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Starting a Clinical Research Site: An Interview With Kelly Willenberg

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It can be difficult to set up a clinical research site for the first time. What are some of the most common issues? In today’s episode, Darshan Kulkarni joins clinical research expert Kelly Willenberg to talk about setting up a compliant clinical research site. Plus, we’ll talk about the importance of adhering to Good Clinical Practice (GCP).

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks, or the show's website at

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have a crowd favorite with us today. We have Kelly Willenberg. And for those of you who don't remember, Kelly is the go-to expert as it relates to billing compliance, and in the context of helping develop a clinical research program. Most recently, Kelly got nominated to the board, I believe, of HCCA. Is that correct, Kelly?

Kelly: That's correct.

Darshan: And can you tell us a little bit more about yourself, and what is HCCA?

Kelly: So I am a nurse who has been in the research compliance industry since I started in 1984. So now everyone knows how old I am, which is kind of scary. But as a nurse, I came up through the ranks doing research, from being a research coordinator at a hospital taking care of sick and dying children on cancer studies, to helping the profession of healthcare compliance throughout the years and producing educational opportunities for people so they can learn about how to set up practices and how to do billing compliance right.

So as a nurse, I bring the medical knowledge that is needed to do that. But I mean, having the experience, I think, is a little bit different than some of the people that are out there that bring knowledge to the table. It's the fact that I've actually done almost every job in the healthcare industry around clinical research, having run a clinical research practice and large academic medical center.

And you ask about Health Care Compliance Association. So it is a organization that was established in 1996, that is a member-based association for healthcare compliance professionals. They do everything from conferences to publications, and a certification for healthcare compliance; healthcare research compliance and healthcare privacy compliance. And it's a way to stay connected with our peers across the world in compliance to help continuing education and develop better standards in a compliance program from across healthcare compliance to the society of ethics. So it's a healthcare compliance community that I bring my knowledge to the table to for the next three years as a board member.

Darshan: Well, they're going be really lucky to have you, is what I have to say about that.

So let's sort of jump into it a little bit, Kelly. So my first question is, in the context of clinical research, when does the average person approach you? When are they usually going, "I don't think I've got this figured out?" What is the thing that they haven't gotten figured out?

Kelly: Well, we have a lot of things that people bring to our attention, but I would tell you that a couple of the areas that we really do a lot of work in, and you and I have had a podcast in the past about, of course, clinical trial billing compliance. And when they find that they've got an issue, or they have questions about how that billing process goes, from the coverage analysis through the claims process.

But we also have a lot of clients that seek our help in establishing or reorganizing their clinical research office. And that can be rather challenging if you really don't have the knowledge or the bandwidth to actually know what you need in the form of a structure to actually go out and seek clinical research and bring it in to your facility, whether you're a practice or a small hospital facility that thinks that they want to do research.

Darshan: Now, in your experience, do you find more clients who are standalone small doctors offices calling out to you, or is it often large academic medical centers, or do you just sort of see an equal amount of both?

Kelly: I would say we do mostly work with independent practices, physician practices, that are interested in doing clinical research, all the way to community-based hospital programs that are either growing research rapidly, or they're a large hospital facility that has recently merged with another entity and they are, all of a sudden, accumulating, or it's morphed into this massive research program that they weren't really prepared for. And a lot of times, that's kind of even scary to even think about, is you've got a hospital system that recently merged with another system or a practice that's bought by a hospital system, and then, "Oh, surprise, we have all this research going on."

Darshan: So it sounds like you're really dealing with people who inherit almost a clinical research practice, and now they're going, "What does this actually mean for us?" Is that fair or did I misunderstand what you said?

Kelly: No, I think that's fair. I think sometimes people, they call us and we go in to look at their research program, you know, kind of analyze what they have, and sometimes they don't really even know what they have because they've recently merged or they've acquired a practice, and, "Oh, by the way, this practice has research." Or we've done work with physician practices that decided, "Okay, we're going to open a Phase 1 unit", or, "We're going to grow our small research that we've done for years. We've had a handful of studies open for years, and now we really would like to go out and seek research and bring it in." So we go in and really help them to set up a management structure that is research compliant within good clinical practice and good business practice, so they can have kind of a strategic plan to how they would grow into more of a solid research infrastructure.

Darshan: So what I find interesting right now is I'm seeing, I know you've seen this in waves as well, every four to five years, you'll probably see a large list of new "SMOs" or site management organizations, or independent clinical research organizations, or whatever you want to call them, or site networks, if you will, coming up. And they're all trying to solve the same problem. What you're saying is that, "I'll help you solve it internally", while they're saying, "We can help you solve it externally." Are there any advantages to doing it internally versus letting someone else take that on?

Kelly: That's a great question, because I think it depends on the site as to what really works best, and if they want to put forth the effort and the dollars that are necessary to build the organizational structure adequately. I sometimes think that sites have the impression that they can just start off and do research, and there's really not a lot to it. And if you're going to have clinical research operations on a daily basis, there's a lot of regulatory processes, a lot of regulations. I mean, you have to have some real careful detailed policies and procedures and training in order to meet the criteria that a pharmaceutical sponsor is going to want you to have if they're bringing in the study to your office. And that sometimes is the luxury of a site network where an office can just utilize the network and not have to have the infrastructure needed to actually do research. Because I think sometimes people don't really understand how important that really is to being successful in a research endeavor.

Darshan: So what do you think are the most common mistakes that they're making when they say, "We're going to pull research and do it internally?"

Kelly: I think sometimes it's clear not really understanding the roles and responsibilities that are necessary to adequately do a clinical trial. And it starts from the PI who has to understand their role and their responsibility, and the trickle down effect in a practice. And it can be a small number of people who have to do everything in order to recruit patients and follow all of the rules of the protocols and the regulations necessary, and then you add on top of that, all the billing compliance and revenue cycle piece. And a lot of times, I think with smaller practices or hospitals, they just don't quite grasp the brevity of taking all that on and taking it on quickly without a strategic plan, and, "How are we going to actually meet compliance efforts to grow or to bring in more complicated studies?"

A good example is a Phase 1 program. I mean, doing clinical research in a physician practice, if you're doing Phase 3 studies, pharmaceutical sponsored, you've set it up where you negotiate with the sponsor, you put a few patients on study, well, then the oncology team says, "Okay, well, we want to start doing Phase 1 studies", okay, whole different ball game now. Because you're looking at having PKs and labs, and things that might not have been done, and overnight stays and weekend stays. And a practice has to think about all of that and the things needed in order to do it well and do it correctly within compliance, because it's a whole lot more difficult to take a patient through a Phase 1 study without all of those necessary pieces in place than it is to open a Phase 1 trial and put a patient on, and they come in for a treatment and they go home for the next three weeks and then come back.

Darshan: I mean, I have a bunch of questions that came out of that. The first question that I'm sort of thinking about is, one of the big reasons that hospitals do this is because they think it's going to be really profitable. In your experience, is that the reason people jump into it? And if so, is it accurate? Does it reflect reality?

Kelly: Darshan, I truly believe that is absolute part of it for some facilities. It's, "Okay, let's open these trials. This is a way for us to increase our revenue", when they don't really understand the current state that they really have, their research portfolio; what they already do that's already open within their system. What are they hoping to gain by opening studies? Do they look at the studies adequately for feasibility? Do they really consider, what does it take to enroll the patients and actually take care of the patients? And the true cost of following these patients and ensuring that you have all of the necessary tools, so to speak, in your tool kit, to do the type of trial that you're going to open; such as a minus 70 freezer, or a certain centrifuge, or the ability to ship PKs on a Friday night at 10 o'clock.

I mean, those are the things that I think people don't always consider. And then they open studies and then it's, "Oh my gosh, this is a lot of work." Well, yes, opening a trial is a lot of work, and there is a lot to do from a compliance perspective that I think sometimes is not the priority. It's more or less, "Well, this is a good idea and we want it for our patients, and we might make a little money on it."

Darshan: I have one question that comes out of that and then I'll ask the other version of the same question, which was, if I was starting a brand new clinical research site and you came back with, "Well, it's a lot of effort", my first thought process would be, "That's fine. I have the people, plus I can just bill it all out. I mean, pharmaceutical companies will pay for that, won't they? So why is this a bad thing? That's just good revenue." What are they missing?

Kelly: Well, I think that sometimes they fail to understand that it takes certain expertise to do certain things within a trial. It's unfortunate that sometimes you'll see a small research facility or practice, or a small hospital, they just, you know, duties as assigned to these people that are already doing other jobs, now we're going to add research to the mix. And in my mind, from a compliance perspective, I always go down the path of, "Well, you have to really consider the OIG's elements of an effective compliance program." Before you start down the path of, "We're going to do clinical research in our facility", you have to think about all of the things that you really need to have in place, because if something goes wrong, what is going to happen?

And that starts with written policy and procedures, and adequate training, and making sure that there is a way to monitor what you're doing, and detecting problems, and all of the elements where ... I go back to one of the first things I said; it's understanding the roles and responsibility, and who has oversight over that research? And are they communicating well? Do they all understand what they're supposed to do to be successful for the patient?

And at the end of the day, that protection of that human subject has to be the priority. And I think sometimes, just assuming that a pharmaceutical sponsor's going to bring a trial in and they're going to pay for us to do it, and everybody just needs to take their little piece and do this, I'm more of the notion that everybody needs to understand what their responsibilities are from a compliance perspective, and how do we do this? And the PI ensure that they have oversight over what we are doing on a daily basis. Because if you have all that and you have an adequate compliance program for your billing process, you will be successful. You might make a little money on your studies that you open, and the pharmaceutical sponsors will see that and they'll want to bring studies to you because you'll be successful and you will meet GCP and regulatory compliance.

Darshan: So you raise this value or the importance of having the right team and that the team communicate well. Here's my question; if I'm a small community hospital who inherited a clinical research program, my first thought is, "Well, that's easy. I already have quality control people in place. I already have a bunch of nurses. I already have doctors. What's the problem?" What are they missing?

Kelly: Well, I think from doing audits and assessments that we do with clients now, and I have for almost 12 years, I think one of the things that people sometimes fail to think about is really, what are the operations? What's the activity? What's the research portfolio? Who are the personnel, and already, what's their workload? If you're adding research on top of it, or you're going to increase research without really looking at resource allocation among the team, do you really understand the current state? What's really going on? And by just saying, "Well, I've already got a team in place", what we try to do when we're looking at this process with a client is we're trying to ensure that not only do they have the right team and right structure, but are people trained adequately for the jobs that they are doing? And do they really understand the compliance aspects of clinical trial research?

Because a lot of times what we find is, there's a lack of training, and there's a lot of turnover in this area, and you sometimes have people that they just are having to do this because it's just an added piece to their job, and they already have a clinic job, but now they're also the study coordinator. And those are types of things, and you and I both know, having worked with clients, those are types of things where some people, they just are on autopilot, just functioning. And that worries me with good clinical practice and human subject protection and data safety. And the things that can get a site into trouble, even down your path of the investigational pharmacy. I mean, if you don't have an investigational pharmacist, who's doing it? Oh, it's the coordinator, who she has all these other jobs.

So those are the types of things, when we're doing a current state assessment, or we're helping to develop a new process for a new office; who's going to do what? What is the resource allocation of the personnel you already have and what is their current workload? And do you need other expertise to come in to meet regulatory compliance, research compliance, healthcare compliance?

Darshan: So the one big reason that people come and try to do clinical research is because they want to make money. The second reason is because you're trying to recruit physicians who often believe that doing clinical research will, A, get their name out there, B, good for patients, and C, "Well, I already have the patients so this can only be a good thing." What are they missing?

Kelly: Well, I mean, you have to really think about, and I see this sometimes, where I don't think that people really understand that ... For some facilities, the reason they do research is because the physicians want it. It's part of their mission. They've come from academia. They want to do clinical research. And in some instances, if you're not doing clinical research, you're not providing some of the better options of care, especially around oncology.

But it's taking that, what you just said, and really looking at the leadership and the stakeholders and aligning what you're going to do from a clinical research perspective so that the strategy and the endeavor down the road is all synced up, and everybody's on the same page. Because sometimes what we find is not everybody is, and not everybody sees research as part of the mission of the organization. So it's a constant battle to ensure that you have this solid research infrastructure and the financial support that you need to do that, if not everybody is on the same page as to where they want to be in the future with research.

Is it part of the mission? Sometimes the answer might not be what people want to hear.

Darshan: Interesting. So I know we're running a little tight on time at this point. Quick question, Kelly; if people want to reach out to you to ask more questions, how should they find you?

Kelly: Well, they can find me on my website, which is And you can always email me, [email protected]

But I think it boils down to really understanding, what is the status of what you have now and what do you need for continued research operations and growth, if that's where you want to go? And it's not just jumping in without thinking about what you really have, because that's where we see problems, is when an organization just kind of doesn't understand that all this applies, whether or not you're doing 10 studies a year or a hundred studies a year. You have to be compliant and you have to have process in order to be successful.

Darshan: I think you're 100% right, because you'll often see a lot of these sites who are starting out start off with, "Oh, I just want to start with one or two. See how I like it before I move on, and see if I really want to dig in deep." And the problem with that is, as you just said, whether you're doing one or a hundred, they expect you to hold yourself to the same standard. So [crosstalk 00:21:16] once, do it right. And unfortunately, you still will have to do it again because you have to keep doing it right.

But anyways, this was awesome, Kelly. Thank you so much for joining us. I'm looking forward to having you on again soon.

Kelly: It's always a pleasure, Darshan. I'll talk to you later. Thanks again.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter at @darshantalks, or the show's website at

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