Hello there. My name is Melinda Goodrum. I'm a dermatologist and clinical researcher from Peterborough, Ontario, Canada. Just by way of introduction, I'm delighted to present the clinical trials outside an academic centre. I finished my residency in 2004 in Toronto and I moved to Peterborough in 2006 to open my own private practice and I started doing research in 2010, so four years into a community practice. So here are my disclosures. These are all companies that I've done research for, nothing that is relevant for this specific talk. I'm also the owner of a clinical trial business that has two sites and we are a member of the Probity Medical Research Network of Sites. So the objectives of this session to really explore the benefits of conducting research as part of your community dermatology practice and also to understand what challenges you might have if you're doing clinical trials in your office in the community, but to appreciate really how this provides satisfaction, professional growth, personal growth from adding clinical trials to your practice. So there's not that many sites out there in private practice, so I'm often asked, you know, I'm a community dermatologist, what are the benefits of doing research outside an academic centre? Especially from younger dermatologists or residents who will be graduating soon, who all they really know is working in an academic centre and to take that leap to go work in the community and support a research centre. So there are a number of benefits and advantages to doing research in the community and I'd say the main one is speed. So we can conduct research really quickly, we can get things going more quickly compared to an academic centre. A lot of this revolves around the central IRB, so the Central Institutional Review Board. So the central IRB can review studies for a number of different sites and provide approval to get the study going. Whereas if you're in an academic institution, you need to use a local IRB, so their own review board as part of the institution. And so you may not be on the top of their list of studies to review. So I have many colleagues who've been delayed in getting started in doing a study and in fact many instances where once they were finally approved by their local IRB, the study was already enrolled and closed within days, which really was difficult for recruitment for them. You also have to think about the negotiation timeline of contracting and budgeting, which really is much faster if it's done with you and the sponsor CRO without all of the extra levels in an academic institution of reviewing contracts and budgets. You also don't need to have any administrative reviews or approvals when you want to do something in your clinic, you can just go ahead and do whatever you feel is necessary. And also a faster implementation of any recruitment plans that you might have. So once the study starts, you can start recruiting, you can start talking to patients, you can put it on social media, and without the approval of the academic institution. Also staffing. So you get to have your own staff that you hire that might be the right fit for you, whereas in an academic institution you may be assigned specific staff based on their seniority. Here you have your own staff and you can direct them where you want to go. So for example, our laboratory technicians at both sites are also trained in phototherapy. So if there's a day that we don't have any clinical trial subjects who need phlebotomy or whatever, processing of samples, then they may be kept busy in the phototherapy center. So I'm able to move my staff around based on where the need is or where my priorities are, where you may not have that leverage in an academic center. So that gives you a lot of flexibility, you can make fast and strategic changes without having to have anyone else's approval. When you get there in the morning, and you see some, you know, one person's called in sick, you can move people around without having to, you know, have staff that are in very specific jobs. Because of the speed, the flexibility, you may have access to more clinical trials because your site may be more attractive to sponsors. So for example, one of my very first clinical trials, I enrolled the first patient globally. So that put my site on the map for the sponsor. And I was also quite high enroller in that study as well. So I was able to get myself on the primary publication for that study, which was quite an honor. But that sponsor now knew my site, they knew that we could enroll fast that we could enroll for them. And for any future studies, they came to ask if we wanted to be one of their investigative sites. So they were coming to us instead of us trying to go out and find research trials. There's also a financial advantage. So there are lower costs of doing research in a community based practice, because of efficiencies and speed and less layers of administration. And that may also be attractive to sponsors, they may want some academic institutions as part of their program, but they may also want a number of community based clinical practices, and you can make yours attractive for them to be chosen. But I make it sound very easy that I, you know, flow through my day. But it can't be that easy. What are the challenges that I have to consider? So of course, there's always the risk of running any business, but the risk management for clinical trials, you need to have your own insurance, you're not going to be covered by an institution's insurance policy. So you need to carry your own thinking of not only things like someone tripping on your front step, but also cybersecurity or, you know, keeping medications refrigerated. Also, the financial investment that you need to make, there's always a potential risk with any financial investment, of course. So you'll have to have staff, you'll have to have equipment, you'll have to have space, and that all costs money. So making that investment is always a risk that you have to take when you get started. Again, the contracting and budgeting is really key for clinical research. And that's why I belong to the probity medical research group of sites, because they take care of all of the contracting and budgeting. And I work with them for that. And I know them and I know they know what I'm looking for. Whereas in an academic institution, you know, you may not know who your file is going to be assigned to as far as contracting and budgeting, and they may not have your best interests at heart. Also payments, so cash flow can be an issue. You know, you're seeing the patients early on in the study, but you're not going to get paid for that for a number of months, sometimes takes up to six to 12 months to actually get paid after you see the patient. But you have to pay your staff, you have to pay your rent, you have to pay for supplies. So you have to have that cash flow available. Also things like dry ice, if you take blood samples, and you have to send them to the lab, you're paying for the dry ice and then submitting your invoices afterward to be reimbursed. So again, that's another cash flow issue, patient reimbursement, again, you're paying the patients and getting reimbursed later on overhead. So equipment such as fridges and freezers that need to be industrial grade. You know, we have monitored fridges, the temperature varies out of a certain range, I get a text message to let me know so I can see what's going on with the fridge. We have not only a minus 20 freezer, but also a minus 80 freezer, you need an incubator for quantifier on a centrifuge, not only one regular centrifuge, you need a refrigerated centrifuge, ECG machine, camera, sometimes these are supplied by the sponsor to do the study, but some smaller studies will not provide the this equipment and you need to have it for yourself. Also staffing. Again, this is can be a double edged sword. You don't have the support of residents and fellows that that you might have if you're in an academic institution. But when you're in the community, that means that you're seeing all the patients yourself and you get to have the benefit of seeing how a medication works. If it's working really fast, if it maybe is taking a bit longer, you get to see the stories of your patients, you're seeing things as they evolve from visit to visit. And that's really quite special. Do I have any advice for a new grad or community dermatologist who wants to do research? Absolutely. You know, I think it's such a rewarding part of my practice. I think if it's something that you're interested in, you should look into some mentorship with somebody who does a lot of research, you could join a research group, you could work as a sub investigator. But if you're already established in your community practice, and you can't really go away from it, then I would suggest starting with phase four trials first. So things like registries that are looking at medications already on the market, things like Corvitas, Target, Solar, just to see if you like how research goes, it's a lot of paperwork. So you really just get the feel of it before you make that investment financially. Because once you move on to phase three trials, that's when you need to get a lot of the equipment to get started for those trials. And then if you love that, move into phase two, move into phase one, depending on how much you love the research. How do you integrate it into your practice? Well, number one, think about the location. Are there other clinics in the area that are already doing research, it might be hard to recruit subjects if there's too much competition around. And you'll always need more space than you think. You know, for patient charts, you would have to keep the records for so many years, and it does take up a lot of room. There's always more paper than you think, requiring a lot of storage, you also need a number of patient rooms, especially if you're going to be doing your research at the same time as you're doing your general dermatology clinic. So you'll need to think of the number of patient rooms that you have available, the scheduling of patients, are you going to do it in parallel, or will you have certain days that you do research patients and certain days that you do dermatology clinic. But you will always need room to move and expand. Anybody I know who started in research has moved to a larger office, or is now renting in the office next door and expanding in size, because it really does take more space than you think. And finally, you'll reap the benefits. You can keep up to date in dermatology with all of the latest treatments, with all of disease pathophysiology, and you may be the first to use a therapy, not only in your region, maybe the country, maybe the world, depending on how early phase you go. And because of that experience, you'll often have used a medication for years before it gets regulatory approval, and you'll have that experience. So you'll be invited to meetings to share that experience, whether it's an advisory board or giving lectures. And with that, if you like to travel, you can travel the world sharing your experiences with these new medications. Also, you get to be an author on key publications in your area of interest. So you can really focus your trials in one area of dermatology, become very well known as an expert in that area, and you'll get to see your name on the publications. So just in conclusion, really clinical trials can be a very rewarding addition to your practice. It provides you a lot of challenges every day you're learning, but a lot of satisfaction. There are many, many opportunities that exist for new therapies, it's just really expanding in the dermatology field, you can become a specialist in your area of interest, whether that's inflammatory diseases, or, you know, hair disorders, whatever, there is so much going on, that you'll be able to become an expert in that area. That will can lead to speaking opportunities, if that's what you want to do, traveling opportunities, whether it's for investigator meetings or advisory boards, you really can see the world with a research background. But there is some effort and stamina that's required to get things rolling. Initially, you have to make the investments, not only financially, but also time, also energy, but really the rewards are there once you make that investment, and it really is worth the trip. So thank you very much for your attention. And please reach out to me if you have any questions about doing research in a community practice.

clinical trials

community dermatology

research execution

financial advantages

professional growth