Big Pharma: Patient Experience and Innovation

The pharmaceutical industry is evolving to consider customer experience – or patient experience, in this case – as a core dimension when bringing new drugs to market. Shifting consumer expectations combined with innovative technologies will have a dramatic impact on drugs and healthcare in the coming years. On this episode of CXOTalk, industry analyst Michael Krigsman speaks with two strong voices on this important issue.


Nov 29, 2017

The pharmaceutical industry is evolving to consider customer experience – or patient experience, in this case – as a core dimension when bringing new drugs to market. Shifting consumer expectations combined with innovative technologies will have a dramatic impact on drugs and healthcare in the coming years. On this episode of CXOTalk, industry analyst Michael Krigsman speaks with two strong voices on this important issue.

Craig Lipset is Head of Clinical Innovation within Worldwide Research & Development at Pfizer. Craig’s team is responsible for impacting clinical research through digital tools, innovative research approaches and novel collaborations. Michael DePalma works at QuintilesIMS as Vice President of Digital Transformation.


Michael Krigsman: Healthcare, patient experience: we've all been to the doctor; we've been to the emergency room, and it sucks! I was in the emergency room myself just two days ago, and I can't tell you how bad the patient experience was! What are we going to do about [the] patient experience today?

Today, on Episode 265 of CxOTalk, we are talking with two folks who know about the pharmaceutical industry, who know about patient experience, innovation, and what we can do about it. I'm Michael Krigsman. I'm an industry analyst and the host of CxOTalk.

Before we begin, I want to say thank you to Livestream for being a great video streaming partner to CxOTalk. If you go to, they'll give you a discount on their plan. Thank you, Livestream, for supporting us. You guys are great.

Without further ado, let's introduce our two amazing guests. To begin, Craig Lipset from Pfizer Pharmaceutical, how are you? Thanks for being here.

Craig Lipset: Thanks, Michael. It's great to be here as well.

Michael Krigsman: Craig, tell us about Pfizer. I think we all know, generally, what Pfizer, but tell us briefly about Pfizer, and tell us about your role.

Craig Lipset: Sure. Pfizer is a 150-year-old biopharmaceutical company based in New York City. Most people know of Pfizer for some of the different brand names, whether it's oncology medicines, rare disease medicines, or some of the consumer products like Advil or Chapstick, but it's a large organization. We make 74 billion doses of medicine every year that get distributed across 125 countries around the world, so there's a lot going on in a company like Pfizer.

It's what we would call a large, integrated pharmaceutical company, and so Pfizer has research laboratories. We have a development organization, commercial and sales manufacturing - a pretty wide range. I look after innovation for the development side of Pfizer where we run the clinical trials, where we take those new medicines, those molecules that are coming out of a laboratory, and we start to test them to understand efficacy and safety so that we can bring those to market and ensure that patients are getting the impact that they're looking for.

Michael Krigsman: Did I catch that right? You said you release 75; is it 75 billion?

Craig Lipset: Billion, with a B, doses of medicine around the world every single year. It's mind-boggling, isn't it?

Michael Krigsman: It is genuinely mind-boggling. Well, thanks so much for being here on CxOTalk. Our second guest is Michael DePalma, who is with IQVIA. It's a name that you probably don't know. But, if you were in healthcare, if you're in the healthcare business, you probably do know their name. Michael DePalma, how are you? Thanks for being here.

Michael DePalma: I'm very well, Michael. Thank you very much for having me.

Michael Krigsman: Tell us about IQVIA, and tell us about your role.

Michael DePalma: Sure. IQVIA is an interesting animal in that that brand, that entity didn't exist before a few weeks ago. You may have known us by our prior names, which were Quintiles or IMS Health. IQVIA is the birth of a new organization that bridges both of those organizations: one being clinically focused, the largest contract research organization in the world; the other being IMS Health, which is very much marketing data and technology focused. We call ourselves a human data science company. We are one of, if not the, largest provider of data technology and services to the life sciences industry.

Michael Krigsman: Okay. Thank you so much, Michael. This issue of being patient-centric, you know we all hear the term being customer-centric; but when we talk about patient-centric and patient experience, what really does that mean? Maybe, Craig, I'll ask you to jump in and start this conversation with that background.

Craig Lipset: I think that there are a lot of buzzwords that all of our different industries face. Right now, in many ways, patient centricity, which has been a buzzword, is actually starting to come into action. It's easy to say that we do things for patients. It's kind of like saying I love puppies and babies. Of course, I'm going to do the right thing for patients, but do you really in terms of the level of complexity that you've created for people?

I work on the clinical trials that we've got going on here at Pfizer. When you look at the historical amount of burden to patients to find a trial, to participate in a trial, to keep coming in and out, the amount of data that was extracted from patients, all of that, it makes it very hard to say that the historical approach for running these studies is very patient-centric. I think it's really embodied in the word "subject."

When you look at most of the studies that are performed around the world, the majority still use that term, "subject," which is a very hierarchical term. To me, it implies almost like a subject that you're trying to paint. You're drawing data out of it, and you're giving very little in return, as compared with a more contemporary view of looking at patients as participants in the process.

Michael Krigsman: Michael, I know you have thoughts on this. [Laughter]

Michael DePalma: I have a lot of thoughts on this. Let me begin by telling you a little bit about what I do at IQVIA because I think it plays into this. I run digital transformation and partnerships at IQVIA. What that means is, "How do we find new ways to solve old challenges? Or, quite frankly, how do we use technology or new methods to create solutions for challenges we haven't yet really experienced, but we kind of see coming down the pike?"

This patient experience conversation--and Craig and I have talked about this a whole bunch--is one of those funny things. We had a conversation earlier. Words matter and we use the word "subject."

It's funny. Actually, Craig, you used the word "data extracted" from patients, right? That's a really funny word. We extract data from patients. It's really unnerving to kind of think about it that way.

The question is: "Are you a human? Are you a patient? Are you a subject? Are you a consumer? As it turns out, you're all of those things. And so, the nomenclature matters, and it also affects, I think, the way that we think about ourselves and the way that we think about the people that we're trying to serve. When we get into that area and we talk about subjects, we talk about data, the question is, how can we as an industry create an environment where human beings feel much more comfortable and confident in receiving care, in engaging with care, in sharing information, and creating that sort of 21st Century environment?

Michael Krigsman: I guess that's the question, right? What do we do when there are so many dimensions to this? There's technology. There's politics. There's regulation. There's the drug development process. Craig, how do we solve this problem? How about if we place this problem right now at your feet to solve?

Craig Lipset: You're placing a pretty big problem because the numbers don't look good. Today, we rely on Tufts University to generate and track a lot of data around the time, the cost, and the complexity of drug development: $2.6 billion, 7-plus years of time. You're starting from a pretty rough place. Then you start to layer on other factors.

Emerging science like precision medicine is actually making the markets for most medicines smaller rather than larger. Yet, these clinical trials don't scale for small studies very well. They're still pretty expensive. Even if you're studying a small number of patients, you have a lot of infrastructure that you still have to set up and manage.

The technology is generating more and more data. Together, these studies are only getting more complex rather than more simple. And so, these different environmental factors are actually conspiring to make it harder rather than easier.

Even in today's climate politically where we're in something of an era around deregulation, remember that that drug development cycle time--six, seven, ten years--that's going to go through multiple administrations. And so, there is still a tendency for most drug developers to try to err on the cautious side. In doing that, it only amplifies this challenge around the time, the cost, and complexity of drug development today.

Michael DePalma: Absolutely.

Michael Krigsman: Let me see if this is correct. The fundamental problem then is you've got this kind of Clash of the Titans, if you will, the titans of patient expectations, government policy, the science of all of this, the need for cost containment, and yet it's very expensive to develop drugs. You've got this clashing of mutually opposed forces. Is that a reasonable way to describe it, Michael?

Michael DePalma: I think it's an issue of complexity. I think what Craig is describing is something we also see in education. I saw this when my kids went away to school. You've got these 21st Century individuals sort of engaging with this 20th Century model to support 19th Century ideas about what it is we're doing, right? That's where there's a challenge.

We've got more data than ever before. We've got more ways that we can touch people than ever before. But, we're still supporting that same existing model.

Again, Craig and I had a conversation around this. There are so many offshoots and components that occur and that exist in this world today that didn't exist in this model earlier in the 20th Century or even earlier in this century, quite frankly. The idea of social, the idea that we can share information peer-to-peer without going through sort of an intermediary component: all these things are complexities that the model in and of itself isn't necessarily ready for yet.

A lot of what we do is try to figure out, okay, so as this technology becomes available to everyone--not just us as an industry, but also the individual consumers, patients, humans--how does that impact what we do? How can that be leveraged for good? And, how can we overcome any of the potential challenges?

Michael Krigsman: We have a question from Twitter from Scott Weitzman who is asking about the role of changing patient expectations. Where does that come into the technology decisions? Any thoughts on that?

Craig Lipset: I think that patients today are, in many ways, amazingly aligned to what industry would have always wished for. There's urgency. There's engagement. Patients are activated. The problem is, they've passed the industry in so many ways. Their urgency is now creating a pull for industry, and the industry is trying to rush to keep up.

When we're looking at the technologies that we're including in these programs today, I'm seeing this great convergence of research teams that are increasingly engaging with patients very early in the process. They want to talk to patients: get input into the best study designs; input into the endpoints that matter most to patients. And it's a great time because then, on the other side when we have new and emerging technologies, you mash those two environments together. And so, it's no longer a case of just a researcher sitting in one of our laboratories in an ivory tower envisioning what endpoints matter most to patients and grabbing an exciting and new technology, but increasingly we're doing that together with patients. We're sitting together, evaluating what endpoints matter most and then what technologies we can bring to bear to help us to measure that. That's where we're increasingly pulling in sensors, wearables, [and] other environmental types of data that we can bring in, and looking at intelligent algorithms that can help us in terms of making sense out of all of that data.

Michael Krigsman: I'm waiting for you guys, and you guys are waiting for me. Hey, guys, just jump in, right?

Michael DePalma: Well, let me do that, Michael, actually. One of the things that Craig is touching on is this concept of collaboration. It's a really funny thing because everybody uses the word. But, when we come to healthcare, patients were the one group that was sort of left out. They were the group that we said sat in the center but basically were preyed upon. They didn't really have a very good understanding of their health. They don't have a good understanding of therapies. They don't have a really good understanding of their own data, what it means, what to do with it, who has it, where it goes, [and] where it sits.

When we talk about collaboration, the first thing is to look at these human beings, patients. Patients are just sick humans, right? It's a temporary thing, we hope. They are consumers. They have certain expectations about the way the world works, about what they can expect.

If you look at the way that collaboration and access and democratization has occurred in places like finance, education, and all these other areas, healthcare still lags a bit, and we're still working on that. But, there are some really, really, I think, encouraging signs when I looked at some recent data. Sixty percent of patients say that they are more than willing to have a video consultation with their healthcare provider. Eighty-eight percent of them said that they were absolutely willing to share their health data if it helped accelerate cures.

I look at that, and I say, "All right, there's a little bit of a disconnect there because A) Are we doing that? B) Are we doing that the way that these consumers understand that we're doing that?

I think that's one of those really cool opportunities for us. One of the things I think you'll see from this, by the way, is a whole new set of industries around serving these humans, these patients, around engaging with their own health, engaging with their own healthcare, be it in clinical trials or other.

Craig Lipset: I'm going to build on that and share a recent example. We have a number of different research programs in immunology and inflammation. Some of those are looking to impact for patients with lupus. The endpoints that we use in research studies in lupus are pretty inadequate. They're inadequate in a lot of indications.

These endpoints — this is what we're measuring in order to understand if this new medicine is working and making an impact. Now, a traditional model might have been we'd go back to our environment. We'd sync up, maybe with some key opinion leaders in academia, some new endpoint and do research to try to validate that to show that it's really measuring something meaningful.

Last year, in more of a 21st Century approach, we sat down together with the Alliance for Lupus Research. They brought in patients and others to share their experiences about what matters most to them. We co-developed an instrument using Apple's research kit framework. Now we've co-invested in a validation study to demonstrate that that new measurement that patients helped guide us and informed what we were actually capturing that we can then validate it and use it in research studies. In the spirit of the GitHub universe of research kit, we can then make that available to other researchers and post it back for the research community.

Michael DePalma: Mm-hmm.

Craig Lipset: That's very different than what it would have looked like in a very insular environment just a couple of short years ago.

Michael DePalma: Absolutely. I agree with that. Let me just add to that a little bit. We talk about wearables. I've got my Apple Watch on. I've got my nerd cred.

It's funny. I was on a stage recently talking a little bit about this concept of fitness tracking. I had written an article some years ago stating that the future of wearables would not be fitness tracking. I've been wrong so far, by the way. [Laughter]

But, what's cool about Apple's watch in this HealthKit is the amount of data, the quality of data that we have access to. As that grows and we see this huge population of these people wearing these things, there are a couple things that go on. First of all, the people who are wearing these things, generally speaking, aren't the ones who need to be wearing these things, which is one challenge, unless you're going to issue them to everybody in a clinical trial, which is possible, and I think it's being done now.

But, what ends up happening is now you end up with this explosion of data. One of the things that we've been guilty of as an industry is collecting data and not necessarily knowing what to do with it next. How do you make that valuable?

That's kind of the point around this industry stack. How do we create a new approach? What are the new levels that need to exist in order for this to be really actionable and make it make sense for people's everyday life?

Craig Lipset: Michael hit on a data point that's been extremely important to me, and it's been an area of a lot of focus for my work and my team. He mentioned that 88% of patients are willing to share access to their health data to find new cures. What's been remarkable is that number has stood up across multiple different surveys, whether it's enriched caregivers of patients at Boston Children's Hospital or highly activated patients at online communities like Patients Like Me or more mainstream patients off the street.

Time and again, nine out of ten consumers say that they're willing to share access to their data to help find new cures with one big ginormous asterisk. There has to be trust. It has to be according to their permission and their wishes. Nine out of ten is like this amazing number that we can only screw up by messing up on trust. But, if we can get it right, it can be game-changing.

Research is fueled by data. It's why we do research studies. It's why we do clinical trials. The entire process is about generating data and communicating the output from those data, the different results, whether to regulators, payers, patients, [or] providers. In a world going forward where patients are able to not only access their diverse health data, self-tracked, self-generated, patient portals to be able to access their EHR data. When they're able to then share that data in trusted ways, that's a game-changing future state.

Michael DePalma: I've got to do something, if I can, Michael. I apologize. We mention trust, and you can't say the word "trust" and you can't talk about data democratization without a shout out to Richie Etwaru and his work on trust with blockchain. Making this technological for a second, so trust is a function, right? You have to do it. Trust right now is a function of an intermediary or an organization.

The pharma industry, we have a bit of a trust issue, I think, with the general public. Some of it deserved; some of it not deserved. A lot of it is just lack of understanding and the fact that that information all goes someplace. I don't necessarily know where. I don't know who controls it. I don't know who has access to it.

The promise of technologies like blockchain allow us to allow patients to decide who gets access, who will I share with, under what conditions will I share, [and] to create these automated smart contracts so that people truly have access and control over their data. I know there's a lot of this going on right now. Some of it seems pie in the sky. Some of it is very, very real.

I'll kind of close this statement with the Philip K. Dick quote. "The future is already here -- it's just not very evenly distributed yet." There are definitely pockets of this going on. The question is when we reach scale.

Michael Krigsman: But I have to jump in and ask a question. I mentioned earlier, I was at the emergency room the other day. I typically go to the Beth Israel Deaconess Medical Center system here in Boston. It's one of the Harvard teaching hospitals. I went to--I forget the name of it--another hospital here in Boston that's also part of the Harvard teaching system. Great care in both places, but their systems don't seem to talk with one another.

I said, "Oh, well, are you part of the BIDMC system?"

They said, "No, no, no. We have our own portal where you can check it out, and you can get all the information."

I said, "But I already log into that other place. I don't want a separate login. Why can't you guys just make this work?"

Michael DePalma: [Laughter]

Michael Krigsman: You guys are talking about blockchain and these two major Harvard teaching hospitals that can't even get their systems to connect so that a patient can just see everything in one place.

Michael DePalma: Let me say this. This may be an unpopular statement, but a lot of the EHR systems, a lot of software is software by and for software engineers. Let's be frank. Having been one of those guys, I can say that.

When we get to a point where we can truly enable the people that we're trying to enable through technology, that's one of the things that consumerization, I think, is doing if you look at apps, if you look at wearables, and you look at the way that we're willing to engage with patients where they are, as opposed to forcing them into some model. Interoperability between EHRs and all sorts of other hospital systems is not a new problem by any stretch of the imagination. I do believe it's a solvable problem, but it's going to take some time and some adoption.

I mention this thing about the future. Blockchain has great potential and great promise. It's not there yet, but we can easily envision a future where you truly have interoperability across health environments.

This is a digital transformation discussion. How do you take an existing system? If you look at a lot of the systems you were just talking about, Michael, in your experience in the ER, they were basically digital paper. I mean that's really what goes on. When we say digital transformation, we don't mean digital paper. We don't mean, take this same form and put it on an iPad. That is not digital transformation, and a lot of what you're experiencing is probably due to that.

Craig Lipset: Let me sprinkle a little optimism for you here, Michael, because--

Michael Krigsman: [Laughter]

Craig Lipset: Health data interoperability, I don't know what it's going to take to move that mountain. There are so many great initiatives out there and data standards initiatives. I love to tell the data standards folks, "I'm so glad they're there because I don't want to make data standards, but I want to be the beneficiary of them."

Here's my sign of hope. Michael, you were at multiple hospitals, and you have these different portals today. The common denominator is you. You have access to your disconnected health data.

Michael DePalma: [Cough]

Craig Lipset: I've been at Partners hospitals. I have some data there. I've been at BU hospitals. I've been at Physician's in New York at Mt. Sinai and here in New Jersey at Atlantic Health. My life, my life as a patient, is spread pretty thin across a lot of different institutions. Some researchers may get very excited to say, "I'm going to partner with the Partners Health System and access their EHR and find this great data," but you're only going to find a little slice about Craig Lipset as a patient in there.

Michael DePalma: Mm-hmm.

Craig Lipset: If you want to get the depth and fidelity about me as a patient, you come to me to get it because I'm the common denominator across all those different disconnected systems. Meaningful use criteria tell those systems, the owners of those systems, if you wanted to get financial incentives from the federal government, you've got to make sure that I, me, the patient, have access to that data. Where we can focus, and this is where research really gets patient-centric in the very real sense where we can focus on empowering and enabling patients to leverage that access and be able to share that diverse data in trusted ways, that's that game-changing opportunity that doesn't have to wait for Beth Israel to be able to share their data with some other hospital right across the street.

Michael DePalma: Yup. Yup. Let me just add one more thing to that, if I can. The one thing that sort of pops up around this that I hear a lot is, do patients understand their own data? Do they understand the value of that data? Do they understand what that means?

The answer is, for the vast majority of human beings, no; the answer is we don't know. There's a whole bunch of stuff that we know about ourselves. The question is, where does that go? What do I do with that information?

You're at this sort of loggerhead on, do we need to educate patients on what their data means? I would argue no because, you know what, I don't need to know how an internal combustion engine works to drive a car. I put the key in and I move. Are there analogs that allow patients to engage with the healthcare environment without necessarily knowing what all these particular numbers mean, but to have control over that data?

I think it's an interesting challenge. We're not there yet. But, I think there's a lot of different interesting work being done around that.

Patients are now aware of their data. They're aware that their data is being collected. They're aware that their data is being shared. The question now is, how do we create a situation where they understand what that really means for them?

Craig Lipset: I often think about the analogy to my credit report, which is probably a bad analogy this year. But, that being said, the consumers use their credit report to benefit themselves every day when they're buying a home, when they're trying to open a new credit card. They don't necessarily go through their credit report in granular detail. Maybe they do when there is a big data breach or data loss. They're enlightened to go take a closer look. We have ways that consumers are able to use that data to take action and to do things that are good for them or for others, even if they're not down with all the granular details.

I think that, to Michael's point, there are some patients that want to get into the weeds. They want to understand every data point that's in their EHR, and they want to challenge if they disagree. There are other patients that aren't going to go that deep but still want to do amazing things when they have that access, and we need to make sure that we have the tools to empower both.

Michael Krigsman: How do we solve this data interoperability challenge? There are so many parties that are involved. And, where do drug companies fit? Is there a role for drug companies, or is this about medical health records? Is it a government issue? How do we even begin to address it?

Craig Lipset: I'm going to put that research lens on. Then I'll let Michael comment if he has a more expansive view.

The last presidential administration had launched a really cool Precision Medicine Initiative that President Obama was very geeked out around. One of the cornerstones of that precision medicine Initiative was launching this million patient cohort study here in the United States. Actually, their aspiration is well over a million. They call it the All of Us Research Program.

This program is meant to collect electronic health record data, bio-specimens, self-track data, [and] all this diverse data from a million-plus patients. How are you going to do that? How are you going to get a million people to be able to share their data?

Something that the Office of the National Coordinator for Health IT kicked off alongside that program is something called Sync For Science. They brought together six or seven of the largest EHR providers in the U.S. I think there were a couple of holdouts. They worked with them to align on a data approach that may not solve all of health data interoperability, but at least gives a common denominator for patients to be able to share their data for research use. It doesn't solve all of the one-to-one connections of health data interoperability, but it solves the many-to-one of enabling all those different systems to be able to share their data to advance research.

Michael DePalma: Yeah, that's a brilliant point. I think there'd been a bunch of different things that have happened. I know the U.K. had a registry program at the NHS [National Health Service] to collect. ..They're one of the most data-rich environments in the world. For a fairly small population, they have a tremendous amount of information about the people who live in that country in terms of health. That's an interesting model.

I think it's really understanding, from a technology standpoint, what the right way to do this is. I think, initially, people envision this massive dataset. Here's everything about everybody that sits in this one spot. I don't think that's necessarily going to be the case. I think it's going to be somewhat distributed, to your point, as it is today.

I think the interoperability needs to change through the technology model. Right now we still had these large, monolithic systems that we expect to talk to each other. I don't think that's really sustainable, to your point. How do you really get these monstrous systems to talk to each other? It's not an easy thing to do.

Does that mean a redesign? Does that mean a totally novel, new technology? It may. I think that, at the end of the day, we need to not make perfect the enemy of good and figure out how we can make incremental steps and changes towards something that's better than it was yesterday.

Michael Krigsman: Right now, then, where are we going? You guys are the cutting edge, seeing innovation in [the] patient experience. Maybe you can share with us what you're seeing, not in the next 20 years, but in the next 3 years. What are we likely to see, and tell us why?

Michael DePalma: Sure. I'll get started, actually. It begins with the increasing consumerization of healthcare. What I mean by that is that healthcare is one of these last bastions of non-consumerism, certainly, in the U.S., We've got about 4% of the world's population. We spend an awful lot of money on them. We don't necessarily have the right health outcomes compared to the rest of the world, certainly per capita.

If you look at the way that we interact with health, again, it hasn't really changed. It's very reactive. It's not very proactive, although there is some movement around that.

The question is, how do we incent human behavior? How do we interact with patients on a daily basis, but not where it feels like this sort of doctor/patient relationship? How do we make them stakeholders in their health? I think the way to do that is through technology. It's where they live.

Craig and I had a conversation about this some time ago about the social structure for humans, for patients, for consumers. They talk to each other, as it turns out. We were unprepared for that. That's something you really need to think about and understand that that's yet another data stream, yet another touch point, yet another opportunity for us to engage patients in not only their own healthcare, but also with their healthcare providers, their entire health circle: friends, family, patients, like them, et cetera.

It's really opening up the spigot and saying, "What are all the different ways that we could interact with these people today?" We can collect data through wearables. We can collect information through their sort of online personas. We can collect it directly through interaction with them.

I know CMS is doing some work around population health. If we have a phone conversation 20 minutes a month, there's a reimbursement. The idea being that if patients are more engaged, they're more likely to be adherent. If they're more likely to be adherent, they're more likely to have better outcomes. If we've got better outcomes, we've got better cost structures.

All of this gets into play, and these are things that are happening today. That's not a flying car conversation. This is very, very real. This is what's going on today, tomorrow, and next week.

Craig Lipset: If healthcare is just starting to figure out [that] patient experience matters, research is a click behind them. When you look at the baseline experience for a patient in a clinical research study today, number one, how do they even find the study? Most patients tell us they want to learn about research studies from their physician, from their treating physician. It's who they trust. Yet, if that treating physician is not the investigator in that research study, we know the odds are very low that that patient is ever going to learn about that trial.

It goes back to what Michael was just saying; the incentives are misaligned. All of the freakonomics of clinical research, the treating physician of most patients has very little incentive to talk about research with their patient or to encourage them to be in a study that may be appropriate for them if that treating physician may actually lose the opportunity to provide follow-up care. There are very real financial incentives that are misaligned.

Then continue to follow that journey of that patient now because, somehow or other, they found out about the trial. Now they're coming in and out. That first visit, they're handed their 30-plus page informed consent, probably still a stack of paper on a clipboard. They have to go through that, and the intent there is to make sure that that patient is informed enough to make a proper decision about whether or not to participate in the study. That's a lot of paperwork to have to go through on that journey.

Michael DePalma: Yeah.

Craig Lipset: All that, and the patient is not even in a trial yet. That next hurdle for them, they're going to go through some sort of screening process. We know that the majority of patients who fail that screening process, they're done.

It's so much work to get to that stage that if they fail screening for one particular study, to any other industry you'd say, "This is an activated consumer. They're aware. They were engaged. They simply didn't match for this one study."

I, at Pfizer, have well over 100 trials. When you look on, there are thousands of open studies that are enrolling.

Michael DePalma: Yeah.

Craig Lipset: Yet, if a patient fails screening for one, they have to go so far back to step zero that it's defeating.

Michael DePalma: Yep.

Craig Lipset: Then just carry that forward. The baseline for patient experience today is ridiculously low. We're doing things in our organization right now. I mentioned, for instance, even just words mattering, calling people a participant rather than a subject; sending thank you notes to patients for participating; making sure that they have access to study results from the trial in which they participated so they can learn just as we're learning; making sure that they can access their own data from that study so that if they just had a blood test that was done while they're in the trial, they don't have to have a copay and another needle stick to get another blood draw just because that first one lives in a study database and isn't necessarily open and accessible as it should be.

There are a lot of experiential elements here that are pretty big fails right now. The technology and the process are there, though, whether it's letting patients participate more from home or finding other ways to make sure that information is accessible and participation is accessible. That's kind of the entry point and where we are today.

I think that this theme about improving access and removing friction is going to be those key themes as we see these very near-term, incremental steps start to move us towards much more significant game-changers. How do patients participate without ever having to schlep into a clinic; bring their own data; participate on their own terms, whether that means I like paper or a digital tool, whether that means I just want to be monitored from a sensor that's not even on my body, whatever that may mean? How do we make sure our trials are more flexible and accommodating of patient preference?

Michael DePalma: Right. Again, this all comes down to one word to me, which is "connectedness." In the early part of your description, you talk about there's awareness, which is, I'm not connected. Then there is, I'm connected, but there's low value. I'm connected, but it's meaningless to me.

At the end of the day, it comes down to that connectedness. Are we connecting dots in every aspect? You look at millennials. Ninety-four percent of millennials expect connectedness in every aspect of their life: their home, their car, their wearables, their phone, everything that they do.

They want their world to follow them everywhere they go. If I want to watch Netflix, I want Netflix to cater to what it is I want to see, whether I'm on my phone, my iPad, my laptop, my TV. That's my expectation of the world.

Yet, when I walk into a healthcare environment, all bets are off. Nobody knows anything about me. In fact, even if I tell you something about me, three minutes later I have to have the same conversation with somebody else to tell you everything about me again, right? [Laughter]

It's this area where we are completely disconnected, and it's very funny. You may have heard me say this before. I don't think healthcare is broken. I think it's working exactly the way it was designed. But, it was designed a long time ago. [Laughter] How do we break through some of those connectedness issues and give people what they expect in every other area of their life, yet don't experience in healthcare?

Michael Krigsman: Go ahead, Craig. I'm sorry.

Craig Lipset: Just to build on that theme of connectedness, we use this jargon to describe trials. We call them randomized controlled clinical trials. We had this [Laughter] fiction belief that there's some sense of control.

Michael DePalma: [Laughter]

Craig Lipset: When we do a research study in a laboratory, maybe there are cages, but our humans are not in those cages when we're in these clinical trial settings. The control turns into controlled chaos. People are living their lives. They're exposed to many different things, and they're connected.

That notion that, for example, once upon a time we might have worried that one patient talked to another in a waiting room while they were in a trial and maybe shared little anecdotes with one another. Today, we need to worry that the entire study is connecting in a community online, or even more so in a private community that we can't even tap into or understand. Whether there's data to be learned from or cautions because, hey, maybe those patients are sharing tips and tricks on how to get into the study and meet eligibility criteria because they want mom or dad in that new Alzheimer's trial; or maybe they're sharing observations that may suggest a safety concern. If somebody posts online that they had a headache after their last infusion, how many more people are going to think, "Oh, you know what? I might have had a headache." That's why we control these or used to be able to control them and keep people apart from one another. The connectedness that Michael is describing, that new reality, research studies have not kept pace.

Michael Krigsman: We've got less than ten minutes left, and I want to talk about where this is all going. I just have to tell you a brief story about my own experience. It seems like I've had a lot of experience with the healthcare system, but you know we all have had these experiences.

I went to see a doctor, and I'm fine. I'm very healthy. But, I went to see a doctor about something. This was a big guy in the hospital and the chair of some department. He said to me, "We have a study that you can help humanity. We want you to participate in a study that's going to track people just like you."

I said, "Fine. I want to help humanity."

He said, "Great because this is really nothing."

Then he said, "I'm going to send the person in. You can sign the form, and this is going to be great." I waited 20 minutes, and I get very impatient when I wait 20 minutes because my time, actually, I think is valuable, and maybe it was half an hour.

Finally, the woman comes in, and she said, "Okay. Here is the form," and she said, "I'm going to walk you through." The form is like 25 pages long, and she's reading it to me. She said, "Sign here. Sign here."

I said, "Whoa! Whoa! Whoa! Wait a second! I'm not going to sign something that's like a 30-page document that's a contract without reading it, checking it out." Then I said, "Send it to me." Fine; she sent it to me.

Then I'm checking this thing out, and I'm thinking to myself, "Wait a second. There are financial relationships. I'm a businessperson. I can smell it. There are financial relationships that are going on here that are not disclosed." Then I started researching this a little bit. I sent them back an email saying, "Disclose the financial. Who is funding this? Where does the money go? What are you guys getting out of this? Tell me, and I'll sign."

Not a peep. That's a problem in my view, the hidden, the lack of transparency about the money.

Michael DePalma: Well, and this is what informed consent is, right? It's our attempt to try to describe to you what you're getting yourself into. There's the message. Then there's the way that we deliver that message. Then there's your ability to understand that and interact with it.

It's very interesting. Michael, you washed out, right? Obviously, you didn't make it. You weren't enrolled. But, it's a really interesting challenge because what we're asking patients to do, in engaging with us around this type of research, is to take risks.

There is some risk to this, right? You took a risk when you cut yourself. You took a risk of going to the ER because you don't know. You could get MRSA. You could have a staph infection. There's risk to everything that we do.

The question is, "How do we adequately connect the dots for patients (for people) so that they understand the pros and cons of all this? How do we do it in such a way that they understand the value of what it is they're giving and getting in return?" I think that we've mostly steamrolled over them. We understand the value prop in every other aspect of the industry. Yet, patients are wholly sort of disconnected from that. The best that we hope to do is we hand them a 30-page clipboard with an informed consent and just say, "Sign here," and moving on.

There are definitely some experience challenges there that we're working on. Listen, there are some great solutions out there that are far better than the experience that you had, and it's continuing to iterate and get better and better. On behalf of healthcare, I apologize for....

Michael Krigsman: [Laughter]

Michael DePalma: But it's certainly not unique.

Craig Lipset: The idea of moving from paper to tablet for consent, this is one of the few areas where there is a clear path forward. There's FDA guidance on the topic. There are a lot of companies that are starting to do it, including my own, and in the U.S. and in other regions. We know from the data that when patients are going through a consent process that's enabled through technology, they retain the information longer. They're making a better-informed decision as a result. They're more likely to stay in the study.

From us, from a compliance perspective, we see fewer protocol deviations because, every time somebody forgets to sign or writes the wrong date or sign the wrong version of a consent, that's a problem to us, and we have to go out and fix it. When we're using technology, that problem isn't there. But, look at the adoption curves for these. They're slow and painful, despite all of those great reasons that I just mentioned.

Now, I don't view informed consent as a competitive differentiator. I don't want a patient in a Pfizer trial to be any more or less informed than a patient in anyone else's trial. They should all be well informed. But, I will say this to my peers in the industry: If two patients are in the waiting room, and the one from my study is handed an iPad is going through with video and multimedia, and [is] really understanding [the materials], and your patient is still getting a clipboard with 30 pages. Think about the decisions that those patients are going to make when they just see each other interacting in those different ways. That's their welcome to the trial, right? That was the first thing you were handed.

Michael DePalma: This is the five-degree problem, right? If you're off five degrees at the very beginning of a process, you're miles away at the end. Anything that we can do upstream has profound impacts downstream. If people had an appreciation, a true appreciation for the cost, the complexity, the challenges, the time involved in research, in bringing drugs to market, if we did a better job up front of engaging them, connecting them, showing them how we can make their life a little bit better, the lives of others a little bit better up front, we'd have profound impact in the backend.

We're starting to see bits and pieces of that. I know, certainly, within our organization, we've got a number of different technologies and solutions that we use for that exact point. How can we better engage people early on to make sure that you don't wash out? How expensive is it when you lose a patient? It's ridiculous.

What happens when we don't have sites that recruit according to the numbers that we need to recruit, which is a very, very common problem? What are the things that we can do to accelerate? Technology is part of that. Communication is a part of that. It's really thinking about what we can do upfront to make sure that we don't have massive challenges later on.

Michael Krigsman: Okay. I have to say I have never had anybody apologize on behalf of the entire healthcare system, so apology accepted, and I really do appreciate that.

Michael DePalma: I'm sure I'll ... on that.

Michael Krigsman: [Laughter] But, we are just about out of time. I just want to ask you both. We could go on for another hour, but we won't. We are really out of time.

In a tweet kind of sound byte, I'll ask each of you to share with us your prescription for the healthcare industry. Craig, you started, and so maybe we'll ask Michael and then ask Craig. You can close us off.

Michael DePalma: My prescription for healthcare, huh? It's a huge industry. [Laughter] It's a huge problem, and it's not one problem. It's a series of problems. And so, I'll go back to my earlier answer.

The answer is, how do we better connect healthcare? That means including patients. That means making sure that they understand what that means to be connected. It means that they are active participants in their own health in every way: with their healthcare provider, on their own. It means making sure adherence works.

It's, how do we leverage technology--in my case--to better connect patients to the healthcare environment and the healthcare environment to patients? That's what it is for me.

Michael Krigsman: Okay. It looks like Craig Lipset, you're going to get the last word. What's your prescription for healthcare?

Craig Lipset: Well, I'm going to narrow my prescription down at the very least to those that are trying to develop new cures and new medicines. We have to remove the friction, all that redundancy, and having people reenter data, all that burden. Get rid of the friction and make our trials fit for participants. Make sure that the burden isn't on the patient to try to figure out how to navigate and do things because it's easier for us, but that we're doing the extra burden so that patients can participate in ways that work for them.

Michael DePalma: Hear, hear!

Michael Krigsman: Yeah! Hear, hear! I love that: patient-centric, and take the burden off the patient. Well, with that, we have drawn to a close on Episode #265 of CxOTalk. We have been speaking with Craig Lipset from Pfizer and with Michael DePalma from IQVIA. What an interesting discussion, and thank you, both. Thanks, everybody, for joining.

As we go out, we have a special treat. Now, Michael, you are sitting in what looks like a studio. Tell us. What's going on there?

Michael DePalma: That's exactly what I'm sitting in. I'm sitting in my home studio. I've got some toys behind me, and I'm a man of many passions. This happens to be one. It's not just all healthcare. I get to make music too.

Michael Krigsman: You're going to make music for us as we go out.

Michael DePalma: Want me to play us out? Okay.

Michael Krigsman: Yeah. Do it.

Michael DePalma: I'll play a song.

Michael Krigsman: Absolutely. Thank you.

[Guitar strum]

Michael DePalma: [Grunt]

Craig Lipset: Michael is an undergrad music major. I'm excited to end our show this way.

Michael DePalma: [Laughter]

[Electric guitar music]

Michael Krigsman: Okay. We're out. Michael--

[Electric guitar music]

Michael Krigsman: He doesn't know.... [Laughter]

Published Date: Nov 29, 2017

Author: Michael Krigsman

Episode ID: 484