Heart of the Trial

Season 2, Episode 2: Designing Trials that Actually Work with Dr. Noah Goodson

• Suzanne Turner • Season 2 • Episode 2

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Designing Trials that Actually Work—with Dr. Noah Goodson

What happens when you approach clinical research like a scientist, a strategist, and an entrepreneur—all at once?


In this episode, Suzanne sits down with Dr. Noah Goodson,  Principal, Strategy & Advisory  at THREAD, to talk about how smarter study design and better technology can dramatically improve trial execution, patient experience, and data quality. Noah shares how he went from retinal neuroscience to rethinking decentralized trials—and why the best clinical strategies are rooted in empathy.


We talk about:

  • What endpoints really are and why they matter
  • Common design missteps (like forgetting who’s actually entering the data)
  • How innovative sponsors are boosting recruitment and compliance
  • Why protocol isn’t enough—you also need a plan that works in real life
  • Advice for newcomers trying to break into clinical research

📘 About the Guest:


Noah Goodson, PhD
Principal, Strategy & Advisory


Noah Goodson, PhD, is the Principal, Strategy & Advisory at THREAD, a leading eClinical technology solution for eCOA and Decentralized Trials. He designs and deploys clinical trials that work for every user, ensuring studies are accessible, engaging, and deliver high-quality data. 


📍 Connect with Noah
 LinkedIn:https://www.linkedin.com/in/noahgoodson/



📞 Connect with Suzanne:

💌 Feedback and Questions:

  • Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!

SPEAKER_02

Hi, I'm Susan Turner, and welcome to a podcast delving into the personal narratives within the clinical research industry. Through candid interviews, we'll learn about the personal journeys and motivations of individuals who have chosen this profession, what I like to call their why. This podcast is not just for industry insiders, it's for everyone curious about the human side of healthcare. Beyond the industry's negative reputation, we'll shed light on the dedicated professionals behind clinical tribes. Join us as we uncover the heart and passion of those working tirelessly behind the scenes in clinical research. Welcome to Heart of the Trial. Hello, lovely listeners, and welcome to Heart of the Trial, where we dive into the human side of healthcare, highlighting the voices often left out of the spotlight. I'm your host, Suzanne Turner, and in this episode, we're joined by Dr. Noah Goodson. With a PhD in neuroscience and a passion for transforming outdated clinical research practices, Noah brings a rare blend of scientific rigor, entrepreneurial drive, and human-centered thinking. We dive into the art of designing smarter trials, the power of technology to reduce patient burden, and why innovation starts with empathy. I hope you enjoy. And until next time, stay curious and stay compassionate. Hi, Noah. Welcome to Heart of the Trial.

SPEAKER_00

Hey, happy to be here.

SPEAKER_02

Why don't we start by having you tell our listeners what it is that you do?

SPEAKER_00

Yeah. Uh well, first of all, thanks so much for having me. Delighted to be here today, have a little conversation. Uh, it's always um people always love talking about themselves. So it should be great.

unknown

Yeah.

SPEAKER_02

I'm sure it will be.

SPEAKER_00

Uh no, I'm uh I'm Dr. No Goodson. I'm a principal of strategy and advisory at Thread. Uh and that sort of vague title um practically means that I work on both uh strategic components, both for our company and for our clients. And I work in advisory services, which is really just basically consulting. So um I I like to tell people like my job is is kind of like a triangle. And if you imagine like one third being like a sort of McKinsey consultant, one third is like building a business and being an entrepreneur, and one third is being a scientist. And then you're always sort of rotating in some combination uh between those three uh three different kinds of segments of of work. Um uh so, so uh work might involve doing a podcast now, but um I think more often than not, um, we're working with clients on how they actually design their clinical trials and how they uh take their endpoints that they need, the actual data they want to collect, and pair that with pragmatic considerations around the people that are in the trial and the technology that's available to actually uh uh bridge between the people and the data you want to collect. So, how do you how do you string together a study that actually makes sense and works for everyone involved? Whether that everyone is a data manager, whether that everyone's a principal investigator, and of course, critically uh the track and the the experience of participants within a trial so that we can we can maximize engagement and retention uh so that folks actually stay involved, the data gets collected, and we're able to make conclusions about safety and efficacy of medication or uh medical device.

SPEAKER_02

So when you say like endpoints, are you talking about like the results that they're hoping to get out of this trial? Like so that it cures the cancer or that it um improves someone's blood sugar or et cetera.

SPEAKER_00

Yeah, exactly. Um these are there's a bunch of there's a bunch of language in the clinical trial space. Uh endpoints is one of them. Endpoints basically is a is a fancy way of saying the data we're trying to collect. Um so there are and there are lots of different kinds of endpoints. So you can imagine um uh in a cancer trial, there might be a scan to see if the tumor has shrunk and how much the tumor has shrunk is a very easy one to imagine. Okay, the tumor is 30% smaller or the tumor's gone away. Now we know that there's there's an effect. Uh it could be it could be blood work. Hey, you had this marker before, now you don't have it, or you you didn't have it and now you do. Um, but there's also kind of uh other endpoints uh called uh clinical outcomes assessments um or electronic clinical outcomes assessments, which are ECOA. And those might be those might be softer things. It might be like, um, do I did I did I get more sleep or less sleep? Do I feel better or more energized? Um, what was my experience like? Um and all the things you see when it when a drug gets approved to market, or if you see drug marketing, those all derive from the endpoints. So when you hear it may reduce your risk of this, that's because an endpoint said, hey, your risk of this went down. And when you hear the side effects, those are also collected in a trial, like may cause uh nausea or or vomiting or whatever, whatever wonderful list of side effects. Those are all things that were collected as part of the trial, whether they're actually endpoints or whether they were adverse events, bad things that happened uh as a result of taking a medication.

SPEAKER_02

Right. And how do you um so so pretty much you're helping, let's say, a sponsor develop that. So they come to you and they're like, hey, we want to do a trial that reduces this, and you help them design every piece of that from scratch.

SPEAKER_00

I have I have done that in the past. I at this exact moment, I'm not usually doing that. In in a trial, in trend clinical trial design, there really are a lot of different folks involved. So you can think at the very base level, right? You need you need clinicians involved, people who understand what the disease state is like and can help say, hey, to test that this disease is changing or improving, we need to pick these clinically relevant uh pieces of data. We need to know in the cancer case, right? Like whether it's blood markers for it or tumor size or spreading or all the other kinds of things you would you would want to test for. So you start with that really clinical perspective. Um there's a team that I work uh closely with here uh that are patient-centered outcomes research. And so they really do help select um and create, even create new endpoints. So let's say you're studying a rare disease and you need to decide what kind of questions do we ask about how this disease is working. You have to actually go and create a validated um kind of survey to say, hey, uh in this rare disease case, these are the kinds of questions we have to ask to make sure that we're from baseline before we give them the drug to after we've given them the drug or whatever else, there's really a change that means something in this specific disease that really means that their life experience has improved in some way in this case. Um so I work closely with those folks, but oftentimes I'm a little bit more at really the practical end of implementing a trial. You've got a protocol, it's mostly together or it's it's largely together, and you're trying to figure out how to execute that. And you're uh the company I work for, the role I'm in is at a company that's a technology company. And so you're trying to integrate the technology with all the other people who are involved in the study. So you because you've got you've got your nurses, you've got your doctors on site, you've got your participants. Maybe the study has some remote aspect to it, or maybe it's all occurring on site. And you're trying to make all these kind of um almost tactical decisions on how you execute against collecting that data effectively. And that's that's really the piece that um I probably work in more often these days.

SPEAKER_02

That's amazing. So that's a lot of moving parts. How how did you get into that? Like what what what was your pathway that led you to this? Because that's that's a lot. That's a lot of things.

SPEAKER_00

Right, right. Well, if my if my job title sounds made up, it's kind of because it is. I mean, roll roll roles like this are just they're they're they're they're very, very important, but they're also like, there's not like a like a totally linear career path. Um there are, I think, very d denoted career paths within clinical research, especially at organizations like clinical research organizations, CROs, um, where you you know become a project manager and then you become a project director and you kind of work your way up those ways. That was not the path I took.

SPEAKER_01

Um yeah.

SPEAKER_00

The so I was, I guess, I guess it probably it probably starts my PhD. I was doing my PhD in neuroscience and was doing sort of basic science research on on retinal development, um, just really in the weeds, you know, with mice and everything like that. And I had looked at going to medical school really seriously and ultimately decided for my life that I didn't want to uh be in school for another decade roughly between that and my so I was like, I think I I think I need a job. Um, and I I I I felt at the time, even though there's a lot I loved about academia, I wanted to do something a little bit with a little bit more, I think, variety and flexibility and dynamism. Um so and I had some connections through my my through my university uh uh at the University of Colorado um or Ansha's School of Medicine. And uh they had they had some programs there related to clinical research. And so I got involved in one of those programs and really got my my kind of kind of dipped my toes in to the clinical research space. And when I did, I realized um, hey, this industry is really a pretty cool space for your career because there's there's tons of latitude for different kinds of jobs, and there's a huge range of roles from from jobs that have become very, very stable, and you can work from home and you can raise a family, and you can you you still work hard, but you can create a very stable life all the way up to like you want to be the CEO of a Fortune 500 company, like you have that career potential if you want to follow that path, or you want to be an entrepreneur, you want to create businesses. And I think that I I was attracted to that. Was one of the things I was attracted to was the latitude of career potential uh in this industry, I think is quite quite broad.

SPEAKER_02

Um, and kind of rare, yeah. Like you don't find that in a lot of industries.

SPEAKER_00

Totally, totally. Um, the second thing I was really interested in. Excuse me, I gotta power up with some coffee here. Uh the second thing that I was that I was really uh really interested in is that I I found the industry to be really antiquated. Um, and I say this with like deep kindness towards a clinical research industry. Um but but even from a technology perspective, from a design perspective, when you look at the experiments we're doing and you just take a purely scientific lens, they're they're really easy. Like the stuff that people are doing in labs every single day in terms of experimental design complexity is wildly more complicated than even the most complicated clinical trials. However, it's still very hard, and it's hard because you're overlapping a bunch of complicated systems together. So it's not hard because clinical trials in terms of a design, once you learn to read a protocol and you understand, okay, here's a here's a in protocols, there's always something called a schedule of events or a schedule of assessments, right? And the a protocol, by the way, just in case your listeners don't know, a protocol is what every trial is run on. You have to write down before you do the study exactly what you're gonna do, exactly when you're gonna do it, exactly how you're gonna do it, and then you have to and how you're gonna analyze that data in the end. You can't just make it up later or just randomly collect stuff. You have to have a very specific plan that gets approved to be uh safe and appropriate to do on humans.

SPEAKER_02

So then you can't deviate from it.

SPEAKER_00

You cannot deviate. In fact, if you do, you have to fill up paperwork.

SPEAKER_02

Yep, a lot of paperwork, and uh you gotta notify all the proper authorities. Yeah, I've I've kind of told the listeners before it's almost like the Bible to a study. Yes, exactly. You follow it. Yes, right. Thank you. Yes.

SPEAKER_00

Yeah, so so in a protocol, if you open a protocol, when you open a protocol, what you see is is a usually a big PDF or a Word document, and it's like somewhere between 85 and 175 pages.

SPEAKER_01

It's very vague.

SPEAKER_00

But there's and there, there's everything in there is kind of important to some degree, but there's really some central pieces you can look at, which is who you're doing the research on, what the endpoints are, what the data you're trying to collect is. And one of the best ways to kind of see what a protocol is gonna be is to go read the schedule of assessments or schedule of events. Now, what that is is if you imagine there's a there's a grid and there's there's dates across the top that might say like uh screening, uh enrollment, baseline, visit one, visit two, visit three, through whatever. And then there's everything you're gonna do in the trial along a column on the, if you're on a screen on the left-hand side of your screen. And then there's kind of usually X marks beside what days you do that thing on, right? So let's say we'll go back to the example of a cancer study and we're doing an MRI screening. You're gonna do a MRI screening at your screening visit, you're gonna do it at baseline, and then you're probably not gonna do it every single visit. You're gonna do it once a month or something. And so that's marked in your uh in your in your protocol. Um so when you read these though, there are a lot of things you're doing because you're doing all these tests on people, but they're not actually that complicated and they're pretty standardized in how they're structured. And once you've learned to read a protocol, you can kind of go to any protocol anywhere in the world, and you pretty much know what they're doing in the trial. You might have a question about a specific assessment, like, oh, how's that, how's that done? How does this neurological test work in the doctor's office? But you can you can pretty much understand what's happening uh in the study. And they're they're not that complicated, but deploying them and implementing them and doing them the right way effectively is really hard. And what that's resulted in is an industry that's super, super behind other analogous-regulated industries, um, particularly from a technology perspective. Um, and so for me, coming into this, I was like, okay, I think there's a lot of opportunity there for innovation that makes a difference because it being antiquated is not non-trivial. It has real side effects. It adds time, it adds money, it makes it worse for people involved in the trial. It makes worse for the people that are running the study, but most importantly, it makes worse for people who are in the study, who are oftentimes already sick, already having a hard time, already taking care of a sick child that is so sick they're in a study for an experimental medication. Like that's a tough situation to be in. And then to have annoying paperwork or technology that doesn't work or having to go into the doctor's office super, super, super frequently. These all add to burden and make it worse for folks. And that that not only is bad for those folks involved, but it slows down the process of drug development to be able to get new things out to market that are safe and effective, or quickly realize it's not going to work and put that money somewhere else. So I think for those reasons, these kind of vague phrases like be patient-centric or or these kinds of things, they actually really in practical terms, when they're implemented effectively, what they do is they speed the process of developing new medications, which is not about pharmaceutical profits for me. It's about actually getting life-changing things to market for people who have no hope or whose lives are going to be meaningfully improved uh by uh by by these uh sort of uh new available treatments.

SPEAKER_02

Yeah. And do you do you feel like you've seen that change? Like that's what made you want to come into it because the change needed to happen. It needs to be updated. Do you feel that you've seen that?

SPEAKER_00

I I think it's been um uh do I think that I've seen that? I think that in some ways we're making progress. Uh it is it is really slow and it's really challenging. Um there are real kind of fundamental drivers of why that's the case uh in the systems that are in place, but also in the um incumbent uh companies and organizations that have power and have money and have a vested interest in how the industry is currently structured because their corporate profits or whatever else depend on it. And so it takes a lot of work to uh drive forward changes that really require a different approach to systems. Um, because yeah, so so I think in some ways we're making progress, in some ways it's it's a it's definitely a frustrating slog to try and push real differences, uh, particularly when there's economic headwinds because people feel less risk, they're more risk-averse. They don't want to try new things, they want to do something that's always been tried and true.

SPEAKER_02

Yeah, under that's understood. And um do you do you think like this actual systems, physically the systems, like the data management systems, the electronic data capture systems, like do they have a lot to do with it? I feel like I've noticed some improvement in the industry where um companies are they're they're thinking about making these things work together better to make things more efficient. But do you feel like you're seeing stuff like that? And if that if that's one of those main hindrances, yeah.

SPEAKER_00

Yeah, I mean, I I like I currently work at a company and I'm there because I I really believe in the mission of that. And that company is all about uh collecting data within studies and trying to put it together in in one system as much as possible. Um I'm not I'm not pitching my company, no. I'm just for context, uh, we provide a software in trials that uh can collect data. So that could be collecting data from participants or from research sites. Uh, you can do telehealth calls, so think of video call with your doctor, but it's it's measured, it's inside the same app system. You can sign your e-consent. So everything you have to consent to in the trial, you can sign that electronically. All of those pieces of data capture, maybe you get reminders and alerts, like you get a reminder, hey, don't forget to fill in your food diary today. And then you you in your app and you open your app and you do your food diary, and then maybe instead of going into a site, you do a video call with your doctor. Uh, maybe you're wearing an Apple Watch that's picking up your heart rate, like all of those things integrated into a single uh system is one of the ways that we're trying, and it's only one piece of the pie, but it is one of the ways trying to to push that forward so that there's there's more optionality in how you actually deploy and design your your studies. And so as a participant, you're having really ease, you're not having to manage, you know, keeping up with paper or submitting things like this, or or ideally you're also reducing the number of times you actually have to go to the doctor so that you can resist people, like people don't want to participate when they have to go in all the time and they're trying to work.

SPEAKER_02

Yeah.

SPEAKER_00

Absolutely.

unknown

Yeah.

SPEAKER_00

Yeah. So I mean, absolutely trying to make a change. And I think that compared to you know, pre-pandemic uh world, I think there's a lot more broad acceptance because people do it in their everyday life. Like when I go, if I'm gonna go to the dermatologist or something, ideally I'm gonna like shoot my doctor a message and have a video call and not have to go in unless it's really serious. And I think as that primary system of the primary healthcare system, how people engage with that evolves, there's more space for the clinical research to have kind of analogous uh functionality and features, and people are used to it and they feel safe and good about it. And so um I do think that there's there's there's definitely there's definitely an evolution that's happening. It's just it's just incremental versus uh sort of being um monumental or I don't know, some cut something like that.

SPEAKER_02

Yeah. And um so so that's what you do in your day-to-day life and how you got there. So what are your what are your goals moving forward? So is it just to continue this innovation? Because you also, um, which we haven't brought this up yet, but you actually have a podcast as well.

SPEAKER_00

Yeah, I I did. It's on it's been on pause for a while, but I've had a couple of I've run two different podcasts in the past um that were a lot of fun. So yeah.

SPEAKER_02

Yeah. So is so what's your next steps with your career and your goals within the industry?

SPEAKER_00

Yeah, I think that's a great question. I I think for myself, um, one of the things I found that I really enjoy is I really enjoy um uh building businesses and taking them uh from one space and putting in place the systems and the culture and uh the values and innovation and and kind of creating a team around that that that thing can collectively go out and do a lot more than I can do on my own. Um so I have a I have a real joy and passion for that. Um and I will probably continue down a path of trying to help organizations grow uh and so that they can better serve and and drive innovation uh in this space. Um I'm not necessarily stuck in the technology space. I think I'm that's where I am right now. Um and I think there's a lot to do there. But there's other service aspects of this industry that I think have a lot of potential to um also advance and uh innovate how we how we serve uh to make to make trials really for me more uh easy to access for everyone and more inclusive that anybody who wants to participate, regardless of where they live, regardless of their socioeconomic or uh other sort of background, they're able to participate.

SPEAKER_02

Yeah. I love that you're doing that because something that um for any audio any of our listeners that may not be aware is something that you mentioned about the protocol is they you they have to. Say who they're trying to help. And they have parameters outlining who can be in a trial. And these things have to be taken into consideration. If someone's struggling financially and they work a nine to five job, getting in to these visits is difficult. So being able to spread that to areas outside are the most convenient. Because not only that, but um these investigators are spread out like let's just take the US, for example, they're spread out all over the US. Right. So it could be three states away is the closest doctor who's participating. So I love that you're you're really aiming on trying to improve the accessibility to patients because that's who we're trying to help at the end of the day, right? Right users.

SPEAKER_01

Yeah.

SPEAKER_02

So um so kind of in line with that, though, it sounds like you definitely intend to stay in this space. Like what is your primary motivation of staying in the space? What's your like, you know, what gives you the good feels and keeps you going?

SPEAKER_00

Uh yeah. I mean, I think that like if you if you come into clinical research, anytime you're gonna be if you're if you're looking at this industry, anytime you're gonna be dealing with something that is complex overlapping systems. And when I say that, there you think like there's a pharmaceutical system, there's the what the investment markets are like really impacts our industries. What the currently, let's say, um uh, how do I say this nicely? There's uncertainty at the FDA and other important organizations. Um uh the healthcare systems in not only the US but globally, and how those are functioning and how they're working for people, um, all of those pieces together actually end up impacting your job uh in really meaningful ways, kind of no matter what you do in this industry. Even if you have a very internalized job as a data manager or something, right? Like you're still gonna really be impacted by this um environment. And so you do kind of need some sense that what you're doing is valuable because a few roles in this industry you get to work directly with patients, but a lot of them, you actually never see the people that you're helping. Um I think for me, there are probably layered motivations. I think I believe in the sort of large vision of what I'm trying to accomplish to um to make trials faster and cheaper and more accessible to everyone. I think that mission is like very motivating to me. And I I personally just made a decision I was gonna work in this industry for at least a decade and then kind of check back from there. So I'm like halfway through that. We'll see, we'll see where I go from there.

SPEAKER_02

Yeah, that's amazing.

SPEAKER_00

Um I I think that like that that sort of just personal commitment for me is like part of just like, hey, I'm gonna give this a run and we'll see, we'll see where we go from there. Um, I think that I like enjoy the work that I do though. Like I really like I I like I like the teams I work with. I work with really, really, really amazing people. We have super, super cool clients uh who are trying to really push forward things. And there's there's definitely frustrations, there's definitely challenges, but the overall of it is a lot of fun. You're you're taking thorny, difficult problems for people and you're really solving them. And you're making it, you're making it easier for folks who are stressed out in their job or stressed out trying to launch a trial to actually do that. And um, and then it's it's going out in the world and the data is getting collected and and and I think for me that's that's that's pretty rewarding. Um that's amazing, you know. Yeah.

SPEAKER_02

That's fantastic. Do you run into um you know, you've mentioned some challenges. What what are some of the challenges that you do run into working with these sponsors who are trying to do these trials? Like, do you find they're more financial related? Are they usually um resource related? Like, what do you find is kind of the trend?

SPEAKER_00

Well, I think I think on a case by case, every every kind of interaction is going to be difficult. I mean, sorry, not difficult. Every action is gonna be different. Every action is gonna be different from each other. Um, I think one of the things that's um sometimes hard if you're working with a very large organization, like a large pharmaceutical company, is that um the power, understanding the power structures there can be really dispersed. And sometimes it's hard to know how to get something done. Or you need you need like four different teams to all align, but they all kind of have their own motivations. And this is just a fractal, this is a fractal, like is an impact of um large organizations. It's not unique to our industry, but sometimes it can be uh it can be it can be frustrating to to want to move at speed and to not and to have to take a long time to get everybody on board to be able to do that. Um, I think another challenge that I find in this industry is that um uh sometimes there is um there's a tendency to be a little bit regressive if you're scared. And uh somebody said it like this. They said, well, nobody ever got fired for a trial failing by doing things the way they've always been done. But if you try something new and it fails, you might get fired. And so I think that that's that's a gross generalization that's not totally true. Yeah, and it certainly depends on the organization, but sometimes it can be hard to get folks to innovate because it's easier in theory for them to do their job by just doing it the way it's always been done. Um and if you just do it the way it's always been done, you're not gonna get a different result. Um I I think that those those are two things that I I sort of am navigating on a daily basis. Um, they're not insurmountable, they're just the realities.

SPEAKER_02

Yeah, I think that's that's fair. Um, one of the things I, you know, as I I work my way up into management that I learned, and I'm sure a lot of people have heard that have heard this, but the the whys, you know, like asking why until you get to the point where you can't answer that question. But usually when when people are like, why are we doing this or why is it done this way? The answer is just that's how it's always been done. Right. It's how it's always been done, and no one has bothered to question it. Um and do you do you challenge individuals when you run into that? Do you say, okay, this is why it's supposedly being done because it's always been done that way. But is there a regulatory reason behind it? Is there is there something actually backing it up?

SPEAKER_00

Yeah, I mean, I think that's like part of my job is to challenge that thinking in folks. I mean, I wouldn't say it's very direct or confrontational. It's actually usually more invitational, like, hey, look, there's some options. And actually, if you look at the regulations, here's what it actually says. So you can you can you can make a decision. There is people have done it this way, but actually, regulatory-wise, you only need to do this. So it's up to you how you choose to proceed. Um, I think that's that's part of being a consultant, is you try to provide people with, and I don't call myself a consultant, but in that role, I am consulting with people. Right. Is I'm you're you're providing people with the best information possible uh so that they're empowered to make decisions. Um and and you're not really making decisions for them. Um, so I do think that challenging folks' thinking and assumptions is a big part of that. Um, I think across the board though, it's this it's just all one big practice of empathy. It's about understanding, it's about understanding when navigating these things, it's like understanding the patient's need, understanding why a person at a research site is frustrated because they have 12 different logins for 12 different trials on 12 different softwares, and why that's hard for them, and why doing something one way or another actually makes their job better. Understanding their workflow, understanding how to make it easier for them when you when possible, understanding that the person trying to drive innovation at the pharmaceutical company is not like some evil person or some like they're they're not being difficult on purpose. They're difficult because they're maybe their job, and actually, most of the people I work with in pharmaceutical companies are, by the way, lovely, amazing people. So this may be a bad example. But my point is my point is there, there's there's reasons why folks, whether they're inside your own company or another company, are behaving and motivated. And the more you can understand that, and the more you can kind of have a practice of empathy towards their life and why their job is difficult in one way or another. I find it a lot better, easier than to go to them with solutions that let you help them be successful and make you allies versus um sort of being like, well, why can't we move faster? You know, whatever.

SPEAKER_02

Um clashing priorities and goals. Do you get to work with um sites a lot directly? Like actual talking to the the sites and um their needs.

SPEAKER_00

So I work some with sites. I don't work a ton with them. I've done like a lot of like site trainings and things. These these particular days, I was doing more of that maybe a couple years ago. Uh these days I'm working less directly with sites. Um, I do have a lot of friends who are running site networks or doing things like that. So I do think like I see I see sites from that uh perspective. Yeah. Um, but I'm not uh I'm no longer going. I mean, when I started out, I was like in a site, like in visits with collecting data, you know, in my PhD, like getting to be part of kind of alongside of what was happening in trials at a very fundamental level. Um yeah.

SPEAKER_02

Yeah. I mean, you were literally at the ground level of it.

SPEAKER_00

Yeah.

SPEAKER_02

And so you were able to gain a lot of experience just by how um the site was being interacted with, then and take that into personal account.

SPEAKER_00

Right. I mean, I think it really helps you imagine, you know, we talked about we talked about earlier at the beginning, we talked about that's that schedule assessments or schedule events, understanding, having been on the ground with a site and know what it's like that that person's sitting in a waiting room for 15 minutes and then they're sitting in an office for 30 minutes, and then people are coming in and out, and the person's coming in, different people are coming in. What is it like to actually be in a doctor's office with this? Because it doesn't look like X is across a Excel spreadsheet. There's an actual experience that's happening in a staged way. Like, oh, wait, when you get that MRI, you have to go to a totally another floor. So that person's gonna have to go to another place, they're gonna have to wait in a different waiting room, they're gonna be checked in by, you know, like what is that actual experience like for people? Um, regardless of who that person is, that's I think at the core of being able to innovate in systems in a way that actually makes a difference, is you understand why uh what it feels like to be in that person's shoes, or you can at least imagine it in a visceral way. Um I find that that drives a lot more pragmatic solutions than sort of this hand-wavy idea of well, we throw technology at it or we just make it this way.

SPEAKER_02

Right. And have you actually, while working with um any of your clients and stuff, have you I'm just curious, you know, if you've said this to them and any of them actually almost been shocked, like, oh, I didn't I didn't think about it from that aspect. I did never imagine myself in their shoes.

SPEAKER_00

Um I I definitely think there's been there's been uh instances where a client hasn't fully thought through uh the implications of something. Um like a great example would be a study that had um uh like like pediatric patients and had young pediatric patients where they're not gonna really have their own phone, then had older pediatric patients that were um, you know, teenagers. Um and there are times in trials where when you have those young pediatric patients, the caregiver, you know, uh is the one who's actually getting the data. Yeah, mom or dad, whoever is the one that's actually putting the data in, right? So they're saying, you know, they slept this well last night or they had these, you know, they're filling out maybe a survey on their phone. They're providing that data for the study about the participant. Um, but then you have to make a decision down the line at what point do you go from the caregiver collecting the data to the participant collecting the data? And so I there was there was, I'm just thinking of one study right now where it's like very obvious where they hadn't this this just client just hadn't thought about like, wait a minute, do I expect us all 16 and 17 year olds to have their phones, or do I expect the caregiver to still be the one doing it? And understanding the disease condition and the countries you're going to and is like, and also what does that mean for your data if it's the caregiver reporting it versus the participant reporting it? Those kinds of like, because in do you switch if they're 15 at the beginning and then they turn 16 in the middle? Now do they get the they now that does it switch from the caregiver to the parent, or do they stay where they were at the beginning? And it's easy to kind of write all that stuff down on paper, but even that pragmatic handoff of well, who's who's having who's actually entering the data on their phone? Is it the caregiver or the patient at what age? Those kinds of things, I mean, that's a very, very simple example. Um, but I think those kinds of things are really um the types of things we try to help clients think through. Yeah. Um, and maybe that's a little over-the-top example, but it is a real one that happened.

SPEAKER_02

Yeah. Well, I mean, sometimes it takes someone being outside of the situation to see something that may seem so I I've had that my experience myself. Like, like someone will say something to you and you're like, that seems so obvious or so simple. Right. But it just takes that outside perspective um to help give you like in your. So it sounds like you're giving them aha moments.

SPEAKER_00

Right. Yeah, yeah. I I think that's definitely, I think definitely doing that. I mean, there's a lot of tools I use in my work with clients um to try and uh that I've kind of tried to help my company at least standardize how we approach certain problems that that make sure that like you don't need you don't need like usually if you if you get the right tooling and processes in place, a lot of times you can avoid having just an expensive expert and only but or you only use them for like set set points in time, and you can instead really have people work through a process together to analyze what the flow is gonna be through a study and where and in the case of my company at least where technology is engaging with the participants and with the research site, so you can make really good decisions because even the best written protocol is not going to contain all of the information you need uh to actually set it up and run it, whether you're a site, a CRO, or or whatever else.

SPEAKER_02

Yeah. So what do you think if if someone were interested in coming into the industry right now and even gearing towards certain areas you're in, how what's your feel on how things are right now? Or do you have any advice?

SPEAKER_00

Yeah, I mean, I think like like like all industries right now around pharmaceuticals and healthcare, I think there's a lot of uncertainty. Uh and that's I that's driven at the the most macro level by honestly by politics and the and the subsequent economics that are interrelated with that. And you don't need to have an opinion on that, but you should know that it is impacting a an industry that is a high-risk industry that has to take long bets. And taking long bets when there's a lot of uncertainty is is very is very difficult, right? Um long, very expensive bets, like five-year $100 million investment in where you don't even know what your regulators are gonna look like in that time. That's a very difficult thing for anyone to do, and that's gonna impact our industry. So I would say that like there's a there's definitely some some hurry up and wait hold in the industry in this exact moment. Um, but I don't think that should I don't think that should get people down. I think if you're passionate about clinical research, there are opportunities in this industry for for you to build a really, really, really amazing career. One of the one of the challenges you'll always face in this industry, especially if you're coming in, just trying to start your career, is that there is a tendency to trade on years of experience in this industry. So rather than trading on skill, actual ability, knowledge, potential, there are a lot of places in this industry where it's just like, do you have five years of experience? Do you have 10 years of experience doing this? And you have to in those organizations, you have to, it's it's more about years in the saddle than how the quality of the riding sometimes.

SPEAKER_01

Yeah.

SPEAKER_00

And so, and that does matter. There are places where really it does super matter. And I'm not, there's no dissing on folks who have been doing this for 20 plus years. It's really amazing the knowledge and experience they bring to the table. But if you're new, it's a real challenge you have to overcome. And so learning how to cross-articulate the skills you have and finding an opening uh is really key. Because once you find an opening and you start getting in with a company wherever it is, it's much, much easier for your talent and your dedication and your focus to help you rise to the top. And I find that this industry is a place that there are opportunities once you once you get in. Um so if you're looking to come into the industry, just try to break in because even if it's not your ideal role, because once you break in, if you're dedicated and you've got the chops, you will find new opportunities quickly to try and get yourself to a place that feels much more satisfying in your career.

SPEAKER_02

That's amazing. That was fantastic advice. I loved it. Okay. Um, I'm hoping you have a fun story that you can share with us. Something crazy that's happened. And working with you know, your different sponsors, of course, keeping confidentiality in mind. Just a fun, crazy story that maybe it's something that shocked you, maybe it was something heartwarming, um, but just has had a lasting impression on you. Um, it's really on the spot, putting you on the spot.

SPEAKER_00

Yeah, well, I think I think like um there are like a lot of sort of fun stories I've gotten to be part of, meeting really cool people, like in my company. I'm lucky enough to work with a huge range of clients. I get to work with the government, I get to work with academia, I get to work with large pharma, biotech, zero, I get to work with a lot of different clients. And so that gives me a huge um range of folks who um are doing really, really interesting things. Um, I think from a like a practical perspective, I think of this one story of a trial we worked on with a large pharmaceutical company. Uh, and this particular trial was a long-term follow-up study in a neurological condition where these folks have a um uh debilitating neurological muscular motor disease, right? Um the the the pharmaceutical and it's a rare disease, so there's not a ton of folks with this. And so the pharmaceutical company wanted to be able to um reach these folks no matter where they are. So some of them are near these kind of centers of excellence, right? Think like major big hospital in a big city where the top docs are. For those folks, they can participate in the trial really in a direct way, right? They can go into the site where the top docs are and they can participate in that way. But um, this client really wanted to be kind of innovative and they were trying to say, but yeah, but we know these other folks are spread out all over the country. How do we get to them? So we work together closely with them. We brought in another partner to be a what's called a central site. And a central site is where there's a principal investigator who is a doctor who's still overseeing the study, but they're able to remotely uh communicate with their participants and they they might oversee participants across multiple states, right? Um, so we used our technology, this our company and this partner we brought in together to help serve the pharmaceuticals goal, which is hey, we know these folks are all over the country. Can we make it so they can join the trial and participate, even though they can't make it into one of these, you know, 17 centers of excellence or 23 centers of excellence, whatever it was. Yeah. And when we did that, what was really cool, there was a couple of really cool pieces of data. As first, as soon as we we rolled that out, they were able to like really maximize recruitment. I mean, there was a huge, huge spike in the number of participants recruited because there were these people who wanted to be in the study, they just couldn't fly to another state, you know, every six months to participate. Yeah. That was the first thing that was cool. And they were able to do that by everything they did electronically. They signed their informed consent, you know, which is agreeing to be in the trial electronically. They had telehealth calls with the central PI with the doctor, and they completed surveys and assessments uh uh remotely in this case. That was pretty cool. The the the so there was there was not only there were there was a it was 7x more effective at recruiting participants uh than the best performing uh traditional sites. You get a lot more participants involved. Yeah, it makes sense, you have a bigger reach, but it was also six and a half times faster, meaning you were getting participants in really, really, really quickly. Um, what I thought was also the coolest data though is when you looked at the compliance data, which is a compliance data saying, hey, are people actually doing the things in the study? Right. And you're trying to measure how much of the things do we want them to do versus what percentage are they actually getting done.

SPEAKER_02

Right.

SPEAKER_00

The folks that were participating remotely actually were 20% more compliant. They were almost basically 100% compliant with the data in this in this particular study, meaning that, hey, these folks really wanted to be part of the trial. They didn't have a way. The sponsor had a really innovative idea. Uh, and we worked with them and another collaborator, and we we together did a thing that meant these participants could not only be part of the trial, but then because they wanted to be part of the trial, they were really good at giving their data into the study and ultimately providing a much better, robust long-term data for this disease condition so that we know that this already approved drug is really remaining safe and effective and having its impact in the long term. So I think that getting to do something like that and see the tail of it, see it go across three, you know, plus years and the results that start coming in is is really, really uh very, very rewarding.

SPEAKER_02

Yeah, that's an amazing story. Holy cow. And you know, that right there just shows why like what your passion for increasing the way the outreach outside of centralized locations is is so important and it shows that it works. that it's doable. And you know, I actually feel like when I was working at the CRO still that um there was a study where they actually had like they hired some kind of nurses or something and actually had nurses going to houses because that like so they were able to do remote and that's one of the ways they made it work is because they still had someone actually physically seeing them versus the patient going to the doctor's office they had a nurse going to their house and doing whatever they needed to do and all. And I just I think that's a really cool concept. And I I hope that we continue to see growth in that way. And the fact that you guys had such amazing data from it is that's mind blowing. No wonder it made an impact on you and was so rewarding.

SPEAKER_00

So absolutely and there's tons of innovative things and it's it's all about balancing what's right for that patient population, what's right for the sponsor in that time and what's right for the actual data you need to collect like you're not going to remotely collect an MRI but you can definitely have a nurse go you can definitely have a nurse go and give a blood draw right you so it's it's it's trying to make sure you balance what's really needs to be important for that patient population for those folks it's specific to them. It's not just a generic uh way of approaching things and and um I think for for those who want to be innovative um there's real there's real opportunity to make a difference in participants' lives.

SPEAKER_02

Yeah yeah I agree with that I feel like this is this is an industry that even if there are antiquated methods or systems like you've talked about there's also a lot of change all the time and having to be able to adapt to those situations. So that's a that's a really great point. But oh this has been a fantastic conversation you've had such wonderful insights and I really appreciate your time today but before I let you go um how can our listeners reach you if they would like to follow you or get in contact yeah I think the uh the best way is probably just LinkedIn.

SPEAKER_00

You can find me on LinkedIn at Noah Goodson PhD so just Noah Goodson on LinkedIn. I think there's only one of me out there right now so uh you'll find you'll find me there. Uh definitely definitely if you have more questions or you want to you want to you want to chat about anything uh please don't don't hesitate to shoot me a message I love meeting with folks whether you're doing something your company or you're you're early in your career and you're trying to figure stuff out I love I love helping people try to find their way to to success in in this industry if I can. So don't hesitate to ping me.

SPEAKER_02

That's amazing. Thank you again so much for your time Noah I really appreciate you being on Heart of the Child.

SPEAKER_00

Yeah privileged to be here. Thank you for having me.

SPEAKER_02

This brings us to the end of today's episode I want to extend my sincere thanks to our guests for sharing their inspiring journey. If you'd like to connect with them you can find their contact information in the show notes. I also want to express my gratitude to you for joining us on this exploration of the clinical research industry. I hope you found today's episode insightful. If so please consider leaving a review on your favorite podcast platform. It truly helps us reach more listeners. If you have any feedback questions or comments about the show feel free to email me at podcast at iceconsultinglc.com thank you once again and I look forward to having you joining us on our next episode of Heart of the Trial