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Clinical Researchers: Are They Made or Are They Born? with Dan Sfera, Clinical Trials Guru
Episode

Dan Sfera, Clinical Trials Guru

Clinical Researchers: Are They Made or Are They Born?

Brought to you by   | hosted by Joseph Kim

 

Clinical Researchers: Are they Made or are they Born?

In this episode, Dan Sfera, the Clinical Trials Guru, speaks about his journey in the clinical research industry as a leader of many different clinical research sites and what it takes to run one successfully. He details what makes a good CRC and shares some examples to explain how every study is different depending on many factors like protocols and team size. He talks about the relationship that sites have with sponsors and with tech from his experience with past sites and his current company Yuma Clinical Trials. Dan shares a controversial tip around sites’ patient enrollment feasibility and a hot take on the popular decentralized clinical trials. Finally, he discusses Latinos in Clinical Research and working for better opportunities and equity within the industry for the Latinx community.

 

Tune in to learn from Dan Sfera’s experience in various clinical research subjects!

Clinical Researchers: Are They Made or Are They Born? with Dan Sfera, Clinical Trials Guru

About Dan Sfera:

Dan Sfera is involved in many aspects of the clinical research industry. He is currently a site owner in Yuma, AZ for Yuma Clinical Trials, LLC.

He runs a clinical trial website called “The Clinical Trials Guru” where he tries to discuss “Clinical Trials in Plain English” and help individuals who work or are interested in working in this industry, understand the subject better while also raising general awareness on the topic. He interviews industry leaders and experts to share valuable content with his audience through these interviews. He also co-authored a book called “The Comprehensive Guide To Clinical Research”.

In addition, he partners with consults and advises various clinical trial companies across the United States. Some of the services he provides are study placement and assisting Sponsors and CROs with selecting appropriate research sites for clinical studies, patient recruitment at both the individual site level as well as national campaigns, CRA training and placement, and business development.

 

Research Confidential_Dan Sfera: Audio automatically transcribed by Sonix

Research Confidential_Dan Sfera: 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:
So today I’m here with the OG of clinical research content, Dan Sfera. Dan, welcome to the show.

Dan Sfera:
Thank you, Joseph. How’s it going, man?

Joseph Kim:
It’s going well.

Dan Sfera:
You look the same as when we first met. You know, back in, we never met in person, I don’t think, but we met virtually many times and you look the same.

Joseph Kim:
Thank you. I did turn 50 this year, so it feels actually, I’m in the best shape of my life because I finally decided to work out, get off my butt. You look a little different because you have a beard now. I think the first time you were clean-shaven, but the beard looks good on.

Dan Sfera:
Clean cut, thank you.

Joseph Kim:
So, listen, like I said, you started a lot of this very good in-depth content around teaching people about clinical research a long time before anyone else was doing it. Tell us, I mean, I want to hear a little bit more about your clinical research journey, but let’s start with why you decided to go on YouTube and start to help people understand, like what it takes to be a good clinical research site. Let’s jump into chapter four here. Tell us why you started doing that.

Dan Sfera:
So there’s a danger with a revisionist history and you making out like 13 years later, you’re like, oh, this is why I actually did it. The real reason was it took a few series of steps. So I started in 2005 at a research site. I was thrown into the mix not knowing a thing, Joseph, I mean, nothing, man. I was PreMed student and I had like a 2.3 GPA in undergrad, in molecular and cellular bio, and there was no chance I was getting into med school. So I decided to intern at my dad’s. My dad was one of like five PIs. None of them knew what they were doing at a site, a small site, and their director they hired ended up siphoning money to another company, like she basically made a shadow company with a similar name, and like she was sneaky on the contract. So just change a little bit the name of the … and boom, she was able to get into her account. So then when we couldn’t pay staff, well not we, but the leadership couldn’t pay their coordinators, coordinators left. So I was there interning and people are just leaving, like walking out, and I’m like, all right. I remember my dad told me to take a box of files to the director’s home because she was no longer partner with them once they found out. And that’s it, and when I came back, my dad is like, look, either you figure out how to do this or just go find a job. And I was like, all right, CRA? I mean, I don’t think I can get a CRA job with like one month of internship. So I had really no choice but to figure out how to be a CRC. We had existing studies, man, like the revenue was there, it was just being stolen by someone, and then the patients were coming in and so I had to figure out. So I remember Googling like what is a 15-72? Like whenever my … would ask me something, I was afraid to tell them, I don’t know what I’m doing, so I just Google. I couldn’t find anything, so that like planted a seed. I finally started hiring people. Five years later, I read this book by Gary Vaynerchuk, Crush It, it talks about how he started his wine business using YouTube. So that really inspired me. I was like, You know what? Yeah, I remember when I was Googling things I couldn’t find, I got to, there’s got to be others. So I started creating a YouTube channel, but initially, I was trying to do it selfishly. I wanted to get patients to my site like, so I thought like if I interview patients, like what is the consent form? Not only will it help the sites, but it’s going to help mostly help patients learn about my site. And if they were a patient in New York, I’m in California, I could probably make a business to refer them to a site there. And I had like a vague, vague business plan, but nothing really. I just wanted to see what would happen.

Joseph Kim:
So did you know that was content marketing at the time?

Dan Sfera:
No, but I learned quickly because I read that book. That book really changed my life, man. Gary Vaynerchuk, Crush It, like it’s his best book ever, despite what he says. But, so it turns out that most of the comments were not patients, to my surprise, and no longer my surprise now, patients are not looking if they don’t know what a clinical research is, they’re not going to look at what’s in an informed consent, that’s just three steps further ahead than where they’re at in their mind. But sites were, and sites were reaching out and saying, hey, thank you for this. How about this question? Can you answer it? So I realized, all right, my audience is like actually sites and wannabe CRAs and want to be CRCs, so I just pivoted the content a year later to that, and it’s been on that trajectory ever since.

Joseph Kim:
Was that the beginning of you as Clinical Trials Guru? Is that, yeah, okay, so you’ve been doing that ten years.

Dan Sfera:
My wife came up with that name, was brainstorming a name like, what’s the name? Clinical Trials TV. I wanted Clinical Trials TV, but she decided Clinical Trials Guru, and yeah, just stuck with it since then. So 2010 when I started, so yeah, 12 years now.

Joseph Kim:
Wow, yeah, truly the OG. So let’s go back for a little bit further in time. So you were a science major, clinical research was not on your radar, what were you going to do before you landed in clinical research?

Dan Sfera:
Honestly, man, in college, like I always had entrepreneurial DNA, entrepreneurial tendencies, but didn’t realize that, I realize that now in hindsight. Ever since a kid, so in college, I just wanted a decent job and my own place. Like I was not ambitious at all, and my dad told me, CRA. So I already knew about CRA like in my senior year, so I started applying to …, all of them, PPD. Of course, I didn’t even get like one message back because they’re not going to hire somebody in college, which I learned later. Like it’s huge, huge issue with the labor shortage there, nothing much has changed actually since then. But yeah, I was like, I had no ambitions, man. Like, I just wanted, let me make six figures and have my own place. I just wanted a simple life.

Joseph Kim:
And then you ended up in this embezzlement Ponzi scheme.

Dan Sfera:
Yeah, man, that lady was so, and she’s done this before. She was like an office manager for doctors. So apparently she was, it wasn’t the first place that she did this, like, ran this scheme.

Joseph Kim:
But where is she now? Do you know? Do you know where she is?

Dan Sfera:
I have no idea, but I ran into her daughter once at a party, and we didn’t even know was her daughter. Her daughter is cool, but I had no idea until later. Like, that’s her daughter, geez.

Joseph Kim:
Was she wearing bling? You know where she got it from.

Dan Sfera:
Well, yeah, she’s fairly wealthy.

Joseph Kim:
All right, so let’s fast forward. Like you had a pretty strong career in clinical research as a coordinator, as site personnel. You started your own company, Yuma Clinical Trials. Tell us a little bit about Yuma. Where are you? What kind of research do you do? How big are you?

Dan Sfera:
Yeah, Yuma Clinical Trials, it’s Yuma, Arizona’s first research center that’s not part of the hospital monopoly that’s here. The hospital does oncology and emergency studies only. So there’s never been an outpatient research site or center in Yuma. Yuma is a town of about 150,000 on the Arizona-California border and the Mexican border, so there’s like three borders here. Very diverse, mostly Hispanic, seeing a lot of the challenges with that. It ties into Latinos in Clinical Research, like our other brand, where we actually try to get more Latinos to work in the industry, hopefully, to get more Latino patients to participate. It’s been surprisingly easy to get studies here, you know, partnered with three PIs and three different specialists and been able to get six studies in a year, which is great. Prior to coordinators, this is my, like my fourth site that I have ran, this one I started, but well, five if you include the first one. So yeah, my fifth site, but one of them is still around actually, and one of them I sold, and then two of them failed.

Joseph Kim:
Yeah, well, that’s how you learn. So your PIs, are they pure investigators, or do they have practice elsewhere? Yeah, and they work with you.

Dan Sfera:
Practice is, they’re private practice first. It’s really tough to get them like used to research like, Oh, this is a monitor. She’s going to come in and, you know, kind of tell us what we did wrong. But don’t worry, that’s my job to keep them happy. So they’re learning, but yeah, they’re busy, and honestly, their value is in their database. So I need them to keep seeing patients because I need more patients to screen from. You know, these studies are very complex now. There’s a lot of exclusion criteria today. I’m wearing the shirt because I have to go to the site later. There’s an early term visit sponsor, drop the patient due to a very small ECG-like fine print on an ECG, technically, they let us randomize her, and the next day they told us we have to drop her and it wasn’t our fault, it was the central reader’s fault, and now the patient thinks something’s wrong with her. So I got to go talk to her about her ACP.

Joseph Kim:
Right, you know<, why are sponsors playing tricks on you by, like, putting stuff in fine print? This is I mean, this speaks to the larger problem that you posted something on, I think it was YouTube, about like, not everyone’s giving you a good sense of direction as to what to do and what order, what tech, like, everything’s buried in different footnotes and sections of the protocol. Talk to me about like that whole issue.

Dan Sfera:
I mean, I get it. One of the things that I didn’t mention when I was introducing myself, I actually started a small CRO for investigator-initiated trials and that opened up a lot of sponsor-side consulting work. So I did a lot of audits for sponsors and I talked to a lot of the people, higher-ups that are designing protocols and simultaneously dealing with investors, so I get the sponsors’ side. I don’t want to bash sponsors like, we actually don’t understand, us at the site level unless you actually get out into their world, you don’t understand what these people are dealing with. It does make sense, if you actually get up under the hood, most of the times. Could they make it easier for patients? Yes, This is a perfect example. Like, I get it, this was a safety issue. Well, it’s a potential safety issue. But what they should have is a separate cohort for these kinds of patients, because she’s already in. So it could be like a separate cohort where you show the FDA, but you say, look, this is why these are in this cohort. I think there’s a term for that too, like modified intent to treat or something like that. So they already have these cohorts, but I think they need more if they want to get truly patient-centric. But yeah, they do a lot of asinine things too. Like first of all, they don’t understand the site side, the site perspective. I talked to a biotech founder yesterday who’s planning his first phase one study and he has no idea how a site works like, zero idea. He was wanting to ask me, like, questions for like over an hour. Like, what does the CRA do? Does the CRA work at the site? They had no clue, man, and they’re about to plan a study like, so they’re just going to hire a CRO who’s going to do everything and load those sites with tech, and no wonder DCT seems attractive to these sponsors.

Joseph Kim:
Yeah, I mean, to your point, we don’t have to beat up the sponsors too bad. I used to work at a sponsor and I can tell you a lot of it is due to sort of innocent ignorance. I’ve learned more in the past like three months than I ever knew about clinical research in the last 23 years because I’ve been working with sites a lot more intently. The end user of our product is a site, even though the values for everyone and sponsors are customers, so I’m not going to bite the hand that feeds me, of course. But to your point, it’s they don’t know the site operations that well, and frankly, there’s no good tool. So a lot of the tech companies out there for clinical research haven’t focused on making the site’s life easier if they’ve been focusing too much on like collecting the data, not how that data gets collected through the workflow that you guys painstakingly have to do.

Dan Sfera:
Yeah, or where that data comes from. I mean, it came from somebody, me, and my CRCs calling 100 patients to get ten of them to say, okay, to get two of them to actually qualify, you know, to get one to be dropped out the next day. That’s a lot of work.

Joseph Kim:
Yeah, right, for this very important reason, but yeah, now you have to pick up the pieces and explain this to her, which is a very human thing that you want to be able to do with excellence. And no piece of tech is going to replace Dan Sfera approaching a patient and helping them fully appreciate what’s going on here. So let’s talk about that, now, go ahead.

Dan Sfera:
Yeah, I was going to say, I mean, tech can definitely make life easier, but a lot of what we do as sites cannot be replaced by tech. I don’t see how unless you clone my CRCs somehow into an algorithm and they’re able to work autonomously. But there’s just so many things, and every protocol is different too, this makes it even more complex.

Joseph Kim:
What makes a good CRC?

Dan Sfera:
Oh man, it changes. So initially it’s like potential, like curiosity. For me, I know the learning curve is insane, like 3 to 6 months minimum and that’s if you have a good trainer. So what I look for is like curiosity and some kind of ambition, at least for your own career, or preferably science-related ambitions. Because it’s a lot of work like prescreening a patient with, on 20 minutes and then cross-referencing that with the protocol where they just list the classes of drugs, not necessarily the names, so then you gotta Google and then, okay, well, what does this actually do wire? Like to get into the nuts and bolts of why and which meds are allowed, which ones aren’t, take some curiosity, and you can’t even train that as the site director. Like you can tell them, but if somebody is not curious and takes their own initiative, like after ten patients, they’re like, Yeah, PI will catch it, I’m just going to screen them. That’s what I look for, and then a willingness to learn, obviously got to have a good attitude, which is actually surprisingly tough these days. And then keeping them once they do figure things out, like after a year or two, retention, and the CROs are struggling with this, I think the sites, the small sites have an advantage because we can allow our employees to climb within our organization as we grow. I already told my first two employees, You guys are going to be directors, you’re going to learn what I’m doing so I can get out and just do biz-dev, and eventually, you’re going to do that too, and we’re just going to keep bringing in people underneath. So there’s upward mobility at the smaller sites. I think that gets a little bit lost at the large CROs, and I’m not sure how that works at the sponsor levels.

Joseph Kim:
I love that you didn’t list like credentials and education and you were really just talking about personality traits that make a good CRC, a clinical research coordinator go. I think to your point, unless we live in the Matrix and you can download ten years of scientific knowledge, no one kind of comes to the table with this stuff, and it’s the curiosity that drives them. And how many protocols might CRC be running at any given time in your, well, I know it’s six, but what’s like a good ratio in your head? Like what’s the max?

Dan Sfera:
For like an experienced CRC of two years or more, it varies wildly on the study. I mean some studies are super complex, some studies you’re never going to enroll anyone, unfortunately, like you’re just going to have five screen failures like our other study. I think 6 to 10, I think seeing one or two patients a day per coordinator is max, because at my site, my coordinator also does data entry, my site coordinator does ISF maintenance, at my site, really the coordinator does everything: pre-screenings, retention, all that stuff. So two visits a day, max, I don’t care how many studies that is, but we have six and we have two coordinators. So we have, definitely, we have room to grow, and if you’re seeing two patients a day as a small site, that’s significant. I mean, we’re talking, if you can maintain that throughout a year, that’s seven-figure revenue for a small business. A lot of these doctors’ offices are struggling to do those kind of numbers, seeing like 40 patients a day.

Joseph Kim:
Wow, in the old day, if you can harken back, how many were you able to do? How many patients were you able to see in a day? And is there like what’s changed between then and now, if at all?

Dan Sfera:
My first site, so when I took over and it was like a sinking ship, it was just me. I was doing like three visits a week and I thought that was like insane workload because I remember I’m learning everything. So when a patient comes, it’s like I’m spending all day making sure, like, get out of there, but then the rest of the day, just like, how do I not screw this up? I hired my first employee and she came from another site and she had a whiteboard and she drew on there. She said, How many, we need to make projections for these studies, how many do you want to see a week? Because I’m experienced, I can see patients. And I was like, Oh, well, I’m doing three now, so if we can do six with you, that’s awesome. And she laughed at me, she was like, No, you can do six a day if you want. So by the time we figured it out, we hired like five people. By 2009 we were doing like six a day and that was a super good year for us, 2009, and then the cuts started happening. I remember the Sanofi-Aventis called us and said, Hey, every patient that’s in, early term them, you know, that’s when Lehman Brothers went.

Joseph Kim:
The world went down the toilet.

Dan Sfera:
Yes, it was like both extremes, like highs and lows of the roller coaster, but yeah, we made seven figures that year. And as a 29-year-old, that’s pretty good. Like I was happy and then I learned the hard way about taxes and all that.

Joseph Kim:
So do you think study coordinators or research sites can get to that six patients a day? And if yes, and if not, tell me, yeah, tell me what has to be true to make that happen.

Dan Sfera:
You need one or two good studies. Good studies where, not ones you think are good, ones that you actually have a history of randomizing patients consistently, because you only get paid when you enroll patients, not when you screen patients. You only get paid when you enroll patients. So if you can maintain that consistently, it’s actually very easy with just one or two studies to get up to six a day. We can actually do six a day now. Well, with our new study, once it starts, we have our five in a few weeks, and that one I think we can enroll. We got lucky with that one. It’s a phase four, but the budget’s decent so we can enroll a lot of patients in that one. So it’s not that hard, man, two studies and two good coordinators, and you can be one of them if you’re the site owner.

Joseph Kim:
Yeah, and you know, certainly, if it’s a study that can enroll a lot like a prevalent chronic ambulatory disease or a vaccine, for sure, others are can be harder where if you enroll six patients, that’s probably you’re in the middle of the pack of the site enrollment curve and that might take you, what, six months to do, and so you’re seeing one patient every month kind of a thing or every other week.

Dan Sfera:
Yes, and some studies like rare disease studies, I mean, you’ll work your ass off to get one randomization and sponsor thinks you’re a hero for getting one patient. Others like this phase four one, where I feel like our coordinators can actually do more than two a day on that one, it’s relatively simple study. So every study is different and we haven’t done vaccine study, I’ve yet to do a vaccine study in my life. I know the numbers for those ones are totally different than what I’m spitting out here. These are traditional phase two, three, four outpatient studies of some kind of therapeutic condition, not vaccines.

Joseph Kim:
Let’s talk about a controversial issue around feasibility and what it takes to actually do the study or at least say, hey, I think I can do it. And talking to Brad Hightower, sometimes it amounts to catfishing, right? Like, hey, here’s the study. Great, I think I’m going to crush it. And then you actually see the real study, you’re like, wait a second, this isn’t. And so what often happens is sponsors may perceive that you’ve overestimated your enrollment. They play this game of cut it in half and then you see the actual protocol and it’s actually half of that. Help us understand that whole weird dynamic there, because I think everyone is innocent in some way. They’re all trying to do the right thing with integrity, but we end up in this weird cat-and-mouse game of, Can you do the study? How many patients you can enroll?

Dan Sfera:
Yeah, it’s very strange. The, Brad, I love that guy. So I wouldn’t say it’s always innocent. I’ve straight up, face to face been told by a CRA that loved our site and she wanted us to get another protocol, I think because we were easy to monitor for her. Make sure on this feasibility that you embellish your numbers. Literally, what she told us, and she’s an ally trying to make sure we get the study. So that right there tells you everything you need to know about how this is now. Yes, just so happens, yesterday, Latinos in clinical research, free webinar every month, free, LatinosinClinicalResearch.com, we had a feasibility, she’s like director of feasibility at a large CRO on, and so this question actually came up and she said you know what we have like an average and then we have outliers, and those outliers we really like kind of audit, we question their numbers, but then in the middle, we discount that. So they already, it’s already built in. So here’s a director of feasibility, at a big CRO telling you no matter what you put, even if it’s the truth, you’re getting discounted. So what do we do? What do we see in the economy? Inflation. All right, well, two patients becomes three, actually, or maybe four, let’s just double our numbers. Every site does this, I don’t care what they tell you, I don’t care what they say at SCRS or DA, it’s all BS, man, all of it, unless they’re brand new and they don’t know what they’re doing. And here’s the thing, Joe, because I try to be honest, like there are studies where I don’t care if I get them or not, right? So I have the luxury there to be honest, and when I do those feasibilities and I’m trying to give honest answers, I have my PI’s database right in front of me, I can search. So they give you the synopsis, you go through the IE criteria, but you don’t really go through it. Here’s the problem, that these studies become so complex. We had a psoriasis study, moderate to severe, they want like very bad on the outside and perfectly normal on the inside. My PI said, it’s not, you’re not going to find these patients. When it’s psoriasis, we don’t do a pulmonary function test, so we have no way of knowing, and that’s just exclusion criteria 19. You know, there’s thirty-three of these things in there. There’s 33 of these exclusion criteria. We don’t do PFT in standard of practice. So how do we know unless we call every single patient in our database and have them come in and do a PFT, we have no way of knowing how many are going to screen fill? By the way, I know the number, it’s 90% will screen fill and that’s just for that one exclusion criteria. So even when you try to be honest, you’re not going to give the sponsor, like it’s not going to reflect in your actual outcomes because the IE criteria is so complex and you have no way of knowing. You’re just guessing, doctors don’t do PFT tests for psoriasis visits.

Joseph Kim:
Right.

Dan Sfera:
They just don’t do that.

Joseph Kim:
It’s not standard of care. So how can we know? And it’s just going to be a crapshoot and it’s probably going to not work in your favor.

Dan Sfera:
And there’s hundreds of these examples, that’s just one.

Joseph Kim:
What about operationally where you say, okay, I think I could do this, and then the SIV comes around and you’re like, Oh my gosh, this is what I signed up for?

Dan Sfera:
It’s not usually the SIV, it’s usually when the patient’s there. So the SIV, you’re just like, Yeah, fine, you know, let’s just do it. Patient comes in, I have another example, all these things I’m telling you are like examples from my clinic, recent. We have a study that requires an x-ray, but the x-ray is not standard of care x-ray, it’s a special type of x-ray where the vendor, we don’t own the x, we’re not CSF, so we don’t own our x-ray facility. We’re thinking about it actually because it’s, it actually looks promising to do that maybe. So we go to the vendor and say, Hey, we want x-rays based for this protocol, by the way, you have to do this training. So let’s book an hour for your tech who’s already overburdened. Let’s book an hour with your tech, I’ll give you like a Starbucks gift card or something. They’ll do it. Standard of care. The patient comes into the x-ray vendor. Guess what? The standard of care procedure is done, not the research procedure. And despite going in retraining and retraining and the vendors keeps having turnover, so there’s always somebody new, and they could care less, Joe. They don’t give a damn, like they get paid the same. And there’s only so many times I can go in there and drop off like gift cards because then it’s somebody new. So we do our best, but that procedure, which is not meant to be difficult on paper, it’s not difficult, it’s becoming the most difficult part of the study to the point where patients had to wait over an hour to get an x-ray because they so worried about screwing it up that they need the right tech to come in and it’s causing the patient to wait an hour or two hour. We have to sit there, coordinator has to babysit the patient, and that’s an example.

Joseph Kim:
I’ve heard other versions of this exact story, and what’s so hard about trying to understand what to do is because it’s in two different manuals or like someone has to watch a video, what’s, what makes it hard? Without giving it away, I guess.

Dan Sfera:
Well, in this particular example, I think the academic medical centers for once have an advantage because they can control the whole process, you know, it’s their vendor like they are the vendor so they can dictate who’s there and how they do it. We, small sites, we’re at the mercy of our external vendors. So I’m in charge of my CRCs, I’m not in charge of this x-ray tech. Like no matter what I say, if their boss is telling them, Hey, just tell Dan whatever he wants to hear to get him out of here. But we have 90 patients waiting right now, so I don’t have that control where an AMC might. But then the AMCs have plenty of other issues, that’s another podcast.

Joseph Kim:
So this is a good segue into decentralized trials because as, if the idea is to have a lot of other third parties deliver per protocol procedures, you’re not going to have authority or influence over some of these folks, but you as the PI, not you, but your PI has responsibility. So you’re kind of upside down with like I have, I stole the responsibility for safety of the patient and delivery of the study, but some retail clinic is doing X, Y, and Z, right? And if you’re going to have five different third parties doing things for the protocol, like how does that square with you? Or have you thought about that implication in DCTs?

Dan Sfera:
Of course. I don’t see how that’s going to work. I mean, my CRCs and me, we’re willing to sit with the patient for an hour, and one of the patients, he’s screen filled, but I promised him a six-pack, he told me, I said, Hey man, I’m so sorry. You know, we’ll give you extra like 30 bucks. No, Dan, just give me a six-pack one of these days, so I owe him a six-pack. But who’s going to do that from a DCT vendor? Like who’s getting that VC money and that incentive in their salary to babysit, pretty much babysit a patient throughout the various assessments? All managed by a third-party vendors, different ones. I don’t see how that’s going to work out. And without giving consideration to the patient’s time, like how can we assume that they’re okay with vendors just showing up, even if it’s at their house convenient to the patient, right. Well? What if they’re not home? Like what if they work? What are you going to do? How is a vendor just going to pop in? Because the sponsor wants them to without checking with the patient. These kind of things are complicated, man, and the more procedures, like the whole point of the DCTs, is to make a life easier for the patients, but on the other side, sponsors see it as an opportunity to throw more assessments in there, to collect more data. Everything is data. So those two things conflict, and I think you need like human beings, put them together, not tech. I don’t think techs can do it.

Joseph Kim:
Well, certainly not five different parties trying to do each little piece of the pie. That gets tricky, and if you’re going to do it better, be tightly orchestrated like nothing else.

Dan Sfera:
I’m willing to drive my patients to El Centro, which is 45 minutes away in California, to do an x-ray if our vendor is not available to meet a sponsor timeline. Who’s going to do that in a DCT? The CEO, once he gets off his platform at SCRS?

Joseph Kim:
Or it’ll certainly be expensive if it’s.

Dan Sfera:
Yeah, it’s not their money, so hey, let’s put them on a helicopter.

Joseph Kim:
Listen, we’re going to definitely have you back. There’s a ton more to talk about, but I want to have a teaser, because I want to talk about Latinos in Clinical Research. Tell us more about this effort and how it fits into diversity in general and what can you sort of tee up for our next podcast around diversity.

Dan Sfera:
Well, okay, so I was inspired by Danielle Mitchell, who came on my podcast from Black Women in Clinical Research, and I interviewed her about her idea, and I thought it was awesome, and I asked her at the end, I said, Do you mind if, I think it’s actually recorded, it’s live, Do you mind if we do Latinos in Clinical Research? If I get Monica and a few other of my colleagues to say yes and she’s like, Yeah, the more the merrier. So not my idea at all, but a very good idea. And first of all, we’re inclusive of everyone, all background. I’m not Latino, I just work with a lot of them. My wife is Latina. I’m like an adopted Latino. But I would have never done this if Monica, Ashley, Judy would not have said yes, because they do most of the work. But basically, we’re trying to provide a safe place for mainly minorities, but really anyone, to come in and share their concerns with the industry, and it’s mostly about hiring and promotions and executive positions. And we hope that if we get more Latinos working in research that we can have a trickle-down effect to patients, more Latino patients enrolling. And we’re even planning on hitting up junior colleges in high schools to get the youngins interested in research, because if we can get them early, you want to spend an hour to talk about medical assistance and CNAs and their career options in regular healthcare versus clinical research. Regular healthcare for a medical assistant, by the way, largely Hispanic, okay. The ceiling is like 60K, if they’re lucky a year if they’re lucky. And that’s changing diapers at nursing homes, that’s doing all kinds of stuff. Research, MA, I hired one, site director, that’s already six-figure plus, right, within a short period of time. If they do it long enough, in-house CRAs, if they want, I mean, they can do so much more in research than they can in regular health care. And if we can get some of them curious about research, I think we’ve done something good for not just our industry, not just for them, but for society. So that’s like the motivation behind Latinos in Clinical Research.

Joseph Kim:
I think you’re totally on the right track. It’s the idea to increase diversity isn’t just plastering the right color person on some poster, right? It’s about the people doing the work. It’s about the location in which they do it. People want to see themselves and interact with others like them, for sure.

Dan Sfera:
That word equity in DE&I, right? It’s supposed to be equality, but it turns into equity. True equity is when you have ownership, right? Whether it’s in a company that’s the purest form of equity. You own a company or a part of it, or you have equity in your own position, meaning you’re in a position that gives you freedom to move up based on your hard work and merit. It’s not something you just give somebody and it’s not just a virtue signal, like it’s real stuff.

Joseph Kim:
Yeah, 100%. Dan, we could talk probably for three more hours, but you have patients to attend to.

Dan Sfera:
This patient’s freaking out because they think something’s wrong with them. I got to get my PI to talk to her, too.

Joseph Kim:
But listen, we’re going to definitely have you back on. Thanks a bunch for coming on. It’s great to have the original gangster on the show. Keep doing what you’re doing, You’re speaking truth to power, and yeah, we’ll talk soon. Have a great day.

Dan Sfera:
Thank you, Joe.

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 war 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. This show was presented by ProofPilot and is powered by Outcomes Rocket.

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Things You’ll Learn:

  • Many clinical research tech companies focus too much on collecting data, not on how that data gets collected through the sites’ workflow.
  • Qualities that make a great CRC are curiosity, science-related ambitions, willingness to learn, and a can-do attitude.
  • The game of patient enrollment estimates is a fool’s errand – Sites inflate estimates on imperfect data and the Sponsor deflates them on suspicion.  Where does it end?
  • Enrollment starts with inclusion and exclusion criteria – simpler criteria = more patients.
  • Small sites are at the mercy of their external vendors who don’t build their solutions with enough flexibility.
  • Some Sponsors have missed the point of DCTs, seeing them as an opportunity to collect more data from patients, not to improve accessibility and ease of conduct and participation.
  • Latinos in Clinical Research provide a safe place for minorities to learn and attract more Latinos to work in the industry.

Resources:

  • Connect with and follow Dan Sfera on LinkedIn, Twitter, Facebook, and Instagram.
  • Check out Dan Sfera’s YouTube Channel!
  • Listen to Dan Sfera’s Podcast “Random Musings From The Clinical Trials Guru” here!
  • Get a Copy of Dan Sfera’s book “The Comprehensive Guide To Clinical Research” here!
  • Follow The Clinical Trials Guru, LLC on LinkedIn.
  • Visit The Clinical Trials Guru, LLC Website.
  • Follow Yuma Clinical Trials on LinkedIn.
  • Explore the Yuma Clinical Trials Website.
  • Follow Latinos in Clinical Research on LinkedIn.
  • Find out more on the Latinos in Clinical Research Website.
  • Reach out to Dan Sfera at dan@theclinicaltrialsguru.com.
  • Contact Dan Sfera at (949) 415-6256.
  • Get a copy of Gary Vaynerchuk’s book “Crush It!” here!
  • 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.
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