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To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.

Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials 

Multilayered strategies such as working with patient advocacy organizations and leveraging technology can help industry better partner with patients.

Evolving Toward Empowerment: How We Are Deepening Relationships With Patients

This November issue of ACT explores those technological innovations in clinical trial recruitment and data collection and management that are being geared toward empowering the research community's most important asset—the patient. 

Advancing for Patients

How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach. 

Enhancing Empowerment in Patient-Focused Research 

The potential of next-generation platforms in transforming patient recruitment. 

Harnessing Unstructured Data and Hospital Interoperability 

In this video interview with ACT editor Andy, Studna, Silvio Galea, chief data & analytics officer, WCG, discusses how sponsors can ensure that patients are properly reporting data.

Ensuring Patient Engagement and Data Integrity in Trials

, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in the clinical trial industry, emphasizing low awareness among both patients and providers. He highlighted operational issues, including the difficulty in identifying and engaging patients, data interoperability, and ensuring data quality. Galea stressed the importance of user experience in electronic data capture tools and the need for industry standards. Prioritizing data collection should focus on safety, efficacy, and efficiency, ensuring data quality, and avoiding workflow disruptions.

A transcript of Galea’s conversation with

ACT: What are some ways sponsors should be empowering their patients to ensure they are returning quality data?

 I mean, obviously we need to, first and foremost, ensure that the firewall between the sponsor and the individual is there and upheld. There's a lot that the sponsors can do to ensure that the engagement on the patient side is going to be there, making sure that there's a call for comprehensive education and training, that the information on how to use these tools and capabilities is clear and that the education material and the certification process is not just relevant, but seamlessly and quickly done. We talked about the expected experiences in the B2C space to make sure that these collection tools are user friendly, that the data has integrity, that it has the right type of checks in place, so that we collect qualitative data, that there's regular communication and support between the individual, the tool, and whoever's overseeing the data collection, so that if I have a question, I could get immediate answers, whether that's through reference materials, through simplistic AI, or other things. I could go on, but I'll focus on those top three to four items.

Videos

In this video interview with ACT editor Andy, Studna, Silvo Galea, chief data & analytics officer, WCG, discusses the lack of awareness surrounding clinical research.

The Need for Clinical Trial Awareness

ACT: What are some challenges you are currently seeing in the industry around patient data?

 Yeah, great question, Andy, and thanks for having me and WCG here today. Before talking about the challenges with patient data, we have to think about or look at the macro situation. If you look at the NIH, it's 5% or less of American adults who've never participated in a clinical trial, and not many more know about it. I was at a dads group the other day, and one of the fathers had shared that his mother-in-law had just come down with Parkinson's and we're talking about therapies and how to go about it. In the back of my head, it's like, okay, well, there probably has to be some sort of new trial out there that, if she is eligible, that this would be a great opportunity for her. It was six of us just talking and nobody brought that up as a channel of therapy. Not to say that trials can be therapy, but there is an opportunity there. I think first and foremost, it's awareness, and not just at the consumer side or the individual side, but also on the provider side. I don't know if this is correct, but I recall hearing something like 3-5% of providers who participate in clinical trials or act as a primary investigator, so when you do the math of number of people who know about it, who've participated, who are eligible, and then number of health institutions, PIs, who are out there open to do this work, the population is very small, and then you have to overcome the hurdle of even, making it viable. It's a big commitment on behalf of the individual to participate. There's a sacrifice that has to be done there, so how are we, as a society, aligned to provide that?

In this video interview with ACT editor Andy, Studna, Silvio Galea, chief data & analytics officer, WCG, discusses the lack of awareness surrounding clinical research.

In this video interview with ACT editor Andy Studna, Rich Gliklich, founder of OM1 highlights personalized medicine and predicting disease outcomes.

Driving Point-of-care Decisions With RWE

ACT: Looking forward, how will real-world evidence (RWE) drive point-of-care decisions?

I love this question because one of the reasons we started OM1 was to both advance medical research, but also to personalize medicine. We think about point-of-care a lot. We developed this, what I would call a digital phenotyping platform called PhenOM and you can think of it as a single assay. Instead of many different AI models, it's one model, one model to rule them all. What it does is it looks for over 500 different dimensions of signals that almost look like a fingerprint, if you actually look at that, and then different areas of that fingerprint might be associated with diagnoses that either have been discovered or not, might be associated with likelihood to respond to a particular treatment or the risk of a particular event, one of things we predict now is the likelihood of death in two years or a cardiovascular event in the next two years. We can use it also to generate for any individual health trajectory, so I come in, I see the doctor for X, Y, and Z; we're doing this now in depression and we're doing it in joint surgery. As the physician is offering me a treatment or procedure, what's likely to happen to patients like me over the next ‘X’ period of time down to the key outcomes that I'm interested in. I think that this is going to personalize the treatment paradigm more so than anything we've seen to date, so that's really exciting.

In an interview with Nico Saraceno at DPHARM 2024, Pellegrino highlights current challenges she is seeing in patient recruitment and the use of technology to identify patients. 

DPHARM2024: AutoCruitment CEO Jill Pellegrino Discusses Patient Recruitment

ACT: You hosted a session on how to “Unlock the Power of the Patient for Better Patient Recruitment Outcomes.” What was the premise of the presentation?

 It was talking about a company, AutoCruitment, which focuses on bringing patient recruitment solutions. There's really two primary points I was trying to make in that. One is that to really substantially change the way that clinical trials are enrolled, and to increase the patient number of people that get access to trials, you really have to develop solutions that focus on a very large part of the population that doesn't get the opportunity to participate in trials when you're working through sites alone. We find that only 10% of the patients that are eligible for trials actually get the opportunity to participate in one with the relationships they have with sites. Our recruitment focuses on that other 90% in developing strategies to access that population. That was the first primary point, but the second point is that you have to have in place the right services to qualify those patients to help support the sites and the patients to make sure that they are translating into randomized patients. We talked a lot about the services and the ways that we accomplish that.

ACT: In your experience, what are the most common patient recruitment challenges that you’ve encountered?

 Access to patients is absolutely one of them, but even when you get access to those patients, qualifying them is really, really critical, because the protocols usually have very narrow inclusion/exclusion criteria. A lot of times that inclusion/exclusion criteria can't be validated unless you have a relationship with that patient or have access to their medical history, so depending on the requirements and the complexity of the protocol, sometimes it can be difficult to find patients that are qualified and appropriate for the clinical trial. That's one of the challenges. The other challenge is that you do rely on the clinical trial sites to make a recruitment campaign successful and clinical trial sites are working on a lot of trials right now, and sometimes they're understaffed and they don't have all the resources they need, so you need to be able to have support for those sites to be able to work with the additional patients so that they can capture more patients in their practice, see those patients, and then put them into trials.

ACT: Could you describe what EMR Capture & Intelligence technology is exactly, and how it can help identify and qualify patients?

 Yes, that was EMR Capture & Intelligence, and that's one of the services that we have to help better qualify patients for complex protocols. Patient recruitment companies a lot of the time rely on self-reported data from patients in order to see if they're eligible to refer them to trial sites, so we're not relying purely on self-reported data. We have a new service, EMR Capture & Intelligence, which allows us to get the consent from the patients directly to review their medical records. It's all automated in our technology, where we can collect their medical records very easily for them, and then we have AI-powered technology that reviews those records and organizes that data and assesses it to see if they're eligible for the protocols. We find that is really effective in some of those harder conditions and more complex protocols to be able to find some of those harder to find patients.

ACT: What other sessions or topics at DPharm have piqued your interest?

 I would say an area that's always top of mind and top of interest for me is different strategies to be able to access patients, as I shared. We find that to be really effective in driving higher enrollment rates, you have to be able to reach that 90% of the population, so I find I'm really pleased to see so many companies that are working in this space now looking for creative solutions and ways to find patients, and that's always an area of great interest to me and AutoCruitment.

Latest Conference Coverage

Jim Murphy, CEO of Greenphire highlights some trends he is currently seeing such as travel reimbursement and minimizing out of pocket costs. 

Current Trends in Patient Reimbursement

What are some trends that you're currently seeing with patient reimbursement?

I mentioned the cost of travel reimbursement, those things have dramatically increased in light of inflation and pressures in recent years. They've also increased because the average distance traveled for a participant to get to their clinical research site has increased materially. In fact, in oncology, it's up more than 40% over the last five, six years, so that shows that people are having to go further. If you're a working age person, it's a lot of time off work, that's opportunity cost, that's direct pressure on you, so there's a lot of considerations about figuring out what services are necessary and being very targeted in that approach that are a need that is constantly expressed to us, that is important for essentially starting the trial out on the right path.

Then the last one, I think, is really important is recognizing that especially as we're trying to make sure that clinical research is open to folks of every socioeconomic class, minimizing that out of pocket expense from the start often is solved by providing travel support, where the participant never pays for it and doesn't have to get reimbursed, it's managed for them, which really takes away a huge stress and an obstacle to enrollment and ultimately, retention. I would say those are a couple of the big ones. There are a number of smaller trends than that people want real-time payments, that's a common theme where patients feel valued walking out of the clinic with a ting on their phone. There's more triggered payments than we've seen historically, so people are hooking up things that are done at home and rewarding protocol compliance like ePRO to trigger micropayments and things like that. All of those things are on the rise, but I would say the macro picture is there's an appreciation that the patient is going through a great deal beyond their health situation in order to be in a clinical trial, and that sponsors are committed to helping sites mitigate those burdens for the participant and certainly, sponsors are trying to do it in ways that don't just displace the effort onto the site or some other third party, they're looking to eliminate it in more strategic ways, leveraging the right balance between technology and service.

In part 4 of this video interview, Jim Murphy, CEO of Greenphire highlights some trends he is currently seeing such as travel reimbursement and minimizing out of pocket costs. 

Jim Murphy, CEO of Greenphire touches on how changing trends in enrollment are creating obstacles with modeling costs. 

Challenges with Budgeting and Analytics in Trials

ACT: What are some challenges that stakeholders are currently seeing with budgeting and analytics in their trials?

 Well, the budgeting process has got a lot of different challenges to it, particularly in the area of patient related spending because there isn't really great data as reference to drive those planning decisions. Everybody starts with an idea of a draft protocol and then models out their expected costs and whatnot, but in patient-specific spend, this concept of patient travel reimbursements for out of pocket expenses and stipends as applicable—it's really hard to know because there's no reference data, so people are called on to just use what they used on the last study and that is generally bad because the conditions of enrollment are changing dramatically, and people are traveling further and then there's inflationary pressures on top of that, which makes it so much more complicated. Meal expenses have increased 30 to 45% depending on geography around the world over the last few years.

The bottom line is startup is always an urgent process, it moves quickly, everybody's trying to get everything done very quickly. There isn't a whole lot of time for people to seriously ponder the implications of patient-related support on the overall cost of the budget. As a result, it sometimes gets incorporated either as an afterthought or as a one size fits all approach which is not applicable or not effective and you end up having to come back and do changes—changes in services being brought in, changes of informed consent to amend it for different conditions. Ultimately, they say a stitch in time saves nine—if you really want to go quickly, you have to spend the time to think about the population and be able to have some reference insight to be able to guide good decisions on how you set things up from the start.

In the first part of this video interview, Jim Murphy, CEO of Greenphire touches on how changing trends in enrollment are creating obstacles with modeling costs. 

Vincent Keunen, founder & CEO of Andaman7 looks forward and highlights some potential advancements with the use of AI.

Potential Advancements in Patient Centricity

ACT: What are some patient-centric advancements you are looking forward to seeing in the next five years?

 The big thing today is clearly AI (artificial intelligence), right? Everybody's talking about it. There's probably too much talk, and there's a hype, obviously, like always, but it's also a real improvement. It really does help for some features. For example, what I’ve personally used AI for is to explain to me a document with information coming from a specialist doctor, and it has medical-specific terms—very hard to understand for patients, and so the AI can explain that in a simpler manner. AI can also summarize. For example, I put a whole document in for a checkup that I did one year ago, just a checkup on heart condition and there were two pages of information, and the AI summarized it by saying, “There is no problem, next checkup in one year,” which was perfect. Two sentences. It's just what I need in my case.

It can also help translate in different languages. That's important if you go abroad on vacation, or if you work abroad for some of the time. AI is clearly a big thing, and I think it will help a lot. Of course, there's all kinds of privacy questions and issues to solve, and quality issues also, all of that is important. Some things that we already know, like the mobile phone and the internet, they don't see innovations as much today, but they are pretty powerful technology for creating communities of patients to help them work together and to help the research industry. Maybe the three main things is mobile phone, internet, and AI put together—that will probably be a very interesting combination of technologies to help patients and then help providers and research also in their endeavor to help patients.

In the fourth and final part of this video interview, Vincent Keunen, founder & CEO of Andaman7 looks forward and highlights some potential advancements with the use of AI.

Vincent Keunen, founder & CEO of Andaman7shares his own experience as a patient when it comes to using digital applications.

Identifying the Most Useful Features in Solutions from a Patient POV

ACT: As a patient yourself, what specific features or functions do you look for in technology?

 I went through some difficult times with my cancer, with my son's cancer, and I realized that those times that it was very hard to have everything you needed. It's basically having access to the right information when you need it, so that's why I think a mobile phone is probably the only solution, because a computer won't work, even a tablet won't work. It's just too bulky, and you don't take your tablet with you all the time. That's why I'm a big, big advocate in having everything on the smartphone. I personally am also very concerned about privacy and data security, so I don't want my data to be in the cloud, and that's a big, big ask, I would say, because it's challenging to put everything on the phone and have the correct backups in case you lose your phone and so on, but I think it can be done. It has been done. We have proven that. For me, having everything on the smartphone, no data in the cloud, and very easy to use software is a first step. Then, if I decide to contribute to research, for example, it must be extremely easy and transparent, right? I want to know exactly what I'm doing and what is requested from me. I don't want anything to be under the table—it happens, still much too often, not only in the medical sector, but globally. You're being offered a tool, and then you become the product, as some say—I don't want that at all. It must be very obvious, and it must be a fair exchange of value. If I'm being given a very useful tool, and in return, they asked me to share some of my data, I can accept that, but it has to be a good exchange of value for both. So, easy features, all of my data very well protected by being only on the on the smartphone, and of course then being exchanged when I consent, and then having a trace of all of the data that has been exchanged is also probably very important.

In part 3 of this video interview, Vincent Keunen, founder & CEO of Andaman7 shares his own experience as a patient when it comes to using digital applications.

Vincent Keunen, founder & CEO of Andaman7 highlights how technology vendors should be keeping the patient in mind when building solutions.

Building Patient-centric Technology

ACT: What do technology vendors need to focus on most when creating patient-centric solutions?

 It seems obvious, but ask the patients. Many don't ask the patients. They think they know or they say, “Well, I'm kind of a patient too, so I kind of know what I need, right?” You have to talk to different types of patients, and patients with a serious condition, patients without a serious condition, but a chronic disease maybe that is also difficult to manage in the long term, so really ask the patient. It takes time. It's an effort, and you will get many different points of view. It's hard to reconcile all of them, but it's always the same when you build software—you always have that tension between the various needs and the various points of views of the users, and then trying to find something that is very good for everybody. It’s a real challenge. Usually, patients want to manage their health information. They want to be in control. They have the right to that normally in many countries, and what they want is having the right information at the right time, which seems easy to say, but in practice, there's lots of interoperability issues, exchange of information, privacy, cyber-security issues—there's a lot. Also, the patients don't want their data to be abused, right? That's really the fine line, because when you ask patients if they want to contribute to research, 85% say yes, but if I'm being asked my consent first, if I can remove the consent anytime, if I know who will use the data and for what purpose. There's a number of conditions, but if those conditions are met, then the patients agree to contribute, but then it must be easy to use, as I was saying earlier.

In part 2 of this video interview, Vincent Keunen, founder & CEO of Andaman7 highlights how technology vendors should be keeping the patient in mind when building solutions.

Vincent Keunen, founder & CEO of Andaman7 discusses how service providers and sponsors can make the lives of patients contributing to research easier.

Current Challenges in Patient Centricity

ACT: What do you think are currently industry's greatest challenges in patient centricity?

 Patient centricity—that's a big topic, indeed. Most projects start as a business, so everybody has to focus on the revenue at some point, right? With that, unfortunately, many people focus on serving who will pay, and who will pay is often a provider, a sponsor of medical research—rarely the patient, right? There is a lot of focus on the institutions, on the companies on that side, and not that much on the patients, so the patient is usually a second thought unfortunately and for some it's a thin layer of varnish, which is very unfortunate. That's a real big challenge, because there's a conflict of interest somehow between the revenue side and who we’re serving in the medical sector, or health sector. It's a bit unusual because there's this triangle between the patient, who is paying, and who is providing the service, right? It's very hard to focus on the patients. At Andaman7, we try to really focus on the patient by first building health records for the patients, and then use it for something else after, so that's one of the approaches that we try to have.

ACT: What should sponsors currently be focusing on the most to improve patient-centricity?

 That's a good question and tough to answer too. Contributing to research per se is interesting for some patients, but not all of them, right? For seriously sick patients, those wanting to contribute to finding a treatment for themselves or for their close ones—that there is a very strong motivation. For others, there's a motivation to contribute to the common good, which is good, but it's not a very strong focus. The majority of patients have more important things to do than contributing to research, and focusing on managing their health issues is very important for them, whether they are significant or less serious, so they need to focus on themselves before focusing on research and helping others—it's only human, it's natural, right?

To get more patients contribute to research, we need to do more. We really need to offer them very interesting tools. Sometimes financial contributions are needed, let's face it, but very useful tools can also be a good solution, for example, a personal health record, or some tool to help them manage their health information or insights, but it has to be really focused on the patients, and not as a second thought, as I was saying earlier. Then, if we provide a very useful tool to the patients, the part that is about research and collecting of data with the consent of the patient must be very easy to do. It should be a no-brainer for the patients. I know by experience that there is more difference in an application that is just slightly better, but much easier to use, will make a huge difference. The patients will keep using it, otherwise they won’t, because it's just a bit too difficult, and if it took you, as a company, three years to build, it’s pretty unfortunate they don't use it. Building tools very useful for the patient is one, and second, it must be very well-designed and very easy to use, so that the part that is contributing to research is very easy for the patients. They don't have much to do.

In part 1 of this video interview, Vincent Keunen, founder & CEO of Andaman7 discusses how service providers and sponsors can make the lives of patients contributing to research easier.

Patient Participation

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