Sponsored Clinical Research, Challenge and Execution
Episode

Adam Larrabee, President at Rochester Clinical Research

Sponsored Clinical Research, Challenge, and Execution

Brought to you by   | hosted by Joseph Kim

 

Let us say: being a research site is no walk in the park.

In this episode, Adam Larrabee, president of Rochester Clinical Research, talks about how a site runs sponsored clinical research and the challenges it has to face to achieve it. Every sponsor works differently, so there is a protocol to be followed when starting a trial to ensure its success. Adam discusses the process and its challenges, from pre-site qualification to the trial’s execution. He talks about areas where there is room for improvement, like training and onboarding, protocol manuals, and patient enrollment. He also speaks about the site’s relationship with sponsors and how it can affect the entire process for worse or for better.

Tune in to this episode to learn how research sites operate when contracted for clinical trials by sponsors!

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Sponsored Clinical Research, Challenge and Execution

About Adam Larrabee:

Adam joined Rochester Clinical Research in 2008, a company his mother founded in 1994, for a credit he needed in college. He got his bachelor’s degree in business/marketing and proved his way to become president of Rochester Clinical Research in 2016. His love of people, quick wit, and ebullient personality make him a natural for developing business relationships with partners and the community. Adam is responsible for strategic marketing and business development and contributes significantly to the corporate strategic plan.

 

Research Confidential_Adam Larrabee: Audio automatically transcribed by Sonix

Research Confidential_Adam Larrabee: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Joseph Kim:
Welcome to Clinical Research Confidential! On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health. But it’s not for the faint of heart. And so on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry, now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
Adam Larrabee, really great to have you. I’m happy to introduce you to the audience. Everyone, Adam Larrabee is the president of Rochester Clinical Research. Welcome to Research Confidential.

Adam Larrabee:
Thanks for having me, Joe.

Joseph Kim:
Yeah, so let’s start from the beginning. Like, how do you get into a business like, clinical research? It is something that I fell into myself, like, I don’t go to college for doing this. How did you end up doing this sort of thing versus, like, flipping burgers or doing, you know, actually being a doctor yourself?

Adam Larrabee:
Flipping burgers was definitely on the table at one point. Fortunately, my mother started the company back in 1994 and I joined her in 2008. I needed a credit for college and I got some real-world experience with her and doing business development, and then I just kind of proved myself throughout the way and became president in 2016.

Joseph Kim:
Yeah, I mean, so I think I met you as a business development person for RCR, and like, what was most surprising to you about trying to sell your site as a clinic for research?

Adam Larrabee:
Most surprising, I mean, I did all this stuff. The number of outreach to cold calling, that was new to me. Surprising business development, now, you reach out to all these sponsors, they’ve got these programs, and the sales cycle was so long, it was eye-opening, it, just how much goes into the process of initiating a trial. So it was always apparent to me that you need to have a lot of different sponsors opportunities lined up because not all of them ended up going forth. So that was eye-opening.

Joseph Kim:
Yeah, which is kind of a blessing and a curse because every sponsor works a little bit differently, right?

Adam Larrabee:
Yeah, they do. They do, and even their sponsors that work differently across therapeutic teams, it’s like, it’s not like, they’re not always talking to each other.

Joseph Kim:
Right, so this is kind of where we’re starting to tug at the corners of what we’ll talk about today, which is like the real challenge and difficulty of being a site because of a variety of aspects, and we can blame the sponsor here. Let’s just be, let’s just call it what it is, like, they are, have a variety of ways of working, like you said, even within their own company. And that variety, I’m guessing, leads to a lot of headache and mistakes that really, let’s be honest, aren’t your fault per se, because you’re smart, capable people. It’s, a lot of it has to do with this variety, it sounds like.

Adam Larrabee:
Yeah, I mean, they certainly don’t make our lives any easier as a research site. They are sponsors. There are CROs that are supposed to help them facilitate trial conduct and onboarding process, but at the end of the day, they don’t really know what we do, how we do it, and everything that goes into supporting a study from the site’s perspective. And if they had a better understanding, I think some things would run smoother, but that requires a significant investment.

Joseph Kim:
Yeah, yeah, so for the audience who may not know all the specific jargon we’re using, a sponsor, in this case, is a, typically a drug or device company who has an intervention that they’re trying to prove, and then the site is a clinic made up of a variety of healthcare professionals and other administrative staff where they actually enroll patients and conduct the study. So let’s talk about what things they don’t get right, and we’ll start from the beginning in terms of like training and onboarding.

Adam Larrabee:
Yeah, I guess training and onboarding, the facilitation of that entire process I think could be better. I think about the pandemic from a research site’s perspective and the ramping up that we had to do, the hiring of all the nurses, the study coordinators, ancillary support staff, research assistants, you name it, there’s a lot of role, and we’ve created a lot of roles, but that was a significant investment of just hiring and onboarding people. And then once you have them, you need to really invest in training and development. If we want to be successful, we have to invest in our people. And I think that, to me, stands out as lacking at the sponsor and CRO, or the contract research organization, that level, I’d like to see more of that same investment in their development of their people because at the end of the day it’s going to make them better and we have to work with them so it will make us better too. And then at the end of the day, the data we’re collecting from the patients through their participation in the trials becomes better.

Joseph Kim:
Yeah, I mean, this is serious stuff. It’s science, right? And it has to be done like, not perfectly, but at the high level of excellence. And if, to your point, if you’re not going to really invest in your people to make sure that they’re experts in the protocol, at the very least, not to mention just expert clinical researchers, there’s only so much you can do as a site to make sure that you’re going to do things the right way. So let’s talk about like the specific site initiation visit, right, where a field person from the sponsor or CRO has to come and like train you how to do the protocol. How effective is that? Ten out of ten times, how effective is it?

Adam Larrabee:
Well, I said, all right, on a one to ten scale, ten being the most effective, I rank your average SSIV I give it maybe a six or seven. That leaves, that final three or four points there are where all the real unknowns are. But stepping back before that SSIV, before that kickoff meeting for the trial, it really, the trial execution starts at the pre-site qualification where the sponsor or the CRO is assessing a research site facility’s ability to do the trial and we’re assessing our ability to perform on that as well. And we don’t always have all of the information about the study. We may have just a summary synopsis of the procedures that are done for that trial for a number of patients. They don’t, we don’t always know how many sites are going to be used or the total number of patients, so it’s kind of hard to project how many they want us to do. And it’s where you play the game of this is how many patients we can enroll for you, and they say, well, we need you to do this many, but they don’t tell us, they need us to do that many all the time because the person that’s assessing us doesn’t always have all the answers. But it’s after that pre-site qualification visit then we’re selected and now we have to determine, are we able to do this? But it’s going on, and then we get more information slowly. So it’s kind of the way of the beast, but it definitely plays into our ability to do it because of course, once we’re selected, they want us to start immediately, and let’s get that SSIV scheduled. So things get better as the process moves along from assessing us to selecting us to initiating us where it’s only a six or seven out of ten at that point to finally being greenlighted, which could be the next day, it could be a week later, or a month. So along the steps, there’s always room for improvement.

Joseph Kim:
Yeah, I mean, let’s put it into the framing of looking for a job and being hired, which essentially is what it is. I mean, what you’re saying is your employer is coming to you with like a half-baked description of your job, and then you say, well, based on what you said, I can do it, but you know full well in your mind they’re leaving some stuff out or they don’t know yet. And then when they hire you, they’re like, hey, let’s start tomorrow. And you’re, and you’re really caught on your heels then with all that.

Adam Larrabee:
And not to mention you’re negotiating your salary after you’ve been selected.

Joseph Kim:
Right, yeah, it’s a little crazy. I have to say, when you think about it just objectively, kudos for you for staying in this industry. So let’s talk about some of the holes you mentioned, right? So you get an incomplete set of assumptions about the protocol, like here are the things you have to do in this order and this timing. And then when you finally get the protocol, what does that document really look like, and how helpful is it as like the real manual for running the study?

Adam Larrabee:
Well, I think it misses some key things, which is why they have other manuals like the lab manual, those are important, you need that. What’s missing is how much of what we’ll need to do the protocol, is going to be supplied. We know our goal of patients, that’s being, we’re being asked to enroll in a study, say it’s 20 patients that they want us to enroll, but are we being given the resources we need to see all 20? And when are those lab kits, the needles, the tubes for us to collect the blood and all the access to all the various portals that we use to enter the data into, those require training and certificates, when are we receiving that? Do they have all the people we have listed as support for us to do this in their databases so that they’ll be given that, those accesses? Those necessarily belong in the protocol, but it’s directly tied to our ability to do the protocol?

Joseph Kim:
Yeah, yeah, exactly, and that’s poorly communicated either because they don’t know or they forget or a combination of both or they’re still working on it.

Adam Larrabee:
Well, I just think it’s known steps that need to occur and we’ll get to them when we get to them, and we have people that will work with you to help you, but they’re in a different time zones, speak a different language, don’t really know the protocol or the program as well as they should. It’s just, it’s all people that are involved in supporting the entire process, whether it’s a project manager, a data manager, a nurse, a doctor, or a receptionist. It’s all people at the end of the day. And I think communication around all these moving parts too, I would rank as a two or three.

Joseph Kim:
Yeah, so even before the protocol starts, wow, 2 or 3, that’s a mid-massive failure. I mean even six or seven, that’s a D plus, C minus right there, so that’s not so great either. So even, so forget about the protocol conduct, even all the prep for doing it, that’s its own project itself. And you don’t have line of sight and it’s just people doing things without being integrated and connected in the final, the total end game, which is like activate the site.

Adam Larrabee:
Yep, that’s lacking. I immediately think of all the other studies, the research studies were doing and the patients were seeing for all the other programs. So any study that we do for a sponsor is just one study for that one sponsor. We have a lot of different research studies. We’re working on a lot of different new and exciting stuff, whether it’s COVID vaccines or RSV this fall and flu this fall, everything’s being shifted, but we still have these COVID vaccine trials that we’re supporting. So the development of these RSV or flu vaccine, vaccines is kind of dependent on these sites that focus in vaccine work that are currently supporting other work and communicating timelines for these upcoming programs and our ability to enroll more patients in those while we support these other trials, it’s becoming more and more difficult. So we have to block days, set aside, designated days to see patients for individual projects, and then those days shift, or they’re not really communicated, or the stuff that we need to do them gets delayed, or IP gets held up and customs, all these things play into any more research sites’ ability to perform on all of their trials because they all kind of affect the work day.

Joseph Kim:
Or it’s all these different supply chains, accesses, drug supply, none of that’s orchestrated in a tight way where you can kind of just let things kind of run automatically where things will get triggered because it’s time to get triggered versus you chasing down all of this like, well, where is this? Where’s this? Where’s this?

Adam Larrabee:
Yeah, that’s right, we do. That’s a great way to put it, we have to chase a lot of stuff down.

Joseph Kim:
I mean, even so, I’m still in a COVID vaccine trial. And this simple thing I saw, witnessed firsthand, which was like, okay, well, I’ve finished your vitals now, let me go find the pharmacist so she can take the vaccine out of the freezer. And so I’m waiting around for 45 minutes, you know, letting them take it out, come to room temperature, and like, that’s just a lot of wasted time versus, it’d be great to have that pharmacist just notified like, oh, Joe Kim’s in the office, he got his first procedure done, get the drug ready. So like, then it’s ready automatically.

Adam Larrabee:
Yeah, different, so that’s a site process. Different sites have different processes to make that faster. Generally, when a patient, for us an example, what we do, and maybe this is a good tip for any other research sites that’s listening, is once a patient is checked into the facility, you don’t want to start thawing the vaccine yet because it does have to thaw, it’s been stored at -70 or 80 degrees. But once the patient does qualify and gets to a point, there should be a trigger to immediately take it out. Sometimes the vials come in multi-dose vials, and you know that you’re going to have X number of patients come in, so you can take it out and let it thaw, and it’s good for 6 hours, so you can, the patient doesn’t have to wait as long, but sometimes there’s limited doses, limited vials, limited quantities because a sponsor wasn’t able to buy enough from another sponsor to supply for their study. And they don’t want you to risk an entire ten-dose vial expiring because you only had two patients scheduled. They want to get more doses out of the vial. So yeah, some of that is very basic.

Joseph Kim:
Yeah, yeah, but certainly, there’s no tools that you’re provided to help make that easier.

Adam Larrabee:
Yeah, and then all the logs on top of, so IP accountability, how many doses do we have? How many do we use? What time did it thaw? What time was it administered? Who did it? What time do we put it back in the refrigerator or the freezer? All those, they vary by sponsor. I mean, some large sponsors have very complicated logs that don’t really need to be as complicated as they are, and it’s all pen and paper. Why not barcode and software? So now I’ve got one binder that my one, my two unblinded pharmacists that are administering the vaccines are using. If I wanted to do any more patients, I need another pharmacist, but I still only have one binder, one log. So now they’re like falling over each other. So we’re trying to do the volume of patients we need. And this is like real insight into what happening in COVID. We were trying to enroll thousands of patients, but the bottleneck was the number of unblinded vaccine administrators I had to give the vaccine. And they’re just, they can’t have three different logs for the same process because that gets messy, you don’t want to make a mistake, so areas for improvement.

Joseph Kim:
Yeah, for sure. Let’s talk about trials that don’t have such high enrolling numbers of patients, right? So, well, let’s start here. How many trials might you be conducting in any given month?

Adam Larrabee:
So this year we’ll probably be doing, have ongoing about 50 at any one time, about 40 to 50 trials. Next year it’s going to be about 50 to 60 trials, and that’s being supported with a staff of 70 people, about 12, 13 of which are study coordinators and other ancillary staff as well.

Joseph Kim:
The real foot soldiers in this whole battle. And then you’ll have a bunch of nurses and investigators that sort of do a lot of the clinical stuff as well.

Adam Larrabee:
Yeah, patient engagement specialists, patient recruiters, research assistants, dedicated lab people, that’s kind of how our model is. As we’ve grown, what’s enabled us to do enroll more patients and take on more trials is parceling out the roles and responsibilities needed to support a study. Some sites, the study coordinator does everything. We have that study coordinator who’s a registered nurse or somebody with an advanced degree just seeing patients, creating the source for the study visits, doing that element and recruitment data entry, regulatory, all done by different people.

Joseph Kim:
Yeah, got it. So let’s make the math easy because I can be done with arithmetic here. So let’s say you’re doing 30 studies, because there’s 30 days in a month. What’s the cadence of patients you’re seeing in each study? Is it like, are you seeing five patients from every study each month, or is it like one a week?

Adam Larrabee:
Great question, this is a constant struggle. You really got to look at it like an assembly line, project management, what we know is we have to, we’re contracted for however many patients, and we have to see those patients, and we have to see them as quick as possible. We know that we have X number of patients that we can see in a day, and if we see all of those same patients for that same study in one day, say it’s 60 patients in a day, we can be done enrolling for that study in one day if the goal is 60, or at least we have all of those patients on, coming on the same day. So now I’ve got my whole staff seeing all the patients for that one study. So now we’ve got consistency, we’ve got support staff, everybody’s focused on the same thing, it’s easier in the lab, it’s easier at the front office, and it’s easier for everybody else, because then you can allocate resources to ensuring consistency. Then there are all those 60 patients are coming back, whether it’s a week later or a month later on the same schedule, so that, now we can shift some, the next day, you can see patients for a different study. Where you can get in trouble is when you’re seeing 120 patients for ten different trials in one day. That’s, now the lab has got so many different more so many different lab manuals they have to go through, and it’s just, the scheduling rules, it just becomes way more complicated. So you try to block days for designated studies for patients’ visits, and it just makes planning everything easier. But we have a difficult time doing that because patients have lives of their own and when they can come in, and we sometimes move away from these bulk days, as we call them, and then we set ourselves up for trouble in the fall when we don’t have as many days set aside for these fall flu vaccine trials where we know we have a high volume of patients we need to support. But also you get yourself in trouble because you’ve got your low-volume trials that may be, the only watch you enroll five patients per week because they want to ensure the quality, they don’t want to overwhelm the system. Now you’re trying to figure out, all right, where do we plug in these five patients? Or it’s really ten because five of them are going to no show? That’ll get you to your five, so it’s all trouble with the calendar.

Joseph Kim:
Right, and then so, and other trials where you might enroll a max of 20, let’s say, and you can’t get them all in one day because it’s, I don’t know it’s asthma, right, or whatever. That looks very different then, because you might see what, two patients a week, or depending on, or four patients a month kind of thing?

Adam Larrabee:
Yeah, we, probably two a week. You know, it all depends on how many people you dedicate to it. We have a social anxiety disorder trial that was supposed to start, but the spots are just found out that it’s, requires DEA licensure. How do you guys not know that beforehand? So now we have to wait for that. But when it does start, our site psychiatrist has to be available and he’s available a half day a week, which means we can probably only see two patients on those days that he’s available, but I didn’t guarantee that two patients on Wednesday, once a week, for six weeks gets us to the goal we need to get to.

Joseph Kim:
Yeah, plus you can’t get a lot of practice in. It’s not like those bulk days where you can, right, so you do two patients and then you, I’m guessing, you kind of forget like how to do that trial until the next patient comes in the next week, and then you’re like, oh, wait a second, how does this all work again? Or how hard or easy is that?

Adam Larrabee:
I mean, the coordinators do a really good job at knowing their trials and they do a good job at communicating with their backup team. I mean, our company, we have study review days where the coordinator who owns that trial, gets on the teams, and shares all the details of that trial. But the coordinators tend to forget if they don’t see a patient for that study, even the backup if they don’t consistently, or on a recurring basis, see at least one patient for one visit, they may forget. And then the visit takes a little bit longer for that patient. They have to talk with the primary coordinator to know, where does this plug go or whatever it may be, that can be challenging, but I think sites do a pretty good job of it, but that is definitely a problem that they face.

Joseph Kim:
I mean, in your defense, these are human beings and they can’t be, possibly, memorize 20 trials in their head, especially if you’re not seeing patients kind of regularly. And what I’m guessing is where I’m headed, like the sponsors don’t give you a lot of support, really, other than manuals to make sure you do things with integrity.

Adam Larrabee:
Yeah, yeah.

Joseph Kim:
I’m being too mean? I don’t think so, right?

Adam Larrabee:
I think you’re right. I mean, it’s. You’re not being too mean, I mean, I guess we’re being a little hard on the sponsors, some do it better than others, but think about it. You’ve got the protocol, you’ve got these manuals and you’ve got the pre-site visit, you don’t get any details. The investigator meeting, which are now remote, they’re, those are where you get all the meat of the details of the trials, what you’re going to need to know about this study to help you do it, and that’s like a two-half days over Google teams or Zoom or whatever it is that they have to learn all about this trial. And even then it’s, all the details aren’t fleshed out. And I’d like to hope that they could flesh every detail out, but the reality is you can’t. We learn by doing what needs to be done better and correcting it.

Joseph Kim:
Yeah, I often think of it like a rehearsal dinner for a wedding. Like you can’t read a document about the rehearsal dinner three months out and then actually pull it off on your wedding day, right? There’s a reason why that rehearsal dinner is literally the night before, and everyone’s there, like, walking through it, like, because you don’t want too much time to wait before the actual ceremony. And like you said, you got to learn by doing so yeah, having a manual months ahead of the actual thing is, is kind of like the worst way to do it. I mean, we wouldn’t do it for a rehearsal dinner, so why would we do it for a really complicated scientific study? You know what I mean?

Adam Larrabee:
Yeah, yeah, that’s written by a really complicated scientific individual and then left to interpret by other people, and people are people and interpret things differently sometimes.

Joseph Kim:
Yeah, I mean, I guess it all boils down to this notion of, like, words will fail us just because they can’t capture every single thing, particularly around a complicated activity like clinical research.

Adam Larrabee:
Yep, yep.

Joseph Kim:
Adam, it’s been fantastic having you on board. Thank you for bearing your soul. I think you’ve highlighted a lot of common things that sites and clinicians are going through when they try and execute research. I mean, this is God’s work you’re doing here. This is not you know, you’re not just trying to sell sugar water or something. You’re advancing medicine, you’re developing therapies, so hats off to you.

Adam Larrabee:
Thank you so much. It’s challenging. It’s definitely challenging. It requires a lot of work. Talking about the issues that we face is step one. Talking about solutions is the next step, and it’s an interesting time to be doing this, so thank you for having me, Joe.

Joseph Kim:
Sure, yeah, next time we’ll talk about payments. I know that’s a, that can be a really fun topic too, but thanks again, Adam. It’s been great having you have an awesome rest of your day.

Adam Larrabee:
All right, you too, thanks.

Joseph Kim:
Thank you for tuning into Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to help@ProofPilot.co. This show was presented by ProofPilot and is powered by Outcomes Rocket.

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Things You’ll Learn:

  • Sites need to have a lot of different sponsor opportunities lined up because not all of them end up going forth.
  • CROs – contract research organizations – are supposed to facilitate trial conduct and onboarding processes.
  • A sponsor is a drug or device company who has an intervention that they’re trying to prove.
  • A site is a clinic made up of a variety of healthcare professionals and other administrative staff where they enroll patients and conduct studies.
  • The Specific Site Initiation Visit is where a field person from the sponsor or CRO visits the site and trains staff on how to do the protocol.
  • There is a pre-site qualification where the sponsor, or the CRO, assesses a research site facility’s ability to do the trial. 
  • The facility also reviews its ability to perform what the sponsor or CRO shares about the trial.
  • There is an investigator meeting, now done remotely, where the site is told the details of the trials and what they need to know to get it done.
  • Sponsors usually don’t provide a lot of support, other than manuals, to make sure things are done with integrity.

Resources:

  • Connect with and follow Adam Larrabee on LinkedIn.
  • Follow Rochester Clinical Research on LinkedIn.
  • Discover the Rochester Clinical Research Website.
  • For more information about Research Confidential please visit ProofPilot.com.
  • If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com.