USING MICROPAYMENTS FOR BETTER COMPLIANCE IN CLINICAL TRIALS

 

Katy Jones from Greenphire discusses how the unification of two dynamic technology solutions can increase engagement and produce positive outcomes for all stakeholders. By leveraging micropayments, sponsors can improve the patient experience and shorten the overall trial length.

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Podcast Notes:

 

Introduction [00:48]

ERT’s Jason Eger and Greenphire’s Katy Jones explore the shifting perspectives on microtransaction payments, and dive into how they can improve retention, data, and diversity in clinical trials.

What is a micropayment? [02:16]

Micropayments are a small financial transaction. The threshold for what is considered a micropayment can vary based on industry, geographic location, and other factors. In clinical research, micropayments can influence and encourage patients to take complete any actions outside of a clinical visit that may be necessary.

Why are micropayments a hot topic right now?[02:58]

The clinical research space has reached an inflection point. Previously, there was resistance to methods that may have been considered coercive. Now, new FDA guidance has clarified how patients can receive compensation for their participation in clinical trials. There’s an overall industry-wide shift toward being patient focused and recognizing the sacrifices patients make to participate in a clinical trial, as well as making that participation more convenient..

What’s the level of sponsor interest in this type of technology?? [04:15]

Sponsor interest in the use of micropayments is growing, along with recognition that sponsors who use micropayments can still engage with sites efficiently. Many sponsors are interested in being the “sponsor of choice”; sites want to be the “site of choice.” How can sponsors engage better with sites efficiently? That’s where this type of technology can come in.

How can sponsors address concerns of coerciveness if they’re interested in using this type of technology? [05:27]

There will always be a balance in the industry between innovating and remaining compliant with regulations and guidance. Vendors like Greenphire can provide consultation regarding this. With micropayments specifically, coercive compensation isn’t a concern – small amounts (>$10) simply encourage patients to continue to comply with protocol and what they’ve already agreed to as patients. Regulatory bodies are starting to see that and are generally supportive of that.

How can micropayments be used in specific therapeutic areas? [06:33]

Micropayments can be used in a variety of therapeutic areas, but are particularly effective in therapeutic areas where diary entries or measurements taken outside of a clinic visit are required, such as in diabetes or Parkinson’s disease. The payment serves as a reminder, encouragement, and “thank you” for the patient’s trial participation. The potential for micropayment uses cases is vast, but they tend to work best when patients need to be engaged in and mindful of their condition and report data outside of a site visit.

Are there measures other than completing a daily diary ( eCOA ) where micropayments can have an impact? [08:01]

Diaries are a common use case, but anything like ePROS (patient reported outcomes) are an opportunity for micropayments. It’s important to consider protocol design and address the site perspective – since the site will need to engage in the technology with the patient – as well as any other technology that will be used in the trial, to ensure that each piece of technology can communicate with the other.

What are the arguments against using micropayments? [10:23]

Most arguments focus on the burden micropayments can put on sites. It’s yet another technology that sites have to engage in, and it can be difficult to go through the set-up process and train staff. However, sponsors need to consider these things not just with micropayments, but all with technology, so it’s important to take a step back and determine if micropayments can provide a benefit to the trial.

How can you measure the effectiveness of micropayments?[12:10]

Multiple studies revealed that micropayments have the biggest impact on patient retention. With more complex protocols, finding the right patient can be like finding a needle in a haystack. Encouraging patients along the way helps ensure they aren’t dropping out of the study and can remind them why they chose to enroll in a clinical trial in the first place.

Where do micropayments fall in the future clinical trial landscape? [13:12]

Any time you’re engaging in a clinical trial, you have to consider the full spectrum of stakeholders engaging with technology and how it will impact them: ease for patients, efficiency for sites, and transparency at the sponsor or CRO level. It’s important to look toward the future in the industry and continue to recognize and thank patients for participating in the clinical trial as we move toward decentralized or digital trials.


Podcast Transcripts:

Intro: Welcome to Trial Better, a podcast series where experts discuss clinical trial best practices and take a deep dive into the latest industry trends and technologies. On today’s episode, we’re discussing micro transactions and how these payments can be used to incentivize trial participation and increase patient engagement. Today, we’ll explore how this tech improves the patient’s experience in a clinical trial and some of the obstacles teams encounter when implementing this method. Leading this conversation is host, Jason Eger and expert guests, Katy Jones of Greenphire. We’ve got a great conversation lined up so stay tuned for another edition of the Trial Better Podcast.

Jason Eger: Hi, everyone. Welcome to another edition of the Trial Better podcasts, an ERT podcast that explores best practices and clinical trials. I’m your host Jason Agar, director of organizational readiness for ERT. In today’s episode, we’re going to discuss micro payments, what are they? How are they used in clinical trials? How do they help incentivize ePRO patients and eCOA compliance? Joining us for today’s conversation, really excited to have Katy Jones from Greenphire. Katy, welcome.

Katy Jones: Thanks. I’m really happy to be here.

Jason Eger: Katy, why don’t you tell the audience by yourself, about Greenphire? What does everyone do?

Katy Jones: Sure. So my name is Katy Jones. I’m the director of client delivery at Greenphire. And in the simplest terms, Greenphire is committed to making clinical trials and clinical research easier for patients and sites. And we do that through optimizing administrative and financial workflows.

Jason Eger: Awesome. And so while it involves all the stakeholders, the sponsors, the sites, the patients, I think today, if I’m correct, we’re going to focus a little bit on the patients.

Katy Jones: That’s right. That’s right. Today we’re going to talk a little bit about kind of from a patient’s perspective and then there are some areas where that impacts sites and sponsors; we’ll probably touch on that a little bit. But I think when we’re when we’re talking about focusing on the patients, I think that’s always a really great place to start.

Jason Eger: Terrific. So yeah, I mean, obviously very important for all of us in the E trial process. One of the terms that we’ve talked about micro payments, so what is a micro payment so everyone understands?

Katy Jones: Yeah, sure. So a micro payment is essentially a small financial transaction, right, and depending on the industry that you’re in, the threshold for that, or the amount for that can vary. A lot of times in the region you’re in, that can vary. But essentially, in the US, most of the time you’re talking about something that’s less than $10; you’re talking about really small amounts, $1 to $2 here. And in clinical research, a micro payment really comes in when you’re thinking about actions that patient is taking often outside of their clinical visit that maybe you want to encourage by introducing a micro payment.

Jason Eger: So my background is eCOA. And I know that we’ve done a lot of work in ECOA and micro payments. Tell me a little bit, why is it a hot topic right now?

Katy Jones: Yeah, that’s a really good question. I think there is an inflection point that we’re at in the clinical research space. I think where there has been previous resistance to kind of coercive methods, things that were thought of as coercive, I think you’re seeing things even earlier this year FDA guidance that are clarifying how we compensate patients for their participation in clinical trials. And the reason that that’s really exciting for me personally, is I think that there’s this shift in the industry towards really being patient-focused, and really trying to understand all the different sacrifices that patients are making just to participate in a clinical trial.

And as trials get more specific, or you have long visits or more assessments at visits and more required of the patient outside of their clinical visit, I think that thinking about how we treat those patients and how we make participation and clinical trials more convenient for them is really important.

Jason Eger:  I mean, obviously, I mean, making their lives easier, making sites lives easier. So as sponsors see this and adapt a little bit more to the technology, what are you seeing as far as their interest? As far as growth in the technology, how do we make lives easier for the patients?

Katy Jones:  Yeah, I think I do see the change in sponsors and their interest in this growing. I think nearly every sponsor that my team talks to – my team is essentially involved in the operational aspects of implementing and onboarding Greenphire’s technology and services platform forms, right? And I have yet to engage with a sponsor that isn’t interested in being the sponsor of choice. And sites want to be the site of choice as well for patients, so there’s all that drive to do that. And I think a lot of sponsors are really focused on how can I do that? How can I engage with more sites, or engage better with sites, but do it really efficiently? And that’s, I think, the really key piece. And that’s a piece that I think Greenphire – that’s where Greenphire essentially comes in.

Jason Eger: Right. So using your expertise, but there’s a slippery slope here, right, that I think we’ve dealt with it from patients compliance and in alarming patients to get data. And it’s a lot of it’s about coerciveness.

Katy Jones: Yeah, right.

Jason Eger: So when a sponsor asked you well, how does FDA feel about this being too coercive to get someone to respond to a daily diary? What are your thoughts? And what are your responses?

Katy Jones: Yeah, and I think you’re always going to have in the industry – there’s a balance, right? There’s a balance between a lot of the innovation in the industry and technologies that can make things either easier or better, but at the same time, you want to make sure that you’re keeping in mind regulations, keeping in mind guidance. I think we’ve seen some of that and Greenphire is able to kind of consult on some of that related to kind of FDA’s guidance as well as country level guidance, because every country’s a little bit different. But when you’re talking specifically about micro payments, you’re not talking about something that’s coercive, you’re not talking about compensating patients vast amounts of money to complete an E diary, you’re talking about really small amounts. And really, you’re  essentially encouraging them to continue to comply with the protocol and with what’s required of them as a patient. And I think that regulatory agencies are seeing that and are supportive of that.

Jason Eger: So it’s really about patient engagement?

Katy Jones: Exactly.

Jason Eger: And so, as we talked about – I don’t know if you can give everybody an example of how it’s used, maybe in a specific therapeutic area if you’ve got one.

Katy Jones: Sure, yeah. I’ve seen micro payments used in a variety of different therapeutic areas, but one would be A, if you’re working in, let’s say, a diabetes trial, where the patient has to keep an E diary for either how they’re feeling about their condition or different things that they’re having to measure outside of the clinical visit. And patients forget, I forget, you know, if I have to fill out a form for my kid’s school, I’m going to forget, but that micro payment is both like a reminder and a way to kind of encourage them and thank them really, it’s thanking them in small amounts over and over again for their participation in the clinical trial.

So I’ve seen it used in that. I’ve also seen it used in therapeutic areas like Parkinson’s disease. There’s a lot of diaries that are collected related to that and whether the patient is on or off in their symptoms. And I’ve seen that used in that as well. The potential for where a micro payment could be used is really kind of vast. It’s anything where you’re thinking about a patient who has to engage in their condition and be aware of what’s going on in their condition and provide data on that outside of the visit.

Jason Eger:  So out of ignorance, I mean, it’s using other technologies just easy way. Is it used for someone just coming to visit a site or coming to a site visit? I mean, are there measures other than completing a daily diary?

Katy Jones: Yeah, I think that there are. I think that there are areas outside of a diary. I think a diary is often a really common one, right? But anything where you’re doing like ePROs, right, and so patient reported outcomes that are collected outside of the patient visit, that’s an opportunity to use those as well. I think it’s important to think about how your protocol is designed as well as what other technologies you’re using within your protocol, because again, you have to think about it both from a patient’s perspective as well as from the site’s perspective or everything else that’s being used in that clinical trial and that the site has to engage in with the patient.

Jason Eger: Right, one of the sayings that I’ve always heard of is “begin with the end in mind,” right? So when people come and they engage your team at Greenphire, yourself, you’re starting, I’m assuming right at protocol development with them?

Katy Jones: Yeah, a lot of times we are engaged, and it’s a great recommendation to engage with Greenphire as you’re selecting your other clinical vendors. That’s the best. That way you’re thinking about—you’re right, start with the end in mind, start with thinking about the full spectrum of what’s going to be used in that clinical trial, what’s going to be expected of your sites, because that all funnels down to what’s then expected of the patients.

Jason Eger: Wonderful. So with all that said, how long does it take Greenphire to help a customer set up a protocol, get ready for this?

Katy Jones: Sure. So, Greenphire to set up a protocol on average, I would say especially if we are integrating with say one of ERT’s platforms as well. A lot of times it’s somewhere around 10 weeks. That may be scary or exciting for some of your audience members, I’m not sure which, but it’s really to make sure that we have collected all of the specifications and the requirements to get the system setup. And then to make sure that our two systems can talk to each other appropriately. So I think 10 weeks. A lot of times what I’ll tell clients is it’s that minimal investment up front to kind of maximize your enrolment and your engagement throughout the trial.

Jason Eger:  So, I think the obvious question is, why would someone not want to use micro payments? Well, I mean, it seems real obvious to help, it’s something for the patients. I would imagine they enjoy the micro payments, right? I mean, imagine that this is, “Hey, this is something new and innovative for us,” Have you heard any arguments why someone would not want to?

Katy Jones: Yeah, the arguments that I would hear from sponsors who don’t want to are really when you’re thinking about burden on sites, right? Is this going to be a burden on sites? I know you have a background in eCOA. I also before Greenphire have a background in eCOA. And that’s something common that I think you hear in the industry of like, this is yet another thing that I have to do, another technology I have to engage in, how difficult is it to get setup? How difficult is it for me to train my staff? And those are all the things I think we have to think about when you’re thinking about any E clinical technology that you’re using with sites is how is it going to be for the sites? And how easy is it going to be for the sites to train the patients?

I don’t think any of those reasons are sufficient enough to not engage in a clinical trial. It’s just a matter of like, you really do have to kind of take a step back and look at everything that’s being required, and then determine what’s the best fit for you. If you don’t have a lot of visits that are requiring assessments, that are requiring something from the patient outside of their visit. Does that micro payment encouraged the patient? Like, where does that fall in? If you’re asking the patient to collect things on paper and then bring them back into – and you’re not using that technology, the micro payment’s not going to make sense in those cases, right? So it’s really like, you know, how often are you asking for things from your patients? And then how efficient are you making this for your sites?

Jason Eger: And so with that, I’m sure sponsors do ask, like, the level of effectiveness, is there a way to measure it? Or have you done that? Are there any studies or data around that?

Katy Jones: Yeah, I think Greenphire has. We do have some white papers and some case studies where we’ve measured exactly that. And really, I think where you see the biggest impact is patient retention, right. It’s really hard for sites to recruit patients in the study. And especially with clinical trials getting more specific, those patients are oftentimes like, looking for a needle in a haystack, right? And so I think that encouraging that patient along the way helps ensure that those patients aren’t dropping out because you know, “This is too much for me, I have to do all this stuff all throughout the day in my daily life and I’ve got to come to these clinical visits,” right. And it’s kind of showing them again, kind of why they chose to enrol in this clinical trial in the first place.

Jason Eger: I mean, it’s extremely innovative, and I hope the adoption is sooner rather than later for everyone, for Greenphire, for the patient specifically, because I do think it’s incentive to staying in a trial. One of the number one problems that we see in clinical trials is keeping people engaged and retention.

Katy Jones: Yeah.

Jason Eger: I want to give you a final opportunity for you to give some of your final thoughts before we let our listeners go.

Katy Jones: Sure. Thanks for that. I think from a final thoughts perspective, I think anytime you’re engaging in a clinical trial, it’s really important, as much as these things are beneficial to the patients, you have to think of the full spectrum of stakeholders really that are involved in engaging with that technology and that includes patients and how easy is it for the patients to use, how efficient is it for the sites? And how much efficiency and transparency do you have at the sponsor and CRO level; all of those things are really important.

Greenphire has been traditionally known in the industry for patient reimbursements, and for in visit, for things where patients coming into their visit, and we’re using our clinic card technology to reimburse that patient. But always thinking about kind of the next step in the industry and kind of looking towards the future and looking at how can we kind of recognize patients and continue to thank them for their service in the clinical trial. Those are all really important things. So thanks so much for having me.

Jason Eger: Katy, thank you again, thanks to yourself and your team of Greenphire. It’s great to have partners that work with us in fighting the number one problem; getting patients, keeping them in the trials and keep them engaged. I think what you’ve done is extremely innovative, sharing with us about micro payments, and teaching us a little bit more on how we solve some these complex problems. So again, I want to thank you. I’m Jason Eger everyone. Thanks for tuning in to E RT’s Trial Better Podcast.

Outro: That’s a wrap for this edition of Trial Better. Special thanks to Katy and Jason for today’s discussion on micropayments and ways we can leverage this technology to increase patient engagement. That’s it for this week’s episode so thank you to everyone for tuning in!   As always please comment, rate or review Trial Better on Apple Podcast or your favourite podcast channel. You can also reach us at trialbetter@ert.com.

Got a question about clinical research that you’ve always wanted to have answered, curious about the future of an industry trend – your feedback on topics like these helps us deliver the content you want to hear. So please get in touch – again that’s trialbetter@ert.com.

Thanks for listening and we’ll see you next time on Trial Better


FEATURED GUEST:


Katy Jones is passionate about continuous improvement and using technology as the pathway to improve the clinical trial experience for all clinical trial stakeholders, but especially sites and patients.

She is currently Director of Client Delivery at Greenphire where she is focused on building innovative project teams, creating efficient processes and developing strong client relationships.

Katy is a healthcare industry veteran, spending much of her career in operations and client services.  She brings over a decade of experience in leading teams within highly regulated industries to optimize client delivery and produce results.


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