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In this episode Maya and Michelle Shogren, CEO of Innovate in What You Do? LLC, are discussing the importance of innovation in clinical research. Michelle has been on both sides of clinical trials - as a patient and as part of the operations teams. She has almost 20 years of experience in different roles - caregiver, research coordinator, site and marketing director, CRA, and multiple roles in Pharma. Michelle is now running her own company with the same goal of helping people navigate and improve clinical trials.
They dive deep into the following topics:
(2:51) Top 3 Difficulties in Clinical Trials
(5:23) How do you find innovative and sustainable solutions?
(7:11) How do you integrate new solutions?
(10:01) Incubation period when implementing a new change
(14:09) How do you innovate while running a trial?
(16:14) Common mistakes when integrating new solutions
(18:10) How do you approach innovation in a small company?
(22:19) How do you pitch your solutions in the best way?
Tune in today and start expanding your knowledge!
Maya Zlatanova, CEO of Trialhub
Michelle Shogren, CEO of Innovate in What You Do! LLC
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Innovate in What You Do? LLC
Creators & Guests
What is Trials with Maya Z?
90% of clinical trials fail, 85% get delayed. Let’s deep dive into the world of planning and running of clinical trials with some of the most experienced and passionate people from the Industry and find out what makes trials more successful or more challenging. Welcome to Trials with Maya Z podcast!
Maya Zlatanova, CEO of TrialHub: https://www.linkedin.com/in/mayazlatanova/
Maya: Hello everyone and welcome again to Trials with Maya Z. I'm today with Michelle Shogren from Innovate In What You Do. And I'm very, very excited because I already had a chat with her before and. Even the first conversation inspired me a lot.
Michelle, why don't we start first with a quick introduction on your, on your end?
Michelle: Yeah. Um, [00:01:00] thank you so much for having me here today, Maya. I'm excited to be here and to talk about these critical topics with you and your audience. Um, as you said, my name's Michelle Sjogren, and currently I run Innovate in What You Do, which is a company that's focused on really helping people bring innovation and make it user-friendly and implementable into clinical trials.
And that comes from my background of 25 years in the clinical research business. Over that period, I've been a patient in two clinical trials. I've had my parents and family members in clinical trials and been a caregiver for them, and I've also worked in several different roles. I started on the site side of things.
I worked there for about nine years, jumped over into the C R O world, um, for about a year, and then went into pharma. About 14 years and during my 14 years in pharma, I started and built, and scaled [00:02:00] innovation function within clinical development and operations for Bayer Healthcare. Um, and during that journey I realized that some things were missing and I decided to start my own company and tried to help more people by bringing those lessons learned to a lot of different parts of the ecosystem of clinical trials.
Maya: And I'm so happy that you did that because last time when we were speaking with you, I realized how much more we need to change when it comes to innovation. The main, main focus of today's conversation will be exactly innovation in the clinical research space. How can we make this innovation sustainable?
And yeah, what can we do to implement change in the industry? But let's start first with the first question, which is, Which are these top three challenges that, um, challenge the success of a clinical trial? Which are these top three difficulties that clinical trials are facing in your opinion?
Michelle: So let's look at that from a [00:03:00] hierarchy standard. So the very top one is the lack of clinical trial awareness by the general public. Whether that is people who have conditions or might want to be in a clinical trial don't even know they exist. Community doctors aren't aware of what's out there and available, and it's not easy for them to find information, and they just don't even have the time sometimes to be able to look into it in the depth that they need to.
So that's. That's the first one. Then the second one is even if we find people that are aware of clinical trials and we have that initial match, the recruitment into the clinical trial is so complex, whether it's because of all of the differences. Inclusion exclusion criteria. We've created the structure of the schedule, the, um, robustness of the data collection that we need to do, including all of the lab samples and the, the scans.
It's very complex to get someone through the funnel of recruitment into the trial. [00:04:00] And then the third one I would say is, okay, now we're in the trial. We made it through that crazy funnel, and we're having to be able to access these people and get the best data possible to look at everything as a whole person, and also make sure that we represent everybody who could be potentially in need of taking this new treatment or medication.
The tools that we're now able to leverage through technology allow us to reach more people, but the adoption of these tools can be very complex. Endeavor for different people and different users, whether it's the patients or the site personnel or the study teams or the sponsor companies, or the vendors.
That whole piece of the technology adoption is very, very cumbersome right now. Um, so trying to solve those three could make a huge difference. [00:05:00] Any of them can make a huge difference in our clinical trials.
Maya: I assume that if you ask, uh, different, like different people from the clinical research, let's say value chain, uh, everyone will say different problem, but I agree that these are the some of the, The main difficulties. as a company, how do you find solutions for tackling not only these problems but all the problems that you have as a company?
How do you find solutions to solve these problems?
Michelle: Yeah, and I think that's the tricky part because there are some things when we look at our span of influence, right? That's the things that we can touch and make a change with. Some things are within our span of influence, like the third one. We all can make that third one better.
Each person in the ecosystem can make the adoption of technology in clinical trials better. Now, when we go up one, that's also where depending on what. The role you have, you may have the span of influence to help. We can decomplex our clinical trials, we can [00:06:00] look to improve our schedule of events. We can look at different ways to collect things.
And you see a lot of that coming from this, flexible clinical trial model or DCT mode that we're talking about. But when we get up to that top one, our span of influence is. We need a whole community to make a difference there. You know, it requires lots and lots of people. We've gotta inspire others and we have to come together and we have to band together to make a difference, to increase clinical trial awareness.
And that's at all different levels. So I think the first thing is understanding what you can touch and what you can change. And then once you see that, see what you can do as an individual to make a difference.
Maya: Mm, I understand. So if I'm to summarize, it very much depends on the level of the problem that you're facing, and sometimes you'll find a single solution. Sometimes it's, uh, the solution is a completely different approach. It's, it's, it's in the community. It's you becoming more open to collaborating with others to bring a change.
Okay. [00:07:00] That's that, that's a good point. I, I know you've worked as, um, as part of many innovations teams, uh, or at least for many years. Um, and I, I wonder what are these best practices that help companies integrate new solutions into their, into their processes?
Uh, because I know how hard it is to fight. old habits, um, budget constraints, um, all sorts of like difficulties. So how do you make, how do you integrate these new solutions in your company, not as a single one-time project pilot, but as something more sustainable, which are these best practices that you can name here?
Michelle: So when I was creating the innovation function with my team we started looking into why things are not moving the way we wanted to? Because in the first couple of years, we started strong. We said we need the innovation, we need to bring it in. But then we were having problems with people saying, yeah, that's a great idea, but not in my study, [00:08:00] and we were failing too.
Be able to implement. We weren't getting the ball across, you know, the field. We were just getting it started and we said, why is this happening? And we found there are three main gaps that most companies are dealing with. It wasn't just at Bayer, it was across the industry, whether it was at a vendor company, it was at a site, it was at a sponsor company or a crop.
It didn't matter. The three gaps were there. The first gap is People aren't starting change management at the right time. They are waiting for the implementation of something new to start doing. Change management. This is a huge mistake. It's a huge missed opportunity. You should be intentional with your change management.
You should start talking about why we need change and building the value of the change. Make sure you're talking about what problems you are trying to solve with the change and that you're not just doing it because it's a shiny object that's out there that looks inviting to you, right? [00:09:00] Having that conversation before you're ready to pick a product or pick a new way of working is critical.
The other thing. Along that journey of change management, you need to handle the second gap, which is there's no incubation happening when it comes to innovation in companies. You have people having the idea and then they say, oh yeah, sounds like a great idea. And then they go straight to implementation.
Let's make that happen. And then they're like, why is this not working? I don't understand. Like it should have worked. It was a great idea. In the middle, there's this huge chasm and you're having to jump it, and it's much better if you can create a platform to walk across instead of having to jump this big, scary hole, and that is your incubation period.
You have to give people a chance to touch and feel and interact and wrap their brains around the new way of working so that they're not afraid of it when it comes to implementation. And you can do that in different ways, but if you don't do it, [00:10:00] You're gonna fall into that pit.
Maya: I just wanted to, ask you like something more about this incubation. Is it something kind of like? Before you start the integration understanding, which are these low-hanging fruits, that will allow you to see some change, some, some results, but also try to set the right expectations so that when you start experimenting or implementing this new solution, you can say, yes, it's working or not.
So kind of like setting realistic goals, is that what you're, what you're trying to achieve within this incubational phase?
Michelle: That's part of it, but part of it is you need to be able to answer the question, how will this impact me for each of your users that have to touch this new way of working and. If you are not able to articulate what it means to them, what's there, I call it the burden quo, right? What's their burden quo?
What, how much extra time is it gonna take for them to learn this new way of working? [00:11:00] What is the data gonna look like if they have added a device into a clinical trial? What's that gonna look like so that they feel comfortable to see it? How long is it gonna take to do this? Um, is there something that you're gonna have to ship around?
Are there logistics involved? What does that look like? Like being able to make people feel comfortable and knowledgeable still in their job? I. At the time you're ready to implement this in a clinical trial can make a huge, huge difference. We started doing it with something we called Tech for Trials, and it was an idea, um, that came up from a gentleman named Julian Kroll in the UK and he said, you know, we've gotta find a way for people to.
Understand fully what they're dealing with and try to approach this fear burden. And we need to de-risk as much as possible outside of a clinical trial before we put something new in it. And he was brilliant because when we started that program, people were starting to say, you know what, I get it [00:12:00] now. I understand how I connect with patients.
And they were also saying, I understand what it's gonna look like. And they would get excited and it, we went from having. A pilot is a punishment, you know, kind of mentality there because it's like more stuff you're just adding on their plate here. Do this too. Do this too. And by the way, stay on time and don't let your budget go crazy.
Right? Um, but here have another helping of this. Um, they went from that too. Hey, you know what? I think this would be good for my study that's coming up. Or this could help patients in what I'm doing because they saw the value, they saw the impact, and now we were having people, volunteer to do these things, um, because of this incubation period we were putting in.
And with it being outside of a clinical trial, you can do it much faster and you can make changes on the fly. So we would practice in a way with the people in the organization, so they would. That hands-on feeling made a big difference. It does go back to what you were saying, [00:13:00] Maya, about having those realistic expectations and understanding and being able, to see what the goals are.
That's all part of it too. But you build champions naturally. For these new ways of working, once they understand it and see the value in it. Right. And then when you go to Pitch for implementation, they're already talking and saying, Hey, I know this is coming up. You should say yes to this.
Maya: It's, it's more like a flow. It's like a natural process instead of as you said, I love what you said, pilot was a punishment. Like, I don't think that, no, [00:14:00] nobody wants to be in, in, in this situation. Um, I was thinking of something while you were, giving like these, these ideas on like the, the intubation period.
I was thinking Okay. What if you have to innovate while you're managing an ongoing clinical trial? Let's say it's not working well, and you are looking to find a solution for a challenge that you're experiencing during the clinical trial. Can you still afford to have these different phases in incubation and implementation, or probably you must have these in to be successful?
Have you seen that before with an actual ongoing clinical trial?
Michelle: So the nice thing about the incubation phase is that you're doing that outside of a clinical trial, which creates this whole pipeline of opportunity during the clinical trial. So then when you're ready to rescue, they've already experienced it. They've already seen it, heard it, thought about it, and then they can.
Kind of pick and pull into their trial. Now, I will say, To have changes in a clinical trial, you have to [00:15:00] remember that's a snowball effect, right? That means you might need an amendment, you're gonna have more time, and you're gonna have to retrain. You have all kinds of other things that come along with it.
Changes during a trial are not, um, easy to do and should be avoided whenever possible. And one way you can avoid that is that third thing about how you can do it. Better. And that's looking for the user's voice during this whole process, understanding what else this is gonna touch and what ripple effect is gonna be there.
So if you have an opportunity to kind of figure that out ahead of time before you get into the clinical trial, you can make a change and not affect as much as if you have to make the change during the trial. It's not nearly as disruptive to everybody involved.
Maya: So I guess it's all going back to we need to plan clinical trials. We need to take more time to plan clinical trials properly because expecting that we'll figure it out once the clinical trial starts is not a recipe for success. [00:16:00] Uh, like your words. Remind me exactly of that. Um, okay. Let me ask you the question but in a different way.
Uh, I think you partially answered it, but I just wanna see if there are maybe. Like there is another perspective. Um, this time I'm, I'm interested to learn which are these common mistakes that we make when we are integrating new solutions.
Michelle: Yeah, I think that we underestimate the amount of support that's necessary at the beginning of the process. Um, we think that if we understand it as a team who is gonna be rolling this out, everybody else must understand it. And that's not the case at all, especially when we are doing something that's a new way of working.
And think about that for all of your users. You have these medical professionals having been on the site side, I was, I'm not a doctor, I'm a nurse, but. Even as a nurse, I'm in front of a patient and they view me as somebody who has some kind [00:17:00] of connection to their life, not just like, you have a connection to my car, or you, because you're gonna sell me a car, or you're gonna work on my car.
You have a connection to my life. So this is important to have that relationship and I need to feel comfortable and look like I'm smart when I'm talking to these people about what. Is gonna happen in the clinical trial. If I don't understand the clinical trial as a study coordinator or as the PI fully to be able to answer their questions, that's a problem.
So we always work hard on the site side to fully understand that. But now you add in technology to it or you know, something where, I might not have been a techy person before. I might not have needed technology to do my job as a regular nurse, but I might now be asked to do all this new stuff with technology.
I need to make sure that I'm getting enough support so when I get in front of that patient, I still have that same relationship as somebody who knows what's happening when I [00:18:00] talk to them. So, Understanding the amount of support that's necessary for all the different users to feel comfortable in doing it is a big thing that people miss out on a lot.
Maya: But you've, you've experienced that thanks to being a part of a big pharma company at the end of the day, and I wonder, like everything you're saying, it feels like you have to have a separate team that constantly thinks about innovation and change and overcoming challenges.
But what, if you're a part of a smaller organization, like do you think there are some? Quick fixes or I don't know, other ways for a smaller organization to still achieve this, this, I dunno, level of innovation or let's leave the innovation aside of the word, but just to kind of like overcome your problems.
Michelle: I think you can approach it. In any size company. I think you can think if you're intentional, when you start and you create, make a user voice strategy and already have something in place, [00:19:00] make a change management strategy, and already have something in place that you already are gonna be talking about these things, those can just become part of your, culture at your company.
That we have innovation, that ha we care about our user voices, and that we are asking these things as we go along. It doesn't require a big, huge, separate group to do these things, right? So those things can be done regardless. Um, if you're not talking to your users, there's, there's also different ways.
Sometimes people say, Hey, I can't talk to a patient directly. I might be a data manager. I don't know how to talk, to the patients to understand what they're going through. Um, and I used to have my teams watch TikTok videos or YouTube videos because people will blog or vlog about them. Their condition and their life to understand better what they're going through.
And then you really think about, I'm gonna ask 'em to do what in the schedule of events, on top of having to deal with that in their lives. You know, sometimes having that 30 [00:20:00] minutes to be intentional and think about who you are trying to help here can make a big difference. And if you can't donate 30 minutes once a week into connecting with your users, You know, that makes me question a little bit about why you got into the job that you're into anyways, right?
Maya: Yeah. They start with why, why you're doing this, uh, why do you need the change? Like, starting with why that's Simon Sinex like, At least that's, that's how where I read it first. Yes, exactly. I, I just love that. And I think we should more often ask this question, why do we do that?
Why we are doing what we're doing? Why are, why we're in, in this, let's say role company, and so on. Um, and what you now mentioned about speaking with the users in general, with the patients, the consumers. Whoever, however the sites like the doctors, et cetera, et cetera. Um, I think it's, um, it's really important and it reminds me, uh, a few years ago we were part of, uh, one of the top [00:21:00] accelerator programs for, for, for startups, and they kept reminding us how important it is to have this North Star metric. To define this north, north star metric, which is the, like, the ultimate metric that will speak about your, your success, your growth, your progress. So, um, like in our cases, like a couple of things, but the users basically how, how happy they are, are they growing, uh, in terms of like how much they're benefiting the, the ba the value.
So I think when we speak about clinical trials, it's about really, uh, the patients. I would also say the investigators, Um, satisfaction because they have to work in a partnership in a synergy. And if that synergy does not exist, then there is something wrong. And you are right that no matter the size of the company, you should find ways to measure that, to have a feeling.
Um, Your clinical trials, how are they, um, building or the other way [00:22:00] around the synergy between patients and, and, uh, and investigators and what they expect and, and require. So, so thanks for reminding me about that. And I have a last question because, um, I, I work closely with a lot of other, let's say, um, change-makers in the industry.
Uh, we've all faced a lot of challenges speaking to, different teams and, different companies. And we want to let's say, integrate our solutions. So any advice, on how can we bring our solutions to the industry? and how can we bring impact?
Michelle: So I think one of the biggest things that I noticed when I would have solution providers come and pitch to us in the innovation group is that. There were probably great ideas and great solutions, and they were poorly executed during the pitch. So one [00:23:00] of the reason for that is not understanding who you're talking to and what they care about.
I have something that I call the high five, and every pitch should be able to talk to this High five. Your high five is your decision-maker It's the person you want him to. Give you a thumbs up, yes, we're going to put this into our trial or our company. you're going to have the budget holder who wants to feel like they're number one all the time, right?
And then you have these three over here, and those are your key influencers. You want them to say, okay, to the budget holder and the decision-maker right? And you need to think about who, based on your solution. Who are those influencers? Who are the ones that probably are going to be touching it or having to work with it?
They might not make the decision. They may not make the budget, but if they don't like it because they're gonna have to work with it or they don't understand it, it's not clear to them, you are not gonna be able to move forward. So, Sometimes we would have people come in and they would pitch and they'd only be focused on one area [00:24:00] and the rest of these people would say no to it because they don't understand it well enough.
It wasn't clear, they didn't see the value. So really understanding who that is for each company that you're going and pitching to is important. Um, and different companies have different roles, so, You know, why should it be easy, right? Everything's complex in this world. So really trying to understand that piece is a big thing.
But the better you can talk to understanding the user understanding, um, the ability of what they're looking for. Cuz some people are gonna want data, some people are gonna wanna know. The people element behind it, some of them are gonna wanna understand the logistics and the timing of it. So being able to talk about all those things in your pitch will make a big difference.
So that just gets you in the door, but the relationship that you have with that other company is what seals the deal. If you cannot respond quickly if you are not authentic and be able to say, you know what? Yeah, we could do that, but we haven't done that before and we're not sure, you know, we'd have [00:25:00] to learn together if we want us to do that with you.
You know, be authentic. We appreciate that. We know not everything has been done. but it's much better to do that than say, oh yeah, we can do anything. tell you how many times someone told me that they could do it, and it's on their roadmap, and they turned around and they probably wrote it on the roadmap and like, Hey, can we do that?
Do you know? So, That's a big piece of trying to get it into these companies. Um, and then just being able to say, Hey, we're gonna work together and share when things went wrong before, how did you get it to go right Beforehand, I had companies tell me, oh yeah, this happened, and three other companies, we hit the same problem.
Why didn't we talk about it beforehand? We could have come up with an idea of how, if this happens, what we can do about it, not wait for it to happen a fourth time, you know? So, You know, a lot of that makes a big difference to get things into companies, but also it's surprising how long it takes at a pharma company, and I see all these solution providers feel bad.
Like it's their fault. [00:26:00] It's not, you have to jump through our antiquated. Procurement, you know, rules and regulations. When you get through that, then you have to find a match for a study. And that's the hardest part because if you don't match to the right study that is gonna help you and set you up for success, it's not a good thing either.
And sometimes the right study doesn't start for a year, and that's another piece that you have to understand. You know, that. It might take a little bit of time and might not happen right when you want it to happen, but once you get there, it's gonna be worthwhile. And yet now you're moving and then that first thing that you do, making sure that it's the best you can do, and it's, you know, as helpful as possible during the process, sets you up for success going forward from there.
Maya: Okay, so change makers. Make sure you speak with all the right decision-makers, not decision-makers. Users and influencers. Make sure that you are ready for goal development versus [00:27:00] we know it all. Be transparent and be patient as well, because, at the end of the day, it's about the right timing and the right processes with the company.
And, I love the idea of co-development and we've learned a lot that way. I mean, if it wasn't for co-development, um, yeah, so I, I, I'm a true believer that this should be the way, because like you said, you don't know what's. What's happening and like, especially with big companies, you know, best what, how you work and how you function in different roles and how things are being done and why they're done.
Like, sometimes they don't make any sense from the outside, but inside they make a lot of sense. So Michelle, thanks very much for, your time today, and for these insights. I wish there are more bridge makers like you, not just changemakers but bridge makers because we need people to translate to the two worlds, how we can make change a reality because change doesn't make any sense if it doesn't really [00:28:00] bring any value at the end of the day.
So thank you very much for what you're doing and thank you for sharing, your know-how with us.
Michelle: Thank you so much, Maya, for the opportunity. Have a great day and I'm excited about what you're doing as well.
Maya: Thank you, Michelle.