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Aidan Gannon and Jessica Perry Examine the Patient-centric Revolution

July 20, 2021

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About the Advarra In Conversations With…

The future of healthcare innovation hinges on research and clinical trials. Advarra sits down with leading experts to dig into pressing issues and explore cornerstone solutions. Join us as we discuss topics and trends impacting the healthcare of tomorrow and advancing clinical research to be safer, smarter, faster.

About this Episode:

Patient advocates and industry innovators Aidan Gannon of Advarra and Jessica Perry of Moderna discuss patient centricity in clinical research, examine COVID-19’s impact on patient-centric conduct, and investigate evolving expectations of trial participants.

Discussions with:

Aidan Gannon
Head of Innovation and Client Services
Longboat by Advarra

Jess Perry
Director of Patient Centricity

Episode Transcript:

Aidan Gannon (00:04): Hello everybody, this is Aidan Gannon, I’m the Head of Innovation and Client Services here at Longboat, now part of Advarra, and I am really excited to be hosting the fifth episode of Advarra in Conversations With. Today, my guest is Jessica Perry from Moderna and I’m going to pass over to Jess to introduce herself.

Jess Perry (00:23): Great. Thank you so much Aidan. I’m equally as excited to be joining this episode. My name is Jess Perry and I am a Director of Patient Centricity with Moderna, looking forward to talking today.

Aidan Gannon (00:35): Thanks, Jess, so what we’re going to talk about today, our topic is patient centricity, the clue was in Jess’ title.

And we’re going to kind of discuss what patient centricity, within the realm of clinical trials and clinical research, is and means and what we think it should mean.

So, Jess, I wanted to start by kind of defining patient centricity within clinical research or what we think of is patient centricity. We’ve been hearing this word being used as a theme of many conferences, for years now, but I feel, and I think you probably agree that it’s only in the last couple of years that it’s been an actual meaningful, tangible, and within our clinical trials. So, let’s start there: what do you think of when you think of patient centricity?

Jess Perry (01:18): Absolutely, thanks Aidan. And it’s a great question, and I think, we do, we both agree that it’s a term that we’ve heard for a really long time. It’s kind of one of those buzzwords in the industry.

But what’s really exciting is that in the last few years, we’re really starting to see some major changes and much more adoption of some of these things that we’ve been talking about for a really long time. So things like being able to bring forward technology that is truly efficient for the trial. So, I think of patient centricity in a few buckets.

One: efficiencies in the trial, bringing the trials to market faster. I think of it in the way of allowing for trials to be done in a way that is less burdensome for participants; so moving away from brick and mortar models and being able to increase accessibility of trials, so things like trial decentralization.

And then another area where I think of patient centricity, is in trial design. So new ways of doing our studies, things like master protocols, which we’ve been doing for a really long time in certain sectors and areas, but we’re starting to see really thoughtful approaches to clinical trial designs across therapeutic areas. I think it’s really exciting and I think these are the things that are really bringing forward what we’ve talked about as patient centricity for a long time.

Aidan Gannon (02:46): Great, and it’s so interesting you mentioned that because I think I’m going to start with the last point you mentioned, there about trial design, because I think in reality, that’s probably the biggest change that’s going to have to be taken by sponsors in their design.

In that, we’ve seen probably since the start of the of the century, increasing number of procedures in every visit and then every protocol and increased complexity across the board in all therapeutic areas.

And I guess that’s been, for the most part, to try and just you know, bring the bring the product to market and get the license. I think that’s probably most meaningful. I’m wondering what, at Moderna, what you guys do in terms of changing trial design to be more patient-centric, maybe planning the patient visit? All of that, when you’re starting to think about a new trial what, what steps do you take to put the protocol in place?

Jess Perry (03:34): So one of the things that we’re doing more and more in the studies that we’re operationalizing is, we take a really close look at the schedule of assessments. So what are the types of assessments that we are planning to do as part of the study for the participants in the trial, and having a really close look at things like how long are they going to need to be on site to have those assessments performed, how many blood draws are we doing during their participation in the trial, how long is the study? There are a whole lot of factors and things that we look at in terms of the assessments that we bring in the voice of many different functional groups within our team. But we’re also bringing in the voice of the participants, so we will work with community groups, will work with advocacy organizations, to help us inform whether or not we’re creating a study that’s more burdensome for them than it should be. And so, it’s that collaborative approach to making sure that our studies are as patient centric as possible.

Aidan Gannon (04:47): That is really great because I think that’s the biggest impact on the sponsors. It’s great that instead of just talking about patient centricity, it is much more of a collaborative experience. You know, because being part of a clinical trial, it’s a lot of time for a patient it’s another thing they have you know they have to commit to, and I think in return, we, as the industry need to commit to supporting them as much as possible.

Within that then, let’s talk about and you mentioned in your answer the flexibility of, within the decentralized trial model within a hybrid trial. So, when we spoke last week we talked about how not all patients want a completely virtual trial or decentralized trial, but some patients will want that, because it just reduces their burden. What do you think about that model about how the current industry is pivoting towards decentralized trials and how will that actually become a reality in the next few years?

Jess Perry (05:42): Yeah this is, by far, one of my favorite topics. So, I would say that it is really exciting in that we have a lot of technologies, or a lot of ways, that we’re able to use technology today to support the decentralization of clinical trials. I think one of the most important things that we’re starting to see is that, as you said, it’s not patient centric to be prescriptive in terms of whether or not a person should go to a site or be able to have a trial activity done in their home. Instead, we need to have that notion of choice as part of trial participation. And a lot of the partners that we work with and technology solutions that we’re starting to see… what’s really exciting is that, we’re actually able to implement that at an operational level and allow that choice for participants.

So I think that’s where the future is going, I think, in the next five to 10 years we’re going to be seeing a lot more of that. And I think it’s important because when you start to look at various demographics of trial participants and when you’re really looking at the patients that you’re bringing into the trials, or the participants that you’re bringing into the trials, not everyone wants to be able to use technology or to do a visit at home. But at the same time, they may not have access, and so we need to make sure that we have flexibility in our trial designs to allow for appropriate representation as well because that’s another factor that’s vitally important, at least to Moderna and the trials that we do.

Aidan Gannon (07:23): I couldn’t agree more flexibility is difficult to offer sometimes, but we as an industry need to get better at doing that, both from the technology and service provider side and with the sponsors. As you say with patient centricity, you can’t dictate that the patient centricity is this way or this way, or for this trial you’re going to be seeing a physician, or for this trial you’re going to be doing it over Zoom. I mean that’s where we need to be. We’ve come a long way in the last two years, and I think the next five years, we really have to make flexibility and choice be the priority for the patients.

And I kind of want to link that to the sites because decentralized trails is the site-less model. In reality, not every, in fact, the majority of studies we run, will not be able to be decentralized or site-less. So I’ve always been an advocate that it’s very difficult, in fact, I would argue, probably impossible to be patient centric — truly patient centric — without being site centric. So let’s speak a little bit about that, and how technologies need to support both the sites and the patients.

Jess Perry (08:30): I completely agree. When we’re thinking about patient centricity, we must consider all of the stakeholders in the trial. So, it’s participants, it’s their caregivers and, as you said, and most importantly, it’s assuring that the people that are physically doing the assessments and running the trials with the participants are our sites. We have to ensure that when we’re looking at the trial designs and when we’re looking at operationalizing the trials that we are also considering the type of burden and the activities that we’re asking of the sites.

It’s also thinking about, from a site perspective, not necessarily just the operationalization of it, but what are some of the insights that they have about that particular therapeutic area that you may be studying, what types of experiences have they had in the past? Definitely at Moderna, the sites and investigators that we work with are incredibly important to us, and we want to ensure that we really have that partnership with our investigators in the trials that we do.

Aidan Gannon (09:40): So I want to circle back on something you mentioned previously, about patient diversity and I also want to tie that into your personal experiences within Moderna. Obviously, you’ve had a very busy year with developing the (coronavirus) vaccine, and we all appreciate your work in that, believe me. So, within the context of designing the vaccine trial and getting it up and running in super quick time, how did you factor in patient diversity within that, as well as making it a patient centric trial?

Jess Perry (10:10): Absolutely, so the COVID trial was really interesting from a diversity perspective, so one of the things that we’ve seen across trials for many years is, it’s really not new, that disparities in health care, have existed for quite a long time. From a COVID-19 pandemic perspective, one of the things that it has done is brought to light the need to ensure that we’re providing equitable health care and access to everyone.

So as part of the trial, we were able to bring that study forward very quickly. But what we’re really proud of, and one of the things that was vitally important to us for the delivery of that study is that we wanted to assure, or we had to make sure, that we were committed to bringing and having representation of people of all backgrounds in the study. So, what that has done is, it has helped us to be grounded as a core value at Moderna in diversity and inclusion. What I mean by that is in all aspects of our clinical development we are thinking about the inclusivity of participants in our trials and it’s really been, I would say, the COVID study was really a catalyst for sharing that we’re bringing that forward and that type of perspective forward in all of our trials.

Aidan Gannon (11:41): Right, I think that is no small thing, given that you know, the world was watching and relying on the vaccine being delivered and that study finishing in record time. So, I think that obviously, is a great thing and kudos to you guys at Moderna, for doing that. Within the context of that, have you even assessed or have you had time to maybe… what lessons, I guess, did you learn from that process, and how are you going to bring that forward to future studies?

Jess Perry (12:05): What I find really exciting is that we have now brought forward the focus of diversity and inclusivity into the operational planning of our trials. So we have, for all of our studies we set targets, and those targets are not necessarily one-size-fits-all across all of our studies, we have to think about the demographics of the people that are burdened by the illnesses and diseases. We have to think about geographies. There are a whole lot of factors that go into inclusivity in a trial, but again, it is truly grounded in our core values and it’s personally been exciting for me to see and to be part of a team where this is at the heart of what we’re doing in our trial planning.

Aidan Gannon (12:54): When we, within Longboat, when we are testing our solutionsm, it’s fundamental for us to go to the end users first and get feedback. I’m guessing that you guys learned a lot from the patients that participated in COVID and the sites. Can you speak a little bit more about what you learned from that process, I guess, are you still going through that process?

Jess Perry (13:18): It’s a great question. So, I would say that what we have learned is that any type of technology that we use on our trials, it’s fundamental to ensure that we are focusing with each individual stakeholder on the rationale, so not only training on how to use a given technology, but helping teams to understand the reasons behind the use of that technology and how it is advantageous to the trial or to them as a stakeholder.

Aidan Gannon (13:54): Right and do you think that Moderna is an outlier within this kind of embracing change so quickly, so maybe COVID was something that sets you apart slightly from other sponsors? Or do you get a feel that this is certainly the sponsor hasn’t already done this, or at least investigated flexibility around their trials, whether it be decentralized, hybrid. Are you starting to see within the industry that that’s meaningful change that is going to last?

Jess Perry (14:23): I do think it is an industry change that, you know, I believe we are going to see more and more technology across sponsors across the industry used in trials and I think it’s fantastic. I think we, we as an industry, need to embrace this and I think it’s really exciting, because it does assure that we’re really offering the option of studies that are easier to do for participants across the industry, so I think that what’s really exciting is and what I love about being part of Moderna, is that we do embrace innovation and we do think outside the box in terms of different ways that we can use solutions for our studies. But I would say that, from a technology perspective, what’s really exciting is that we are seeing changes in the use of technology a lot more on studies.

Aidan Gannon (15:13): Yeah and I think the speed with which the regulators reacted and how they were realizing that within COVID, clinical research had to continue and they kind of came out with that guidance document that allowed such things as, obviously with everything being regulated and checked, but they were open to virtual visits. That is something that would have taken, I think, probably a lot more time to come through had COVID happen, so we are seeing a change within the industry, and I think it is here to last. So here’s a difficult question: What do you think patient centricity is going to look like in 2030?

Jess Perry (15:53): Yeah, I think that there’s a lot we don’t know yet, but some things that I think are going to stay certainly is the ability of choice in trials. Today, we talked about having choice and trials, meaning, you can either go to the site, or you could have a visit done in your home so that’s something that we you know sort through today. I think as we accelerate into the future, I think that we’re going to start to see a lot more of those kinds of options where investigational product is shipped to someone’s home and they’re able to you know have more of those activities done at home, or perhaps we’re going to be working more with pharmacies. I think a lot of those changes are already starting to happen now, and I think that’s going to continue as we get even further in the future.

Aidan Gannon (16:50): Yeah, I agree and I think from my perspective, I think that by 2030 we’ll be a lot better at implementing this and will have learned a lot and the choice of how you do conduct a visit from a patient perspective will be a real thing where they can say I don’t want to do next week’s one in clinic because I’ve got something else going on and data from wearables and diaries completed at home, maybe home nursing visits will supplement all of that, so, we have that much more freedom. And, as we said at the very start, you know much more choice in terms of how patients conduct their visits and if they want to decide they want to go and see their physician next week, that’s possible for them to do.

Jess Perry (17:28): Aidan, I think you raised a really good point around implementation. I completely agree that in the future, as we get further and better at being able to implement solutions on trials. I think that it’s going to allow for us to have a much more efficient trial process and bring our drugs to market sooner because we’re better at being able to implement these solutions in studies.

Aidan Gannon (17:56): Thanks, so I want to finish up with another difficult question for you. We know that less than 5% of patients who are eligible for clinical trials choose to sign up. What do you think are the most important things that we, as an industry, need to remember and factor in as we continue to drive towards being a much more patient centric and inclusive industry?

Jess Perry (18:21): Yeah, I think that’s a really important point and one of the things that we didn’t talk about yet, but I think is worth discussing is that one of the outcomes that we’ve seen actually from the pandemic is that knowledge about clinical trials has become much greater; awareness of clinical trials, what clinical trials are is much more prominent than what it was prior to the COVID-19 pandemic. I think that what we need to do as we move forward in the future is really use this as a launching point to build on that awareness and to be able to bring forward more education around clinical trials, around the types of therapies and vaccines that may be available or are in development, so that people continue to have that interest and that awareness of what is available to them or potentially in the future for healthcare. So, I think we have a great opportunity now where we are in the industry to really continue to drive forward education around the clinical trial process and around the need for inclusivity and trials, and we’ve got interest that maybe wasn’t there as much before that we can build from. So I think it’s a great opportunity that we have right now and to be able to build from that.

Aidan Gannon (19:49): I completely agree. We’ve learned probably more in the last 18 months than we have in the last 20 years and it’s an ideal platform for us to be more inclusive.

It’s been great to talk to you today about patient centricity and diversity. And I hope, well, I actually think now, that maybe in 2022 when we start going to conferences again, when we talk about patient centricity will have some meaningful conversations and items we can actually point to and lessons we can learn from having implemented a lot of these things that we’ve spoken about and putting them to action.

I want to thank you for your time today Jessica, it was really great conversation, and I hope we can continue it very, very soon.

Jess Perry (20:28): Thank you so much Aidan. I completely agree and appreciate the time to be able to talk with you today, and look forward to future discussions, and thank you.

Aidan Gannon (20:40): Great. And with that we’re going to conclude today’s episode, the fifth episode of Advarra In Conversations With. If you have enjoyed today’s discussion, keep an eye out on a Advarra’s social media or have a look at Advarra.com where you’ll find details of the series and get notifications on our next episode. Thank you, goodbye.

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