Presented by Jason Cole, PPD
Patient centricity is ever growing. The field has expanded the involvement of patients and their voice into planning, execution, and even the purpose of clinical and medical research.
The next evolution of patient involvement is the patient portal as part of clinical/medical research. Although minimal-use patient portal have been used for some time (e.g., websites for patient training), comprehensive, real-time, and dynamic portals where patients can be a part of the research are now being developed for use in clinical/medical research studies.
Portals may include study news bulletins, physician finders to self-refer into a study, customized patient results, moderated patient forums, and much more. This presentation will discuss the types of modules to include which foster greater patient involvement, regulatory and ethical considerations that may come about, timelines for development, and how such portals can be best executed in conjunction with ePRO delivery.
Good morning everyone. So I think we started out today at the 330,000-footlevel, and Jeremy’s presentation introduced us to trying to engage the patient at a greater level. And I want to talk a little bit more about that in something that we’ve been working with over the last couple of years. And honestly, before we started this almost two years ago, I’d never even heard of it. It’s the aspect of having a patient portal as some way to enhance your engagement and understanding with the patients. And so I want to spend a little bit of time today talking to you about what the patient portal is, what it can do for you, things to be aware of as you’re creating it, some concerns as you’re perhaps considering putting one together, and some ways that it can be integrated into your general plans for implementing perhaps eCOA.
So we’re at a technology summit and I can’t press fast forward on a button here, so apparently something’s gone amuck. All right, thank you.
So the first thing to ask is, what is a patient portal. In its most basic essence, a patient portal is a website that has various tools to help engage the patient. And we’ve worked on two different patient portals. In fact, I would say we’re currently working on two different patient portals. One of them has nothing to do with the trial at all. It’s for patients of a certain disease. And the goal was to bring together physicians, patients, and various advocacy groups from around the globe to help create a community and provide them with tools for interacting, including completing some patient-reported outcomes. The patient-reported outcome piece seems to be a central part, but not necessarily the only part by any means. In fact, one of the biggest pitfalls that I think a lot of people get into when they consider these portals is, there’s so many options available that you almost shut yourself down by going, my God we’ll never get all of this done. So one of the first things I tell people is, don’t worry about that, think of the three or four things that you want to have up and running right away, and then we’ll update quarterly and maybe add something at another point later on. Because, just like a website, you can get it up and running with the basic information and the basic tools that you need to do right away, and you can add to it as you go.
So we have some basic things that your site can do, there are interactive components to it, and there are other key aspects that you can have as a part of it here. Obviously, another part of the patient portal aspect is being a study portal, if you will, something that’s related to a data capture study where you want to have patients, physicians, sites, all kinds of people coming together to both look at information and provide information. And so some of it’s interactive, some of it is unidirectional. And that can consist of a huge array of activities. And we’ve listed just some of them up here for you.
One of the things that I want to discuss is why we found that there’s a need at all for these patient portals in relation to a study. So one of the things I heard Jeremy saying is, you know, I recognize that we’re in a heavily regulated environment. And when I started my role at PPD two years ago, I had come from another CRO, where we were doing a lot of Phase II, Phase III work. And then suddenly I was placed in a late stage group. Thankfully my group still does the whole nine yards, we do early through late stage, but I was given a much broader introduction, an almost crash course into late stage research, which compared to II-III is the Wild West. In late stage or medical affairs research, they have a lot more flexibility on what it is that they can do. And as they attempt to separate themselves from their colleagues in Phase II-Phase III, they’re also looking at things that they can do that they never had an opportunity to do otherwise. Patient engagement early on is one of these things. As they’re speaking with physicians about what’s going to be critical to advance their knowledge of this disease state with this new product that they have and want to release, they’re also talking to patients at the same time and saying, what is it that’s going to make you want to be a part of this study. What is it that you want to know in order to be a healthy patient. And patients are just banging down the door saying, you’ve got to give us more information. We need to know more about how we’re doing in the study. We want to have an influence on what the physicians are seeing, and you know, we want to see what the physicians are seeing. And I will tell you, one of the questions that came up toward the end is, what do the physicians think about this. Honestly, they hate it. They are not big fans typically of saying, yeah, share all the existing patient-reported outcome data with the patients. As a psychometrician and somebody who develops this, I can understand that. But this is what patients are asking of us. And more and more, if we want our patients to stay engaged—and some of these, the one study that we’re looking at here, is a nine-year study—if I want patient to stay engaged for nine years, I’ve got to do stuff to help the patient along, that gives them something that they’re asking for. So we need to start thinking outside the box in order to maintain patients involved in a study where there’s a strong probability that they’re going to die during the course of the study. (You’ll forgive me for keeping certain aspects of it confidential. Right now there’s nothing public about this.) But the ability to engage patients and have them start entering information, being able to track information as they move forward, etc. is something that patients are very excited about. And our sponsor said, we need to do something more than simply give them tools to give us data. We want to also allow them to have access to data.
Now some of it is very simple. Put online the training videos that tell them how to use the eCOA device. Fine, that’s easy, right. Give them access to a calendar where they can see their upcoming appointments—yeah, that’s easy too. But some of the things are really controversial. Allow them to speak to the other patients inside of a study. What? Why on earth would we do that? We subject ourselves to risk by doing something like that. This is one of the number one things that they want to do. And by the way, if we think that they’re not doing it on our site, and therefore they’re not doing it anywhere else, we’re naive. Patients are talking to each other all the time about the studies that they’re on, the drugs that they’re taking, and trying to determine if they’re on a placebo or if they’re on the actual medication itself, if they’re in a placebo-controlled study. So there are now new options for having moderated forums, 24 hours, all languages for your study, so that you can allow patients to do this, but stop a conversation when certain criteria are met. Obviously this is a delicate situation—I won't try to get into all the criteria here on when they want to and may not want to. But clearly one of the things that you need to know about is adverse effect reporting and being able to control for that.
So continuing on. The basic information that we want to have versus actual health engagement platform. So again, you know, we talked about that you could provide some basic information to patients, going to them unidirectionally. We can also make this an engaging platform, where we’re continuing to have the study and patients interact with each other. One of the things that we’ve worked through on our study platform is, when there’s a new medical journal article coming out that’s related to their study, that we will ask the physicians and maybe the oversight board of physicians to come up with a curated discussion with the patients about what’s in this journal article. Because some patients are savvy enough, they’re going to find out about it, and we don’t want it to be a surprise to them, we want to involve them and let them know that more information is coming out. So to have a curated discussion with the board and the patients about what’s in a new journal finding is a nice way to have an interactive discussion, and it can all take place on this board, so again, we have a way to track the interaction and find out what patients think about it, etc.
There is an ability to start including more data. And I’m going to get into this in another slide, but if you wanted to, from a technology side, it’s simple enough to include things like labs, like the patient-reported outcome data, monitor it over time, show progression for patients. If you’re in a disease state where we expect a patient to get better, there are perhaps fewer moral concerns about the issue of tracking data over time, whereas if you’re in an oncology study, where you know that patients are going to probably die throughout the course of your study, then that may be more disconcerting and have more ethical considerations that you have to have. But these are all possibilities, I’ve got an app right now on my phone, where when my physician does some blood work, it all populates to their website, I can go on and look at it and see how I’m doing. That’s kind of cool, so why not be able to provide patients with the same thing when they’re in a part of the study. And of course we can include the message board for patients to communicate with one another, share their experiences, etc.
So patients in the study team benefit from the use. Obviously some of the benefit is, we see improved compliance and improved retention. And right now, we’re very early into this, and in general, patient portals are very new. So initially this is what we’re seeing. I don’t know of a single study that’s gone more than a few years at this point with an involved patient portal, so that we can track if retention rates stay strong. But this is a way of engaging patients in a consistent manner over time, with devices that they already have on them, or already have access to at home—say their home desktop, etc. And you can continually re-engage patients by adding new content, by having new discussions, by adding a new curated article discussion, etc. and have new ways for continuing that discussion throughout.
So continuing on. Obviously, we have the ability to create multiple ways for the others to stay involved and informed. You can include, for instance, informed consent updates on here. So if a patient needs to sign a new update, and they’re not coming into the office on a regular basis—say you’re in a long-term monitoring study—why have them come back into the office simply to sign an informed consent. Obviously there are technologies that are stand-alone to be able to do this, but if you’ve already got a system set up, you don’t need to add a new piece of hardware, or even a new piece of software. They can do it all within the same system. This portal starts to become a home for all of your electronic engagements with the patient, is really what this is.
Okay, so what else do we have here.
Caregivers can monitor their own patient’s progress. The caregiver involvement here is really another step. We think about the simple involvement of the physician and the patient and the site. Maybe the CRO and the sponsor. But in studies where we have long-term debilitating diseases, where we know or suspect that there’s going to be some kind of caregiver involvement, the caregiver becomes a really strong partner in the study, because not only are they able to go in and tell us how the patient is doing, if we’ve got some caregiver-reported outcomes. But additionally we are able to go in and ask them, hey by the way, we’ve noticed that the patient hasn’t completed their forms. Now of course, you’ve got to get the informed consent of the patient to be able to do all of this, etc. But presuming we’ve done all of those right steps, we can help get the caregiver involved in making sure that we collect our patient-reported outcome data in a timely manner. Now, in some of these long-term studies you may have, say, a two-week window where when you collect your data every X number of months, you can have the patient do it. If by the end of week one, we haven’t seen the patient even log on to the site, maybe we send a notification to the caregiver to help get them involved as well.
There are other novel ways to get people involved. Payers. Jeremy presented last about an issue where patients were able to pool data together to go and talk to their payer and say, hey you might want to consider covering this because there are actually a lot of us who have this issue from one of the medications. And so if you can imagine a situation here too, where pooled data might be made available in some context that on a long-term study you could have it made available on say an annual basis, that payers could go in and check data, with maybe being able to play with a couple of the fields. Maybe this feeds right into some of their economic models that they’re using to judge either the relationship for payment or their budget impact model, etc.
So the other interesting part that we might be able to do is to pool data together for research purposes here. And so, if we have researchers that are already approved to be able to go in and access data, well now we can go in and start looking at some data cuts, doing this already within the website itself. Clearly there may be data that sit outside of this, if it’s a study, but if this is a patient portal that is just for a disease group, then you may have a research panel that’s affiliated with this patient portal that can go in and do their own cuts of data to find out how various treatments are doing for their patients over time, etc. There are going to be some biases in the selection that they’ll need to report, but this is a neat way of allowing patients to already provide their data in a pooled manner so researchers can start publishing it.
So the development of the patient portal, there are some considerations. And so things to think about. Is patient engagement key? When isn’t it. Will the study team benefit from increased interaction? Usually. Are caregivers a vital component? Sometimes. Would it be useful for patients and healthcare providers to see the progress of data over time or in comparison with other patients of similar demographics? For instance, one of the things that have been a consideration on the patient portal that sits outside of the study that we’re working on is, should we allow patients to compare physicians in their local area who are a part of this board to look at their pooled patient data for treatment efficacy. Which physicians are doing better in their area. This is controversial, no doubt. But it is a consideration that we now easily have the ability to do, should we have sufficient numbers of patients in certain areas. Or at least allow a physician to go in and pool their patients on one treatment regimen versus another treatment regimen and find out how those patients are doing comparatively over time. This is something that can be built right in, no problem.
Will the study population have any hardship with electronic communication? Will the study be taking place in countries or regions where internet access is sparse? So we start with the really obvious yes questions to the, well these are things that we need to consider, make sure that we really do have. Because if you’re counting on this patient portal to give benefit throughout your study, but you’ve got regions in your study where you’re just not going to have good internet access, then you may be creating a differential bias that you don’t want to have.
So other considerations. Timeline. Typically, these portals take about three to five months to set up at the beginning. Now, this has that important caveat that you’ve limited your scope appropriately. I’ll get into some other considerations that we’ll have to have regarding legal, ethical, and translation issues that may slow you down as well. But three to five months is a typical startup time that you’ll need. And often this is because you’re working with a group of people either from an advocacy group or from a sponsor who have never done a patient portal before. And they initially look at this and go, oh God this is scary. And then they look at this and say, oh God this is Candyland, we can play with all of this stuff. And so you need to both inspire and yet contain so that you don’t try to do everything all at once.
So the other issue is, how are we going to plan for the device. We’re typically not going to requisition anything for patient access unless we’re already requisitioning devices, say for an ePRO solution, then that could be the case. But typically, if we’re doing this, we’re going to allow for multiple points of access. So it could be web access, tablet access, smartphone access, and obviously, then there are some simple programming considerations to make sure that the screens are formatted appropriately for all of the various points of access. We know that for instance smartphone access is now becoming the most common point of access for most websites. So if you don’t have it ready for that, you’re really hurting yourself.
So the development of a patient portal, some other issues to go into. The issue of making sure that the technologies, the network, allows for the integration of physician-patient access. You need to make sure that—I think we’ve covered most of this basically already. I’m going to skip this one. Because I know she’s going to yell at me about time here in just a minute.
So one of the big things that I want to get into is, if you’re doing this for a study and you have ePRO already planned, clearly the ease of allowing for a simple smooth integration between your ePRO system and your web portal makes it very attractive. So if you can, with the click of a button on the patient’s portal, say yes I want to go in and also complete my ePRO data right now, and it gets you into the ePRO system because you’re already logged into the patient portal, it knows who you are, it just moves you right over, this is a big advantage. It saves patients time, there’s not a second app for it, the more that we can do to make this a seamless process, the more we’re helping our patient out. Also, when we want to allow for the physicians to have access to see data, to see how completion rates are coming along, if we have a portal planned and we have our ePRO planned and we have merge those together, again, we give ourselves the opportunity to make sure that physicians don’t have to go to multiple sites, sites don't have to go to multiple websites. They can do it all in one place.
Okay, so again I’m going to skip that and I want to go here, into some of the complications that you’ll need to consider.
So when it comes to ethics, ethics per se have not really caught up to where we are right now. The ethics considerations, however, change frequently. Europe in particular is always advancing its considerations. And mostly they’re doing this with laws. But you do want to continue to check with your ethics boards to make sure that if there is any particular consideration for a country you’re in, that when you’re going through your study approvals you make them aware that you’re doing a patient portal, these are the things you intend to do, and do they have any considerations that they want to review. Now, laws get a little more complicated here, and most of these have to do either with data privacy or data transfer. For instance, with data privacy, we know that in France, if you’re going to collect this type of data, you have to have a server that sits in France. It can’t sit in the UK and collect these data on French patients. It must sit in France. I won’t pretend to know all of these legal issues. These are just some of the oddities that I’ve heard as starting to manage this process. Additionally we know that Europe recently came up with some harder regulations about transferring data between the European Union and entities outside, and it freaked a bunch of us out for about a week until all of our eCOA providers came back and said, you guys are good, don’t worry about it, we’re okay. I’m going to hope that they’re right, but they know a lot more about it than I do. So again, these are just issues to stay on top of, because all of this is going to apply here. We’re going to be collecting data on patients probably in multiple countries, and we’re going to be transferring those data very likely between countries. So make sure that you’ve got your data privacy people involved, that you’ve got your legal review people involved, and that you’re staying abreast of all of these different considerations. Now when it comes to translation, you’ve got some bad news, which is you’re going to translate this probably in every language that you have for your ePROs, because if you want to have patients involved, you can’t just presume that your people who speak Russian in Germany are going to be okay with overall Russian. Now this is a broad consideration. It’s probably going to be okay. But that’s a question language by language that you’re going to want to consider. For instance, if you’re careful enough with English, I think that I could get most English used in most countries if it’s written. I can’t understand what my Scottish colleagues speak, but I can understand when it’s written out. So I think that you may be able to get away with some of it. The nicety is that you also don't have to go through the rigor that we do when we do a PRO translation. For instance, you’re not going to need to go through linguistic validation in order to have a website that's ready to go for a couple different variants of your languages, or even maybe just 20 different languages in different countries. You’ll probably be okay just doing a simple translation process. I believe that later today we have some folks from TransPerfect who are going to come up and maybe they can speak to that as well.
So, summary. Among all of the new e-fads that are out there, I really think that this one has a lot of staying power. The ability to engage patients in a new host of manners that keeps them involved in a study, that keeps them compliant in a study, keeps them interested and informs them, allows for broader ways of communication between all of the various providers inside the study, I think there’s really great staying power. We don’t know what any of these e-fads are going to do coming up, but I think that this one has a lot of interesting staying power to consider as you’re looking. Don’t delay beginning the portal because of the number of options. Begin with a small core, portal tools, and then expand that and give it stages. Once a quarter, once a semester, you know, once a year, just depending on the length of your study, etc. Engage patients before the portal is finalized. And your stakeholders. And then moreover, throughout the study. For instance, as I mentioned, one of our studies literally is a nine-year study. If I want to think that patients at the very beginning of my study are going to have the same interest in this portal as they do three years into it, I’m kidding myself. They now have had three years of looking at the same set of tools over and over again. They're going to want to see something new, and something is going to bug them about what we already have. Engage them on a regular basis so that you can keep updating the system to meet their needs.
Okay. That’s all I have today. Thank you for your time.
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