Get ready to learn about clinical trials operations from an expert. This episode is an opportunity to learn all about the essential aspects of managing such trials and the core role of contract research organizations (CROs) in the process. We have the privilege of introducing Becky Baggett, Associate Vice President of Project Delivery at Rho, who unravels the complexities of clinical trials for us. She not only lays out the distinct stages and components of a clinical trial but also enlightens us on the crucial collaboration between the sponsor and the CRO, the importance of clinical research sites, data management, and project management. She underscores the absolute necessity of establishing solid relationships, trust, and experience in this highly controlled and regulated field.
As we navigate further, we plunge into the thrilling and demanding world of technology in clinical trials. This part is a trove of information on how technology can streamline trials and why it's crucial to tailor technological applications to the specific needs of therapeutic areas. This episode is not just about information, but also about engaging in a thought-provoking discussion, where we examine the subtleties of conducting trials across different therapeutic areas. We end on a note of aspiration, echoing the collective wish for increased funding in the industry, which could potentially fast track more life-saving medications from lab to market.
Guest
Becky Baggett
________
Reach out to Sam Parnell and Ivanna Rosendal
Join the conversation on our LinkedIn page
Get ready to learn about clinical trials operations from an expert. This episode is an opportunity to learn all about the essential aspects of managing such trials and the core role of contract research organizations (CROs) in the process. We have the privilege of introducing Becky Baggett, Associate Vice President of Project Delivery at Rho, who unravels the complexities of clinical trials for us. She not only lays out the distinct stages and components of a clinical trial but also enlightens us on the crucial collaboration between the sponsor and the CRO, the importance of clinical research sites, data management, and project management. She underscores the absolute necessity of establishing solid relationships, trust, and experience in this highly controlled and regulated field.
As we navigate further, we plunge into the thrilling and demanding world of technology in clinical trials. This part is a trove of information on how technology can streamline trials and why it's crucial to tailor technological applications to the specific needs of therapeutic areas. This episode is not just about information, but also about engaging in a thought-provoking discussion, where we examine the subtleties of conducting trials across different therapeutic areas. We end on a note of aspiration, echoing the collective wish for increased funding in the industry, which could potentially fast track more life-saving medications from lab to market.
Guest
Becky Baggett
________
Reach out to Sam Parnell and Ivanna Rosendal
Join the conversation on our LinkedIn page
You're listening to Transformation in Trials. Welcome to Transformation in Trials. This is a podcast exploring all things transformational in clinical trials. Everything is off limits on the show and we will have guests from the whole spectrum of the clinical trials community and we're your hosts, ivana and Sam. Welcome to another episode of Transformation in Trials. Today, in the studio with me, I have Becky Baggett with the Associate Vice President of Project Delivery at Roe. Welcome, becky.
Speaker 2:Hi, thank you so much for having me.
Speaker 1:I'm so excited to have you here with me Today. We're going to be diving into the topic of operating clinical trials and this is one of those core topics for our podcast and I'm very excited to have you here to discuss this with us. But before we really dive into it, to set the stage for our audience, can you tell us more about how a clinical trial is usually managed?
Speaker 2:Yeah, certainly, and I'll zoom out and do it for a high level. But the clinical trial space, it's a highly regulated space, as you can imagine, for good reason. But the bare bones of it, most clinical trials are run the same way. So you would have a pharmaceutical company in those range in size and pipeline depth in terms of how many drugs they're looking to bring to market. But whether they are a large size or a smaller size, they may engage with a contract research organization, such as the one that I work for, and they hire a contract research organization to sort of put boots on the ground, if you will, to run these trials and the clinical trials the the big components of them really are. You know, you have the clinical research sites where patients are going to be evaluated if they're appropriate for the trial, receiving the investigational medication, being carefully monitored for any safety signals and also, just you know, other signals of efficacy as this drug actually working. So the contract, a clinical research organization, will provide staff who oversees those operations at the site. They'll travel to the site, they'll meet with the staff and the principal investigator just to make sure everything is going according to the protocol and according to the you know the laws, gcp that's put in place. Also, there's some folks on the back end right.
Speaker 2:So we have data that we're collecting from all of this great information that the patients are sharing with us, and we have data managers who are putting all of that data into an aggregate form and cleaning it, and what we mean by that is we're just looking for things that you know perhaps it was a transcription error at the site, where somebody was typing something into the system, the electronic data capture system where it doesn't quite make sense given the other data that we're seeing and you know, making sure that those things get corrected along the way.
Speaker 2:And then, once the data has been cleaned, we have our brilliant statisticians who analyze the data and provide pharmaceutical companies, biotechs, with what we call a readout. So here are the results of what you were trying to accomplish and where you know the data is showing you were perhaps successful, or maybe places that you know you weren't successful, but it gives lots of information about the medication itself and whether or not it's viable to move on for further development. And then, of course, on top of all of that, you have a project manager who is sort of the hub of it all you know, communicating with all parties, making sure that everything is being conducted per the timeline, per the regulations, per the budget and the scope of the project. So lots of responsibility, sitting on top of that with the project manager. So, in broad strokes, that's what are the major components for clinical trials.
Speaker 1:That makes sense. So it sounds like the CROs are actually the experts in running the clinical trial, with all these different specialties that need to work together to make it happen.
Speaker 2:I would say you know operationally for sure. You know the pharmaceutical companies are the experts in their products. You know that, there's no debate about that. But when it comes to operations, when you're working at a CRO, a clinical research, contract research organization, you have to really wear a lot of different hats. You have to learn about a lot of different therapeutic areas and the new challenges that come with those different therapeutic areas, which you don't always get the same exposure to. That when you're working on a single product, or you know one or two products and one or two indications.
Speaker 1:That makes sense. And well, all the life science companies I have worked for have used CROs to run their clinical trials, so it's a very common model. But I'm curious to learn what are some of the challenges that can arise when you work between the sponsor and the CRO. Well, we only have 30 minutes, but I'll try to hit some of the major ones.
Speaker 2:It's funny because I was thinking about this the other day and honestly, it's not terribly different than maybe any other industry. A lot of what we do comes down to relationships, trust, experience, and I don't see that those things are much different than other industries. But it's true there can be challenges. If it's not a great fit between the Life Science Company and the CRO, we try to do our best, at least at our CRO, to show the client who we really are, so that can have that full picture in order to make sure they are selecting the right partner, the right collaborator, because it makes a difference.
Speaker 2:You really need to think about what type of collaborator do I want to work with? Am I in a place where I feel like I know exactly how I want everything to go and I really just want somebody who's going to provide these resources? That's one type of CRO, one type of culture. Or, hey, this is kind of a new space for me. Or I don't have a ton, I'm a startup, I don't have a ton of operational experience, or I'm a very lean crew. I need somebody who is going to take over and run with it. Has the experience, I get a good feeling from them. That's important as well. You'd be surprised how many times it comes down to I'm really connected with your CRO. That can be the decision maker, and it's important.
Speaker 1:But it sounds like there are also different kinds of engagement models. Can one CRO operate in many different kinds of models, or is it more about picking the CRO that operates in the model that you would like to work with as a sponsor?
Speaker 2:I would say, for the most part, most CROs can operate in multiple different models. Some have larger staff. If you're looking for an FSP model, which is just somebody who is going to be resource dedicated only to your study and it's not a team, you're hiring individuals then some of the other larger CROs might have more staff available to do that or that's more of what their structure supports. It really just really pays off to take the time to interview the CRO.
Speaker 2:Know for yourself what you're looking for, and that will definitely help you figure out who's the best fit.
Speaker 1:That makes sense. Well, it sounds very common sense actually, for how do you pick any collaborator? Well, you need to get to know them.
Speaker 2:Yeah, I mean right, it's not unique.
Speaker 1:I don't think to this space, yeah but how are some of the ways that you've experienced establishing the collaboration for success? Are there some things you can do? Is there some expectation setting you can do in advance, before you get into the thick of things?
Speaker 2:Yeah, it's a great question. So you know I can speak for my company. What we really like to do is, once we receive a request for a proposal, we try to get a synopsis, a protocol synopsis, if we can, because that's really the meat of, you know, the project, and we try to take a look at that with the proposed team and determine okay, what do we foresee as risks? You know, what should we raise to this client? And honestly, that is happening. Whether they choose us or not, we want them to have the information you know to make sure that they are aware of all of these risks so that when they move forward, they're you know, they're eyes wide open, making sure that they can mitigate those risks, make plans for them, and that goes into all of the other processes that follow.
Speaker 2:So we develop our budgets based on you know what we would foresee, taking the study in order to operate it, what that budget would be, and then we also carry that into the bid defense. When we are speaking with clients, we raise them again, we talk to them about it have you thought about this? You know what is your plan for this? And then, once we get to that kickoff meeting all of these conversations have already happened. So when you get to that kickoff meeting, it's much less of a formality where you're going through all of your standard operating procedures, and it's more that you can actually roll your sleeves up and get going. And I feel like that setup really helps to just sort of, you know, dive right in and get going a lot faster because you have done a lot of the hard work upfront.
Speaker 1:That makes sense. I wonder also how, when you have to project manage a clinical trial, like you have to do when you have to operate it, you also need to really understand a lot of the sub disciplines that go into making a clinical trial successful. What is a good way to develop into being a clinical trial manager?
Speaker 2:Yeah, curiosity, I would say, is key. I mean for myself. I started in data management. I did that for about seven years and then I moved on to clinical monitoring and then on to project management and now I'm in this executive oversight role and I think it really helped me shape sort of my view of the operations and certainly, you know, allows me to understand every step of the way.
Speaker 2:If you know, if you are a curious person, go for it, ask questions, go, attend seminars about things that you want to learn about, and hopefully you have an employer that allows you to do that. I also have my regulatory affairs certification and that was just so I could really understand, like, what are these constraints that sponsors are facing when they're running their clinical trials? And that really helps me. Also, you know, sort of shape that view from when we are supporting them, you know, trying to help them meet these goals and having a basic understanding of what might be underneath all of these requests. That may not seem, you know, reasonable at the time, but it allows me to sort of, you know, understand and push my team forward and help them understand it as well.
Speaker 1:I think that's the best advice I've ever heard, because there's so many tiny nuances in our space. Right and the only way. There's no education that will enable you to take on this role.
Speaker 2:No, you're absolutely right and it's just going to be that curiosity and the self-motivation.
Speaker 1:Yeah, that's a great advice. I also would like to ask we've talked about the cooperation with the sponsor, which is, of course, very important, but there's also collaboration with the individual sites where the trial runs. I'm wondering what kind of dynamics have you experienced in those collaborations?
Speaker 2:You cannot run clinical trials without sites full stop. So you really need to understand who your sites are, who has the experience, who knows these patients that you're looking to recruit, and the good sites will emerge and you continue those relationships with those sites. And as a project manager I always saw myself as an advocate for all. So I was advocating for what the site needed, I was advocating for what the sponsors' goals and desires were and I'm advocating for my team trying to make all that work, which can be hard sometimes, but it's all very important. So a lot of times sponsors don't fully understand why a site is asking for a piece to get their budget and you just need to talk to them. They'll tell you and I think that the sites really appreciate that when they have that advocate, they can tell that you really want to work with them, you're listening, you hear them and you are going to the sponsor with these requests to try and facilitate their operations for the study.
Speaker 1:No, that makes sense, and it's an interesting way that you put it that you need to advocate for all. But I think that's a very good point. That's the only way to get all these loose ends to tie together, if there's at least one person who tries to ensure that's coherence.
Speaker 2:Yeah, and it's the only way it's going to work is if everybody's communicating and listening and trying to understand. It doesn't mean you always have to agree, but you do have to listen.
Speaker 1:That's so true. I was also thinking about the role that you have seen technology play in trial execution. Maybe also some examples of where it's been used for good, and maybe some examples of where it makes everything more difficult. Yeah, that is a slippery slope for sure.
Speaker 2:You know some of the studies that we work on. I'll give an example, right, e-pro. Everybody knows E-Pro, so many people use E-Pro. But there really are some cases where sponsors will come to us with these requests for vendors or technology that they definitely want included in their study. But then when we go and talk to the sites, they're just they're like that is over complicating it.
Speaker 2:So there are some studies that we work with sites and the patients are in confinement, and so you know, the request for E-Pro when somebody's in confinement isn't necessarily a worthwhile expense, right, because the patients right there, they're not going anywhere, they're not going to lose their diary and if you're really only answering a few questions one or two a day or even more than that it's still far more cost effective, much lower risk maybe to use something as low tech as paper.
Speaker 2:So you know, we really do try to look at that. When clients come in with requests for lots of different technology, does it make sense in the context of the study design and the sites are a key piece to that conversation because they'll tell you this doesn't make any sense and if we can save our sponsors money and hassle, all the better, right? We will definitely provide that feedback. And you know, and I feel that there are also a lot of vendors out there trying to sell their greatest. You know, technology which sounds awesome, but sometimes when you put too many of those technologies, too many of those vendors in one project, you are taking far longer to get up and running, and for what benefit in the end. So, always thinking about the end in mind, what am I getting out of this? Is it worth the money and the additional time that it's likely getting?
Speaker 1:I think that is so true because we have so many ways we can put technology together. But in some cases, like removing stuff maybe beneficial and just thinking about how can we get through this trial the fastest.
Speaker 2:Yeah, or maybe just saving the technology you know for those key endpoints that you feel it would benefit the most, and maybe you don't need the other things that aren't as important in your analysis.
Speaker 1:That's a great angle. I'm curious does role focus on some specific theoretical areas?
Speaker 2:Yes, and we have recently shifted to focusing on what we call our core for, and that really it doesn't mean that we don't do studies outside of those therapeutic areas, but it really is so that we can focus and become those true experts in these spaces.
Speaker 2:And so we focus on. Analgesia is one of our core, for we do a lot of psychoneuroscience, we do. Respiratory is another one of our core for, and then we have dermatology and we have done oncology as well. But those are the main areas that we focus on and it's just because, you know, we have the deepest expertise in those areas and we have a smattering of expertise in other areas as well. But really wanting to make sure that our you know project managers and our field team leads and other functional areas don't feel stretched to thin, we want them to be those therapeutic area experts where they feel like they can make educated decisions moving forward in projects, because a lot of times you're working autonomously and that's an uncomfortable place to be if you're having to make those decisions on a therapeutic area that you really don't even know.
Speaker 1:And I think that's an important point. Expertise really makes a big difference in a therapeutic area. I would, I would be curious to understand if there are a lot of differences or similarities when running trials in these four different areas. Oh wow, that's a great question. A broad one, sorry.
Speaker 2:I'll go back to my original, you know statement about how clinical trials are run right. So at the very basic level, there are the components that go into. The clinical trial are the same and you're never going to get away from, you know, having to work very closely with research centers to understand where they're getting patients from, how are you going to find patients, and it's different right for every therapeutic area, but the process of uncovering these things is the same and we're running these trials generally the same. And again it goes back to this is a very highly regulated industry, so you do have to follow, you know, these laws and that guides a lot of the decisions right that are made in the clinical trials.
Speaker 1:Yeah, that makes sense. Yeah, well, I think we are going to start a edging towards the last question that we always ask our guests in the show, and that is, if we gave you the special transformation in trials, magic ones, that has one wish that can change the life sciences industry, what would you wish for?
Speaker 2:So don't judge me for my very polyanna answer. But you know, honestly, if money was not an issue, that would be my wish. I've seen so many great companies, right, have to pull their studies because they've run out of funding or you have to limit what you're doing in a study or what you're looking at because of the funding. And obviously FDA has put some grant. You know guidances and allowances in place for rare disease, which is excellent, right, we want to make sure that all areas can be studied and it really is so sad when you have to hear you know about, well, they had to prioritize one therapeutic area over another for funding purposes, and it seems to be. You know, and I'm not naive, I know that money makes the wrong go around, but it would be if we were able to remove that restriction. I mean, just think about the possibilities and you know how many more medicines could come to market.
Speaker 1:I think that's a great wish, and I do wish it comes true, because there's way more we could do and some of those trade wars are really painful and we end up having drugs sitting on the shelf that could benefit patients, but we just didn't have enough money to finish it Right. Exactly. Yeah, that's painful. Well, if our guests want to learn more about you, becky, ask any follow up questions or learn more about Ro, how can they reach out to you?
Speaker 2:Oh, certainly, so you can go to our website, which is wwwrowworldcom. You could reach out to me directly. My name Becky underscore. Bag it at rowworldcom, happy to answer any questions.
Speaker 1:Awesome. Well, this was a big pleasure to have you on the show, Becky.
Speaker 2:Thank you.
Speaker 1:It was a pleasure for me as well. You're listening to transformation in trials. If you have a suggestion for a guest for our show, reach out to Sam Parnell or Ivana Rosendale on LinkedIn. You can find more episodes on Apple podcasts, spotify, google podcasts or in any other player. Remember to subscribe and get the episodes hot off the editor.