Research Confidential_Ted Trafford: Audio automatically transcribed by Sonix

Research Confidential_Ted Trafford: 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:
And today I’m here with Ted Trafford, who I’m really excited to talk to. He’s the director of business development at Probity Clinical Research. Ted, welcome to the show.

Ted Trafford:
Thanks, Joe. Great to be here today.

Joseph Kim:
So, Ted, you made a recent splash with a certain poem you wrote that was full of acronyms and ended with a take on DCTs. So you and I met in Toronto at a recent conference talking about clinical research and a wide variety of topics there, and you brought to light a lot of different aspects and perspectives on decentralized trials that I think few have really taken to heart. Everyone’s just been thinking about, oh, it’s easier for access, and enrollment’s going to be better, and there’s all this technology, and we get kind of hypnotized by all that. So I definitely want to get into all that with you shortly, but first, let’s talk a little bit about your own personal journey. A lot of people come to clinical research and they just fall into it, but this is not something that people often study as an undergrad. So tell us about like your studies at university and like how you ended up in clinical research.

Ted Trafford:
Yeah, absolutely. It was really interesting because when I started looking at what I was going to study in university, of course, my mother wanted me to be a doctor and she actually suffered from lupus at the time. And so her vision for her son was, oh, my son can become a doctor, he can study lupus and help people who suffer from my problem. Well, that didn’t evolve the way she had wanted, but I went into kinesiology at university, and so I was studying human movements and in my senior thesis was studying brain trauma and Parkinson’s and patients with MS, and rehabilitation for those people. And when I graduated, I just didn’t know what I wanted to do, just knew I didn’t want to continue with my schooling at that time. And one of my parents’ friends gave me a graduation card and in it was a job posting for a research assistant, and so I didn’t really have any other options at the time. So interviewed for the position, became research assistant for a physician who was a single site, ran a couple of trials at that time, fast-forward 27 years, still with the same company and we’ve grown considerably and we now have 60 sites that we support across five different countries. So it’s, I didn’t fulfill my mother’s vision for me of becoming a physician, but have spent my entire career trying to help find therapies for people who need them.

Joseph Kim:
Yeah, on some level, you did better. You did better than what, instead of helping individual patients, you’re helping scores and thousands and millions of patients by bringing new therapies to market.

Ted Trafford:
Yeah, and you know what? That’s what’s been so rewarding. And with my journey starting out as a research assistant and then a study coordinator and flowing through all the different jobs at a site level, it really connected me with patients, especially in some of those really early trials where there were no treatments available for those patients. And to have them come in and just talk about how life-altering it was for them, it’s really kept me grounded in that over the years. And now I continually bring it up with our staff that, to keep that as our focus because it’s an incredibly rewarding part of this business.

Joseph Kim:
It’s amazing that Probity started out as just a single provider and one research site doing what, like one or 2 or 3 projects a year or?

Ted Trafford:
Yeah, yeah, exactly. That’s exactly where it was at. And what, so it evolved was the founder of our company, Dr. Kim Papp is a dermatologist and he had been practicing medicine for a number of years and really wanted to expand, and so started talking to his colleagues about clinical trials and did a couple of clinical trials, some really challenging trials, like trials we wouldn’t even agree to do nowadays because they were so difficult. But very early on he had a vision and that vision was research is really hard and it’s really hard to do on your own, and he wanted to do it in collaboration with other physicians, and that’s how it started. And it’s funny that we talk about decentralized trials and hybrid trials now and all the things that, all the ideas, all the concepts that are being evaluated are things that we were looking at 25 years ago when we were trying to figure out, how do we connect other sites? So the concept of using satellite sites for a research study or things that we did. I specifically remember a hypertension study we were doing and I was driving a drug to a family physician’s office so that they could see the patient and involve patients where they were at instead of making them come to us. So it’s not a new concept, but we’re really excited about the potential that it can bring.

Joseph Kim:
But I suppose the difference between, I think, ideas like that today versus enacting those ideas in the past was, there was a specific need you were fulfilling and you weren’t just doing it to do it. Is that a fair statement?

Ted Trafford:
Yeah, absolutely. We needed the involvement of multiple physicians in order to achieve the objectives of the study, and we had to be creative and I think we’ve learned lots of lessons over the years, I’ve learned lots of lessons over the years. And sometimes in clinical research you have to be really creative in order to find ways to connect with the people who just don’t know about the research, but would be really interested in participating if they only knew about it.

Joseph Kim:
Yeah, want to make a parallel here and I don’t want to force it, but some people know that you are a wildlife photographer as well, and I’ve seen some of your work and it’s astounding. It’s some stunning shots. And so if it doesn’t, I don’t want to shoehorn it in, but I imagine there are advances in photography that today weren’t around 20 years ago. And certainly, there’s always advances in any field, and it’s whether or not you want to use them or why you use them. So I’m just going to plant that seed there and help to, I guess, explain some of this innovation in clinical research. And then maybe if there are some parallels to photography where certain innovations there make total sense, and of course, we should be doing this, and others that are like, yeah, well I only use this if I’m doing X, Y, and Z, so just keep that in the back of your mind. And for those listening, I don’t know, Ted, what’s, how do they find some of your artwork?

Ted Trafford:
So probably the easiest place is on Instagram. My name is Traffoto. So T R A F F O T O. I also do have photography website TraffordPhoto.com. But yeah, thanks for bringing this up because it’s something that I’d love to talk about. Photography is my passion. It’s something that I find, I find peace in and it’s relaxing. It can be incredibly exciting one moment and then hours of nothing happening the next moment. So it helps me unplug, unwind, and you’re right, like the advancements in technology over the years for photography has just been incredible. And I think when we met at the conference, I was using the illustration of how our industry develops tech versus how a camera company develops tech. And the pharmaceutical industry has a tendency to see a need for clinical trials and then develop tech to meet that need, but most often it’s with very little site engagement. And sites are the end users for most of this tech, and when they get the tech, it’s frequently flawed, it’s inefficient, often doesn’t work, and most regularly comes with just terrible technical support, and so it’s created quite a burden for sites. And so the challenges are real. We see a chasm growing between sites and the sponsors, the CROs, and the patients, and this chasm is being filled with all this tech. And the more time that sites have to spend with this tech, the less time they’re spending with their patients, and so it’s created a lot of challenges. And the difference in how I see photography tech being developed. I’m a big Canon user, sorry, to the Nikon and Sony users out there, but I got introduced to Canon, and once you’re committed to a brand, you kind of stick with it because the lenses that we purchase aren’t interchangeable, so you tend to stick with a system. But a company like Canon, when they’re developing tech, they will engage photographers at every level. They’ve got photographers on staff, they consult with photographers, they have photographers that they get to test their equipment, and so it’s really driven to the needs of the end user. So it’s, in the end, we get tech from the photography company that we can really depend on, that rely on, and that really fills a need and enables us to get out there. And when we have that split-second opportunity to actually make that shot, you’ve got that confidence that it’s not going to fail you. And I think sites just don’t have that same confidence in the tech that we’re given for clinical trials.

Joseph Kim:
Yeah, that’s a great framing of the stark difference between tech for artists, let’s say, and tech for clinical research professionals. Let’s jump into this notion of DCTs, I think it means a lot of different things to a lot of people. And we recently dropped an episode from Hassan Karam from BMS, and he at least has a form, a formal definition of four things that make up a DCT for BMS. But if you talk to ten other people, they’ll have ten different ideas. For you, what does decentralized trials actually mean?

Ted Trafford:
So for me, it’s really about the potential. So I see an enormous potential in decentralized trials. The, what I go to most rapidly is when we’re talking about rare diseases. For years we’ve been trying to figure out how to enroll participants in rare disease studies. And we’ve had this vision for a long time that really the only way to do it is to go to where the patients are, and.

Joseph Kim:
Because they’re far-flung.

Ted Trafford:
Because they could be anywhere, and we have to connect with them somehow. And so for me it’s, what I see is the potential. We have concerns that sometimes we get off track because our industry tends to, when it embraces something, to really dive in and head down that path full steam ahead, and then we have to backtrack. And so I see the potential in many different aspects, but that’s where really what it means to me is potential. I don’t think it’s being realized yet. I think it remains to be seen whether we’ll get there, how we’ll get there. But I think that one of the concerns I have is the real lack of site engagement when we’re looking at either developing tech for DCT trials or even when we’re designing the studies themselves.

Joseph Kim:
It’s, you’re calling out a specific need for, one specific need for decentralized trials, which is these patients are rare and they could be anywhere. So I’ll use the photography analogy, like you don’t need a high-powered zoom lens for portrait because that’s, so to force that in when the person’s 12ft away from you, it doesn’t make any sense. So to force in DCT when there’s not like a specific need also probably doesn’t make a lot of sense. In addition to the idea that sites aren’t involved in the tech.

Ted Trafford:
Exactly. And the other thing about, that just comes to mind, is when we’re coming up with these concepts like bringing the study to the patient, making things more patient-centric, the, our industry tends to inform sites how it will be done. Industry comes up with ideas and tells sites, okay, we’re going to change it this way, that we’re going to have a local nursing agency do at-home visits for you. We’re going to make it easier for you and take this off your plate. Let’s, not necessarily what the site wants or needs. The site has the capacity to do these home visits themselves. And so instead of just charging down this path and coming up with these solutions, we should be engaging sites and saying, how can we support you in developing your own solutions to fit these needs? Because I think a lot of sites would embrace that rather than having work essentially taken off their plate, being supported and helping them develop their own solutions to these problems.

Joseph Kim:
Right, so what happens is it becomes further fragmentation of the workflow and responsibilities, but yet all the accountability still sits with you as the PI. That doesn’t seem right.

Ted Trafford:
Absolutely, absolutely. And those are some really important questions that need to be answered. So we’ve had a number of hybrid trials where they have at-home visits and nursing agencies being used for those at-home visits. And many of the PIs just are not comfortable delegating authority in a clinical trial where they’re responsible for absolutely everything in the study. And they had no role in selecting the provider, training the vendor, or really feel that they don’t have proper oversight of this, of the individuals that are going to be going out and seeing the patients. And there’s been examples of challenges where things have just not gone well at these visits. And then who’s responsible ultimately? And I think the concern is that the PI is going to say, even though I didn’t contract this company, I’m still responsible.

Joseph Kim:
Yeah, can you give us an example, even a hypothetical one, of that.

Ted Trafford:
Yeah, we had an experience where a home healthcare nurse went out to the site or went, sorry, not to the site, to the patient’s home and assessed the patient, took the blood, during the visit the participant mentioned that they were tired, didn’t get queried, didn’t get documented, and it wasn’t until the participant came to the site for their next visit that they mentioned that they were tired. And so, fortunately, the study coordinator flagged that and brought the PI and the PI assessed the patient. They did more history, they actually did some blood work, and turns out that the patient had an MI, and fortunately, the patient is okay, but it just raised lots of questions about how you have people who are going into the home, and yes, they may have received DCP training, but are they really adequately trained to recognize some of these really subtleties and nuances of clinical research? And sometimes it takes a lot of experience to get a coordinator to that point.

Joseph Kim:
So, right, so maybe a home nurse is seeing, I’m making this up, but I think the order of magnitude might be right, 50 patients in 50 different trials, maybe once or twice, whereas you, in traditional brick and mortar model, you’re seeing that same patient all throughout the longitudinal sort of timeline of, and so you just get a better context and overview and understanding of that patient that just can’t be substituted with these point personnel doing their finite bit of work. Is that a fair statement?

Ted Trafford:
Yeah, it’s really challenging and especially when you’re thinking about one of the things that study participants say that they love most about doing clinical research is that contact with the site, with the study coordinator, with the PI, the amount of time that they get to spend with a medical professional is typically far greater than what they do in a typical interaction with the physician, and they get to know the participants in the studies in a really deep level in some cases. And so it’s that attention that that involvement, that engagement of the site that really adds value to the clinical trial experience. And that’s why I think you see a lot of clinical trial participants want to come back and do another study when they’re done. And many of them will do studies over the years because they’re getting just such an amazing level of care.

Joseph Kim:
Let’s talk about the personal connection and how that may influence a patient’s willingness to sort of stay in a study, particularly when maybe the visits get long or the intervention is rough, or there are ways to deal with?

Ted Trafford:
Yeah, I think that the connection is an important piece of it. I mean, it’s always important to remember that at any time the participant can withdraw for any reason and that needs to be respected. But I think when they feel that they are being well cared for, the PI, the coordinator has their best interests of heart, I think they will likely want to continue with the study because it is such a good experience, because the site is looking out for their best interests. And what will remain to be seen is, can we achieve that same level with the decentralized trials, with the, with hybrid trials, with remote visits, even with virtual visits? I know there’s a lot of people that like virtual visits, but there’s also a lot of people that don’t, just rather come in and see their physician or their coordinator one on one.

Joseph Kim:
Yeah, I mean, let’s take it in. Let’s use a different analogy. There’s a reason why if you sit in the exit row of a plane, somebody personally, twice, even sometimes three times, personally asks you to say, can you help? And you must verbalize, yes. There’s a different level of commitment when it’s a face-to-face interaction than a checkbox on a portal, right? And I think there’s some level of that going on here, too, when there’s a mutual commitment to try and do something successfully, that personal relationship is no match for it.

Ted Trafford:
And I think that’s one of the challenges that we face in our industry, is when we’re looking at what needs to be done in clinical trials, and a lot of what we do is spent accomplishing things to check a box. So not to take this sideways, but if we talk about clinical trial training and protocol training and disease assessment training, a lot of that training is done to check a box to say, oh, this individual is trained. But when we step back and we look at the content that’s being provided, the fact that PIs are frequently having to do five, six hours of training before a study starts, is that individual actually trained because they were forced to just sit and watch a PowerPoint presentation and then take a quiz? I would suspect that many aren’t, right? Like it’s something that we do because the box has to be checked. We want to be able to show, yes, this person was trained, here’s the content they’re trained on, they’re responsible for everything. Are they actually going to remember that information two years into the study? I don’t know. It’s a real challenge in our industry. Training is just one example of that.

Joseph Kim:
I mean, forget two years, even three months, in and amongst 5 or 10 other protocols that they’re doing, that’s pretty hard. And I think you’re right, there’s something, there’s a difference between knowledge, skills, and practice, right? And just because you have some knowledge doesn’t mean you can actually practice that knowledge until you’ve actually practiced it, so to speak. It’s why we do residencies, it’s why we do student teaching, it’s why we do minor-league baseball. It’s all about practice. Let’s talk a little bit about protocol feasibility, that is, for those who don’t know there, it’s the mutual assessment of a protocol and whether or not a site can quote-unquote, do it. And on some level, it’s just about, do you have the patience? But on another level, it’s can I actually do this thing, conduct the study? And I imagine it’s hard enough when it’s a traditional in-house brick-and-mortar trial, but how much harder is it when someone says this is going to be a decentralized trial and like, just help me understand how hard it is to assess a protocol for brick-and-mortar, and then is it that much? Is it an order of magnitude harder to understand a decentralized model and what it means for the site in terms of conduct?

Ted Trafford:
Yeah, absolutely. And I think that the important thing to remember when we’re talking about feasibility for a trial is that it all happens last minute. And once everything is already set, typically, and for the vast majority of the studies, when we are contacted about feasibility, we’re asked about is, are there any challenges that we see with the studies? But my concern is that most sites are very reluctant to be honest about the challenges for fear that if they raise them, they’ll get flagged as not being able to conduct the study as well as another site and miss out on the opportunity. And so just to give you an example of that, years ago, we had a trial and we were approached by CRO and one of the physicians responded that he was anticipating a 40% screen failure rate, ultimately, wasn’t selected for the trial. And so I ended up going around the CRO directly to the sponsor, and I went to them and just pointed out, look, this physician who answered the feasibility questionnaire is one of the most experienced sites in the world for this condition, and he was excluded from doing this study because he was honest about the screen failure rate. And then, when the sponsor considered that I sent the CV, the sponsor replied, added the investigator to the study and ultimately was proven right during the course of the study when that ended up being the global screen failure rate. But the CRO didn’t want to hear that because to them it meant, Oh, it’s out of range from what we’re hearing from the other sites. The other sites either didn’t have the experience or they just weren’t being honest about the screen failure rate for fear that they weren’t going to get selected. And I think that just points out a flaw in our whole feasibility questionnaire system, that most often it’s after the protocol is finalized and we’re collecting information from a group of people, that’s really only objective is to try and get selected for the study if they think it’s going to be a really good study. And so the last thing they want to do is put something down that’s going to exclude them. So then you take that and you add that, the complexity of a DCT study, to a site and try and get a site to understand all the things that are going to be required of them. Quite frequently we have these studies come up and it really isn’t until you start the study that you really understand what you’ve gotten into. And so my personal opinion is that our feasibility system is really flawed. It’s not going to give sponsors accurate information about who are the optimal sites to do the study, and if there are real challenges for the study that aren’t coming to light until after the study starts. And I think that’s one of the big reasons why we see delay in getting sites started for studies, because if they don’t fully understand everything they’re getting into and they’re just figuring that out as they are getting started for the study, it’s going to delay the start-up timelines because they have to put in more resources or more things to get ready for the study, and then it also affects recruitment. If these things weren’t addressed before, while the study was being planned, then yeah, it’s, it of course it’s going to have an impact on recruitment.

Joseph Kim:
And I think most people have been very clear to say, although they don’t report this back to the sponsor, in the study is, when that study becomes too hard, they just stop doing it. They don’t say that, they just stop doing it, right? That’s the truth.

Ted Trafford:
It is, like momentum is such a critical aspect of clinical trials, and I think a lot of people don’t understand that. So by looking at different aspects of investigator motivation, like what motivates investigators to do trials and what affects their motivation, and there’s really a number of key categories. It’s one, how important they feel the study is and might be a particular molecule that they’re really excited about. It’s going to motivate them, but in that extra effort, in a trial. But then on the other flip side of things, there’s things like impediments, impediments to the research that come up that make it frustrating. And the more of these things that come up as you’re doing the study, then the frustration increases, and once you start to lose momentum, so things like drug supply issues, all of a sudden in the study, things are going well, you’re enrolling and there’s drug supply issues, that’s an impediment. Or you have, you can’t get lab supplies, I mean that’s been a huge problem over the last few years is keeping sites with the proper lab supplies to do the studies. And once you keep having these things happen what might be tech in a study that is just really frustrating to use or doesn’t work properly in your coordinator spends more time on the phone with IT support than they are in with the participant, all these things affect the motivation, they affect the momentum, and once you lose momentum in a trial, it is really hard to get it back.

Joseph Kim:
Yeah, like all things in life, that Momentum Killer can just become just create failure or stoppage. Let’s zero in on some of the feasibility, the reasons why. So clearly you’ve talked about this sort of culture of non-transparency, this culture of, I’ll just say it, culture of deception, right? Like meaning we’re not going to tell you everything and we’re going to tell you what you want to hear. There’s this a weird culture there. What about the representation of the protocol itself? Like, what do you normally get? Is it just like two pages of words? And is that all you’re, is that how you’re given to say, hey, can you do this? Like, what do you get to see?

Ted Trafford:
Oh, so that varies on many different levels. So it varies depending on the organization that we’re dealing with. So, for example, there’s some sponsors that we work really closely with, and so we get a lot of detail very early on, and a lot of times because we’re consulting with them on the design of the project. And so those are really the projects where we can best help them with and best assess because we know the study intimately by the time they come to the feasibility process. But just to take a step back to show one extreme, we may get an email from a CRO that says, look, we’re looking to do this study, here’s the condition, here’s the length of the study, and let me know if you’re interested, and we really have not enough information to make that decision. So we’ll typically go back with our list of questions and we may get some of them answered, maybe not, because the CRO is doing an RFP for the study. And then there’s varying degrees of other feasibility questionnaires that we get. So we may get a synopsis of the study that gives a little bit of detail, and along with a 20-page feasibility questionnaire that we’re supposed to complete.

Joseph Kim:
It sounds like it should be the other way around, it should be 20 pages of detail and then like a two-page questionnaire, right?

Ted Trafford:
And most of the questions are just irrelevant, and they’re not going to help you assess whether the site is actually the ideal site for that project. And, so that’s one of the things that makes it hard. And then we’ll have, sometimes we’ll get the full protocol. After you sign a CDA, you get the full protocol, you’re able to review the protocol, but the protocol doesn’t always tell the full story, and that’s one of the challenges.

Joseph Kim:
It never does, I would say. It never does.

Ted Trafford:
Yeah, that’s fair. I think often we, it isn’t until you actually see the CRF you realize in all the components of this study, you get the lab manual, you get connected with all the different IT. Frequently, we’re not informed of the IT that’s going to or the technology that’s going to be used in a study when we’re doing the feasibility. And that’s another really big breakdown in transparency and collaboration between sites and sponsors is that sites the tech that works well and the tech that doesn’t work well. And if they were asked at the decision-making process while sponsors are evaluating the tech, they could provide some valuable input to say, okay, here’s our experience with using this piece of technology and why it is or isn’t good. So I think the lack of transparency is on both sides. If we had more collaboration, more transparency, then we could end up with better study designs. And so ultimately what we see, when we’re engaged very early with the sponsors, when we’re consulting on not just the protocol design, but I work with sponsors now, and granted, this is part of the result of having a big network and having bells represented within our network that we do get connected with some sponsors very early in development and we can work really closely with them. We can give them feedback and saying, here’s, if you’re looking at doing this assessment, here’s the vendors and our experience with them, and that can help inform their decision when selecting the vendors. We can look at the protocol and really ask some very hard questions sometimes to say, okay, why did you build this in your study? Is it absolutely required or is it just adding complexity that’s going to make it harder to recruit? And those studies tend to go way better, enroll much faster, and we can, in a sense, kind of drive the recruitment in the process because there’s been such a great level of collaboration and transparency through the entire process.

Joseph Kim:
Yeah, I mean, it’s almost like if someone asked you to commission you to do some photography, all they give you is take a picture of this bird in this country and then they ask you a bunch of questions about your inventory of equipment. Like, wait, there’s all these other questions I have about this bird and like, how will I get there, what time of day, so on and so forth. So just bring it back to your photography expertise as well. But let’s talk about, because you mentioned something that caught my ears, which was you often don’t know what it really takes to do the study until you see the CRF. At what point have you signed a contract and a budget to say you could do this study in relation to when you see the CRF and how often are those things mismatched?

Ted Trafford:
Yeah, so often we don’t get the CRF until we are ready to start the study. So a couple a few days before, maybe a couple of weeks if we’re lucky. And there are almost always nuances in the CRF that change how things are going to be conducted. And so it makes it very difficult, it makes it difficult to plan for the study, it makes it difficult to build your source, note worksheets so that you’re ready to conduct that visit, because ideally we want to be able to start seeing potential candidates as soon as that initiation visit is done and we have the green light to go. But getting everything at the last minute really impedes that and it makes it incredibly difficult to budget for studies. So in a sense, some of what we do is just knowing who the sponsor is for a particular project, we just know we’re going to see different kinds of things, so we need to budget for that, even though it may not be listed as a line item in the protocol, and that just comes with a lot of experience. But there’s a lot of challenges when it comes to the budgets and the contracts because those are done long before we really get all the information that we need in order to conduct the study really effectively.

Joseph Kim:
I mean, I’ll just say it, it’s a little perverted that happens in that order, right? Agreed to do this at this amount of money, oh, later, this is what you’re really doing. This is eye-opening for me. I’ve been at working for sponsors for 23 years. I never knew there was such lack of clarity there. And you only discover what you’re really getting into after the fact. How hard is it then to go back to a sponsor and say, hey, listen, this looks like a very different study than what we budgeted for? Let’s revisit this contract and budget.

Ted Trafford:
So I think it, that depends on the nature of the relationship with the sponsor. I think it’s a lot harder for a small independent site to do that. We have a really robust contracting and budgeting group, and so I think it’s a little bit easier for us to say, and I think it depends on what the item is and how much of it change it is from what we budgeted for. But I think more frequently what happens is when there’s changes in the study, that there’s additional things that need to be done that are introduced after the contract and budget is finalized, those are much easier to go back and say, okay, that’s great, we can do these things, but we need to revise the budget because the budget doesn’t contemplate these items. And I think that again, because of the size of our group, it gives us the ability and the confidence to do that, and I think it’s very difficult for the small independent sites sometimes to do that, and especially when they maybe don’t want to ruffle feathers.

Joseph Kim:
Yeah, I mean, it’s a shame that it depends on the relationship. I mean, it can be good, but it should just depend on the objective data of like, this is more so now let’s revisit it. And let’s face it, a site won’t continue to do a study if they’re losing money on every visit. That’s just, that just doesn’t make any sense. So they’ll just stop, right?

Ted Trafford:
And that’s what we were talking about before, is the real danger is when a site goes quiet, then you’ve got something to be concerned about. When you’re just not hearing that much from the site anymore, you’re seeing activity drop off as far as recruitment goes, engagement, then you know that you’ve got an issue that you have to address and a lot of sites won’t speak up. They won’t. They’ll just turn their attention to another project that’s going better.

Joseph Kim:
Yeah, sites maybe invented the whole idea of quiet quitting, right? Because this has been happening for decades, I imagine. And then how much more complicated is this when you layer on a DCT model on top of all the budgeting and feasibility and quiet quitting, what does that look like or how much more difficult is it?

Ted Trafford:
I think it’s quite a bit more difficult just because we’re still very early on with DCTs. They’re not as prevalent for us as the typical studies that we do every day. So we’re not seeing a lot of these projects come through. And so when they do come through, you’re just not as familiar with all the different aspects of the study. So trying to figure out what might be expensive or might be time-consuming or consume resources is a lot more challenging because we just don’t know at this point. And so we’re learning as we go and as we see more of these studies, then I think we’ll get better at it. But right now, we’re still really early days.

Joseph Kim:
Yeah, no one wants to learn by getting burned. It’d be nice to have it all kind of laid out in a single integrated way.

Ted Trafford:
That’s how we learn best, though. That’s how we learn best.

Joseph Kim:
Let’s end with your poem, you don’t have to recite it because you recited it on LinkedIn and it gets it just got a great reception in Toronto and equally on LinkedIn. What inspired you to do that, to write that poem in the first place?

Ted Trafford:
It was really our staff, so, … we had hired some new people who were new to clinical research, and I just felt for them instantly. I thought, wow, this is a really steep learning curve. We’ve got this whole language that we speak, and it’s gotten to the point, to be honest, there’s a whole bunch of acronyms now that are used in research that I don’t know, and I’ve been in this game for 27 years, so I can’t imagine what it’s like for someone who is really brand new, just learning all the aspects of clinical trials, and then we’re going to throw all these two and three and four letter acronyms at them that they have to learn, and then to make it even worse, most sponsors will come up with an acronym for their trial and then want to use that. And so that’s a whole other topic for discussion, but I just thought, you know what? It might be fun. I love to write. I kind of discovered my writing voice when I started posting on LinkedIn. I only started posting on LinkedIn back in the spring, and at the time I just decided, you know what? I want to speak up for sites and I see some troubling things that are affecting sites in our industry, and really, I’ve got a voice I need to use it. And so then I started writing and I sat down and I started writing some articles. I started writing some posts. And then I decided, you know what? This is a topic that that maybe can have a little bit of fun with, and that’s how it began. And I started throwing ideas on papers, had a list of acronyms just up on one screen, and was throwing ideas down and decided that I just wanted to point out a little bit about the absurdity of our obsession with creating an acronym for everything we do. And then of course, because CCTs are the biggest new acronym to come out, I decided to have a little fun and make that the punchline.

Joseph Kim:
Keep it coming. Yeah, I love that second poem about like naming studies in a certain way because honestly, I was on the fence, but like you’re making really good points out here, so, and the way in which you do it is it makes it really accessible and it’s not too confrontational, but honest and candid. So, Ted, keep it coming. Thank you again for joining us on the show. It’s been a real pleasure to get down and dirty and really see kind of the inner workings of what it takes to run clinical research at a clinic.

Ted Trafford:
Well, thanks, Joe. It’s been so much fun talking to you. I could sit here all day and talk about clinical trials and photography, so.

Joseph Kim:
Yeah, awesome. Have a great day. Talk to you soon.

Ted Trafford:
Thanks. You too, Joe. Take care.

Joseph Kim:
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