Beyond The Protocol

Navigating Uncertainty: Leading Clinical Teams in a Shifting Research Landscape

• Melody Keel • Season 1 • Episode 7

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With recent cutbacks at both the FDA and NIH, the clinical research industry is entering a period of deeper uncertainty. Budgets are tightening, timelines feel even more fragile, and the pressure on operations teams has never been higher.

But while the environment may feel unpredictable, our commitment to patients—and the teams who serve them—remains steady.

In this solo episode, Clinical operations strategist Melody Keel addresses how leaders can steady the ship amid change.
 
She unpacks how to lead with clarity, empathy, and strategy during times of flux, and how to help clinical teams stay anchored in purpose while adapting to what's next.

What You’ll Learn:

✅ How the current federal cutbacks may affect clinical trials
✅ The emotional toll of uncertainty on trial teams—and how to manage it
✅ What adaptive leadership looks like in real-time
✅ How to stay mission-driven in resource-constrained environments
✅ Ways to reinforce team morale, stability, and quality under pressure

Whether you're facing budget cuts, team fatigue, or shifting timelines, this episode offers practical tools to lead with steadiness, empathy, and direction—especially when your team needs it most.

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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🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/

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

Melody: Hello, welcome back to Beyond the Protocol. I'm so glad to have you today. Episode number seven, the weeks are going by fast, aren't they? And I am solo today. It's just me and I think that's pretty cool 'cause I wanna cover a topic that I think a lot of us have in the back of our minds getting the current state of what's going on.

And so it's just us. Although I love having my guests and we'll pick that back up next week for sure. So current state of our research industry and what's going on. I've had a lot of conversations with friends and colleagues and clients, and I think there's just this level of uncertainty as we try to adjust and keep going forward, even though there feels like an elephant in the room or a big question mark where we just don't know because we're in unprecedented times.

I thought it would be good just to take a time to share that and it would be great if you would drop in the comments your perspective or your thoughts or what you're feeling and the way that you are navigating this to stay on the right side of the line. So what is happening?

I think sometimes we get so bubbled in our own little world. I. 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 think about the bigger picture.

And for our fellow researchers that have been impacted significantly recently with the layoffs and 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 we 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 and 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 spewing 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 and make sure they know.

Even if you don't have an answer, it's better to sit down and speak and say, we're in the process of trying to understand and navigate this, and we don't have all the answers, but we wanna acknowledge and have a discussion and allow you to share your concerns or ask the questions you have. I think it helps, it lends itself to the culture that we hope to build within our organizations where there's transparency and a sense that we're in this together and we're not necessarily siloed and no one's speaking with one another and acknowledging an elephant in the room, per se.

And I think that matters. It matters on both sides. It matters in leadership and it matters for the teams that are implementing the work day to day and wanting to do a great job, but also. Have fears and anxieties on the personal side as to what does this mean for not only my organization that I support and am connected to, but for me personally, and I think that's the new normal and it's probably gonna be with us for a while, the uncertainty, the unknown.

What does this mean? We already have so many changes happening in our industry right now with AI and DCT and. There's just a lot of pillars and components that we're all like watching and observing to understand or even, or tell what his means. What is it gonna look like in five years or 10 years?

Is my role going to be the same? Will my role be eliminated? And I think those are real questions that many of us have that no one's talking about necessarily collectively or corporately. And we should be, even if we don't have the answers, we should have a formula platform to talk about these things and to hear from people who have some expertise or knowledge and can give us insights into what they believe it looks like.

Because I think even though it's not an exact science, it helps us as individuals to understand where do we fit in. How do I need to adjust? How can I retool? Should I be looking at other areas of research and start to understand and get experience? Maybe I'm in operations and I've always wanted to know what regulatory did and get more experience there, so maybe I should start to look at that.

Or maybe I love, I don't wanna leave operations, so how do I adjust and take the experience that I have and I. Find a way to ensure I can evolve and progress with the changing times. And so I think those are questions we have, those are discussions we should be having in there. Valid and real. And so getting in a community and connecting with people where you can have these discussions and feel like they are informative in helping you to navigate, I think that dissipates some of the fear and unknown and anxiety you have.

Don't stay siloed, connect, have your network, have these discussions and link up with the communities and organizations that can hold the conversation in a positive light in an informative, educational way so that we know how to proceed forward. And so what does it mean as we proceed forward and we move ahead in this unknown, uncertain time that we find ourselves in?

I think this is the call for leadership and if you are a leader in clinical operations or whatever side of the line, it may be the pharma, biotech sponsor side CROs, vendors even sites. If you are finding yourself in a position of leadership and you are responsible to lead teams to implement the work that needs to be done.

You have a responsibility to support your teams and help them navigate through the unknown, even though you as a leader also are in this space. But teams that are coming to work every day and still pushing out the work and even now may feel more pressure because now we may need to get this data delivered sooner so that we can press, compress our timelines to submissions because of what we know that's happened with the, cutbacks in our FDA and NIH departments, et cetera. More pressure, do it faster, get the data get the patients recruited, all of that. We expect them to commit to these additional requests and requirements and critical path timelines that are now on us as a result of what's happened in the recent weeks.

But then we don't stop and have conversations either collectively or one-on-one to say. This is how you could be impacted or this is what's happening or the discussions that you're not privy to. But we still need you to be committed. We're still all in this together, even though we're not sure what's ahead for the moment.

This is what it is. And be transparent is possible. Knowing that you oftentimes can't give all the information, and it may not even be known what the strategy is or yet, but just sharing that, that it's not known. But we appreciate you. We know we're putting you under. Additional pressure, and we need you to stick with us through this.

Even just a message like that is, is so helpful and beneficial to the teams that need to hear it. And so I think that's appreciated. It doesn't need to be another happy hour or pizza lunch, it just needs to be an honest, transparent discussion with the teams to let them know you acknowledge there's an elephant in the room.

You may not have all the answers, but. We're going to get through this together, and if you have the appropriate culture in place anyway, that's an easy lift. If your culture isn't so great and you're already dealing with challenges where teams are not motivated and you're experiencing fight quitting and all the things that I talk about and post about only then I think you have even more work to do.

But that doesn't mean you don't have the transparent, honest conversations about what's happening. In our industry and how that impacts your teams. So how do we support our teams and the humans that I'm always advocating for, who are running our trials and operationally the foundation of what we do day to day?

I, mental health is a big thing and I'm so happy to see that there's more conversations about it. There's more support around it. Jess Thompson is doing a conference and I saw her post. That there will be yoga and quiet rooms, and I think it's excellent that we're focusing on that, but it should be the norm.

And I think we need to acknowledge that mental health is real and they, we as humans have situations outside of work that we bring to work and then we add the pressures of work. It can bring us to a breaking point. And a lot of people are. At that point, whether they're employed or they're laid off and looking for work.

And I think we have to be fellow humans and acknowledge that and support one another and find a way to lift each other up and just give a positive, encouraging word or space. And so if you don't have that currently in your organization, there are ways to get that. And organizations and individuals and people.

That can gladly come in and help you provide a mental health space and support for your teams. And I think it's the right thing to do as leaders of our organizations. And it doesn't have to be a considerable investment. It just takes time and a little bit of effort to bring that into your organization and it's worth it.

And so simple ways you can show up for your team when you're not certain. Talked about it a little bit already have one-on-ones. Just listen to the concerns of your teams and what they're feeling and what they would like to see. Give them the opportunity to say, it would be great to have this. Maybe they have some views and points that you don't and you haven't considered.

And they could be simple solutions to keep your team motivated, to keep your team feeling like we're in this together. And that even though there's a lot of uncertainty and we're not sure. We feel okay with continuing on because we know we have the support around us as much as what can be done through this.

And then encouragement direction having a strategy, having a plan. Strategy and plans are so much more than just strategy and plans and when it feels like the earth is shaking and hurricanes coming. If we have a plan and we know how to spring the action, it feels so much better than everyone's what do we do?

The world is falling down and everyone's just standing here scratching our heads. That doesn't feel so good. It's like when it's stormy and my dog is terrified, it, I become scared of the storm. He goes into a whole nother dimension. But if I'm calm and I know what to do, then he's kinda oh, she's good.

I'm gonna be good. It carries over into our work world too. We as leaders have to understand and know what the strategy and plan is when things go awry. Because if we don't guess what it trickles down and know one else knows what to do either, and then we're all frozen in fear not going to be a great outcome.

And we can avoid that by having strategies and plans and contingencies. Just some basic understanding of what we'll do if we need to go this route, and that's where risk management comes in. If you have a good risk management plan, then you have some form of strategy where you can go to those, plan B, C, and D and put those into play.

So essentially find a way to support your teams and the humans that are supporting you to get the work done. I think it's fair and it's right to do. It's also at the end of the day, helps to get us to the end goal the way that we need to. And so essentially my message today is we're in an uncertain time for sure, but for those of us that have fear and anxiety about it, I think we should proactively find ways to address that and not just stay in that space.

It's not good for us physically. It's not good for us mentally. And it really doesn't help anything, right? It doesn't change one thing to stay fearful and anxious and worry. And so connect with communities, connect with people that can help get you out of that and find ways to address the things that have you all tangled up and tied up, for sure.

And then a call to the leadership and those that are responsible for leading us through these clinical trials and the operations that we do. Day to day take care of your people, find ways, and if you don't have the resources individually, get them and bring them into your organizations. It's just that simple.

Sometimes we make things so hard, but they don't have to be support your people and help them through this time that we're in while we continue to do the work that we have to do despite what's going on around us. I think that is what I wanted to share today. So please, I'd love to know your thoughts.

I'd love to see comments from you about how your organization may be helping or Things you would like to see. Send me a message. I've had some really great conversations with people and even people that feel like they're really alone and they don't have connections and they've been in positions. For four or five years, didn't think they would have to start looking or gusting off cvs.

And getting a presence on LinkedIn. How do I interview or do screenings with ai? This is completely madness. I don't understand things have changed so much. I think you just have to find people to talk about it with and connect, and that's the way we're gonna get through it, is together and navigate the changes that we find ourselves in.

And do that. Don't stay on your own on the island and I look forward to speaking with you at the next show. Thanks.

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Melody Keel

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