Beyond The Protocol

Behind the Metrics: Leading Patient-Centered Clinical Trials

• Melody Keel • Season 1 • Episode 6

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What if metrics could do more than track performance—what if they could transform the patient experience? 

In this episode, Andrea Bredin, a seasoned clinical project manager with over a decade of experience, shares how she blends data-driven decision-making with deep empathy for trial participants. 

From reducing burden to leading cross-functional teams, Andrea offers a fresh perspective on building clinical trials that are both efficient and human-centered.

What you’ll learn:

  • How patient-focused design leads to better retention and data quality
  • Which metrics truly drive meaningful improvements in trial operations
  • Ways to align cross-functional teams around shared patient-first values
  • Why great clinical leadership starts with listening—to data and people

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: All right, so we're back with another episode of Beyond the Protocol. I'm so happy for episode six to have Andrea Bredin join us. Again, the power of LinkedIn. We met through a connection request and we did a virtual coffee, and our conversation was so good that I was like, oh my goodness, you have to come join me on the show so that others can hear this discussion too.

Because it was really resonating with my soul, what we were talking about. So keep for joining me and please introduce yourself and tell me a little bit about your journey.

Andrea: Oh, thank you, melody. It's really you to invite me in it. It was really nice to meet you over LinkedIn and as you say, the power of LinkedIn, it's incredible, right? What it can do. Yeah. So yeah, my journey into clinical research. I originally started working as a clinical trials coordinator.

So my background is actually in nutrition and my degree was in nutrition and I done that and I really enjoyed my degree. However, I felt like there was more things I wanted to do in terms of helping patients outside of the clinical space. So basically I started looking into what else I could do and I discovered there's a world of clinical research.

And with clinical research I noticed there's so many different things that you can do and in terms of what you can do in terms of how you can help patients, et cetera. And yeah, then I got my first job in oncology as a clinical trials coordinator. In the NHS in the uk, which is the National Health Service.

So yeah, and I've been in clinical research now for over 10 years actually. Yeah, A long time 

Melody: goes fast, doesn't it? 

Andrea: It does, it really does actually. Yeah. When you think about it, it's crazy. Yeah. 

Melody: So what drew you over to trial management? How did you land on this side of things? 

Andrea: Yeah. That's a really good question because as I say, there's so many different things you can do in clinical research.

So when I was a clinical trials coordinator, I actually got to meet some trial managers and some project managers. And I seen that when managing a trial and when you do project management, you can actually, have it in terms of the trial design. You can write the patient information sheet, the ICF.

There's so many things you can do, and actually if you do them properly at the beginning of the trial, I feel that can have a big impact in terms of preventing problems further down the line. So for me that I thought that was really interesting and I wanted to shift into that area where you can have a bigger impact and also you continuously learning as well, which I really love as well.

So yeah, that's how I end up moving into management. Yeah, 

Melody: I still feel like every day I learned something new, like literally 20 years came and I'm still learning, which I think is amazing 'cause your day is never the same. No matter how hard you try for it to be, and you just keep learning pretty ugly, I'm like,

Andrea: oh no, go on. 

Melody: Okay. 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. They're 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, reakfast changes, 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 amendments later, we forget to think about how this impacts the patient and their experience and even their trust in research. Will they do it again? Will they encourage other people to do?

I think that's really important aspect that we. Operationally forget. 

Andrea: Yeah. Yeah. I think it's so true. And for me, like that is a big part of why I got into research and I think because of my background in nutrition and working with patients, I think for me, that's at the forefront of the clinical research that I do, and I'm always very aware of that.

And I have actually spoken about the importance of involving the patients. Before in some of my LinkedIn posts, because I think it's so easy to forget about the patients. And if you do then, why are you doing the research? What's the point of the research, at the end of the day.

So 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 writing them it might make sense, but actually when you show it to a patient, that might be something completely different Actually, 

Melody: yeah.

It's no sense to them. The late terms that we think are normal, everyday, text, it's still rubbish or for that we approach and so I think we. 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, assume that the investigators will take care of the gaps. 

Andrea: Yeah. Yeah. And I, it's interesting that you say that because sometimes what I've noticed over the years is that it's an us and them. So like it's the sites and then it's us as the, 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 we're. We're 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. It's really makes a difference. 

Melody: I agree. And I always think, and maybe there are companies out here that are doing this and I just haven't had the privilege of working with him, but wouldn't it be amazing if in the planning stages.

We actually had some of our KOLs and their site staff, like their study coordinators their phlebotomists, their pharmacists actually be part of the protocol design and saying and the pharmacy manuals and saying, this is not practical for us, or what you're asking to be done here is something we don't have in place and it's going to surprise people and so maybe we should adjust or do it this way.

And I think. We forget to include all the folks that will be part of this, including patients. There's so many patient advocacy groups and patients that are willing to be part of that process if they were just invited in. 

Andrea: Yeah. Yeah. I think it's so true, and it reminds me of an example that I had where I worked on a large quality of life project.

It was looking at quality of life in patients who had a neurological condition. There were issues with the data that was coming in, et cetera, but basically what we'd done was we amended some of the data guidelines, and when we amended them, I thought, okay, it might be a good idea to actually check with the sites.

Does this make sense and how to enter the data? Because actually. If it doesn't make sense to the sites on how to enter the data, then the data we get back is not going to be very good. So it was actually really useful to get their opinion and their feedback on if it was useful, that this data guidelines that we had updated and it made a significant difference to the data we got back because there were again.

Changes that they wanted to make around some of the vocabulary and the words that we were using that didn't make sense to them at a site level, but to us made sense. What you were saying earlier with the patients. And when we done that, like I say, it made a huge difference to the data we got back.

So I think it really is working together, 

Melody: I agree. I agree. I know I've been on a project and it was so disappointing. That a project that I was on failed, and it, I don't think it necessarily was a result of the drug not working, but the practice and processes that were put in place around the primary endpoint, the sites weren't used to it, and we didn't do an adequate job of training them and standardizing how this assessment tool was used.

And so the data that we got back, exactly what you're saying was all over the place. But it was, we were so far in that when we tried to clean it up and make it better, it just couldn't come together. And so much time and money and resources and patience, that to have an outcome like that as a result of not having everyone's input and making sure we were all aligned and working together was really.

And I'm sure disappointment is probably not the right word for many of the stake

being in that.

Andrea: Yeah, that's it, isn't it? It's but that's, again, it's so important to try and get it right at the beginning, and. Yeah, but it can be so difficult I think when there's so many different people involved and sometimes as well, like I think there's egos involved. People wanna say, I youngest and, but you have to think again, and I know I keep saying it, have to relate it back to the patient, put the ego aside and actually really think about will.

What is the end outcome for this, where it's, yeah. 

Melody: My teenage son always tells me, reminds me, there's no I in t and like his, and all the things he does, he gets frustrated when people are so focused on their individual contributions and the outcomes based on what they've done as an individual.

And he says, mom, there's no I in t. You should just work together so we can win or upset when he loses. And I think we need that approach in our world. Just stop individually operating and come together and work as a team on all sides. 

Andrea: Yeah. It's very valid what your son is saying.

Indeed. There is no i a team. Yeah. And I think that needs to, yeah. I think it's really important to put things aside and focus on the main thing, the patient. Yeah. At the end of the day. 

Melody: So tell me a little bit, let's talk about trial design and how you feel it directly impacts patient recruitment, because I know that's also something that's nearing gear to your heart as well, getting the trials actually recruited for and the patient aspect of that.

So share with me your thoughts on that. 

Andrea: Yeah. I think for me, when it comes to trial design, it's. Thinking about again, the patient at the beginning. So for example, thinking about things like say you're recruiting patients who have mobility issues, thinking about is it actually okay, do they need expenses for parking or do we need to think of where the sites are going to be in terms of public transport?

Also another thing we thinking about, again the jargon that you have in the ICF and the patient information sheet and keeping them as simple as possible. And another thing as well, I think is the sites. Making sure that the sites you're picking for the design of your trial are actually sites that are well equipped and have the staffing levels to recruit the right number of patients to recruit.

To make sure that the, they have the right equipment, et cetera. There's so many different things that are involved in trial design. Yeah. 

Melody: There really is. And you just said something that really has come to my mind, the forefront of my mind recently, and I'm such an advocate for new sites, and getting new researchers and new investigators so we don't continue to utilize. Sites over and over again. So I'm very much an advocate for that. But the flip side of that is as we bring in new sites, we have to be to making sure they're trained and they understand. GCP and how to run studies.

You, you, it's not as simple as having a clinic and then accepting a protocol because you're now part of a new site network, right? And so now you have access to research and you have the therapeutic area or the patient profile that they use at least kind do this research study, assign a research nurse, assign one of the doctors to be a sub-I and go, and that's all they hit.

And it's not fair. To a sponsor first, but more importantly to the patients because they get brought into a situation where no one understands the process of research. And things you just talked about on the side don't get conveyed. And so when they read that protocol and just said, okay, do it, they didn't think about those things that you just mentioned and how impact review for their patients, do we have these things in place?

Are we able to provide transportation and organize this? Do we understand the questions we should be asking the sponsor to make sure our patients are taken care of and that we can do this from our resources and knowledge perspective? 

Andrea: Yeah. It's so important and I like that you said about bringing in new sites because you're right, we should give those new centers the right opportunity, but then it's finding the BS that actually bring them in.

But also, I. They have the right training, et cetera in place, and that they understand the nuances of clinical research as well as GCP. Yeah. Yeah. 

Melody: It's unclear and many of them are in the trenches right now, and they're like, what have we done? Because once you're in, you have patients, they're on trial and you now you have a CRA coming to tell you all the things that you're not doing right.

And now you have a follow up letter with action items a mile long, and you don't have the resources to deal with this, let alone your clinic is still moving. And so I think we need to be very transparent about what it means to participate in clinical trials, both from the patient perspective but also the.

Andrea: Yeah, and it's so important to hide that transparency at the beginning of the, looking at the feasibility of the site. Having a very honest conversation. And I think also having an honest conversation with the PI about what they need to do. It's not just signing a delegation law. There's so much more, I think in that realm that needs to be addressed.

That it's not just oh yeah, I can be the PI and I can just sign delegation. 

Melody: The level of responsibility. And I know we have this 1572 form and a lot of times it just gets signed. You just sign it and keep going. But there really, it really is a contract and there really are bilities and accountability there.

When you agree to be an investigator for a trial and then it trickles down right to the site staff who are now on the delegation mob and they was some responsibility. And so I think sometimes that gets lost in all the things we have to do to get the trial moving and running and maintained. 

Andrea: Yeah. No, it's, I think it's it's really important.

And I, I wonder with the new the kind of newer sites, is that something you're seeing that PIs are more involved or is it maybe something different? No. Okay. 

Melody: No. Oh, I'm seeing especially sites that are connected to organizations that are helping them get research, and I'm all for that model. But you have to make sure everyone is.

What they're buying up for. And a lot of times the investigators they're so busy, right? They have so much going on their own research, their own practices. They're saving lives in a different way. And then you add this component and we have to make sure they understand the time commitment and what's required.

And it's okay to say, at this time, I'm not available, but I can recommend another who could become the principal investigator. And I think we have to be flexible. And acknowledge that. And we always want to have our key opinion leaders, which is absolutely an a must, but I think should also be honest with ourselves in saying maybe our KOL is stretched too thin and we find an alternative to make sure our a OL is part of this, but maybe not an investigator directly for the trial.

And so I think it's just finding some new ways. So that we stop doing the same thing over and over again and getting the same results. 

Andrea: Yeah, exactly. Because obviously when you do it over and over again and you get to think there's something wrong there, you can. Yeah. 

Melody: And the patients are the ones that end up at the bottom of the barrel.

They're the ones that pay for those types of oversight, that type of oversight. 

Andrea: Yeah. And also I think sometimes it's easy to forget when you're doing the day-to-day job of, operations or, data management, the various tasks within the wider clinical research environment to forget actually that patients are giving their time to the study and 

Melody: yeah.

Andrea: Wow. 

Melody: For, yeah. 

Andrea: Yeah. Yeah. 

Melody: I wanna pivot a little bit and talk about metrics. Metrics are really important in our world, right? And everything thrives on metrics. How many sites are we, have we activated? Where are we a study startup? Where's our patient enrollment? What's our STV, like, all of these metrics that we live in.

And I think you have some interesting insight about kind of vanity metrics and what Rick is to focus on. So I'd love to hear a bit more about that from your side. 

Andrea: Yeah, so I think sometimes when we talk about metrics, there's, as you say, there's a lot of things like how many sites you've got on board and how many sites have been activated.

But for me, sometimes I think we maybe need to focus more on like how many patients have completed, in the study, how many patients. Are actually that we have in terms of retention. And I think also think looking at things like protocol compliance, like what are the metrics around protocol deviations and things like that.

Because actually if you're having a study where there's a lot of issues in terms of protocol deviations. That to me would signal that actually there's an issue with the protocol or maybe there's an issue with the training in terms of the site staff don't understand training, so maybe they need more training again, or maybe we need to do an amendment because the protocol is just too complicated.

I think these are again, the nuances that we're not really looking at or focusing on other things. I. 

Melody: Agree. I feel like protocol, a deviations are like a treasure chest. We don't want them, but if we have them, why did this kind of, brush 'em off? We have a monthly meeting, approve them right line by line and we make the decision.

Is it major, minor, important, non important, all the things, but there's so much data in deviations and if you like, extract and trend, figure out. What types of deviations are we having? Why are they centered around certain types, side types? Or is it across the board? Is it in a certain patient demographic like you can really dig in And as we have more technology at our fingertips like ai, I think we can really get that spouse need a lot of investment in human resources to figure out the trends that are happening from that start your chest of protocol deviations.

So I agree with you. I think we miss the mark sometimes on really interpreting metrics and finding the right ones to help guide us through and lead us to where we need to go in terms of managing our trials. 

Andrea: Yeah, because it's, as you say, like it's a treasure trove of okay. It's obviously seen as a negative, a protocol deviation than it is, but if you dig down and you try and figure out what's actually going on here?

And again, I think it feeds back into what I was saying about sites and sponsors working together to try and iron out any issues, 

Melody: exactly. All right. So I think I'm all about teams and supporting our dean, the culture that we build our teams to thrive in. Share. We, let's talk a little bit about cultures and building across on teams that know how to engage with each other to push our trials in the right direction.

Andrea: Yeah, I. Working in a team. It's it sounds very cliche. I know, but I think it's important to try and create like a safe environment so that everybody feels they can contribute. It doesn't matter what the data is, what the person is. And I think it's also important that you create an environment where it's solution based, instead of arguing about things, you're finding solutions and digging down to what the problem might be. And I think collaborating as well and communicating with each other. And if there's an issue with communication, then being transparent about, okay, there's an issue, we need to speak about this further.

To try and figure out what's going on. So I think for me, an open and, a safe environment Yeah. Is important within teams and within the culture of working within the team. Yeah, 

Melody: I absolutely agree. And a lot of times we're so focused on the hierarchy and who's so senior who's been here the longest that we use some really great opportunities to collaborate and gain experiences and have that bought into our team that could help us, that could help us change a process or improve something that we're doing.

Because people are afraid to speak up because they're not in the positions of, senior or they've not been at the company the longest, and so they just wanna shrink back and it's missed opportunity for sure. 

Andrea: Yeah, I, and I feel like it's. Everybody can contribute something. We all have come from different backgrounds.

We have different experiences that will contribute and will make a difference to the overall study. It's just actually, I think, again, creating that environment where everybody feels that they can say something, 

Melody: it's so important. All right. So I love to wrap up with some advice or something you could share with.

Leadership, the folks that hold the decision making and they're the ones that take us forward. What would you share with our industry leaders in terms of next steps and moving operations forward in our trials to where they would, where they, we hope to see them go?

Andrea: I think listening to patients is a big thing. I think sometimes at the top, they're just so far away from the patients that they just forget to listen. And I think also leading with empathy and compassion and that at the end of the day, we're all human. We all have lives outside of work, but actually if you listen actively with, empathy and compassion, that can actually go a long way.

Yeah. Yeah. 

Melody: Andrea, it was so good to have you and to be able to have this discussion and share it. I hope everyone enjoyed it and got some really good takeaways. And it's, we say patience first, but I think to not just say it, but to actually walk it is two different names. Some hopeful people come away from today's show and remember that, that everything we do.

We should keep the patients close. 

Andrea: Yeah, definitely. Thank you so much, melody. I really enjoyed the chat. 

Melody: Yeah, love to have you back again. 

Andrea: Definitely. It was really interesting. I have to say I was a bit nervous when I came on because I've never done a podcast before, but it's so interesting when you speak to others and you have a chat, it makes such a difference.

Melody: It does. And I think people really enjoy being able to be part of conversations and getting their own insights and taking it back. So I'm really excited. And people seem to really enjoy the conversations about operations and I thought, oh, boring. I don't know if people are, but people are listening.

So I love it. I'm so excited about this show and that we're gonna keep this going because I think people really enjoy it. And I also. 

Andrea: No thank you. And I think it's great that you set up this podcast. 'cause like you say, you were thinking, oh, like nobody's gonna listen to this. And I think when you start, typing or writing on LinkedIn or doing whatever on LinkedIn, you kinda say, oh, nobody's gonna listen to this, but it's actually really surprising and you know what happens.

Melody: No, I, it's a surprise, but a good surprise. Yeah. 

Andrea: Really good surprise actually. Yeah. And then I get to meet amazing people like you, which is. So great that you're doing this podcast and I really like with the podcast you're having different people on. I seen that you had Elizabeth on the other week and I think this week you have is it Brian?

He's a recruiter in America. 

Melody: Brian. He's wonderful. Yeah. Really like Brian. He's great. Yeah, you know what, I think this discussion we've had could just, we could have gone on for two or three hours, so we'll come back together again I'm sure. And with the. Right now, I think I think there's a lot to talk about, so we'll come back together for sure.

Ah, 

Andrea: there's just so much to talk about yeah. There's just so many different things going on in clinical research now. You've got AI, obviously, and then you've got all the stuff going on in the US with the politics and DI and Eye and Yeah. 

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Melody Keel

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