Hi there, my name is Sakshi Khaptri and I'm a Rheumatologist and Dermatologist at the Icahn School of Medicine at Mount Sinai. Today we'll be talking about clinical research unit or CRU for short in an academic center. Oh, that's me. Okay, so before you start, you know, when you're thinking of starting a clinical research unit, thinking of doing clinical trials and you've never done it before, or you've been exposed to it in some way, shape or form, you have this high degree of motivation, but then you kind of don't realize how much work there is that needs to be done. So don't get overwhelmed. And the whole idea of this talk is to sort of give you a high level overview of what to expect and what to think of. So, you know, there are two types of clinical trial units or clinical research units. One is centralized. So if you have a dermatology division, then that's within the department of medicine. So that's a centralized CTU or CRU. Then the second type is a not centralized one. So if your dermatology unit is a department as opposed to a division, so that's when you have a non-centralized clinical trials unit. At the Icahn School of Medicine, we are a department, not a division. So my talk will focus on that. So, you know, just to sort of give a brief overview, you need space on a work area. You need the right staff. You need equipment. So those are like those basic things that you have to check. But then what happens next, right? So in terms of a dedicated space or work area, you need a place for your study coordinator or your staff to sit where documents will be stored. You definitely need patient rooms. You know, a consult room where the consent process takes place. You need exam rooms. You need a lab area for processing samples because when you're doing a clinical research or a trial, you have consent process. You see patients for their visits. You'll be drawing labs, skin biopsy. So you need lab areas. And then you need a secure room with limited access by people for storage of whether it's the study drug. That's an important place. And that area should be secure. So this is just an image of a patient room in our clinical trials unit. This is where we do the consent process. And it's no different from an exam room. This is where we do the examination for our visits as well, biopsies, labs, and whatnot. So it's kind of no different from what you will have seen in a clinic or a practice where you're seeing patients. So staffing will either make or break you. So it is very important to hire staff that are competent. A clinical trials coordinator or a research nurse to handle the administrative aspects of clinical trials is this person will be your right hand, assuming you're right-handed, or your left hand if you're left-handed. Just to sort of, the whole idea of me emphasizing on that is that this person is the most important person. So make sure that you hire right. The second point to note is that if you're just starting out, you will need to dedicate time to seeing subjects that come for follow-up in the clinical trial of a consent. So you will be the person doing all those visits until you expand and hire either nurse practitioners or physician assistants or other MDs to assist you. The third thing is that if you're thinking of infusions or doing clinical trials with infusions, you need a nurse to help with administration of infusions. And so these are just some things to think about. The first two points are super important. Infusions, again, depends on whether you foresee yourself doing that. In terms of equipment, it's the usual. You need a thermometer, you need a height-weight scale, you need a refrigerator where you could store the studied drug, assuming that it needs to be refrigerated. You need monitoring devices for the room, for the refrigerator. You definitely need a centrifuge, an incubator, and then dry ice if the protocol requires shipment of samples on dry ice. So you need a big storage chest for dry ice. And then, you know, there should always be a backup generator for rooms or equipment where you're storing studied drug or biological samples in case of a power outage. So people tend not to think about it. So this is a super important thing to think about as well. So these are just examples of our refrigerator. You could see where there's a temperature monitoring device. We have a centrifuge. So this is what our rooms look like. So in Mount Sinai, we do a lot of clinical trials, and we have three main locations where we do clinical trials. Two on the Upper East Side, and then one in Mount Sinai Union Square. And then, you know, just to sort of give you an overview of the clinical trials that we do in our department. You know, you can have federally-funded clinical trials. You can have investigator-initiated clinical trials, you know, something called IIS, my bad, IITs. Then you can have clinical trials that are sponsored by pharma companies, right? Or if you get a foundation grant, that can be used to do a trial as well. And then if your department has resources or they wish to invest in a clinical trial, they could do that as well. When it comes to investigator-initiated clinical trials, it could either be a single site or a multi-site, and same thing as for pharma companies. Sometimes you can have a single site, you know, if it's a clinical trial, if it's an orphan disease state, or if they wish to recruit a limited number of patients, or generally, pharma clinical trials tend to be multi-center, you know, that being said. So if you have thought of doing a clinical trial or setting up a clinical trial or a clinical research unit, what next? First of all, you should send feelers out there to pharmaceutical companies that you have the setup, you're thinking of it. So if a pharmaceutical company approaches you, you have to complete what is called the confidentiality agreement. Always review the preliminary protocol if they share it with you to understand whether you have the ability to enroll the number of subjects that they want to enroll. I mean, assuming you even see that disease state. Then you complete a site survey, which is basically a CV for both your experience as a researcher and your site's ability to perform research activities. Then you meet with the sponsor for a site qualification visit. The representative or the sponsor will review the general requirements of the protocol with you, they'll inspect your equipment, the workspace, the rooms, just to determine if the site can feasibly carry out the study. If you've been selected, what next? That's when you start the heavy work, which is initiating budget and contract negotiations, completing regulatory documents, making sure that you have an IRB application that's prepared, submitted for approval by your institutional IRB. Also, things that people tend to forget is that make sure that you start making a list of patients that have that disease state for which you're doing a clinical trial and seeing whether they are eligible based on the inclusion exclusion criteria. So you can sort of get going with reaching out to them once the IRB approval is granted. Make sure that you've received all study supplies, lab kits, study drug. Often, these are the things that delay. You want to make sure that you have everything because if you're doing that screening visit, you don't want to realize when the patient is sitting in the room waiting to be screened, consented, that you don't have the lab kit. Or if they come for randomization, realizing that you don't have the study drug. And then required trainings. You have to finish all required trainings that are provided by the sponsor. And site initiation visit is another step. And that's when the sponsor or the representative of the sponsor will go over the specific requirements and procedures just to ensure that the staff is familiar with the details of the protocol. And this also gives you an opportunity to ask questions or clarify things if there's any confusion. And then once you've got the green light from the sponsor, you start screening subjects. So what's behind the scenes? So we kind of talked about pharma clinical trials so far. Now, what if you're thinking of an investigator initiated clinical trial, or you have a grant that covers a research idea that you have? So here is where that clinical research coordinator that I talked about can be very helpful. Because he or she can help with the protocol development. So like I said, this is your right-hand person. I'm not gonna repeat my joke. But this is your right-hand person, assuming you're right-handed. So he or she can assist you with the regulatory process for approval, activation of the research study, and this includes protocol, budgets, contract, IRB submission, back and forth with the IRB, things that you may not have a lot of time to devote. So this is where hiring the right person is important, who has experience with these steps. I will sort of help, I will build this up before I talk about this slide. So this way it's more clear. So these are different aspects of the optimal infrastructure. You need space, exam rooms, areas where you have to sort things. Maybe it's an EKG machine, refrigerator. So you definitely have to think for space. And it's always good to think of how many clinical trials do you foresee yourself doing once you've established yourself? So always good to start off with additional space if you can from get-go. Because sometimes it might be hard to get more space in the future from your institution. And do you have funds or resource allocation for starting things? Administrative support, again, very important. It's not like one is more important than the other, but just want to emphasize on the fact that administrative support is very important. You need a person or people that have experience with dealing with the FBA, making sure that clinicaltrials.gov has updated information about your clinical trials. IRB applications, NIH applications you might consider for application, submission for NIH grants. And then this person or people, a group of people are also helpful in protocol development support if you are doing an investigator initiative clinical trial or you get grants from a, you get research funds from a grant. Then training, you have to make sure that you're up to date with the training that's needed for each protocol based on if it's a pharma versus not. And then GCP or good clinical practices is important and that's a training that's done ever so often. And then continued, and that's a part of the whole continued education. So when you have all of this and you can start thinking of marketing. Hopefully I've not put anybody to sleep. So just like a brief overview of things to consider, make sure that you review the study and you know what the product or the drug is before you say yes to becoming an investigator for a study. Look over the content and the design of the study. Understand the time commitment that's needed from you as the PI. And then negotiate, negotiate, negotiate, negotiate the budget. If you think that this is not adequate for the amount of time that you're putting into it, ask for more. If you don't ask for more, you won't get more. So it's important to ask and you need to negotiate. If you're just starting out, a few things to sort of be mindful of is start with a later phase study, maybe a phase three study when you know the drug or the device has undergone initial safety and efficacy review. I take informed consent and staff oversight very seriously. Be prepared to recruit outside your practice. And this is where the whole marketing comes into place. And then understand that if you're recruiting within your practice, that there could be ethical issues that come about. You know, as a physician, you have a lot of influence over patient decision-making. As a researcher, you have an obligation towards research. So you have to sort of make sure that you balance that, you know, being a physician versus being a researcher. Eventually, you know, it is a business decision, right? You know, nobody wants to talk about the business in healthcare or the business in medicine, but if you're doing a clinical research unit or the clinical trial unit, you have to understand that this is a business decision. You have to make sure that you are prepped for success and that, you know, it generates a profit and that you don't lose money on this decision of yours. Staff, physical space, and always good to have some sort of foresight that, you know what, if we were to expand, do we have the ability to have additional space? So always start off with that, right? Then the next few slides, we sort of talk about a few do's and don'ts. Do, you know, it's okay to start small, you know, just to sort of test the waters, get yourself established. Start with one trial where you do really well. The goal should be to, you know, enroll as many patients as you can to the best possible job. And of course, when I say enroll as many patients, this means that, you know, successfully these patients are able to complete the clinical trial and then they're not dropping out. So that's an important thing to sort of be mindful of as well. You know, don't take too many things on your plate. Don't take too many trials until you're sure and confident. And because, you know, you need to build your reputation. So it's always good to start small, you know, one trial, do it well, you know, let that be your launching pad. And then build a patient database for, you know, various diseases. And then let pharma companies know that you're interested in clinical trials or that you have the setup for clinical trials. A few things that can also help you sort of disdifferentiate with, you know, with others is if you're doing something different. So things like mechanistic analysis, you know, biopsies, biomarkers, you know, tape strips. And we talk a little bit about that. And then, you know, pick trials smartly. You know, is it a novel mechanism? You know, does it kind of make sense from a mechanism of action perspective? You know, is this a disease state for which there aren't many FDA approved medications? You know, the other things to do is, you know, make sure that you train your staff, you know, make sure that you attend all investigator meetings and you understand the protocol. You need to understand the protocol, its inclusion, its exclusion criteria, because, you know, that's how you'll be prepped for success. And then, you know, I previously mentioned about, you know, something special, you know, make sure that you're doing something special. So at Sinai, we do a lot of, you know, tape stripping, and we've sort of, you know, Dr. Gutman has, you know, is the expert in tape strips and evaluation of biomarkers for inflammatory skin disease. And, you know, her lab, you know, gets tape strips or, you know, biomarkers for, you know, trials that we don't even necessarily do at Sinai. So it's always good to sort of pick a niche or a niche, depending on how you pronounce it, and, you know, sort of become an expert on that, right? A few other do's, you know, treat your clinical trial patients as a part of family. They are, you know, giving their time, they're giving their skin biopsies, you know, if that trial involves skin biopsies, they are trying maybe an investigational product. So, you know, treat them as a part of your family. And then, you know, if a clinical trial is done and they completed it, don't wash your hands off of them. You know, if they need to see you afterwards for free visits, give them free visits if they don't have insurance. They will, you know, feel valued like that, and they could come back for other studies that you might have in that particular disease state. And then be sure that you include appropriate patient reimbursement as that, as a part of your budget, because that is a key component to success, right? A few do not do's now, we're switching gears a little bit. First, do not be afraid to ask experts in clinical trials questions. Even if you're not comfortable with something, you know, reach out to your mentor, to your colleagues who are familiar with clinical trials. You do not want to hire too many people in the beginning because you want to make sure that you, you know, first of all, have the right stuff and that you succeed. And then you expand gradually. Do not take too many trials in the beginning. It's like I said earlier, it's better to do one trial and enroll, you know, 10 patients, because then you can have your name listed on as a co-author on a paper, rather than doing multiple trials where you're just recruiting one or two patients. I understand that some disease states might not be amenable to recruiting 10 patients. You know, I do rheumatology as well. Rheumatomycitis sort of comes to mind. There's no ways, it's hard to recruit 10 patients for DM, but it's easier to recruit, say, 10 patients for atopic dermatitis. So, you know, start off with a trial that you know you will be able to recruit patients in double digits, right? Because the idea is, you know, you want to build a reputation and you don't also want to lose money because a clinical trial is, it is a financial decision for the department at the end of the day, right? Do not hire inexperienced people if you cannot train them yourself. So it's very important to rely on experienced patients. Don't shortchange yourself when it comes to hiring. You want to hire the right people so that you're prepped for success. And then specialize. You know, there's a revolution in inflammatory skin diseases that's going on. A lot of trials that are done in inflammatory skin disease state get published in high-impact journals. So, you know, specialize. Find a niche, you know, find a disease state that doesn't have much going on and, you know, become an expert on that. So it's always good to, you know, think ahead. Do not be too confident. That's when you start to make mistakes. And again, in the very beginning, and this sort of holds true for, you know, even if you become a seasoned investigator, if you have phone calls, you know, whether it's with your pharma company that's doing the clinical trial or trainings, do not miss them. Don't just outsource it to your reliable staff. You know, you are the PI. Eventually, everything is your responsibility. And then, you know, the third point in this slide talks about, you know, do not enroll a patient that you have concerns that they will not be compliant with the study because you want to minimize dropouts. And, you know, this is something that sort of you learn on the go because you do not want to be that site where, you know, you enroll multiple patients, but guess what? 50% of your patients drop out. So that's not a good number. And I'm just like making that number up, but that's not something good to be known for, right? You want to make sure that you're enrolling patients who will continue and, you know, complete the study. So you don't want to enroll somebody who tells you that, you know what, they're probably going to move because they're interviewing for a different job and they're not sure that they'll come back or they'll stay in your geographic area for longer. So, you know, that's like a red flag. So just be mindful of those things, right? And then, you know, research is feast for famine. Sometimes you have lots of trials that are going on. Sometimes you have none. You have to be all in, you know, or wholeheartedly have a skilled team or just don't think of doing it at all if you're not all in. And that was it. So thank you so much for listening. Hopefully this was helpful in giving you like a brief overview of a clinical research or a clinical trial unit in an academic center, you know, in a department as opposed to a division, because in a department you have more agency of what you can do, what you can ask for as opposed to when you're a smaller piece of that pie if you're a division. But so again, thank you so much for listening and that's all.

clinical research unit

clinical trials

Mount Sinai

patient recruitment

trial management