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Trend Forecasting: What Does 2022 Have In Store for Clinical Research?

February 10, 2022

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.

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About This Episode

What will be the 2022 trends in clinical research? In this episode, Advarra’s James Riddle and Wendy Tate forecast what is coming up for clinical trials and clinical research in 2022, including changes in study design, gene therapy innovations, decentralized clinical trials, consolidation of research sites, and increased knowledge about clinical trials and research in the community.

Podcast Transcript

00;00;05;19 –> 00;00;18;00

All right, welcome everyone to 2022. It seems like it was just yesterday that we were talking about getting ready for 2020 and now all of a sudden, it’s 2022. Time just really flies by. Wendy, Happy New Year!

00;00;18;00 –> 00;00;30;07

Happy New Year James! I love new years and I think it’s a great time to refresh and restart and I think a lot of people are really excited to refresh and restart this year so I’m really looking forward to what 2022 brings.

00;00;30;07 –> 00;00;36;25

We’re going to get to talk a little bit about our predictions for what’s coming up for clinical trials and clinical research in 2022.

00;00;36;25 –> 00;00;45;28

It should be fun to see what happens in 2023 when we look back on this episode and see if we were right. So, what do you think, should we dive in?

00;00;45;28 –> 00;00;55;07

Oh, by the way, for those of you who haven’t tuned into our podcasts in the past, I’m James Riddle, I’m the Vice President of Research Services and Strategic Consulting here at Advarra. Wendy?

00;00;55;07 –> 00;01;01;24

I’m Wendy Tate. I’m the senior clinical research strategist and I’m just going to jump in. So, James what’s going to happen this year?

00;01;01;24 –> 00;01;17;16

Oh, goodness, well, I think the biggest question is going to be what’s not going to happen this year. But we don’t have hours and hours to talk about this so one of the things that I think probably is going to be a big focus this year is changes in study design.

00;01;17;16 –> 00;01;36;11

Right, we’re going to see continuing innovation from sponsors in how to make their trials friendlier for decentralized clinical trial technology. We’re going to see some people getting more and more into real world evidence.

00;01;36;11 –> 00;02;08;10

Maybe some continued innovation in gene therapy and mRNA research so maybe we could start there. I think that this is going to be the year where we see changes in how studies are thought through, developed, and implemented and, hopefully, this is just my own personal opinion, hopefully it’s going to have a big focus on increasing participant engagement and increasing the participants ability to participate in clinical trials. That’s my big prediction – what do you have in mind?

00;02;08;10 –> 00;02;16;03

Yeah, I think study design is a great place to go. We’ve seen over the last several years you know all of these kinds of pockets

00;02;16;03 –> 00;02;44;22

You mentioned a lot of them – decentralized clinical trials was kind of like the 2021 buzz word, we have a lot of new adaptive study designs we’ve seen prop up over the last decade, gene therapy, everything is going mRNA these days.  So, I think this year is where we are going to see them consolidate and really focus on participant-centricity, getting trials more accessible to more people and seeing these actually come together, not as their own individual trial designs, but together –

00;02;44;22 –> 00;03;07;05

How do we actually take these adaptive trial designs and mix them into a hybrid or decentralized clinical trial arena using these really great platforms that are coming up with mRNA and some of the other types of biotech that’s coming through and really seeing clinical research push forward into the next era, so I think it’s really exciting to see that. I think we’re seeing some guidance coming in, ICH obviously has been doing updates and they’re expecting more this year, you mentioned RWE. FDA just came out with several guidances on real world evidence and how you can use that in clinical research so I’m excited to see how those actually occur. Keeping on the evidence portion, coming from health outcomes research,

00;03;30;17 –> 00;04;00;10

You know that’s something that’s been going on for a long time. We’ve used a lot of that information in observational trials and things so I’m also excited to hopefully see some of these other methodologies coming in from where we see in social behavioral sciences, or some of the other Public Health sciences, really, seeing that get integrated into clinical trials, because we are trying to get out into the community more. We are trying to get out of the brick and mortars and the clinics, what do you think about that?

00;04;00;10 –> 00;04;37;28

I think that that’s spot on because in the social behavioral realms we’ve been doing activities for remote data gathering, and it wasn’t really until the last two years, which have just flown by, that we really started to see a huge evolution in clinical research where now rather than coming to the tertiary site, to get your blood pressure and fill out your diary once or twice a week, we can do that on your phone, you can get your EKG on a little device that you buy from Amazon for like 20 bucks or something. And we try to wrap all that together in this terminology of decentralized clinical trials that seems to be the term dejour.

00;04;37;28 –> 00;04;56;23

But that can be anything from simply doing more in home visits, more in home collection, all the way to completely decentralized clinical trials, where a drug is shipping from some other place and participants are consenting online and doing Teladoc to do all of their visits.

00;04;56;23 –> 00;05;00;20

I had a very nice conversation with one of my colleagues, the other week about how the introduction of decentralized clinical trials and the movement away from every single visit being at the clinic to having more options for remote participation improves the everybody’s ability to participate in clinical trials, so if you think about a rural setting.

00;05;21;10 –> 00;05;42;15

Right so somebody who lives 50 to 100 miles away from the big tertiary Academic Medical Center that’s conducting the research, maybe they can drive in to get their initial screening and their MRI and all the stuff that you have to do with the hospital setting to start, but from then on, now they can get their stuff done at home and now with decentralized technologies, we can actually do that.

00;05;42;15 –> 00;05;52;02

And it improves our ability to kind of reach out in the community and expand and diversify the pool of people who are able to actually participate in the clinical trial.

00;05;52;02 –> 00;06;06;10

But I want to expand that I think we’re going to actually see this year a diversification of our clinical research staff because, with these decentralized modalities we’re still going to need professionals in the community to help these people with those.

00;06;06;10 –> 00;06;29;04

And I can see our local pharmacies getting more involved or the minute clinics, which a lot of times aren’t pharmacies, but might be a physician pop up or some of those more ancillary clinics that feed into a tertiary center but maybe they don’t. Maybe they’re a standalone, really seeing them get more engaged and more involved and really contributing to evidence based research, which can then, of course, give us more data.

00;06;29;04 –> 00;06;46;05

With all that data we’re getting from the community, from the population kind of measuring in real time in the real world what’s really going on, I think, hopefully we’ll see a shift in some of our clinical trial outcomes to be more accurate to what we might see post approval.

00;06;46;05 –> 00;07;01;23

I know here at Advarra, we’ve seen a lot of sponsors coming to us asking how I appropriately integrate these technologies into my trial design? So remote data collection is a very good example – everybody has seen the Google images of the Fitbit tied to the dog collar.

00;07;01;23 –> 00;07;20;15

Right, so instead of coming in, for a three-minute walk test now you’re suddenly trying to monitor somebody out in the real world. And you’re getting better data, hopefully. I mean if you really want to get good data on how people were really doing you measure them where they’re at, you don’t have them come to a clinic setting

00;07;20;15 –> 00;07;34;13

In a very controlled environment, you know you measure them out in the real world, but it creates a challenge for the data integrity. How am I going to collect the data, where am I going to store the data how am I going to validate that the data didn’t come from a Fitbit on a dog collar?

00;07;34;13 –> 00;07;47;15

Well, I think there’s one more thing that’s going to happen this year, though with all of this data. I mean you mentioned a Fitbit. I used to have a Fitbit. Now I am team Garmin. There’s so much data that comes off of this little watch.

00;07;47;15 –> 00;08;06;29

You know we’ve had so many reports on how the number of parameters that are being collected, as part of a clinical trial has just skyrocketed over the last couple of decades and now all of a sudden, with all of these remote technologies and the ability to collect data that’s going to just explode exponentially.

00;08;06;29 –> 00;08;16;25

However, at the same time we’ve seen almost an improvement in being able to target exactly what data, we want to measure with some of the Covid trials.

00;08;16;25 –> 00;08;42;18

It is basically: we want to get this trial done quickly, what do we actually need to measure the outcomes we’re looking for the objectives that we’re looking for and let’s just collect that. So, what I would love to see in 2022 is basically this explosion of data coming in and the maturity to actually only collect what you really need, and if we can bring those two together, then we can continue doing clinical trials quicker.

00;08;42;18 –> 00;08;48;29

But hopefully with more of this reality-based information that’s going to happen this year too, of course.

00;08;48;29 –> 00;09;02;13

Of course, of course, that’s going to happen this year. With this change in modalities of the protocols and switching to more decentralized clinical trial capture remote collection, etc.

Chapter 2: Resurgence of Clinical Trials in North America

00;09;02;13 –> 00;09;18;29

I think another bold prediction and we’ll see if this will see if this rings true when we do this show again in about 12 months, I think this is the year that sponsors start to bring research back into North America.

00;09;18;29 –> 00;09;36;16

Because a lot of research has moved to other areas of the planet and some places are easier to do research than others and North America has the most well defined and best regulatory framework for conducting human clinical trials. It’s easier to do research here than it is in some other parts of the globe.

00;09;36;16 –> 00;09;55;03

And I think that with the advent of decentralized technologies that allow us to capture that gentleman who’s 100 miles away from the main clinic and give them the ability to participate or my neighbor who can now participate after hours because they you know previously; they couldn’t participate in the research.

00;09;55;03 –> 00;10;14;03

Combined with the just general overall public awareness of clinical trials and the importance of clinical trials and why they’re there and what they do. I think the population of individuals that are interested in participating in research here in North America is a lot more than it was two years ago.

00;10;14;03 –> 00;10;35;08

I hope it does, I think there are a lot of good opportunities in North America and, especially, as you mentioned, with increased awareness of clinical research and just you know how the process works in general but also really focusing on you know, making sure that we have inclusive and diverse populations and that’s not just talking about race and ethnicity, but also gender and rurality and all of these different study designs coming together and being able to say we need to include all these people, because we need it to be able to be reflective of our population.

00;10;47;10  –> 00;11;07;08

I hope that, with the greater awareness and I think that’s the responsibility that scientists have in 2022, is to really create a relationship that’s positive with the public to really bring them in as a partner and research. We’ve talked about patient centricity for a long time now.

00;11;07;08 –> 00;11;24;15

I think that was the buzzword about a decade ago, but really to bring them into this conversation and say how can we make this research accessible to you? We want to do that and we have methods to do that now, but what actually works for you? Not going to the public and saying this is how it works for you.

Chapter 3: Consolidation of Clinical Research Sites

00;11;24;15 –> 00;11;45;18

So, another thing that I’ve seen that I think will continue in 2022, and that is we’ve seen a lot of consolidation in clinical research sites that I think for the last decade we’ve seen a lot of consolidation and health systems or hospitals health systems merging together to create larger health systems under a common

00;11;45;18 –> 00;11;56;07

administrative framework. We’re now starting to see that accelerate in the clinical research site, the private clinical research site, and I think that trend will definitely continue into 2022.

00;11;56;07 –> 00;12;23;13

And I’m encouraged that many of the clinical trial site networks that are forming they have a very strong centralized administrative apparatus which for an IRB person or for somebody who’s looking at clinical trial startup or somebody who’s looking at billing or contracting and it will ultimately enable us to be able to have

00;12;23;13 –> 00;12;36;12

faster trial startup more consistent operations and collection across the various clinical research sites which will ultimately help with the data quality that goes into the sponsor and, more importantly,

00;12;36;12 –> 00;12;48;00

It will enable us to continue to have well-funded and well performing clinical trial sites that are part of a larger network, they have resources they can tap into

00;12;48;00 –> 00;13;03;24

And I think it will facilitate decentralized trials, I mean we have, we mentioned, you know these huge health networks. And they’ve got these ancillary clinics all over the place that probably haven’t performed research before, but now they’re hooked into this hub of sites and potentially academic partners, and you know huge hospital systems that are doing research in the major urban areas.

00;13;11;17 –> 00;13;26;28

That approach, I think, will generally accelerate because if you think about how many people did, we enroll in COVID trials? Like hundreds of thousands of people have gotten signed up and participated within the course of the last two years.

00;13;26;28 –> 00;13;44;18

That was not going to happen with just tertiary academic medical centers right. That was going to happen with large numbers of private clinical research sites with or practices that started to do research with patient care attached and things of that nature, and I think it will continue to be that way

00;13;44;18 –> 00;14;10;11

That there’s going to be a need for more clinical research sites to be able to handle and approach he populations and those clinical research sites are going to maybe look a little different. With the virtual trial technologies, they might look like a CVS or a minute clinic. They might not look like the research office associated with the big hospital, for instance. That should be interesting to see what happens here in 2022.

00;14;10;11 –> 00;14;24;04

Yeah, absolutely, and hopefully we’ll be able to see a lot of really relevant research, what matters to the community. Obviously COVID has been on everybody’s front of mind for the last couple years but you know that doesn’t get rid of the fact that we still have

00;14;24;04 –> 00;14;47;17

You know, we have a diabetes issue in the nation, we have cardiovascular health issues in the nation, of course, cancer and oncology. And so, as we see these communities that come up and say this is important to me, you know, this is what we want to see out here. I hope that we can really see some really cool community research happen that are addressing very real problems to the patients that are currently experiencing them.

Chapter 4: Increasing Knowledge and Interest in the General Public

00;14;47;17 –> 00;15;04;05

And I’m looking forward to having continued conversation with folks who are not generally tuned in to what’s going on in clinical research, be able to talk about it at parties, at gatherings or just on the airplane talking to the folks next to you.

00;15;04;05 –> 00;15;23;16

People seem to be much, much more engaged, and knowledgeable as a general population about what’s going on with inside research. I think that that overall public awareness of research is going to do a couple of things. One, it’s going to improve people’s general appreciation for what this overall enterprise does.

00;15;23;16 –> 00;15;41;07

And I think two, it’s going to generally increase the pool of people who are willing to participate and to our point earlier, the more percentage of the population that’s willing to participate the easier it’s going to be to get these really important trials started, enrolled.

00;15;41;07 –> 00;15;52;27

Find out the data that we’re looking for hopefully we get that key information that you were talking about earlier and get these get these things done and get the data that’s necessary to know whether the drug works, or doesn’t.

00;15;52;27 –> 00;16;20;15

is sometimes we do find out that it doesn’t work as is one of my favorite quotes from one of our IRB chairs, Dr Ran Goldman is sometimes research is the process of going down a blind alley just to find out it’s blind. And that is research, sometimes it doesn’t work, but the faster we can get to those answers the much better off, we will be in a from a public health setting and from the ability to advance human health and deliver new cures out to the population soapbox speech for 2022.

00;16;23;28 –> 00;16;28;12

Well, I’m adding one more to your list because I also think that, on top of science education,

00;16;28;12 –> 00;16;48;04

We are now also impacting the younger generation. I happen to have children in high school. And it’s really been awesome listening to them come home and granted they have a different perspective and a little bit more knowledge, because of what their mom does for a living. But they talk about these studies in school, and they talk about what this means for them.

00;16;48;04 –> 00;17;06;06

And so, you know you and I have joked before nobody goes to college to join the IRB like you don’t even know what an IRB is. I’m hoping now because of all of this science discussion and clinical research discussion that’s permeating through all levels of our community, including our kids and our education systems.

00;17;06;06 –> 00;17;14;25

That we’re going to see people who want to go into clinical research careers and it’s not Oh, you have to be a doctor or you have to be a nurse, it’s going to be

00;17;14;25 –> 00;17;26;19

You know I’m really interested in marketing or finance or I’m interested in regulatory law and there’s a place in clinical research, for me, and if we can get people started on a career faster.

00;17;26;19 –> 00;17;42;22

We’re bringing all these disciplines together these young minds these great minds and instead of falling into clinical research which so many of us have done and loved we have people who are proactively joining and really facilitating faster research smarter research.

00;17;42;22 –> 00;17;53;26

Well, it’s going to be a great year. We’ll be back again in 2023 to see if any of our predictions hold true but I suspect they probably will. I’m looking forward to it and looking forward to the journey.

00;17;53;26 –> 00;18;02;12

Me too James and we will definitely be doing it together and I’m going to hold you to it. Let’s get back together either the end of the year or next year and see where we land.

00;18;02;12 –> 00;18;32;15

Wendy thank you and to all the listeners that are tuning in, thanks a lot for joining our conversation today. Really hope you took something away and learned something. If you want more content check out Advarra’s website. If you want to listen to the other episodes of “Advarra in Conversations With…” with please go to the Advarra website or download them for wherever you get your podcasts. Thank you and have an excellent 2022.

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