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Starting a Super Successful Trial Site: An Interview with Deena Bernstein

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Setting up a clinical trial site can be a difficult process. How can you create a successful trial site? Join Darshan Kulkarni as he talks with clinical research site adviser Deena Bernstein about how to set up a site while remaining compliant.

Narrator:
This is the DarshanTalks Podcast. Before this week's interview with Deena Bernstein on starting a super successful trial site, Darshan will introduce this episode with the recap for the week of Thursday, May 21st, 2020.

Darshan:
This week has been an interesting week from a news perspective. Things seem to be taking a turn, companies that were investing into vaccines saw a potential return because there was hope, and the hope then got snatched away. However, I've been speaking to other companies that are all talking about bringing some version of vaccines or therapeutic products to the market. So the general rule seems to be that companies in the life sciences still seem to be proceeding exactly the way they wanted. However, they are in some senses looking forward to accelerating as soon as the market's opened up in terms of the coronavirus allowing people to move around.

Darshan:
However, this has also resulted in some ramifications to companies that you hadn't considered. The event market for example. I did a podcast recently with Kelly Willenberg, who's going to talk about some of the experiences around marketing using events. So stay tuned for that. It's been a really interesting couple of weeks especially going from no changes all the way to seeing some hope and seeing that hope snatched away, and that is science. If this is not the example of how science actually proceeds, I don't know what is. People expect that the first drug you try works, people expect that the first vaccine you create might be ideal. And obviously everyone hopes that that's what it is. The entire world is literally looking forward to that. However, sometimes that doesn't quite work out. And I'm hoping that for all of our sakes, things get back to normal quicker. Events and event planning companies themselves are being hurt however, and it has resulted in the opportunity to talk to multiple people, there have been more zoom meetings.

Darshan:
So, overall what I've got is that, from a compliance perspective, this is a really good time to look back at your own efforts and take a step back and evaluate if all the steps were in place. If there weren't, you need to consider about why they weren't in the right places and fix those changes. If there's something else going on, maybe this is the opportunity to look back at your audit program and evaluate things that, the last time you did the audit you found problems. If you have questions, if you have concerns, feel free to reach out to me at, [darshan@conformerlaw.com 00:02:34], that's Darshan@conformerlaw.com. I'd love to talk to you further.

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, darshantalks.com

Darshan:
Hey everyone. Welcome to another episode of DarshanTalks, we have a special guest, we have Deena Bernstein. And Deena has 20 years of clinical research site operations experience. She joined Circuit Clinical Solution on August 2019, and is a senior strategic advisor, very impressive. [crosstalk 00:03:12]. She's actually helping with one of their products and she'll talk a little bit about that as well. What I love is also just her raw expertise. She started at Sheridan Clinical Research and helped create and develop a research program which supported an organization of over 6,500 physicians nationwide, which deployed research. Her last gig was VP of Qcare IQVIA, where she developed and operated the first SMO from the ground floor. She onboarded Qcare's first eight sites, and built the infrastructure for the business unit. She is a founding member of ACRP in Southeast Florida, she is part of WIN, which is the women inspired networks. She's a HBA member.

Darshan:
I've known Deena for, I'm going to say about 10 years. She's an overall bad-ass. I don't think I'm allowed to say those words, but here we are, it's my podcast, I'll choose what I want to say. Welcome Deena.

Deena:
Thanks so much. Wow. What an introduction, I really appreciate that.

Darshan:
So, first of all lets start [crosstalk 00:04:19].

Deena:
And thank you for making me feel special.

Darshan:
Well to be fair, you are special. We've shared a lot of fun moments over the last several years and special definitely begins to describe you. You are more special than special. So Deena, one of the things I want to talk about, and we'll get to COVID, and we'll talk about some of the stuff you're working on as well. But I want to talk about sites, and you are one of the preeminent site experts in the country. And I want to talk to you a little bit about, just your history of Sheridan and what your experiences were. How do you manage a large SMO light service? What are the variants you've seen? What are some of the problems you've seen? So, can we start from there?

Deena:
Yeah. Absolutely. Great start. That's where I got my start in the clinical research industry. So I was working with Sheridan prior to working in clinical research. I held another role and we had started to hear as our organization, which was a physician management for the [crosstalk 00:05:24].

Darshan:
Before you go down this path before, what did you do before? Because one of the big questions we get is, "I've never done clinical research, Can I do this?"

Deena:
Yeah. I think we all seem to stumble our way into it, and then we get that research bug and it stays with us forever because we find a passion within clinical research and doing something really good for developing medicines for patients that need them. So yeah. I started in the healthcare field working for a dialysis company, and I stayed in that industry for a few years where I was helping to support the dialysis facilities and recruiting patients into our dialysis units. And then from there, I went to work for Sheridan in a similar role but not in dialysis, more in the primary care field where I worked with patients coming when HMO's were starting to populate within South Florida, which is where I'm from. Bringing patients into our primary care centers and attracting all the payers, different insurance plans that were covering HMO's to bring them into our primary care network.

Deena:
And then from there, we started to hear within the organization as a crew across the country, Sheridan started to get more and more contracts for their hospital based services. And before you knew it, we had over 5,000 physicians, but we started to hear the doctors were participating in clinical research and they were employees. We didn't have a clinical research department, so we thought it would be a great idea to create that department and help support our physicians if that's the route that they wanted to take. And I would say, what challenges are that clinical research isn't for everybody. We know that, physicians that want to do it really have a passion for it but don't always have the time in regular practice. So that's how the model started. They needed the help to support them and remove those administrative burdens to research, help them find the right studies for the patients that they were treating.

Deena:
And even before it was a coined phrase of bringing, CRAACO, which is clinical research as a care option. That's what we were doing. So interestingly enough, we started to support doctors more and more physicians within, Sheridan started to engage in clinical trials, and from there we grew. And we were covering a lot of different therapeutic areas, our main therapeutic area was anesthesia and neonatology. Then we moved into emergency medicine, women's health, GYN oncology. We had a very diverse and interesting group of opportunities come our way. So that was really where I got my start. I learned everything from the ground floor up, doing all of the jobs myself. Excuse me. And then started to hire, and as we grew, our company even grew.

Deena:
As I was leaving, I started another division within it that was more of an academic approach, and allowed physicians to foster their own ideas and investigator initiated research.

Darshan:
So it is funny you say you were part of how clinical research was built from the ground up. As I see it, you built the ground for that building, for that structure. So it's funny to me the way you describe it. But I have so many questions that come out of this. One of the easiest one is, when you talk to sites, one of the big things sites say, is they talk about how unprofitable it is. On the other hand, there's a big desire for physicians to get into clinical research. In your experience working with so many thousands of physicians over all your career, is it even profitable?

Deena:
It can be profitable. Absolutely. It needs to be treated as a business and looked at as a business. You need to cover your costs and leave some room for some profit and building budgets to accommodate the infrastructure of the business. Very interesting that you said that sites are struggling. Site sustainability is a major, major issue within our industry even before COVID. And now, I mean we don't even know what the impact is going to be. But for example, 59% of the sites in 2019 told the society for clinical research sites and their site landscape survey that they do every year, that they only had three months or less of operating cash. And that's been a standard probably at least I know for sure, being part of SCRS and their leadership council and being able to see those surveys for over 12 years. So that in itself is staggering and straining when you're trying to run a business. Now imagine putting COVID into the mix. And we don't even know what that impact's going to be.

Darshan:
So, what I hear you saying is, this is an extremely unprofitable time or this might be something that propels your site into the future because a lot of competing sites may not survive this?

Deena:
Yeah. That again, good point. Absolutely. There are site networks out there and organizations that have been in business for many years that are profitable. I think the hardest part is for physicians, if they think that they can jump right in and become profitable, that it's nearly impossible. You have to invest in your infrastructure and not just dabble in research. We've heard a lot about physicians that they're the one undones. Because it's not quite what they imagined clinical research to be from profitability. And they just take a first opportunity that comes their way. And let's face it, it's a business that needs a lot of attention.

Deena:
You need to pay attention to who is enrolling patients, what your strategies are for patient recruitment, do you have access to those patients that you said you could enroll in a study? And then the overall business of retention and meeting the goals of your enrollment that you committed to. So there's a lot of aspects of clinical trials that maybe somebody just wanting to get into the business doesn't quite understand and thinks that it's very easy to incorporate clinical research into regular clinical care and it's not as cut and dry as that.

Darshan:
So that really dovetails into the comments you've made on clinical research as a care option. I have to admit, I've been in research for decades at this point and I've heard the term, but I don't fully understand it. So what exactly is that?

Deena:
Right. So where it starts is really at a physician practice. I think it's the statistics are less than 3% of physicians participate in clinical research. So patients don't even know that clinical research is available to them as a care option. But wouldn't it be nice if your physician that you went to and trusted, was able to offer you clinical trials as an option? So if you had, for instance, diabetes. Diabetes can be treated in a way that standard of care. But if you had a clinical trial for diabetes, and your doctor could actually have that one to one conversation with you and offer clinical trials to you, you might consider it. But if you're never offered that option, then it just is nonexistent.

Deena:
And that's part of the problem in clinical research awareness. Not a lot of patients don't even know that it exists, and the benefits of participation. And then there are a lot of benefits. I mean there's no guarantee, but there's opportunities where we here that patients feel like they've been taken care of better than a standard of care.

Deena:
They're getting more attention, they're getting more [inaudible 00:14:12], they have access to free medication in most cases and more engagement with a staff member, meaning a clinical research coordinator. And that's what clinical research as a care option means. That at that grassroots place where you go in for your clinical care, that you're offered opportunities to participate and choose if you like.

Darshan:
So, two things come out of that from me. So I had this interesting conversation recently with another set of sites, and I was talking to them about what I guess you're calling clinical research as a care option. I asked them, and these were owners of clinical research sites, these were people who participate in clinical research. And I asked them, "Would you actually participate in clinical research as a subject?" And I had I think 15 people on the call, and they always said, "If I ran out of options, I would." And I found that to be really interesting. So it wasn't their first go to. Why do you think that is?

Deena:
That's a good question. Who was your audience again? This was site owners?

Darshan:
Site owners and people who worked at sites.

Deena:
Wow. I don't know. I have no idea why they would say that. I mean it depends on if they were maybe be a oncology site. I think that in oncology, a lot of patients do turn to clinical research as an option when they run out of options. But for regular care, I can't really imagine, especially if you're operating clinical research and you know how it works, why you wouldn't want to participate. It's always good to walk the walk and be in a clinical trial if you qualify, if that's the business you're in. Maybe they were afraid of being put on a placebo, but being in the business you know better than anybody that you can opt out at any time. That's your rights as a patient and a participant.

Darshan:
Right. I thought [crosstalk 00:16:38].

Deena:
I don't know. I don't know. I see a lot of benefits.

Darshan:
[crosstalk 00:16:42] even in the meeting, so I totally get it. But one of the big answers that came out when we asked about it was, "Well, I'd rather get the medication that I know is a standard of care." And I don't know what the... Not necessarily the placebo, but if the competitor med, or device if you will. Is not effective, why would I risk it? [crosstalk 00:17:08] Why not just get what I already know works? I just thought that was interesting. We're willing in some cases to invite patients and subjects to be part of this, but on the other hand, when we have to put on that shoe, would we actually do it.

Darshan:
And I just thought that was an interesting dichotomy. I didn't know that happened. Because again, different conversations happen. I also was curious. As you know, I teach bioethics as well. And one of the big interesting things we talk about is our participants in clinical research subjects or patients.Because a patient has a reasonable expectation of getting better because of the interventions. And in research, by definition we're saying, "We don't know what happens to you."

Deena:
Right.

Darshan:
So, I just thought that was an interesting piece. And with clinical research as a care option, do you think that muddies the water or do you think that we already have someone looking over their shoulder, and if it's not working, we're going to stop it?

Deena:
Yeah. I would go back to the rules of research and engagement. And first of all, I just have to say I hate the word subject, I would never use that word, subject.

Darshan:
No? It so interesting. Why?

Deena:
I don't think it gives what we're doing a good connotation. I would like to hear the word volunteer, because it's [crosstalk 00:18:40] completely voluntary or participant. But for me, that word just is not [crosstalk 00:18:46] I like to use. I've even heard test pilot, which I think is catchy. But going back to the question at hand seriously is, if you're consenting a patient appropriately, it shouldn't muddy the water at all. It is by consent that you participate and if you're engaged in that consent process as a research professional offering clinical research to a patient that's within a practice, they should clearly understand that it's not standard of care. That they're volunteering to participate in a clinical research trial and what those ramifications could mean, what the benefits are, what the risks are and all the other elements of consent. Yeah. I think that's-

Darshan:
I appreciate that feedback again from Deena Bernstein who knows a lot about this stuff. Right? So to me, that's valuable perspective. Here's an interesting question though. Now one of the things you've talked about is how most sites keep about three months of cash on them and with COVID, that becomes problematic. Do you have any idea if whether the three months of cash, if you will, would suggest or imply that they need that much working capital or is COVID going to itself, by the fact that they may not have worked for the last month essentially caused destruction? Even if they had the three months of working capital because they'll never quite catch up.

Deena:
Yeah. I mean, again, we don't know the ramifications. But right now, I would look at it from an industry perspective at hold that no matter if you are a site, a sponsor, CRO, every study that you were doing right now is in rescue. Right?

Darshan:
Right.

Deena:
I mean, some were halted, some were put on hold. The active patients that were already in trials, we need to retain them and ensure that they don't drop out. There can be, I've heard as high of a 30% data gap within this period of time, that we're not seeing patients in maybe the traditional ways, but to catch up financially, for some sites it may not be possible. Some sites may look for other opportunities within the COVID pandemic times that they can participate in current COVID or future COVID trials, depending upon how diverse they can be in their research practices, meaning if they have access to all kinds of patients and maybe not just a specific therapeutic area. But I think that it will be interesting to see what the future holds for the sites.

Deena:
And one of the things that I have seen that has been very positive from a cashflow perspective is, that sponsors are recognizing that sites are in dire need of cashflow, and that they have been doing something unprecedented with payments. Where in the past most trials when you budget for them have a 10% hold back feature within built in your budget. And some of the sponsors are paying that forward and paying it upfront. So-

Darshan:
That's really interesting. Coming together aren't they? Finally.

Deena:
Yeah. And that's big. I mean we're all in it together. [crosstalk 00:22:34] Sites are on the front line, face to face with the patients engaging with them on a regular basis. Even with the decentralized clinical trials approach. There's still a human aspect of that and we still have to keep patients engaged. Right? So the sites are still always going to be, in my opinion necessary.

Darshan:
Oh. I definitely want to talk about decentralized studies and virtual engagement in a little bit. But before I go there, I want to raise something that was spoken about in the news, which I thought was really funny, because it just seems from a research perspective, this seems like such a bad idea. But I'm going to say it to you and you tell me what you think.

Deena:
Okay.

Darshan:
Did you hear about the, I think it was the mayor of Las Vegas who said that we will opt to be the control group to see what happens to a city if we just allow people in?

Deena:
Oh, I did not hear that. That's interesting. If we do not let people in?

Darshan:
No. If we let people in. It's if you want to open up [crosstalk 00:23:42]

Deena:
Oh. If we let the people in [crosstalk 00:23:45], we'll be the.... Yeah. Okay. Well, I don't even know where we are going with that Darshan. How do you feel about that? Are you going to Vegas anytime soon?

Darshan:
It makes me try to run away at the times that it's actually safe.

Deena:
Right. I don't even know if I can make it a weekend.

Darshan:
Yeah. That worries me a little bit.

Deena:
Regular times anymore. That is interesting. I mean-

Darshan:
So [crosstalk 00:24:11] don't comment because you haven't even heard that statement [crosstalk 00:24:13].

Deena:
Yeah, I haven't heard it. I read something about how Sweden, I mean it's not Las Vegas, but Sweden took a different approach where they didn't really adhere to any type of lockdown and I think their results were pretty good, but who knows. I mean, it's too early to tell what impact I think this is going to make. The next six months will be very eyeopening to all of us. And I think we'll have that opportunity for lessons learned and different approaches on what worked and what didn't work. Since these are so unprecedented times. Now that almost sounds cliche because everybody's saying it, but I mean these are historical times, and we're going to learn a lot, good and bad.

Darshan:
I agree. So, let's actually talk about historical times that make for a opportunity to pivot and survive and hopefully even do better. I mean I've done a bunch of different interviews recently and one of the big things everyone is talking about right now is, the rise of remote studies, the rise of decentralized studies. People tend to get both of those confused. Obviously there's significant amount of crossover between the two concepts, but one really goes to monitoring, one goes to the actual execution. But either way, there's crossover there. And while you're trying to do these studies, how do you keep patients subjects... What did you call them? Test pilots [crosstalk 00:25:48] involved?

Deena:
I say participants. But yeah. There's a lot of meat right there. So, let's talk about decentralized hybrid type model of the way that we see patients from a psych perspective. We've been talking about decentralized trials for I'd say at least three to five years, not knowing exactly when it was coming. Some sites have seen a hybrid model where you give patients choices of how they want to be seen. Some patients might select a TeleVisit that when appropriate or some patients maybe don't have that technological skillset that it's intimidating to them to even try to do a TeleVisit. So giving that option to a patient, I really liked that. That model. And not all visits are going to, perhaps be able to be done in a Telemedicine type way.

Deena:
There's always still going to be, if you need a blood draw, we're going to have to accommodate for that. Could it be at a home? Right now, sites have been able to go to homes, collect blood, do site visits at home, and have so many more options, but in a forced way. So we've learned to adopt very quickly during these times. And I think we're going to carry some of our adoption with us, and pick and choose what we can do in the future in study design to make it more palpable to a patient to participate.

Darshan:
So you're talking about the palpability and why it's advantageous for patients to participate. And you talk about the idea of patients choosing, which is obviously goes to the core of patient engagement. Here's a question for you, and I think you and I had very briefly discussed this yesterday when we were prepping for this call. But are site's ready for Telemedicine? I mean people are using Skype right now and people are using Google Hangouts and all these things, which is great because it gets care where it needs to be. But for a true longterm pivot, it's unlikely that the office of civil rights is going to say, "We're just going to wave HIPAA for the long term, and anyone who can do studies using Telemedicine as long as you Skype." So are sites, generally speaking, investing in the infrastructure that is going to take to pivot to this type of a structure?

Deena:
Yeah. So, good framing there. Well, we know now with the laxed regulations, that sites are figuring it out. Whether it's by phone or on Skype on their computers, they've had the opportunity to test the market. But, going back to what we were talking about, that sites really don't have a lot of cash on hand to invest in equipment, unless they're a sophisticated large site network work that, I mean, has been successful for years or it can find some investment for the equipment, that I think that it may be a little slower on the uptake. But definitely, in mind and strategy for future growth because we know that we can do this, and we can do it fast, and it's working, and we to take the good things with us that we learned from COVID-19. And we know that there are more efficient ways to accommodate participants and in that engagement aspect.

Deena:
But, what's interesting because I've been looking at some platforms through my work with Circuit and in our clinical side of the house, and most of the trials out there that are these hybrid trials that are offering Telemedicine visits, eConsent, are all sponsored driven. Which means to a site, that the sponsor's going to provide to the site the different equipment that they need to accommodate the TeleVisits for instance. But personally, I would like to see the sites take it into their own hands, if they have the wherewithal to do, choose their own equipment for eConsent and TeleVisits and be able to offer it to the sponsors. But that's in a perfect world and not all sites are going to be able to accommodate for that.

Darshan:
I find that response a really interesting response because, my experience in negotiating clinical trial agreements, like if I'm going to go, "I need these costs, and I need these cost." For the most part can I go, "No, that's just the cost of you doing business. I'm not absorbing your cost of doing business." The question becomes, are sponsors going to start very soon going, "We expect Telemedicine." That's just you guys doing what you need to do to keep in touch with your patients. Because patients are now used to being at home, not waiting two hours in the office, waiting to see their doctor, they just make an appointment and then jump on to a meeting and have that meeting.

Deena:
Yeah. It may go that way, but let's go back in time.

Darshan:
Okay.

Deena:
Do you remember the times when we had CRFs that were in binders and paper-based?

Darshan:
Yes.

Deena:
Okay. So then we heard about this novel idea of ECRFs. [crosstalk 00:32:04] Right? And a lot of sites didn't have computers then. So you know what happened? All the pharmaceutical companies that wanted to try out this new novel aspect of ECRF, started sending laptops to the sites. I can tell you that in the sites that I was operating, after the studies were over... We had several different laptops from several different pharmas that we had to send back that were never even being collected at the end of the studies. By the time the study was over, the piece of equipment was antiquated, and we had all this equipment on hand.

Deena:
So I'm curious to see. Is that going to happen again? And we're going to have all these different screens coming from all these different sponsors in order to accommodate a specific study. And it may or may not be the case. But if there's a good site that has performed for a sponsor and they don't have the equipment, I can't see a sponsor saying, "You know what? I'm going to abandon the site that I've used for the past 20 years that really brought patients and enrolled patients to the trial that I'm working on just because they don't have the equipment that this particular study requires?" But again, it may be an opportunity for other sites that weren't always selected for certain trials to be able to showcase that they've made that investment and have the capabilities and training because training is going to be part of Telemedicine visits to accommodate a hybrid or [inaudible 00:33:47] complete decentralized type approach of a trial.

Darshan:
So what I'm hearing you say though is essentially, "Darshan, don't be so quick about it, they'll probably be some transition period." [crosstalk 00:34:01] In which some sites become... Go head, I'm sorry.

Deena:
Yeah. Go ahead. Sorry.

Darshan:
Yeah. So where some sites [crosstalk 00:34:07]reposition themselves as technology leaders, other sites that were non technology leaders, but they knew how to recruit, may still have an opportunity to catch up. But those that don't adapt may die?

Deena:
Yeah.

Darshan:
Because-

Deena:
That may not be the black Swan that makes them leave the business of clinical research, but it contributes. Because it's a financial aspect of the business. Right? [crosstalk 00:34:38] If the sites are already unsustainable and struggling and have laid off staff, I mean, essentially it's all interrelated from the financial aspect of solvency.

Darshan:
So let's talk a little bit more about the financial aspect of solvency. And what I mean by that is, we're talking about, the immediate future where you've got, what's the word for this?. You've got Telemedicine and you've got TeleVisits if you will. One of the things that... I do a lot of futurism stuff and I loved looking at where research is headed and what people are looking at. Do you see a future where Alexa is reminding you to take your study med while Alexia is doing your informed consent? Where your Siri is reading out the protocol to you and you're interacting with your Siri to go to confirm that you understand it, just so you can still stay home, but you are more engaged as you continue. What is the future if you will, of clinical research?

Deena:
Yeah. I think it's very much in it, we're very much in a digital age where we are going to have compliance features. There's already compliance features out there, smart pill bottles for adherence to IP and reminders through text messaging. But I think what you're proposing is definitely a part of the future. How it's all going to play out is, I have no idea. I still think that our patients still want a human touch. An engagement is... I can't say engagement enough. Engagement, engagement, engagement. Keeping participants engaged in a study, as we become more digital, is going to be even more important than it is today.

Deena:
Because it's very easy if you don't have an interface with a human, to just blow something off and say, "You know what? I'm done. There's no consequences for me and I'm just not that interested anymore." So taking that temperature on engagement with [inaudible 00:37:00] I'll talk a little bit about trial scout, which is a wonderful way to stay engaged with patients. is going to be even more important.

Deena:
It's not just an email, it's not just a [inaudible 00:37:10], but it's really hearing what patients say and hearing the voice of the patient through a platform where patients can speak their voice that fosters trust and transparency and respect for being in the clinical trial. But learning about how patients feel about the process. And being able to gauge if they become less interested in perhaps even model what dropout might look like based on some of the feedback that you get from participants that are in trials.

Darshan:
So you said engagement, engagement, engagement. Reminded me of real estate where they say location [crosstalk 00:37:54].

Deena:
Location, location, location. Yes.

Darshan:
So give me the Deena Bernstein three top rules you get your patients to engage.

Deena:
Well, that relationship that fosters trust. So there's definitely people behind that, and speaking to patients, listening to how they feel, being compassionate to what they're saying and making an absolute acknowledgement of what the concerns or issues might be. So what if a patient said, "I really love the staff. The staff's making feel very important that I'm doing the right thing by participating in a trial. I feel good about it. I might feel better, I might feel worse. I don't know what drug I'm on." That's not important, it's all about being engaged in the study. And having that conversation through whether it's a digital platform or an actual conversation. So what if I said, I'm in a trial and I'm feeling really good about the place I'm going and the people that I'm working with, but I don't like the parking.

Deena:
You know what? The parking is an issue for me. I have to park down the street, I have a hard time walking. It's a nuance. I don't know. I'm starting not to feel like I wanted to do this because of the parking situation. If I didn't know that, I couldn't make a change, I couldn't make an impact. What if I heard the parking was a situation and the patient didn't realize there was valet parking? Or that we could add valet parking to our building or make parking some way more accessible to clinical trial participants were putting them up in some designated parking spots up front. If I wasn't engaged, I never would have known that. And that could be a reason that a patient drops out of a trial.

Deena:
If you're not asking the right questions, to get to the crux of the issue that someone might be having, then you're not truly engaging and if you don't make a change based on what patients say about the trial, then it's not really a two way street. So being able to make an impact based on what somebody says about their participation, I think is really that crux of staying engaged in a clinical trial.

Darshan:
So I'm trying to read that out. So that one is trust, one is listening to your patients, what else? What was the third one?

Deena:
[crosstalk 00:40:38] Respecting what they're saying.

Darshan:
[crosstalk 00:40:43] There you go.

Deena:
And it might be a good thing to you. When you start asking questions to participants, you might think you know, but until you hear, you don't really know what for them is a potential issue or something that's really good. I mean, you can find out a lot of great things about your site. You might know that you hired a great staff and I'm thinking about one review that I saw recently and the patient said something and called out a coordinator by her name. Like, Rita made me feel that I was really part of a trial and I hate to even say what the patient wrote, and not a Guinea pig. Which isn't a word again, I would never use to describe anybody in a clinical trial. But the patient knew the word and the phrase and used it.

Deena:
And if I was a site owner, a site operator, and I heard that direct from a patient, how my coordinator made this patient feel. I mean to me, that would be everything. And imagine what it would do for the site and being able to hear as a employee that, these accolades. You'd feel wonderful all the way around. So asking questions through digital platforms where patients can have a voice in the process and share, it's so beneficial on so many levels.

Deena:
I mean the sponsors might hear things that they could learn about their protocol, not specific in an unblinding way, but things that potentially could drive a protocol in the future to maybe the patients would be more adherent to. Or from the site perspective, positive feedback and having that loop. And then from a patient perspective, if I was questioning and I didn't know what it was like to be on a clinical trial, being able to hear that in an online presence way from other patients like me, it might really guide me to want to participate in the future.

Darshan:
Deena, I can keep going on with all these questions [crosstalk 00:42:56].

Deena:
I know. Couldn't we? We just love our sites and this industry so much.

Darshan:
This has been amazing. I'd love to have you back if you're interested and-

Deena:
Absolutely. Would love too.

Darshan:
Perfect. Well, you guys heard Deena, stay tuned, she'll be back. And this was really, really exciting. Thank you again, Deena. [crosstalk 00:43:16].

Deena:
Thank you Darshan. Always a pleasure to work with you.

Darshan:
Pleasure.

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 @darshantalks.com.

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