Decentralized Clinical Trials & Sustainability

EPISODE 20: Decentralized Clinical Trials & Sustainability | PODCAST

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Show Notes:

On this episode of Pivot Points, hosts Tripp Underwood and Danielle Malvesti sit down with Kelly McKee, Medidata’s Vice President of Patient Registries and Recruitment. Join us as Kelly breaks down the benefits of decentralized clinical trials and the work that Medidata is doing to put patients’ experiences first, encourage research participation and improve clinical trials’ sustainability. 

Transcript:

Elise Orlowski:

I’m Elise Orlowski, a senior video director here at Cramer.

Tripp Underwood:

And I’m Trip Underwood, a creative director at Cramer.

Elise Orlowski:

And at Cramer, we work with so many incredibly fascinating people from all over multiple industries.

Tripp Underwood:

We have so many great conversations, many that are just too good to keep to ourselves, so now we’re sharing them with the world.

Elise Orlowski:

Right here from Cramer studious.

Tripp Underwood:

This is Pivot Points.

Elise Orlowski:

Cut.

Tripp Underwood:

Hi, welcome to another episode of Pivot Points, I’m your host Tripp Underwood and I’m joined today by my co-host, Danielle Malvesti, VP of Client Engagement here at Cramer, and today we’re going to be talking with Kelly McKee, Vice President of Patient Cloud at Medidata. She’s a 20 year veteran of the clinical trial operations and patient recruitment industry, and what that means basically is, she’s an expert at bringing people together for important work, specifically connecting patients and trial participants with the research organizations that are working so hard to cure disease and solve the impossible, and once those connections have been made, she and her team are instrumental in making sure they’re as smooth and productive as possible for both parties, because that’s what leads to progress. She’s been named one of Farmer Voices, 100 most inspiring leaders, a top innovator and leader by both CenterWatch and LifeSciVoice. Kelly, thanks so much for joining us today.

Kelly McKee:

Thanks for having me.

Tripp Underwood:

Awesome. So basically you’re a master at connection and communication, both of which are really important to our audiences, so let’s start there. In your opinion, what makes for great communication around a clinical trial?

Kelly McKee:

I think there are a couple of things. The first is, so many people don’t even understand what a clinical trial is or have misconceptions about what a clinical trial is. It’s not about being a guinea pig, it’s not about handing your body over to science, I like to think of it as being at the forefront of the next great medicine or the next great vaccine, and if we change our mindset around that from thinking that it’s a last resort, to a first option, then we’re really going to open it up to more people, so there’s that part, and then there’s also the part that people don’t even know where to find a clinical trial, there’s disparate information in so many different sources, many doctors don’t even know where to point their patients to, and so I think we really have where it’s incumbent upon us to get the word out about what a clinical trial is, what it entails and then where patients can find these options.

Tripp Underwood:

How does the average participant, if that’s even the right word, but how do people usually find out about these trials? Are they alerted to it by a PCP or are they searching for it online?

Kelly McKee:

Both.

Tripp Underwood:

Okay.

Kelly McKee:

Ideally, patients want to hear from their physicians, but fewer than 15% of physicians are involved in clinical research and many of them for only one time, or they don’t know about it, it’s not taught in medical school, it’s not something that you just pick up the newspaper, well, no one picks up a newspaper anymore, but go on your phone and find it. There’s a website called clinicaltrials.gov, which is very cumbersome for both patients and physicians to be able to find opportunities. So while patients want to find out from their doctors that this is an option, many of them are finding out through internet searches or from friends and family or from an advertisement that they would respond to on the T, for those of you in Boston, or on Google or as an ad word or on Facebook or Instagram.

Tripp Underwood:

Okay.

Danielle Malvesti:

And do you think that the misconception around clinical trials has changed over the last two years with the pandemic that’s been going on or has it made it worse?

Kelly McKee:

I like to think that it’s better.

Danielle Malvesti:

Yeah, same.

Kelly McKee:

I mean, I was a participant in one of the vaccine trials for COVID and I mean, I talked about it all the time. I talk about clinical research all the time, I talk about it to Uber drivers and maybe that’s why only with 4.92 rating instead of a five, which I guess isn’t that bad, but we’re all perfectionists, right? And so, I think that more people understand that new vaccines and devices and medicines only are possible through clinical trial participation, but I think there’s still a lot of misconception, and the fact that people just don’t view it in a very positive light

Danielle Malvesti:

Or to your point, a lack of awareness. I mean, really the only time I feel like I find out about clinical trials is when there’s a one page printout in the bathroom of my doctor’s office.

Kelly McKee:

And those are terrible, aren’t they?

Danielle Malvesti:

Yes

Tripp Underwood:

Yeah. Clinical trials came to the forefront of the natural conversation around COVID at a time when many people could not go to traditional trial sites, very much what Medidata, right in your guys’ wheelhouse, but I wonder if you could walk our audience through a little bit of what a decentralized trial is and how specifically y’all at Medidata are working to make those experiences better for everybody involved.

Kelly McKee:

Yeah, absolutely. So let’s start by talking about a traditional clinical trial. In a traditional trial, a patient or participant, we don’t like to use the S word or subject at Medidata, because patients just don’t like it.

Tripp Underwood:

Yeah.

Kelly McKee:

Would have to travel…

Tripp Underwood:

It’s impersonal.

Kelly McKee:

Exactly. Have to travel, sometimes a great distance, upwards of two hours plus to go to an academic medical center. So think about Mass Gen or Boston Medical Center, the big hubs of medicine in your city.

Tripp Underwood:

In a big city.

Kelly McKee:

Exactly.

Tripp Underwood:

Already eliminating so much potential participant.

Kelly McKee:

Exactly. So taking time off from work, traveling, sitting in a waiting room, signing something called an informed consent, which just goes over the trial and the expectations, et cetera, on paper, getting lots of blood drawn, other procedures, et cetera, and then going home and then coming back, and that could be once or twice a week, once or twice a month, couple of times a year, et cetera, depending on the protocol and the protocol is really just the recipe of a clinical trial, what needs to happen? What to expect.

Tripp Underwood:

The steps.

Kelly McKee:

Exactly. In a decentralized trial, some of those aspects can be done at home. So think about banking, when was the last time you went to a bank?

Danielle Malvesti:

Oh, yeah.

Kelly McKee:

Never, right?

Tripp Underwood:

Or even an ATM at this point, it was replaced by the ATM, and now it’s on my phone.

Kelly McKee:

Well, exactly. Venmo and everything else. So that’s taking some of those activities and doing them on your phone or at home, and that can be done via an app or a website or like a Zoom call or receiving medication delivered to your home instead of having to go to the doctor and getting it, and so when we take any of those aspects that would traditionally be done at the site and we do them at home, that’s decentralization.

Tripp Underwood:

Okay.

Kelly McKee:

It’s a big word, a mouthful of a word, but that’s what it means, it just means doing some things at home or at the office, but not in the hospital.

Tripp Underwood:

So, a few moments ago, you mentioned that you yourself had been a participant in a clinical trial, and I’m just curious as to what it’s like to be on that side of the glass, so to speak. What was your experience like?

Kelly McKee:

Well, I’ve been working in this field for over 20 years.

Tripp Underwood:

Okay.

Kelly McKee:

I was a participant in one of the COVID vaccine trials in late 2020.

Tripp Underwood:

Okay.

Kelly McKee:

So when I heard, thankfully, that vaccines were in development, I said, “I need to be part of this, because I’ve been doing this for so long”, it was time for me to raise my hand and say, “yep, it’s my time.” I don’t think it’s right to ask people to do something that you wouldn’t do yourself.

Tripp Underwood:

Fair [inaudible 00:07:31].

Kelly McKee:

But it was hard. It was hard to find a trial. I went on clinicaltrials.gov, which we talked about a little bit before, impossible to find a site. I heard on the news that Boston Medical Center was running one of the trials, I have friends who work there, I called a friend and it was like seven steps for me to even get to be able to email the doctor at the site to get in.

Tripp Underwood:

Inefficiency again, [inaudible 00:07:55] inefficiency

Kelly McKee:

Exactly. And I’ve been doing this forever. If it’s that hard for me to do it, how hard is it for everybody else? But then met with them, I qualified, I signed the informed consent and it wasn’t like it was super easy, right, I had that like, “oh, should I do this? It’s an experimental vaccine, what if it doesn’t work? But what if it does work?” And unless people raise their hand and say, “I want to be part of the solution”, there is no solution. And so it was easy for me to do it, and it’s easy for me to do it because I have a very flexible job, and I have a company that’s very pro-clinical trials, obviously, and I have resources to help with my children and my dogs, et cetera.

Tripp Underwood:

Proximity to the trial side.

Kelly McKee:

Exactly. Right. I live outside of Boston, it’s not hard for me to get there, but for so many other people, it is hard. And so, participating was a really eye-opening experience. So even though I’ve been doing this forever, I hadn’t been a participant, and so unfortunately the trial I was on did not use Medidata technology.

Danielle Malvesti:

Well, it must not have, because you’re saying you had to drive there and fill out all the forms.

Kelly McKee:

So many are hybrid. So I had an app on my phone where I had to say if I had any symptoms of COVID every week and this app was just terrible.

Tripp Underwood:

Oh, okay.

Kelly McKee:

The grammar was terrible, and I know a lot of people aren’t grammar sticklers, but I am.

Danielle Malvesti:

Well, Tripp can relate too.

Tripp Underwood:

Well, it make things confusing. And also talking about this idea of it’s confusing, bare minimum for non confusing conversation.

Danielle Malvesti:

And you’re so educated in this area, imagine somebody who’s…

Kelly McKee:

Who’s not.

Danielle Malvesti:

Yeah.

Kelly McKee:

Exactly. I would get notifications when I didn’t need them, I wouldn’t get notifications when I did need them, at one point I wanted to, and it was on my own phone, so I had the option, which was great, of getting a provision device or my own phone, and I chose my own phone, I’m a one phone kind of girl.

Kelly McKee:

I wanted to throw my phone against the wall and I had to convince myself, “no, this is important”, but again, to your point, if I didn’t know it’d be so easy for me to say, “don’t want to participate anymore”, and so at Medidata, one of the things that we’re really passionate about, for lack of a better term, is making the experience a good one. So all of our technology solutions are developed with patients and we test them out with patients, so the shoes you’re wearing were on someone else’s feet when they were designed, you wouldn’t just put a pair of shoes out, not your exact shoes, but you know what I mean, the prototype, but in clinical trials and in clinical trial technology, so many just are pushed out without being used on real patients first. And one of the things we’re so proud about at Medidata is that we involve patients in the design of all of our patient facing solutions.

Tripp Underwood:

Like any industry, if the UX is terrible, you’re going to run out of potential customers, partners, whatever it is you’re looking to go. So that idea of, to spend all this time research and honestly money on creating something and then spend zero effort in trying to help people navigate to said thing.

Danielle Malvesti:

Or reduce their friction in their experience.

Tripp Underwood:

You talked a little bit about explaining these concepts or the communication of poor grammar, and then lack of properly explaining either what’s happening, what people can expect, I mean, I’m not sure if risk is the right term, but explaining to everyone what is going to be happening, what they can expect here, here and here, sounds to me like is also lacking. Is that a form of health literacy and/or this idea of the medical and research communities at large need to do a little bit a better job about explaining exactly what it is they’re doing to the general public? Do you think that affects some type of participation, this not clear understanding of what’s happening, just this idea of communicating to patients.

Kelly McKee:

I mean, communication is a huge thing, that’s why we’re here today. The informed consent form that we talked about earlier is a massive document that goes over everything. You need to do it, regulations make you do it, it’s the right thing to do too, but not everybody learns very well by reading text heavy 13, 15, 20 pages of data, right? We all learn in various ways and we want to learn as we go, right? So if I give you a calendar and say, “here’s your calendar for the rest of the year”, are you going to remember it in three months?” No.

Danielle Malvesti:

Right.

Kelly McKee:

But if I say, “here’s the notification of everything you need to do today on your phone”, or, “Hey, let’s watch a video about what you need to do”, you’re going to learn about it in a different way. And so, health literacy and clinical research is really about providing options to patients so they can get that information and digest it in a meaningful way. We also need to understand, not only do people learn about things in different way, but we’re all different, and so diversity is really important in clinical research, because we want the medicines and vaccines and devices to work in the population that eventually is going to have them as a marketed product, but if we make it so difficult to participate in clinical research, that only a subset of the population can participate, then not only are we missing out on including a more diverse audience, but we don’t know that that medication or vaccine or device is really going to work in the general population.

Tripp Underwood:

Data is not as a robust as it possibly needs to be.

Kelly McKee:

Exactly.

Tripp Underwood:

Nevermind should be

Danielle Malvesti:

Right. And talk about building, I’d imagine, trust in those other communities, it’d be much harder to do so without their buy-in during the clinical trial process.

Kelly McKee:

Exactly.

Danielle Malvesti:

How long has Medidata been playing in this space?

Kelly McKee:

Yeah. Medidata’s been playing in the space forever as well.

Danielle Malvesti:

Okay.

Kelly McKee:

So, Medidata actually ran the first decentralized trial over 20 years ago with Pfizer. We’ve run the largest decentralized clinical trial, which looked at different doses of aspirin, and we like to say, we’re running the most important DCT, which is yours, right? So the first, the biggest and the most important, that’s Medidata, many people think that DCTs are a new thing, because they started hearing about them during the pandemic, because Tripp, as you said, we couldn’t…

Tripp Underwood:

That’s how I heard about it.

Kelly McKee:

We couldn’t travel, but they’ve been around a long time. And if you think about DCTs as any aspect that, as we talked about before, you could do at a hospital or doctor’s office, but you’re doing at home or at your location of choice, then that really opens up decentralization. Now, so many companies have come out in the pandemic with lots and lots of flashy marketing materials, but they don’t have the expertise. At Medidata we support, I think the last thing I heard was, 70% of the world’s clinical trials in one way or another.

Danielle Malvesti:

Which is impressive.

Kelly McKee:

Yeah, that’s huge, right?

Danielle Malvesti:

Right.

Kelly McKee:

We have not only that breadth of experience, but we have employees who have been doing this for a long time. Our leaders in the field, it’s not just one head person, it’s all of us, and we’re all passionate about the work that we do, and so when you look at global reach and expertise and passion and wanting to make things better and better, Medidata is the best DCT provider, hands down.

Tripp Underwood:

And I imagine you guys are benefiting also from the rise in telehealth and people just becoming more comfortable with the concept outside of decentralized trials, might spill over into the research realm as well.

Kelly McKee:

Yeah, ya know, patients are ready for it. We’ve been ready for it for a long time. We talked about banking or Instacart for groceries, or I mean anything has been decentralized, if you want, but sometimes pharma lacks behind. So that push in the pandemic really made it more mainstream and made it more acceptable, if you will, but patients are ready for it. Patients are ready to learn about opportunities to participate when it makes sense for them, and I’m not saying the clinical trials are the right option for everybody, but I want them to be an option for everyone, and then by really focusing on experiences and optimizing those experiences, we’re not only going to be able to offer clinical trials to more people, but when more people participate, we’re going to be able to speed drugs and vaccines and devices to market.

Tripp Underwood:

Get them to the people that need it [inaudible 00:16:33].

Kelly McKee:

Exactly.

Tripp Underwood:

Perfect.

Kelly McKee:

Yeah.

Danielle Malvesti:

Kelly, against Medidata’s competitors, have they been in the space just as long?

Kelly McKee:

No.

Danielle Malvesti:

As you’ve been? Okay.

Kelly McKee:

Yeah. No, not by leaps and bounds.

Danielle Malvesti:

Okay.

Kelly McKee:

We’ve been doing this for a long time

Danielle Malvesti:

Yeah. Again, I just go back to the pandemic and really, it was like the curtain was lifted during the pandemic, I think, for so many people on the steps in a clinical trial, and of course I’ve had the privilege of working with Medidata in that same timeframe, and so it really is phenomenal of the steps that Medidata is taking in this space, which makes me feel a lot of trust around the space that I really knew nothing about prior to the pandemic. So I imagine others are in the same boat.

Kelly McKee:

Yeah, absolutely. So it’s about having that expertise and that breadth of knowledge, but it’s also about focusing on patients, sites and sponsors, all three are super important, and you can’t do research without them, right? And so when we look at things from the perspective of those three stakeholders, you’re really able to optimize experiences and just make it a better situation for everyone. So many people think, “oh, innovation is like two guys in a garage”, it’s not.

Danielle Malvesti:

Well maybe for Apple.

Kelly McKee:

Maybe a million years ago.

Danielle Malvesti:

In the healthcare space, a little different.

Kelly McKee:

Exactly. Yeah. Clinical research is a heavy regulated industry, for very good reason. We have a sorted history, we’re not pushing that under the rug, we’re only going to make it better when we use that experience, understand what has happened and what needs to happen and then involve real patients and real sites and work with sponsors to find the very best solutions.

Danielle Malvesti:

I just want to pivot a little bit into a different topic around sustainability, we’ve been hearing companies really focus on this area, especially in the healthcare space, and we know that decentralized clinical trials are helping not only Medidata be more sustainable, but also partners and patients, so can you share with us some of the steps that Medidata’s taking in that space?

Kelly McKee:

Yeah, there are a couple. So not only about bringing clinical trials to patients, instead of bring patients to clinical trials through our my Medidata and patient cloud, or our decentralized clinical trial technology, but also in the fact that we’re moving from treating clinical research as a transaction, to being continuous engagement, and what do I mean by that?

Kelly McKee:

Well, if we bring clinical research as an option for more people and in the pre-trial space, help them prepare, educate, empower them to be able to choose clinical research, and then in the post-trial space, return their data, make new opportunities available to them, we’re creating sustainable patients. 98% of patients who participate in clinical research would participate again, they have pretty good experiences, we can always make them better, but pretty good experiences, but yet they’re never asked to participate again. So we’re missing out on that entire pool of patients who could be re-engaged, they already know that they like clinical research, they already know what to do, what it’s all about, but yet, because clinical research is pretty much a transaction, they’re discarded. So if we think about sustainability outside of just the extra devices or gas to get to your trial site and really think about it holistically, then clinical trials can be sustainable by continuing to engage people.

Danielle Malvesti:

That’s really interesting. I never looked at it that way, but it kind of reminds me of some of the work that we’ve done with a pharma client that we have really around building a community to help those with an illness, better adhere and giving advice to the community, and so it kind of sheds some light on me, especially as we look through the pandemic, and how many of those people, to your point, that participated in a COVID vaccine trial are actually being engaged now that they’ve received the shot and helping to inform the community or build awareness.

Kelly McKee:

And I haven’t, as part of my clinical trial, I just do it on my own, but it’s a missing piece.

Tripp Underwood:

And I think it goes back to what Kelly said earlier, it’s treating participants as people.

Kelly McKee:

Yeah.

Tripp Underwood:

It’s not thinking of people as subjects, transactional, really remembering this holistic idea of the people participating in said trials are people first and foremost, patients next, and the idea that they can be reached out to, they can be engaged better and anything we can do to make their experience better, it’s better for the research, it’s better for the sponsors of said research and it’s better for the population in general, because we have more robust data to create the medicines and therapies that we all need. Great. Well, this has been super helpful, Kelly, thank you so much for joining us.

Kelly McKee:

Thank you.

Tripp Underwood:

This has been another episode of Pivot Points. I’m Tripp Underwood, and we’ll talk to you soon.

 

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