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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:
Hi everyone! It’s great to be here with Edye Edens. It’s always a tongue twister for me. She’s here from First Class Solutions as a Senior Research Compliance Consultant, but she has a long history at IU working on a compliance, and quality, and clinical research. She’s an expert in this field. It’s a kind of an enigma of a topic. But Edye, it’s great to have you on the show. Thanks for coming.

Edye Edens:
Absolutely. Totally my pleasure. I’m so glad we could put this together. We’d crossed paths in enough little discussions in rooms and posts and threads. It was time to just get on the mic.

Joseph Kim:
Yeah, totally.

Edye Edens:
Thanks for having me.

Joseph Kim:
Sure. So we’re going to talk about compliance in a number of different lenses because I don’t think people really know how big that category really is. So I’ll ask you to break that down in a moment. But first, give us a bit of your history, because you’ve been in this, unlike some folks in the industry who’ve hopped around a lot like you, this has been like a deep vertical for you. So give us your history of how you became.

Edye Edens:
Yeah, I’m fiercely loyal. When I find something that I love or someone or a company. So I was very serendipitous. I have a whole family full of healthcare providers and even really deeply contemplated med school. And it was a very, I had gotten sick in college, switched majors temporarily. Go figure, I wound up being a creative writing major and realized that while I liked science, I was having so much more fun with the written word. And so, of course, everyone in my family is like, We think the baby got switched at the hospital. Like, what is she possibly going to do with this? But supported me, and I really had gotten, I’ve been very blessed and very privileged to start traveling at a very young age and studying abroad at a young age and just recognized the need for those who have the ability or empowered to speak out to protect those who aren’t, because there are so many individuals who experience different types of human rights violations. So I was very focused in grad school in going toward international human rights law, and I didn’t actually think I’d go to law school. I ended up going to law school at the same decade my parents both did. It was a second career for them, so I had no interest. You never want to do what your parents do, right? And so I went all the way through law school, actually working, traveling, having opportunities with the United Nations. And anyone who knows me from law school would say, she does what? You know, she’s the human rights girl. Like she would never shut up about all the international human rights. And then I graduated in the great wonderful recession of ’07, ’08 era, and no one had a job. It just, it didn’t matter how high in your class you graduated. But I graduated from Indiana University. They have two law schools. There’s one in Indianapolis that practically shares a parking lot with the med school. And Indi is such a life sciences city, right? We have Lilly, we have Roche, we have a cancer center. We have two level-one trauma units in downtown. We have it all. We have VA, you name it, we have children, and so I wasn’t not cognizant of that, and we had a phenomenal health law program, which is what most people think I did at IU. And I graduated, and I thought, well, crap, I don’t know what I’m going to do, and I received, I sought out and received an offer from the Air Force JAG Corps, and I was like, okay, they’re not going to go under in this recession. It’s not quite where I saw myself going, but this is a service-oriented job. It fits, come out in four years, see if I want to stay, see if I want to jump. This is my best opportunity. And it was competitive, I was very lucky to get an offer, but I had nine months, so they send you to officer training school, and I had a dear friend who I had graduated with who was all about health law. She was the person who knew in kindergarten she was going to be a healthcare attorney, and she totally is still today. And she said, Hey, I’ve got this job. It’s really, it’s a little bit prickly. It’s a contract job, so you wouldn’t even have to lie to anyone. It’s literally nine months. So this fits perfectly. It’s better than whatever you thought you were going to do, bartend, whatever, for the next nine months, which, by the way, is super humbling after you’ve just graduated law school and passed the bar, and then you still, like I still don’t have a job and you’re like,

Joseph Kim:
What more can I do, right?

Edye Edens:
What more can I do here? So at any rate, she’s like, You’re going to be an IRB consultant. I had to interview and everything and go through it, she said, But this is what it would be. And I’m like, Great, consultant sounds great. What’s an IRB? And so, I was learning on the fly, and the reason they hired me was obviously not my extensive IRB regulatory knowledge at the time. She had seen me in several different environments under some serious duress, even including getting banned from a country permanently, still do the right thing, still follow the compliance. And so she was like, Look, she’s smart enough. She knows compliance in another venue, in another setting. She’ll, her mind will click into this. Plus, she was raised in a medical world. She doesn’t know about research just generally, and we need her for this very specific project where it’s going to be very tent settings. It’s going to be going in and telling, unfortunately, Hey, researcher, you didn’t do anything wrong. We did administratively, so we have to stop all your research and completely start an IRB application from scratch for you. And you can imagine how fun giving that news is and the responses that you’re going to get from tenured faculty members who legitimately didn’t do anything. And so this was a really, that was my way in, was the fact that someone melting down on me was not going to make me lose my cool. But I had to do a lot of front-loading reading, and I was learning from other lawyers, which I was grateful for, in the sense that we go to the source man, we do it law school style. You read the regulation word by word. You read it, you learn it, you annotate it, and then you begin reading cases or examples of it to see how it’s applied. Because, getting back to your point, compliance is, it looks very simple on the page. There’s a rule, just follow it. It’s so black and white. And then we live in the gray, right? We never live in the black and white. So suffice to say, at the end of the nine months, there was a full-time position at IU in the research administration, and I kindly declined the JAG Corps, went ahead and accepted the position at IU, stayed until 2017, had a chance to move through just about every facet of compliance I could possibly be interested in. Very much focused on those enterprise-wide risk management grants, contracts, IRB, restructuring, and accreditation of IRBs like AR; and then building out several new and exciting elements and facets of the Human Research Protection Program in conflicts of interest, building out a research Integrity and Misconduct Office, building out a clinical research compliance office. And the last two, the research integrity and the clinical research compliance got me very close and involved with the med school, even more than everything else ever had. And so it became very apparent to me that kind of cycling through these deep dive, very nuanced jobs where I did nothing but that for a couple of years, it was incredible experience. I got to travel. I got to be on NIH grants. I mean, I couldn’t, I got to publish, got to present all the fun nerdy stuff, even got to go get my master’s, international research ethics at IU, but outside of a really large academic medical setting, you’d never have these jobs. Like, they’re just so nuanced, and they’re only at huge academic medical centers. So, okay, are you ever planning on leaving IU? Do you ever think it’s possible? And I’d married someone from Indy, and we love Indy, so I wasn’t inclined to, but if you ever think you’re going to leave, you need to get the whole picture of experience. So far, what you have, you probably have to leave Indy to get another job. You’d have to go to another big agency. And I’m a future thinker. Like, I love to live in the moment, don’t get me wrong, but I can only do that so long before I have to know, okay, what’s the five-year plan, the ten-year plan? So I had the opportunity to pivot inside the cancer center there, which people always say oncology is like, You either love it or you hate it. You know what I mean? You’ll either never do research again, or you’ll stay in oncology forever. And I really did want to get closer to the patient and the clinician because it does feel awfully far away when you’re in administrative building on the side of campus, even when they call you all the time, and you know you’re helping and you know you’re making a difference, you live in the shadows, you know what I mean? It’s just different. And so there was a first-time position, which I kind of made my name at IU, taking a lot of first-time positions and helping build out an office that basically didn’t exist before me. So I wasn’t real scared about that, and in fact, I kind of see it as a challenge, and I like it. And it was to be the compliance, the quality and compliance manager for the cancer center, and not just their clinical trials office, which most large cancer centers basically have an in-house CRO, but for the whole center. And that had never been done before, it wasn’t to say they didn’t have compliance, it was just piecemeal. There wasn’t someone driving an entire program taking over all these different teams exploring outside of the CTO, etc. And just like that, overnight, suddenly, 700 FDA trials, including phase one, were keeping me up at night. And I remember going into work about the second week and thinking, why did they hire me? Did they understand I had no site experience? Like, they must have really been desperate, like, Oh my God, what have I done? And it was a very interesting experience. I expected people not liking compliance. I expected people being a little like, Wow, there’s a lawyer in the building now. Watch what you say, right? Like doctors don’t love lawyers. I get it. I have a father who happens to be both. He’s very conflicted. But what I didn’t expect was, and it’s stupid now looking back, was, I came from the compliance side. I came from the they people, and now I was amongst the us people. And so it was like, is she like a secret mole for the IRB? And I never understood when I was at the IRB like, why do you hate us so much? Like I get that it’s red tape and it’s not fun, but we do a good job. We do this because we want to protect you, the university, the patients. This is a good thing. Plus, we’re required to do it. Like, come on, just let’s do it and do it well. I saw the other side? I saw the other side. And I saw how hard it was to operationalize some of these concepts that when I was sitting in the office or the compliance office for clinical research, it was like, why can’t these researchers get this right?

Joseph Kim:
Right. Because it’s theoretically, on paper it sounds very logical. And, but when you hit the, when the rubber hits the road, and you’re in there with people doing real things, the logic doesn’t apply.

Edye Edens:
And it was just eye-opening. I was in love. I already loved what I did. I’d already been there seven years, so it wasn’t like I didn’t love clinical research, it didn’t love compliance, but the site was just like where it was at for me. And changing the relationship between the site and the regulatory bodies they were subject to, like there was so much fostering relationship and training that I felt like I was able to bring because I wasn’t scared to call the IRB. I knew them. I knew who to call, probably had their cell phone number. I was like, Hey, I think if your office and our office would sit down and talk about this, we’d stop being mortal enemies and instead realized we’re like on the same team. It also just exposed me to this incredible world, the inner workings of a cancer center, especially a large one and a comprehensive one at that, are just unbelievable. Like the red tape that’s outside that cancer center is nothing compared to what’s inside it and how self-regulated they are. And you’d never just never seen clinicians that were so passionate. And it wasn’t like passion because they wanted to break the rules as one very candidly, in a very tense conversation said to me, and rightfully so. And I always give her props for saying this like, I want to follow your rules, I’m not trying to break anybody’s rules. I don’t think I’m above the rules. But you’re you, the IRB, the FDA, etc., etc., are not the ones who have to go walk in that patient room and tell that patient, I don’t have hope for them. Okay? So you real sure I have to do that? Are you really sure I have to go do that? Because what if that was you? What if that was your mom? What if that was your husband? And it was like, Oh, okay, wow. You have made your point. Hold on. All right, let’s start from the top. At least run it down one more time. I don’t want you to have to tell a patient that. And it just made it so much more real. And so when the time did come that I had an opportunity to jump into consulting and put my entrepreneur shoes on, it was a real blessing that I’d kind of done the whole spectrum there, and I very much credit you. I still teach at the law school. I’m still very involved in mentoring students and helping them, frankly, explore this world if they’re interested in any world in health law, but a lot of them have gotten really turned on to this, and it’s fun. And I teach some doctrinal classes on the subject matter there too. But yeah, in 2017, I was a weird deal, right? Like, you get it. You’re an attorney. You’re supposed to go to a law firm and practice in a courtroom, and I’ve done none of that. So law firms are like, We’re not sure what to do with you. Like, you’re smart, but you didn’t go through this whole partner track dance. Okay, fair enough. Fair enough. Didn’t come in like everybody else. But consulting firms want you to come with a client book because if you’re not coming straight out of school, then you’re expected to come with a client book. Again. Totally fair. I showed up with neither. So who’s, like, what unicorn bucket do I fit in?

Joseph Kim:
Let’s, so let’s actually get into some of the actual topics now. So this is great history.

Edye Edens:
So this is, and this gets there. This gets there. So this is where first class comes in. So I loved compliance, but if you are a compliance professional, the thing that keeps you up at night is what’s going to get your organization or you, frankly, in trouble because there’s no such thing as 100% compliance. As I lovingly say to everyone, every student, and every client, if you have 100% compliance, if you have an open checkbook for compliance at your organization, please hire me immediately, please call me, and no one’s ever called. Because what you’re trying to do is do a risk-based approach to whatever type of compliance, whatever industry you’re in. Of course, we’d love it to be perfect every time. We’re working with humans, that guarantees it won’t be, that’s just a statistic of fact you have to bring into the equation. And so, for me, what I kept running into in my compliance career where I wanted to jump on the consulting side was, one, I wanted more variety. I didn’t want to just be pegged into one type of client or one type of compliance. And two, I wanted to know that, and politics play a role in every organization, as does money, as does everything else, right? So just because you realize you have a compliance problem doesn’t automatically mean it’s getting fixed. That doesn’t mean you don’t still have to justify the money spent, the FTEs the time. Maybe you propose this solution, somebody proposes this solution, and you finally meet in the middle, that kind of thing. So it’s a lot of negotiation. Like, when my students ask me, What’s the best class you ever took for what you do? I say conflict resolution because that’s what I do all day. And so, for me, I wanted to work with clients where I could give them their options, and they could then factor in their politics and make their decisions. When you’re the compliance person who goes home with a problem, and you’ve told your higher-ups, and it doesn’t change, that keeps you up at night, right? And, like you said, there’s all these different buckets of compliance. So you have to think about organizational compliance. You have your own layers.

Joseph Kim:
So before you get into that, because I think we’re skipping a few steps here, right? So people who are listening to this or don’t understand compliance really, and why it’s important. So, right, so let’s level set here a bit. So when we think about research, right, you’re bringing people in, and you’re not supposed to be treating them, quote-unquote. You are bringing people in to test the safety and efficacy of a drug. There’s other kinds of research, but this is the kind of research we’re talking about. So in that context, when we’re talking about bringing human beings in, waive some rights to a lot of different things, you know, their data, treatments, so on and so forth, and then have a bunch of other weird experimental things done to them, there’s a lot of rules around doing that responsibly, and rightly so, because there’s been so much bad behavior in the world, particularly with Tuskegee and Nazi regime. There’s been plenty of bad examples. And then certainly, there’s good people who do, who make mistakes and do things inappropriately, not because they’re bad, but because there wasn’t a framework. So given that as the context, help us understand, like what does compliance mean to you in that world?

Edye Edens:
So in that world, compliance very much started out as reactive, right? We had this ultimate other than a Hippocratic oath. We had this ultimate trust of a clinician, and research was very much viewed as just an extension of clinical practice. And in fact, if you go back into the history of research, even in the early 1900s, right, even some of your, I won’t name names, but they’re on the sides of a lot of different medical schools and buildings because they had great discoveries, but if they were in today’s regulatory schema, that wouldn’t happen, right? Because your quote-unquote subjects were yourself, your family members, right? Their stories and Pedes oncology about the particular oncology physician getting obviously verbal permission, but nothing like what we do now to try a certain medication on his neighbor’s children, like that, and at that time, that was appropriate, right? I’m not bashing on them at all. And so because we went so many theoretics, there’s a lot of folks who would point out we didn’t. But at least for better or for worse, in the eyes of the general public, we went well into almost the 60s and 70s, and 1900s, right, before we had anything that was so known and exposed of a clinician being a bad actor, not making a mistake, but being a bad actor, right? Taking advantage of a patient. And it broke this trust immensely. And so in the United States, at least our regulatory schema, you’ll see, when you do your homework, doesn’t really start till the 70s in research or at the timing is all very coincidental, and it’s very reactive, and most compliance is, right? The best organizations are going to have a proactive preventative compliance program wrapped around each and every type of activity in their therapeutic area of study that they do. That’s going to start with training, retraining, policy, procedure, quality monitoring, auditing internally, etc. Even just routine, not for cause.

Joseph Kim:
So let’s break those down into bigger chunks, right? So I’m going to make a couple guesses here. Like certainly, there’s compliance issues that are under an umbrella of, let’s say, financial responsibilities, right? Like you can’t pay, overpay a physician for doing something because that looks shady. You can’t, you certainly don’t want to underpay them because they need to be paid for their work.

Edye Edens:
Because they’ll leave. They’ll leave, that’s it, they’ll leave.

Joseph Kim:
Other medical compliance, right? That we might call GCP, but maybe there’s more, like break out, break down the big buckets of –

Edye Edens:
I look at it as, and I say this because, and I talk about them a lot. My father is a chief medical officer, so he does all clinical compliance all the time, right? And I do all research all the time. And the way that breaks down is within each of those, you’re going to have elements, right? So the type of financial or billing compliance that you’re concerned about in clinical care is different, but has just as big a gravitas and penalties if you get it wrong, just like we have in clinical research billing compliance, right? So you’re going to have some hallmarks, like HR. I always say HR, it’s really more employment law labor following the rules, keeping your people safe, which is even harder in a medical environment where we do use needles, where we do potentially have a patient who’s fighting the treatment, right, or isn’t well enough and is struggling to receive what you’re doing, right, might roll over on you unintentionally, something to that effect. So you have a lot of safety issues, and in a hospital setting, you have to be even, and/or a research setting, even more careful because a lot of these things, when we’re talking about a more administrative office, somebody misses a step, somebody doesn’t secure a record or a document, you’re talking about a privacy breach. Dangerous, yes. Something similar, a certain training step is missed, for example, I always think of an example my dad gave of, there’s a certain window after instruments are used in the OR that a certain solution must be applied to them, otherwise, you don’t get them fully clean. And obviously, when you’re using this inside people, it has to be perfectly clean, even autoclave, and that one step was missed. That one little step was overlooked by someone because everyone else thought someone had done it, and it led to a near-deadly and fatal infection in a patient several steps later, right? And so the gravitas of some of the errors are so much even bigger because of those steps. So you’ve got when you’re thinking of that compliance plan as whole, you’re thinking, what do I have to train everyone on that’s all role-based, right, in each different department? How do I handle my finances? How do I handle my hiring, firing, discipline, right? You’re going to deal with that in every industry, when you release people, there’s a lot of reasons they might fire you, or excuse me, sue you, right? Or be upset. And similarly, as in healthcare, as a part of hiring and firing, you also have to think about licensing and credentialing, so that’s another element of the compliance, because you are the entity who’s letting them practice there. And so you are saying you’ve checked that their license is clear, just like if they do something wrong while they’re in your facility, you’re the one who has to report them to that licensing board, right? So, and you have to check things like, in clinical compliance, physicians have to carry a certain amount of medical malpractice insurance to be able to operate in your operating room. So, and there’s a lot of different relationships in the hospital setting. We actually get this a little bit easier in the clinical research setting. In the hospital setting, you have some doctors that work for the hospital, some that are private practice outside of the hospital. So how you relate to your different centers and how you give them their KPIs of how they’re going to get paid is very tricky because it’s very different for each practice and each setting. And doctors are human just like anyone else. If one of them finds out that their partner is making more money than them and they swear they do a better work than them, believe me, they’re going to be in your office complaining about it. It’s no different than any other profession. So you have these areas of compliance. And then the overarching piece is everything, when you think about training, thinking about proactive, you think about ensuring you’re hiring the right people, you’ve given them the right onboarding, you’ve credentialed them appropriately, you’ve set them up with the right resources to succeed at their assigned task, then we have to check on them. You have to have some type of way internally, routinely, not just when something goes wrong all the time where you’re checking on them, and I say, check. You’re just, you’re checking in.

Joseph Kim:
Trust but verify.

Edye Edens:
Exactly, thank you. And so you’re trusting but verifying. And obviously, you will find some things that probably need to be fixed. So finding a constructive system that has that nailed down, right? And then you move into reactive, which is, okay, so everything’s gone wrong, everything’s gone. We hired the wrong person, we forgot to credential them, they treated a patient wrong, like everything’s gone wrong. You have to have a whole separate system set up for that. Then you’re proactive, which is if we move through enough of the proactive, hopefully, the reactive doesn’t happen that often. And it’s interesting. We focus in clinical research on the TMF, right? The trial master file, our red binders, our docs from that perspective for clinical compliance, it is medical record management, and it’s very similar, they mirror each other. So a hospital could get visited by the accrediting body JCAHO, whereas a research site might get visited by the FDA, right? Very similar, looking at and telling you you’re deficient in these areas.

Joseph Kim:
Is it fair to say that a lot of compliance, especially the documentation, is trying to help whoever a third party come in, regulator, whoever it is. And try to prove that the story that resulted in some data or outcome is verifiable. Like you’re really trying to piece together the story. It’s the archaeology, the anthropology.

Edye Edens:
What I love about it, I mean, to me that was the solving of the problem and still is, like when I have a site that’s undergoing an audit routine, or for cause, and the auditors just all lit up about something they found, it’s not that I’m invalidating him, it’s that I’m going to then pull my staff aside or my client aside and say, backtrack. What happened here? Just tell me the truth. Start with the truth. Like I’m not trying to, nobody make anything up. Just they found this with this, let’s take it a step further. Where was this? Where was this? It’s root cause analysis to get to the real story. And sometimes that’s on the page, but more often than not, it’s not institutional knowledge. You’re praying that there’s some study coordinator that’s been there for 20 years. You can go, Oh, I remember that, that was when left such happened. Doesn’t mean you’re going to have a good answer for the auditor. Like you’re going to have to translate that from the ball got dropped to, okay, here’s what happened, and here’s how we’re going to make sure it doesn’t happen again. But it’s tough, it’s really tough. And people don’t realize because in the moment you think, who wouldn’t know that this happened; or we have this policy or this procedure, but if you don’t have documentation, then a year from now or six years from now, truly we won’t remember, and you won’t know what happened in that setting. And that’s the deal. Nothing, if it’s not and we say this over and over, it’s not documented, it didn’t happen. That’s clinical and research. Some of that is CYA, honestly, right? For you, for the site, for the clinician, for the patient. Some of it’s overkill. These 45-plus page informed consents in oncology pretty much send me over the edge, especially when you work in oncology and you’ve seen a patient go, Just tell me where to sign, you know, one on this trial. Like, we’ve defeated, and at that point, that consent form is to protect that university or that hospital.

Joseph Kim:
Right? When the alternative is certain death. Something like diarrhea, it doesn’t really.

Edye Edens:
I always say, when you have stage-four scary, you will agree to a lot of things if you’re wanting to fight it. So I think that’s an area we have a lot to do better on, but admittedly that’s why we’re so hard on documentation. That’s why we need to see policy and procedure. I can’t just take your word for it. You have to have a process.

Joseph Kim:
I think part of it is, if you don’t have a digital process that automatically captures when things happen, well, then you have to create some other mechanism to document that you did something. So part of this, the symptom of it is almost like, well, there’s not enough of the right technology to capture that.

Edye Edens:
That’s what kills me. We are in 2022. We are in an industry that truly actually is curing cancer in some spaces, that is giving people more years of quality in their life, that is saving people from conditions that only years ago would have killed them. We’re making incredible progress and we’re doing it on paper. It kills me because, and I always give a huge shout-out to … I don’t know if Raymond, who’s over there. They’re really fantastic … and the reason is they created a way to go paperless, because paper is frankly every compliance officer’s worst nightmare. The minute I have a human taking data out of a system, copying it down, then ferrying it to another system or using it in another documentation, I just asked for a mistake to be made. Not because anyone meant to, but hello, we are all human and you’re doing everything really fast. And if your workload is like mine, you know you’re going 90 miles an hour all day. So you transposed a number, you forgot something. If you have a system and it’s digital and it’s been customized for that trial so that when you did accidentally hit a typo, it goes, no, you couldn’t possibly have a lab value like that, you must have a typo, then you’re catching things before they ever even happen. And that’s one of those pieces I’ve never understood, even in compliance. I know compliance officers who love their paper, love their paper, and I will never understand it. I’ve been on this soapbox for a long time. Because the technology out there would make the documentation better, it stands the test of time like it’s never going to be in a basement banker’s box that got rained on. You know what I mean? Like, it shouldn’t in theory, you should be able to back it up, and it can give you actual timestamps. It can give you the initials of who was logged into the system. Like there’s no forging anything, we know it was you, Joe. Your initials were there. It was at 5 p.m. You did it,now tell us why you did it.

Joseph Kim:
And let’s be reasonable, right? There’s no amount of security or compliance or process that can prevent the worst, most egregious foul play, right? That’s just going to happen.

Edye Edens:
It’s the worst part about our job. It’s the worst. You can’t, there are bad actors.

Joseph Kim:
But I might say that’s very few and far between, right?

Edye Edens:
It is.

Joseph Kim:
Most criminals look for easy targets, right?

Edye Edens:
Oh, yeah.

Joseph Kim:
They’re not really.

Edye Edens:
They don’t want to have to work hard. If they wanted to work hard, they’d be doing it the right way.

Joseph Kim:
Ocean’s 11 is a movie, right? People are not.

Edye Edens:
It makes it look so sexy, though, doesn’t it?

Joseph Kim:
Yeah, but my point is, like, you’re always going to get critics of technology saying, Oh, well, someone could hack into X, Y, and Z. And it’s, for me, it’s more about like, really? What’s the motive, right? This is what law enforcement’s really looking at. Like, is there a motive? First, I would argue that there’s rarely a motive. Well, and there are bad people, but.

Edye Edens:
There’s pain, there’s growing pains to every piece, the same way that paper gets destroyed in a fire. Yes, someone can hijack your EMR and make you cough up a lot of money to get it back in the middle of your hospital operations. It’s nasty, it’s ugly, again, like you said, there are bad actors. It’s the same people who are trying to scam you on your credit card or steal your Social Security number. They’re everywhere, and we’re not immune in healthcare. But it’s also why you see hospitals and major pharmaceutical companies taking out huge cybersecurity threat policies now to deal with exactly that because it’s what’s happened.

Joseph Kim:
But at the site level for research conduct, it’s really just about helping people, good people, not make mistakes, right.

Edye Edens:
And usually what you see, like what I tell people time and time again, and it’s why I get so mad when you see, so, for example, the case that just came out where the clinical trial coordinators were fudging the numbers on a study, I want to say it was out of maybe New Jersey just hit the news. They just they actually were sentenced and are going to do some time for faking data. Yes, and someone was expressing their outrage to me. And I said, and she was like, you know, you’re probably just so calm about this because you’ve seen it so many times. And I said, actually, no, it sends me over the edge, sends me over the edge more than you. Because here’s the thing, that’s what gets sensationalized on the news, not the 555,000 times it didn’t happen. The time it did. And the impact of things like that, like vaccine hesitancy, all of the research that all of Hollywood clambered onto, completely fabricated. It came out seven years later, but man, you’re not going to change people’s minds about that, right? Never they’re going to think that you’re a conspiracy person if you try to tell them that literally it was discovered this person falsified all their research, it was completely bunk crap. And that’s what you see, that’s what, that’s the one shark attack that you hear about all summer, even though there was one out of, you know, 7 million opportunities for one, and statistically, it was not significant. And it sends me over the edge. It’s, because that one person does it for the whole industry, right?

Joseph Kim:
Yeah, I’ve had to tell lots of my friends about like, you never hear about all the failed drugs. Like working at pharma companies, like I’ve seen all these failed drugs happen and people, billions of dollars down the tube.

Edye Edens:
Effort hours.

Joseph Kim:
If there was any motive to try and cook the books, it certainly would have happened, but I have not seen it in my day. I’ve seen more losses.

Edye Edens:
What I see more of, and that’s what I tried to console my colleague and say is, look, I’m just angry as you. It’s like being in traffic, and you see some female on her phone driving like crap. And I’m like, You’re making us all look bad. We’re not all like that. So it makes me mad. But the reality is that the majority of the time when I’m going over, pouring over and over something for a client, for a research site, it’s because they want to do it right, but they also are really aggressive about caring about their patient. They want their patient to get the best possible options. The notion, and we don’t ever want to promise therapeutic benefit in research, but the notion that you can take clinicians who live and die by standard of care and therapeutic benefit and just sort of dawdle across the dotted line into research and just drop all that. That was another one of the things I learned being on the site side, that I didn’t get, when I was sitting in IRB land, HRPP land, is how do they not get this? Well, duh, this has been beat into them. This is the whole reason they do what they do, and they’re good at it. You can’t ask them to not still be looking for therapeutic benefit. It’s research that they’re doing.

Joseph Kim:
I think it’s totally naive for the pharma companies, IRBs, whomever, to think that there’s not hope in research.

Edye Edens:
Of course, there is. In oncology. Hello?

Joseph Kim:
Because you can only you’re only eligible when you’re sick, right? Which by definition means we’re trying to make you better. Now, even in standard of care, you can’t guarantee this as either. So, right? Like it’s the same thing. Like, I’m not sure if this is going to work is the question. But you’re sick enough that we can see it, we’re going to try and see a difference. Like, I’ve got some conditions, but because I’m controlled, I’m ineligible, right? I can’t get any better. That’s the whole point. So we’ve been dancing around this whole like, Oh, you can’t promise. Of course, you can’t promise therapeutic benefit, even in standard of care. It’s a silly.

Edye Edens:
No, of course not.

Joseph Kim:
A flimsy way of like, trying to protect ourselves, I think.

Edye Edens:
Well, another one of my long-standing bosses at IU, mentor, and dear friend, like, my gosh, my life would be different if I had never met her. She said it in the fall of 2020, and she said it so, just rattled off her tongue when we were having lunch and we were finally getting back together in person. And she said, This is the science everyone was getting really nervous about. Okay, the vaccines on the forefront sounds like it’s going to come out by the end of the year. Do I want to take it? Was it rushed and kind of it was getting sensationalized, and people were really frustrated by all the different changing advice about masks and distancing? And it was constantly being updated. And she said, this is a scientific method. It’s always been this way. We’ve always had to try multiple things, change our guidance, tweak change, go backwards a little bit, then go forward a little bit. It’s just that we’ve been doing it behind an iron curtain where no one saw it until it really hit the market, and now they’re seeing behind that curtain.

Joseph Kim:
Yeah, science is messy.

Edye Edens:
Right, and so for all of us who knew science is messy, we’re sitting there going, Yeah, like, how did you ever think this all worked? Get it right the first time?

Joseph Kim:
Maybe the first example of showing how science is messy was, remember that show MythBusters?

Edye Edens:
Yes, yes.

Joseph Kim:
So those two guys would actually try something, it would fail, try something, it would fail, and eventually it would work. We need to connect that dot better. Hey, listen, we’re running out of time, but I want to get I want to try and get one good war story from you regarding specific clinical research. You don’t have to name the sponsor, of course. Give us an example of some, an egregious compliance mishap.

Edye Edens:
A mishap by them?

Joseph Kim:
Either way.

Edye Edens:
I find, my really good ones right now at the top of my tongue are about recruitment reimbursement because I’ve been on a bender to get my sites more reimbursed. But what I find generally is two things. From the sponsor side when I’m there helping the research site, right, and speaking to the representatives of the sponsor. From the sponsor side, two things happen. If it has anything to do with money, even if what we’re providing you is high quality and I’m very hard on my sites about you itemize, you track time, you’re going to effort track like you’ve never effort track before, right? Because I’m not going to go make a big ass without some real data behind it. That would be silly. But when we’ve shown up with the data, and we’ve shown the quality, and you’re clearly picking us year after year, because you know what you’re getting with this particular site, and then you go like, Yeah, 2000 more dollars can’t do it. And what I’ve learned is there’s actually usually incentivization inside the sponsor for whoever’s negotiating on their behalf to whittle it down. And it almost always takes one, me being in the room, even if I say nothing and I am just sitting there smiling for the hour, which is to me just so ridiculous that my client has to pay for me to be there just to have a presence, just to have a lawyer in the room, right? But that it always comes down. We could be on the phone for three hours, and it will come down to the last three minutes, and it won’t be until I say, okay, so let me level with you where we’re at. We will not continue to provide these services until this price point is matched. So are you at a point where you were telling me you’re willing to forego business with my site, and or do I need to talk to someone above you about making that decision? And that’s when suddenly it’s no problem. Or let me go talk to my superiors, and suddenly, it happens. And if we were asking for millions of bucks, I get it. But it’s usually like we’re talking a couple thousand dollars, and for what they’re getting.

Joseph Kim:
You’ve documented it.

Edye Edens:
And you’ve documented it. So that’s one scenario that just sends me over the edge. Because it’s like you had that power the whole time, You want to talk about dragging things out, making research slow, making it laborious, making it difficult for unique community sites to get involved, this is the problem. It just took you three hours to say something you could have said in an email, never even had to do this whole dog and pony show. Like that just, that really sends me over the edge. The other one is, I have clients who, they’ll be working with a sponsor, and I educate my clients, I train my clients, I don’t want them to be totally dependent on me, that’s not the point. I want everyone to have access to the information because let’s face it, the regs are public. If you want to know what I know, you can know it at any time. And so I’ll have a client that’s doing really well, only calls me when they really need me for something and they’ll call me and go like, All right, the sponsor just won’t come on that we have GCP violations or that we don’t follow a particular IRB policy. And so they’ll dig in and tell me what it’s about. And I’m like, I don’t, client, I don’t think I understand what their issue is. And they’re like, Yeah, we don’t either. We thought maybe you would. And we want to lay on the client, we want to do what the sponsor says, whatever it is. We’re trying to preserve the relationship, but we can’t figure it out what it is they want. And one particular example comes to mind where I kid you not, it’s like the CEO of the client, their compliance person, and their VP, me on their behalf, and we must have been operating in eight different time zones. And the sponsor, the person who raised the issue, that person supervisor, a VP on top of that, so here’s like ten people, most of who should be compliance regulatory professionals on the phone, and again, on the phone for 45 minutes dancing around, and finally, kudos to the client, the CEO said, look, this is an expensive phone call for me. Like, could we get to it? Like we don’t, we’ve told you we’ll do whatever you want to be compliant, but we genuinely don’t understand. And they they explained it very, I don’t think they meant to, but in very small words, condescending, lots of acronyms, like we didn’t get it. And I literally just said, okay, I know everything you’re talking about, but where can you cite to me, like which regulation is this in violation of? Which practice is this? That’s the thing, because I’m looking at the same thing you are, I’m educated and trained on the same thing you are, and it’s not there. And we will, again, we’ll do whatever you want, but you can’t seem to tell me what the problem actually is, you just know there is one. And immediate shuffling, muting, all video going off, and then suddenly, call wraps up, and issue just dissipates. And I genuinely, like when my client asked me later what I thought happened, I said I think the person was in over their head. I don’t think that they were regulatory professional, that maybe they thought they were, or they were hired to be, or maybe they’re still learning. And I think they thought they found something wrong, and when they were pressed, they realized they didn’t. And I said, but here’s the thing, that just cost how many hours, how many dollars, and what small sites and startups have that bandwidth to play with, They don’t. So at a huge, massive research organization, they don’t love spending time on this, or money on this, but they’ve acquiesced that this is part of margins.

Joseph Kim:
It doesn’t make it right that they can.

Edye Edens:
But that doesn’t make it right. And why did it take this many people on the phone and this much time to just go, you know what, I made a mistake. This isn’t actually an issue. Forget I brought it up, let’s move on. Like, and those are my worst stories where I just go over the edge, you know what I mean? I have some real good ones. I always tell people when I was in-house at IU, I had an auditor who pretended she was a cancer patient to get free parking.

Joseph Kim:
For free parking?

Edye Edens:
Yeah, and you want to piss off a building full of people who love oncology patients and really give their every day to save their lives? You pretend you’re a cancer. So we had, we outsourced the valet parking that we provided for patients and their families, and not once in the history of the cancer center being open had parking services ever had to come to our office and say, this person not only didn’t give us their keys, like they just parked like they could stay there. It’s a valet, we have to move your car. We have been tracking them all day, they came to your office, and they’re definitely not a patient.

Joseph Kim:
Yeah.

Edye Edens:
Don’t ever let them. And that’s the thing, she did it the next morning again.

Joseph Kim:
Yeah, well, here’s back to what we said earlier. Like,

Edye Edens:
There’s always bad actors.

Joseph Kim:
There’s always bad actors. The best process someone’s, but, and who’s really harmed.

Edye Edens:
Well, and I think what the takeaway from that was, I had a choice on my hands, right? As a compliance professional, you have a choice in that moment. You can just let it fly and roll your eyes. You can get really mad, right, and you know, hem and haw about it. Or you can actually do something that’s functional. And so, she’d been made aware the day before, and we knew she knew what she was doing. And she did it again, I called the sponsor and asked to speak with her boss and just said, Look, this is pretty ballsy, and my study team was mad. My PI was really mad. He was like, You ruin this relationship with the sponsor, we’ll have your job. And I’m like, But that’s not what I’m doing. I’m not playing tattletale. What I’m saying is, if one of my people were in your building behaving this way, I hope you’d call me because I want to know who, how they’re representing me.

Joseph Kim:
There was a fourth thing you could do, which you didn’t, which sounds, which is great. Which is like, create a whole bunch of other processes and rules to try and weed out the next person to do this.

Edye Edens:
That’s what I always tell my clients. It’s even what I said when I was in-house at IU. What I need to know is, is this a systematic issue? In which case, yes, we have to address root cause, and …, and write our policies, and get all compliance on it. Or was this a true one-off mistake? It’s okay to say it was a one-off mistake. We still have to report it. We still have to own it. We still have to talk about, could it have been prevented? But there’s just a difference between, I mucked up, and I’ve done it this way every single way because I was trained to do it the wrong way.

Joseph Kim:
Right, right, right, right, Exactly. Well, Edye, thank you so much for joining us. This was a lot of fun. I think a good takeaway for the audience would be like, don’t overthink the policies and compliance. Focus on what’s true in the regs, because if it’s not there, you probably do have a leg to stand on. And at the end of the day, we’re all human. And sometimes things that are black and white, in black and white, are definitely gray in the real world.

Edye Edens:
Yeah, just stick to the truth, be honest, and don’t overcomplicate it, absolutely.

Joseph Kim:
Thank you so much.

Edye Edens:
Thank you for having me. So appreciate it.

Joseph Kim:
Have a great day.

Joseph Kim:
Thank you for tuning in to 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 is presented by ProofPilot and is powered by Outcomes Rocket.

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