And so we need to begin working across companies, through partnerships and into more of an integrated perspective and approach, which means that we’re going to have to start picking some platforms that might be able to enable this. AARP had a study a few years back and they called the family, the chief of staff. And it’s usually the daughter who is responsible and she wants to know everything that is going on at all times. So respecting that as we integrate the technology, respecting that those not only need to be informed and will frankly demand to be informed, but they also can be used to help the individual in the trial, that’s the subject to be more effective, make sure they’re keeping up with their diary, make sure they’re giving appropriate honest feedback, et cetera. That’s where we kind of land on where does that patient want to be?

Tom Rhoads:                   24:08                   It’s convenient for them to be in a clinic. That’s where the physicians are, that’s where the nurses are, the PI, et cetera. And that’s the easiest place to care for an individual. But it is not the easiest place for that subject to be that subject. The easiest place for that person to be is at home. And so I think there’s a lot of excitement around the model shifting to a direct to patient focus and I think that’s putting a lot of pressure on clinical trials to begin to honor that and figure out how to modify processes, how to modify regulations, how to modify, you know, the approach in general that we take to ensure that we can serve them in their home. Because let’s face it right now, we’re still seeing 30% dropout rates from trials. As you get in the more and more orphan type drugs, it’s more and more difficult to recruit patients. So if we can begin to allow them to participate in these trials from afar, in their home, minimally reducing the number of site visits that may be required, I think we’re going to get a much better participation rate feedback and frankly data to determine whether the molecule is working as it should.

Janet Kennedy:                25:21                   Thanks for listening to the first episode of the Voices of Disruption. We’d like to thank our contributors to this podcast episode, including Eva May, Darcy Forman, Craig Lipset, Jennifer Byrne, Carly Flumer, Julius Wilder, and our own Gayle McCracken and Tom Rhoads. Look for our next episode of Voices of Disruption, where we look at the importance of the staff training that you do to make your clinical trial teams more patient-centric. If you’ve enjoyed this episode, please share it on LinkedIn and Twitter where you can find us @spencerhealth. Subscribing to the podcast ensures you’ll always have the latest episode in your favorite podcast player. I’m Janet Kennedy and I thank you for listening to “People Always, Patients Sometimes”.