Beyond The Protocol

Beyond the Protocol: Insights That Shaped Season One

• Melody Keel • Season 1 • Episode 10

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As we close out season one of Beyond the Protocol, this special finale captures the collective wisdom, passion, and hard-earned truths shared by clinical research leaders who are reimagining how trials are designed, led, and delivered. 

Across every conversation, one message was clear: progress in clinical trials doesn’t come from process alone, it comes from people.

In this episode, we reflect on the themes that resonated most and the cultural shifts reshaping clinical operations from the inside out.

This isn’t just a recap—it’s a pulse check on the state of our industry, and a preview of where clinical operations must go next. 

If you're leading teams, evaluating technology, building partnerships, or just trying to stay grounded amid the chaos—this is the episode you’ve been waiting for.

Stay tuned—Season 2 of Beyond the Protocol is coming soon, with new voices, fresh perspectives, and deeper dives into the issues shaping the future of clinical research. Announcement coming soon.

Welcome to Beyond the Protocol—where authentic conversations about clinical research happen.

Hosted by Melody Keel, bringing together diverse professionals from across the industry to share insights and experiences about what it really takes to deliver successful clinical trials.

This isn't about perfect processes—it's about real people sharing real solutions.

Let's go beyond the protocol.

That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials. 

If you found value in today's conversation, please subscribe, share with your network, and leave a review. 

Have experiences or insights to share? Reach out and be part of the conversation.

Join us next week as we continue to discover what lies beyond the protocol.

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This Podcast is Sponsored by The Research Associate Group, Inc.

Melody Keel: Thank you for joining another episode of Beyond the Protocol. This has been an amazing first season for me and doing this show. I didn't know how it would be received or. How it would go. But it's just been an amazing journey. The guests have been wonderful. I've met some incredible people and the messages and the dms in my box early LinkedIn, it's just been so rewarding.

And so we're gonna wrap up this season. Today we're just gonna share some aha moments. The best of season one, did you wanna say? And so my focus is people, culture and processes. That's what I'm all about. And I think for the people that know me and have worked with me, they can vouch for me and say it's about service for me.

How can I help you? How can I make you better? How can we win together? And that's where we are. And I'm launching this podcast or this show because I wanna continue to have these conversations. I wanna make our industry do better. And I think we get really caught up in the idea of it's always been what we've done.

Even though it might not work. It never work, or it's not working anymore. We just keep doing it. 'cause that's what we know. This series gives me an opportunity to have conversations with the people that know it's time to move away from that practice and become innovative and outside of the box on how we can do better for the patients at the end of the journey, who get to benefit from these amazing therapies and drugs that we're developing.

So what's going on in our industry? I think that's a conversation that is being had. Every day I talk to friends and colleagues and I see messages and posts on social media. Everyone's kind of feeling. There's almost an uneasiness about where are we headed, and we know that in our industry it takes a while for things to change.

We know it needs to happen, but it could be another five years or 10 years before we really see the needle move and we begin to do things differently, which I think is fascinating. Knowing that we're a research based industry and we have data that shows us what doesn't work and what does, but. We continue to do the things that don't work amazing to me, but here we are, we're gonna talk about it.

We're gotta find the people who are just as passionate as I am about clinical operations, clinical research development and what we can do individually and collectively to make this better. And so that's where we are. The podcast aims to be something different. I didn't wanna just have another show where you walk away and you feel like that was entertaining.

I think there's some amazing podcasts out there in our industry but a lot of times they don't really focus on clinical operations and the companies that. Are on this side of it. The sponsors, the biotechs, the CROs that are partnering with the sponsor companies to get this, get the work done. And so that's what this is about, that perspective of it and how we can collaborate and connect with vendors and psychs and people who push this train forward rather heavy and clunky train.

But amazingly, we get the job done and that's what ClinOps is all about. So in my almost 20 years of being part of clinical operations teams mentoring, coaching, providing strategy here in the latter part of my career, I see it over and over again where we focus on processes less on people, and then we wonder why we get the outcome that we do.

On the flip side of that, the companies that seem to understand the human investment making sure that our people are happy, they know how to do their jobs, they feel supported and they're working in a culture that's collaborative and honestly, a safe space to be the best that they can be within the role that they've been given.

Those are the companies that seem to do really well. Even if they may not be as sound and tight on their operational processes, their SOPs may not be as great as some of the other companies, but they're getting the work done in a really good way. And so I think that's what has led me to bring this idea through the research associate group of helping people.

Be better but feel supported and able to optimally do their jobs and within the clinical operations circle. So I'd love to kind of understand how you bring your experience in. I know you are part of an amazing organization as well. That also provides support in a different way to the clinical research space.

So I would love to just have some insight from your journey that brings you to this point forward. 

Jeremy Mitchell: Yeah. You know, I'd say in a nutshell, everything that you're talking about is something that we've seen on both sides of the house in the industry, right? It people are hesitant to participate in trials because they don't wanna feel like a number.

They don't just wanna feel like they're on an assembly line. That goes the same way for people who are performing the trials, right? All of our people that are putting in their blood, sweat and tears wanna feel like they're actually valued. And I think that's one of the things that's so exciting about taking this approach is that not only are we upskilling people where they can understand how to do their job more effectively, we're also taking an interest in them as an individual saying.

We know that you probably have other aspirations. How can we put you in the best place to succeed? You know, we're not just going to replace you, you know, easily. We want you to be here and we've invested in you. And it benefits us as a whole to make sure that you're in the best position to win, right?

So I, I think that as we continue to work with people on this side of the house, you know, in the industry. We will see that their approach will kind of resonate more on, on the outside as we're dealing with the public. You know, who doesn't really understand? I believe, you know, as a layman, I've only been in clinical research now about five years, so I still tell people I, I see it from both sides, right?

I'm an outsider still, you know, so I know what the, that type of people are saying and what they think. We didn't understand what clinical trials were and, you know, and what this industry was all about. The only time we hear about it is in, unfortunately, a lot of times in negative emphasis.

So I think that if we can figure out a way to have people feel more confident in their roles or as they're dealing with, you know, non-industry related people, that will play off very well. Yeah, just. Just awesomely excited about this. I hope you can see the passion that's coming through on that.

Every time I talk, 

Melody Keel: I want you, I wanna talk about the landscape of mental health in our industry. I think just in knowing right, our colleagues and our friends that are in this with us we both had similar experiences where you take on a lot professionally. I. I know five years ago I had a mild stroke and it was almost fully because of my workload and not managing the stress that I dealt with at work and then it coming home and I never turned it off.

And just physiologically it just turned into that. And I think we both have similar experiences where we had to have a light bulb moment and realize no more. I have to adjust what I'm doing. So I would love to hear your story. 

Jess Thompson: And I just wanna thank you too because that is such, that's where I think we, you and I bonded initially was just we hit that rock bottom and we didn't want other people to hit that because like you said, with your stroke and mine, I ended up having to check myself into somewhere just 'cause I couldn't function anymore.

Like I was crying between meetings. I was, it was not good. I was, I couldn't imagine having to exist in my body for one more minute. Any more time. Yeah. 

Melody Keel: Yeah. A lot of people are living that right now. Like they, they haven't hit rock bottom yet, but I think if we can convey to them that it's not worth it and to just then it's worth us coming together and having this show today.

Jess Thompson: I could not agree more. And I always say like. Whenever I first came out on LinkedIn, I think that's where I really started getting a lot of following followers on LinkedIn was because I just put it out there. I just said I had to check myself in somewhere 'cause I was having severe anxiety and I was diagnosed with panic disorder because I.

It got to the point where I'd see my company's name on a pen and have a panic attack just because of the name of the company and just like timelines and deadlines. And I know a lot of us after Covid, especially everybody, the world, saw how fast we can work. But the thing is, we were all coming together working on a pandemic.

This was unprecedented. This was not, this should not have become the normal. And unfortunately it became the normal 

Melody Keel: after day. It did not that pace and that way of working did not leave us. It's still very present five years later. 

Jess Thompson: Exactly. And the 

Melody Keel: mission to see if we can do it faster. I hear this all the time, can we do it faster?

Can we do it faster? I'm just like, 

Jess Thompson: oh my goodness. And if you do it faster, what are you gonna be asked next time to do it even faster? I. And to do it cheaper. And that's one, I mean, and as project managers, we all know that's literally impossible. There's only so much you can do with a certain amount of funding, a timeline, scope, and quality.

There's only so much you can do. And I. In clinical research, we don't want our quality to suffer. So much of us, so many of us, you know, we're type A's, we're type A personality. We're, you know, overachievers, perfectionists, like we're literally set up for running ourselves into the ground, following what we're passionate about on our own.

Oh, yeah. Oh, absolutely. I can tell you 100% that I live at fault for getting myself in that situation because again, type A perfectionist. Passionate driven, like I'm an Enneagram three. I don't know about you, but like I'm a through and through. I am that person. And I know so many of us are that way, and so we're just really fired for it.

So it's naturally drawn to clinical operations. Exactly. Because we're so good at it. But at the same time, it can be our detriment and. And I don't know about you, but I, it's been really cool to see over the last five, oh my goodness, five years, three, three to five years maybe, of how the, that conversation has changed in our industry of it being almost taboo to talk about it.

And I know whenever I posted about it, people were telling me that, you know, you better watch out. You might get sued, you, all these crazy kind of things. Boom. The things people weren't seeing was the hundreds and hundreds of messages I got in my direct messages from people saying thank you because this gave me hope to stay one more day.

Karen Harris: Yeah. And 

Jess Thompson: so from there, I kind of adopted the whole heal out loud so others don't die in silence because I love that it's so hard and it's hard to talk about your mental health, but we're in men, we're in healthcare like that we should be able to. If anybody should be able to, it should people who are in healthcare and trying to find cures for these illnesses and these diseases and without killing ourselves in the process and becoming the patients ourselves.

Melody Keel: I agree. And I think five years later from the pandemic here, we are kind of in another, you know, situation that our world is going through and I think our industry is feeling it right. At least the beginnings of it, and we have no idea what's to come. And that brings the whole new level of anxiety and stress and unknowns.

And I think we just, people just have to remember what's really important and not to get 

Elizabeth Tabor: sucked into this black hole. Networking is a skill and not a lot of people are taught this skill of networking. I was like, let me, you know, help bridge that gap. I agree. I agree. Which 

Melody Keel: I think as we evolve in our industry and even our world, right where we are right now, I think employability is changing right before our eyes and how we work and earn a living and find our space to share our gifts and what we've gone to school for and our expertise.

I think we need to begin to prepare ourselves for this change and networking and understanding how relationships can help you with that is so important. And I think you really you're ahead of the game in terms of understanding that. And I love your LinkedIn handle. You're the connector.

I, I agree with that. And you really enjoy talking to people. And engaging with people and you connect people together. I know you've even given me some tips and hints on LinkedIn on how to make my connections better. So share with me where you are and why you feel that it's so powerful to maintain relationships and network within our industry.

Elizabeth Tabor: I would say that we are a global industry for one, and oftentimes people talk about patient recruitment and the barriers that we face, and networking, in my opinion, helps solve that problem. By talking to other clinical researchers across the globe, you start to understand what's working in different communities.

So that knowledge sharing is just so important in pushing the industry forward. Because without it, you know, we wouldn't know what's working and what's not working. And for me, in my opinion, too long, people have just not been talking and the conversations are kind of appearing to be in a circle instead of just being like, Hey, what's going on over here?

And being able to implement a solution quicker. 

Melody Keel: I agree. I think that's something that we all experience in all areas of what we do in this industry where we find ourselves looping. We just keep doing the same thing. I think this is a theme in a lot of my conversations I've had with guests on the show is we just keep going in circles and we have to find a way to snip that circle and go forward so we can make the changes necessary that we all know need to happen.

We just haven't seen them come into fruition the way we want to. 

Elizabeth Tabor: Yes, totally agree. I often tell people with networking, you can learn something that took somebody 20 years an hour, and when you consider that time trade off of having that information, you see how valuable it is to just ask the question.

Then doing everything yourself, which is unrealistic and really wastes a lot of resources when you have people available to help you. 

Melody Keel: It does. And when you're able to like, gain from someone else's knowledge and experience, that's a form of wealth. I think we miss that sometimes. That you just scrunched in the timeline for what you would need to spend in order to obtain that skill or that information or that wisdom.

I know I work with a lot of project managers and CRAs in my world, and it's evident the ones who are. Networkers and relationship builders and they like to spend time with people and learn because their bucket to pull from in terms of the experience is so much greater than the people that kind of silo themselves and they don't make those connections.

So I do, I think it's another form of wealth, honestly. We're in the cycle of layoffs and changes in our team structures and how many resources we can have on a team that directly correlates to our budget tightening situation. And so I'd love to hear your perspective on where we are right now and what the challenges we're facing.

Bryan Blair: So to put it, there's no way to sugarcoat this. The job market right now, especially on the candidate side, is not good. We are very close to bottoming out based off of the data that I'm seeing on job posting. It's something I follow very closely, and how many of those positions are getting filled, but we have had 10 quarters now.

Of a regression in overall postings in the industry, and they've been cut in almost half over that period of time, going from about 19,000 job postings 10 quarters ago to now about 10,000 open roles that are posted. So I, it's substantial decline. I think macro economic conditions are actually playing a larger role in this than.

Anything related to like science or particular drugs. Obviously those play a big factor, but I've come to learn that interest rates are so influential in our industry because we need venture capital to invest in biotechs. And it makes the whole system go around. Yes, it does. 

Melody Keel: Yes. And I think for those of us that are in the day-to-day and we're in the trenches running trials operationally, and we feel like.

We have a job right now. It's not on our, it's not front of mind. We're happy where we are. We are not dusting off our resume. We don't have any plans to leave. And then we find ourselves in the situation where we now have to look for other opportunities, and that's when we realize how bad things may be and how difficult it's going to become to find another position.

Bryan Blair: Yes. And I've had a lot of people who've been doing this a lot longer than I have who were, you know, in the industry for 2008 during the recession. It wasn't as bad as it is now. And so a lot of people recently laid off, they are expecting to find another job like that and probably even find something that they'll love.

You know, they've never not had options. And then we're at month six and it's I. I still haven't found a job like this is bad. 

Melody Keel: I agree. And I wish that there was something that I could say on this call that would, you know, that we had a magic wand and could see in the future say, if you can just hold on for this amount of time, it's going to open up, but we can't.

And so then I start to think of what are other ways that we can help folks that are in these situations? Maybe pivot in the interim and move to consulting. So many people are like, I don't even know where to start with that. But in speaking to the clients and companies I'm connected with, they're far more open to bringing in a consultant and having fractional team members who are open to just being there for three months while we take care of the data for this BLA filing.

And then we can part ways and we're not committed to an employee in the full-time commitment of that. And so I think if people could kind of grasp, even if it's just in the interim during this time that they're open to that and can set themselves up to become fractional consultants, then that's a way.

But of course that's scary if you've never done it. I'm used to it. It's my life. But if you haven't, you've been an employee. It's not so easy just to say, okay, I sign up. I'm gonna be a consultant for a few months and ride this thing through. And so I, I would hope that somehow people can tap into communities.

There's some great ones out there that can help them navigate different territory until they can get back to what they know. Great. I know we've had some discussion about the impact we have in operations. On patients. So you said something that really hit me, that when you do things right at the beginning, at the start of a trial it can really impact the success or the outcome or the journey towards the end of the trial.

And of course, the patients are supposed to be, the primary focus is supposed to be first in all of this. And so when we set things up on the front end. It really does lift the burden for the patients and what we sometimes unnecessarily put them through with amendment changes or process changes or study visit, things like that.

Once they've started the program or the trial and they try and consent for it to be one way, and then nine protocol amendment later, we forget to think about how this impacts the patient. Their experience and even their trust in research, will they do it again? Will they encourage other people to do it again?

I think that's really important aspect that we sometimes operationally forget. 

Andrea Bredin: I think it's so easy to forget about the patients, and if you do then, you know, why are you doing the research? What's the point of the research, you know, at the end of the day, I think for me it's really crucial if you can, to involve the patients and to really be aware of certain aspects.

Like for example when you're thinking of the ICF and the PIS, like how is the language in those documents for the patients? Does it make sense? Like when we're right in them, it might make sense, but actually when you show it to a patient, that might be something completely different actually. 

Melody Keel: Yeah.

It's no sense to them. The latest terms that we think are normal, everyday, you know, text, it's still rubbish or for the patients that we approach. And so I think we definitely have to do a better job and put ourselves in the shoes of those that we are serving and make sure they really understand and not just delegate or hand it over to the investigator and his team.

To explain it. And so we say we bought the level down, but then we just, I think, kind of assume that the investigators will take care of the gaps. 

Andrea Bredin: Yeah. Yeah. And I, it's interesting that you say that because sometimes what I've noticed over the years is that it's kind of an us and them. So like it's the sites and then it's us as the, you know, the project managers or the data managers.

But I really think if we work in unison, that is really, it makes such a big difference because at the end of the day, I feel personally that we're all. Working towards the same thing. It's for the patients that were doing the research and also to understand more about treatments about certain diseases, et cetera.

So yeah, I think if we work together it can make such a difference and not have a sort of a us and them mentality. You know, it's really makes a difference. 

Melody Keel: Sometimes we get so bubbled in our own little world of clinical research and being in our pockets if we're on the government side. Public health.

Industry, pharma, biotech. We do what we do day to day and we know what we know. But sometimes we forget to kind of think about a bigger picture. And for our fellow researchers that have been impacted significantly recently with the layoffs in the FDA and the NIH and the cutbacks I think we have to remember.

Even though we're on this side of it impacts us. We're all in one circle together, and eventually you will feel that if we haven't already. And I know there are those of us that are watching, that are in this transition stage where you are not employed or working right now due to layoffs and things.

I think we should stop and acknowledge that some of us are business as usual and maybe feeling uneasy. And then there's some of us that have completely had everything turned upside down and are looking for the next position and have that level of concern of what's going to happen tomorrow.

And so with the NIH and FDA changes and all of the research cutbacks that we see. What does this mean for us in operations and clinical trials? Not fully sure. I don't think anyone can have a crystal ball say exactly what this means downstream. I do think it will have a domino effect. Some companies and some of us as individuals will be impacted more.

Some of us not as much, but I think we will all fill it in one way or another. We could see delays in approvals and, the regulatory process getting more bottlenecks, right? As we look to the FDA and the departments that have been impacted significantly as they adjust to try to keep things moving, we will feel that.

And then just a general disruption in clinical trial activities of the things that we plan for such as inspections and. Updated documents and guidance and things like that, it changes. And so we have to know that and be ready to adjust for that. And I think that unknown lends itself to what the clinical teams and even leadership is feeling right now that we just don't know.

And sometimes not knowing lends itself to fear. And I think we should find ways to speak about that and acknowledge it and not just pretend it doesn't exist. Because it does, and as leaders, I think there is a responsibility to be transparent and honest with the teams that you support. So I think that's a great segue into research, being personal.

And I know both of us have had experiences in, in, in situations with loved ones where clinical trials. Have impacted us, not just on a, the research that's being done has impacted us, not just on the professional side, but we it's been part of our lives personally too. So I'd love to hear kind of what that means for you from your side, what your experience has been.

Karen Harris: You know, we all have that thing, you know, that time in life where it's like nothing's gonna happen to us. My son choked on food one night and we just thought he choked on food. And come to find out after, you know, fur eat the testing. He was, you know, he was diagnosed with a rare disease. It's called eoe.

And my kids even laugh at me when I say the word all the time, but it's eosinophilic esophagitis. It is a rare disease, but unfortunately I think it's becoming more common. When he was diagnosed at 12, he just turned 18 a few days ago. There weren't a lot of approved drugs, so it was, Hey, let's try this inhaled steroid.

We've seen this work, let's do, let's take some food allergies out. Let's start with your basic, you know, milk, egg, dairy. I mean, we did all of that and he went through three scopes in the matter of four or five months and we still didn't have any type of remission. Fast forward, you know, a few years, he called me again from school after just some struggles and he like, mom, I cannot breathe. I felt like he was gonna choke to death, and it was at that moment that I was like, we've gotta do something different. You know, go back to the pediatric gi and she just said, I think it's time. You know, they finally just approved to pick probably six months before this episode for eoe.

Dupixent had been around for a while, but again, because of the clinical research and the studies that had been done on Dupixent. And the follow up. They started seeing the depictive, you know, was great for atopic derm. Then it was great for asthma patients and then it became approved for eoe. Just recently they're talking about it, you know, being approved for COPD.

So that's where research is evolving, where they're continuing to look at other indications that a drug may help. You know, we had to. We had to take that chance and say, let's give it a ch, let's give it a try. And it's very hard to look at your son who's 15 at the time and say you're gonna do this weekly injection, the biologic injection.

But it's probably one of the safest that was on there. And because of my research brain, you know, I asked every doctor that I could read every single thing that I could in clinical trials.gov. And we finally took a chance and within three months. He was already able to tell a difference. He could eat, he could swallow.

We started seeing that he was able to gain weight, and we did a scope. At six months after the department started, for the first time in three or four years, he was in remission. Wow. That he just sent a, he just took his a hundred 18th injection this past Monday and he is flourishing, he's gaining weight.

He's put on 25 pounds this past year. I mean, he. He is doing very well in life. So to me, I can see the passion of clinical research has now been such a positive experience for my family, that I hope and pray that we can continue to do this for all of the people that are suffering with rare disease or other, 

Melody Keel: when we say patient first and research matters that's why.

Like this story with your son and the experience, and that's what so many of us that's a similar story for so many of us, and we wouldn't have, I think that's what we sometimes just forget if we didn't do this, what you and I do, and so many everyone that's in the industry, that gives so much to be part of it.

That's what it means. So that there's a therapy, there's a, there's an option. Available, especially for those where it seems like there is no option and then now suddenly there is and it gives an outcome that we, that's good. That's why we're here. I think the times that we're in our industry very specialized addressing a gap in and partnering with companies.

Yes, that can come in, be nimble, flexible. And address the problem. And we don't have a lot of red tape, and we just know we're the expert. We can get this done and we can deliver results in a very efficient way. And I think I'm starting to get the opportunity as a result of LinkedIn to engage with more and more companies like yours and like my company where we have the ability to do such amazing things.

But I feel like sometimes we may be overlooked. Because we're not as big, but we bring such a great alternative option to get a solution in place quickly and effectively. 

Jason Spivey: I completely agree with that, and that was why I was so excited the first time you and I ever spoke because I saw the same thing and I see the same thing when I talked to others on LinkedIn, much like you, right?

I'm getting this opportunity now. I, we see this proliferation of individuals or small startups. Work in these types of spaces, right? Where all of these little gaps are, and I think the big driver behind that is we're seeing studies that aren't being put together or they don't have the same components the same way they did 15 and 20 years ago, where a more traditional oversight model where execution model was practical.

Not to say that those places, those pieces don't have a role. 

Jeremy Mitchell: They do. 

Jason Spivey: But I think they absolutely have a role. But there's so many more. Very specific and very nuanced details that go into newer trials, whether it's things like decentralized trials or very specific therapeutic areas or therapies that are being, you know, tested out in these trials or even academic studies.

I've seen some really interesting heated efforts there, and I think because of that's where you're seeing this need for additional support. Niche support in those areas because those are the areas that aren't fulfilled and then teams are left kind of spinning their wheels. For days or weeks or months 

Melody Keel: solutions.

Absolutely. Yeah. I think this is a great segue into the actual technology, right? And why it's such a critical component of our trials. And I know you know the buzzword is ai. But it's not about ai. It really isn't. There's so many companies that offer amazing solutions under the tech umbrella to help us deliver our trials in in the best way that we can.

But when you don't know how to put them together properly and the teams don't know how to utilize all the functionality of the systems, then it's almost what's the point? Why do we have all of this here? Why do we pay millions of dollars? To bring in a company with this technology expertise, this platform, and then we don't use it fully and we just use a little bit of it, and then we have a system over here and then, oh, we better go get this system for this, and now we need to do a data review, so we're gonna go get this platform.

When ICU had just stopped and had an expert to strategize you may have only needed two systems. You already have instead of going out and buying five more. And we'll be back, we'll be back in a few weeks with season two, and we've already got some great guests lined up and we're just gonna continue this discussion beyond the protocol.

I just continue to get feedback that people are really enjoying it. It's been informative and it's been really helpful to see other perspectives from people that are in our industry. Within clinical operations and all those that are part of clinical operations in one way or another. And so I'm just excited and I hope you will join us and continue to engage with us If you have feedback.

If you'd like to be a guest, please reach out to me. I'd love to speak to you, and we're looking forward to the next season. Take care.

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