In this episode of Clinical Trials Spotlight, host Andrew Pucker, OD, PhD, FAAO, sits down with Christopher Lievens, OD, MS, PhD, FAAO, to discuss everything you need to know before getting involved in investigator-initiated trials (IITs). The conversation explores how clinicians can develop, fund, and execute IITs, from asking the right research question to building the team and infrastructure for success. This episode offers practical guidance for clinicians looking to take their first steps into clinical research.
Andrew Pucker, OD, PhD, FAAO:
Welcome to Clinical Trials Spotlight, the podcast where innovation, research, and patient care comes into focus. I’m Andrew Pucker, Chief Development Officer at Mintra Health, and your host for this series exploring the latest developments in optometry and ophthalmology clinical trials. Each episode, we’ll sit down with leading clinicians, researchers, industry experts, and innovators shaping the future of eyecare. From emerging innovations in study design, patient outcomes, and regulatory insights, we’ll take you behind the scenes of the clinical research transforming optometry and ophthalmology.
Whether you’re a clinician, researcher, industry professional, or simply passionate about advancing vision science, this podcast is designed to bring you thoughtful conversations and practical insights from across the ophthalmology and optometry community. Clinical Trials Spotlight is co-produced by Mintra Health and Ophthalmology 360 and Optometry 360. Thank you for joining us. Let’s get started.
In today’s episode, we’re shining a spotlight on investigator-initiated trials, or IITs, an important pathway for clinicians and researchers to pursue meaningful scientific questions and advance patient care beyond traditional industry-sponsored research.
Joining us today is Dr. Chris Lievens, professor and director of clinical research at Southern College of Optometry. Chris is a co-founder of an optometric site network called Eye Research Associates. Chris is also the host of The 4-Eyed Professor Podcast, and today’s episode is in collaboration between the 2 channels.
Chris, thanks for being here. Could you please introduce yourself and how you got started with IITs?
Chris Lievens, OD, MS, PhD, FAAO:
Sure, I love it. Thanks everybody for attending the 4-Eyed Professor Podcast. As you might witness, at present during this attendance, I often like to do something that I’ve never done before. Today, I am the interviewee being interviewed by Dr. Andrew Pucker about investigator-initiated trials.
These sometimes go by different terminology, and we’ve touched on this before in other episodes: investigator-initiated grants, investigator-initiated studies, investigator-initiated trials. Our industry partners call them different things, but they all kind of mean the same thing.
On quite polar opposite sides of the research spectrum, you have on one side, what most of us would classically think about when we bring up the term, “research,” where a researcher comes up with their own novel idea. They figure out what questions they want answered, they dive in, they design a protocol, they collect data, they analyze the data, then they disseminate the results completely on their own.
Then, on the far opposite portion of the spectrum are sponsored trials. An industry partner, for example, might need a pharmaceutical to be approved for human use, or a medical device to test on humans. It’s a requirement by the FDA to collect data to make sure said device or pharmaceutical is doing what it’s supposed to do. That’s completely designed, analyzed, and disseminated by our industry partners.
Then, there’s this middle ground, which really lands smack in the middle between those two extremes, under the heading of what we’ll refer to today as IITs or investigator-initiated trials.
Andrew Pucker, OD, PhD, FAAO:
It seems like there’s a lot of opportunities out there to do research. The IIT, I think, is one of the more fun ones because you’re the creative person coming up with these ideas and you’re pitching them to companies, or maybe you’re just kind of doing it with your own internal funds if you’re at a university.
Just for context, Chris and I have been doing IITs together for roughly a decade. We’ve worked pretty closely on these, and we’ve learned a lot of things along the way.
Chris Lievens, OD, MS, PhD, FAAO:
100%.
Andrew Pucker, OD, PhD, FAAO:
We know now what an IIT is, but Chris, what kind of questions do you think are best suited for an IIT?
Chris Lievens, OD, MS, PhD, FAAO:
Well, it’s a great question that you asked about asking a question, Andrew. Being succinct, and trying to go after, ideally, 1 question and not 10 questions, I think is optimal for an IIT. Something that you can design, that is in the industry partner’s best interest to have answered, in a less-than-biased way.
When it comes to complete sponsored trials, I think the reader of a manuscript understands in a sponsored trial that the industry partner has money in the game. They’ve got a stake in the game. They have some implicit bias in how questions are answered, how a study is conducted and performed, and then the conclusions.
An investigator-initiated trial is written and is designed completely by the investigator in collaboration with a sponsor, but it’s still independent. There’s less implicit bias when somebody else asks a question, answers that question, and then shares the results.
The 1 take-home that I recommend is, go after 1 thing. If you try to answer too many, it becomes confounding. The results in the analysis can be messy, and sometimes it’s difficult to get published. But if you’re really focused in the research design, not only can you answer it, but then it’s much easier to disseminate that through quality manuscript publication.
Andrew Pucker, OD, PhD, FAAO:
I love that advice. I’m thinking back to my first IIT, and I was looking at this basic contact lens discomfort question. I wanted to do like 15 visits. It was insane. I’ve learned over time, you got to knock it way down to like 4 visits max.
Chris Lievens, OD, MS, PhD, FAAO:
One of the hallmarks of research is you have 50 questions you want answered, but then you’re forced to be selective and answer one. Then by the time you answered that 1, you started with 50 questions, you answer 1, well, now you have 100 more questions. The questions keep coming.
It’s really tempting to go after a lot because there’s so much, we still don’t know, but the strict recommendation is to be narrow and as focused as possible.
Andrew Pucker, OD, PhD, FAAO:
Yeah, you want to have 1 kind of clinical nugget at the end, and then you will publish that, of course. Then you can run with that on the company side, to maybe make a, I wouldn’t say new claim, but to have justification to say that your medication or device can do this additional thing.
Chris Lievens, OD, MS, PhD, FAAO:
Agreed.
Andrew Pucker, OD, PhD, FAAO:
Yeah. Thinking about that, Chris, what do the companies get out of this? Is it like marketing? What’s your opinion on that?
Chris Lievens, OD, MS, PhD, FAAO:
It’s kind of everything. It could be marketing. It could be there’s a product on the market and company may realize, “Wow, our product is intended to do X and approved for use X, but we think it also can do Y.” A company may have an option to do an FDA phase 4 trial, which would be a sponsored trial, post-approval, but it’s still sponsored. It comes with that same bias that we mentioned before.
They also have the opportunity to go the route of an IIT. If they can collaborate with an independent researcher to answer that question, oftentimes it can be done much more efficiently. Timeliness sometimes is key for both parties.
But then, as soon as this gets to print, from a marketing perspective, they may have the opportunity to say, “Hey, now this product can do Y, and here’s the data that’s been disseminated by an independent researcher or independent research team.”
Andrew Pucker, OD, PhD, FAAO:
I think that brings up a couple of good points. I think in general, an IIT is a post-market study, not always, but usually.
Chris Lievens, OD, MS, PhD, FAAO:
Right.
Andrew Pucker, OD, PhD, FAAO:
You are avoiding, I’m just going to say, the red tape associated with FDA level trials.
Chris Lievens, OD, MS, PhD, FAAO:
Absolutely.
Andrew Pucker, OD, PhD, FAAO:
That’s perfect for your everyday clinician who just doesn’t have the time or resources to deal with that. Then, with these trials, you’re kind of going after that one thing like we’ve talked about. That’s awesome.
I know you’re a busy guy; you have your own podcast, you’re director of research at a university. Why do you want to do these trials?
Chris Lievens, OD, MS, PhD, FAAO:
Well, whenever I’ve had previous podcasts on research in eye care and research in practice, the common theme has always been, to me, this is untapped potential. If you interview 10 ECPs, ophthalmology and optometry combined, can you do and incorporate clinical research into your private practice? They may say, “Yes, I could, but I really don’t know where to start.” Many may say, “No, I don’t think I can.” I think that that’s where the miss is.
There is tremendous opportunity and there is ample need and desire for practitioners to incorporate clinical research in their practice. It just takes them some time and effort to get set up for such endeavors.
I really like the variety in the mix. Of the 3 pillars of research that, just from 30,000 feet we’ve covered, I like the mix of being able to have independent endeavors, questions that I’ve just come up with all by myself. I like the sponsored varieties as well. This intermediary gives me an opportunity to be creative with some singular focus, to help industry partners have an unbiased delivery of messaging to our peers, through publication and abstract presentation, but also be partially funded as well.
I didn’t really mention the funding piece, but independent research is completely funded by the researcher. Sponsor trials are completely funded by the sponsor. IIT is, again, this perfect blend of the 2. They allow me to be creative and analyze and disseminate information under my name, but they’re also funded. It really is a happy balance. I think that mix and variety helps drive the research in a practice, or the research in an institution setting, but it also is kind of the spice of life. I think it gives me enough variety to make me continually excited on a day-to-day basis about what I’m doing.
Andrew Pucker, OD, PhD, FAAO:
That’s great. You’re kind of like the research artist, you’re coming up with the ideas, you’re pushing these projects.
Chris Lievens, OD, MS, PhD, FAAO:
Yeah.
Andrew Pucker, OD, PhD, FAAO:
Then I think there’s some other downstream benefits too. You said you go to conferences and present these projects. Have you seen this help build your network too, through meeting with the companies?
Chris Lievens, OD, MS, PhD, FAAO:
Sure. Anything in life, there’s advantages to who you know, number 1, and who you meet and who you learn to know. But there’s also tremendous benefits of delivering good-quality work. When industry partners recognize that, “I haven’t worked with Chris and Andrew before, but I think let’s give it a go.” Then Andrew, you and I deliver really quality of work very efficiently, then they say, “Wow, this is a great partnership. We need to continue to use them for future activities.”
All these things build on themselves and build momentum so that really the floodgates open. What started as 1 singular question, now we’re going to try to answer be 100 questions that remain, and we become a good target and partner because we are really delivering. It helps develop our reputation and helps develop our expertise as really good quality partners who deliver on what they promise to deliver.
Andrew Pucker, OD, PhD, FAAO:
I’m sure if you’re delivering on these IITs, you’re going to interact with companies and get asked to do sponsored trials and other opportunities, right?
Chris Lievens, OD, MS, PhD, FAAO:
Yeah. One leads to the other. Back to the theme of, maybe a practitioner’s dabbling in this idea that they want to incorporate research in their practice, or maybe they’ve started a little bit, or maybe they just don’t know if they want to get into this. My recommendation always is to start with something small. Maybe start with a sponsored trial that requires the enrollment of, let’s say, a small set of subjects.
Then, once that’s done, maybe you can go into a larger one and then a larger one. Then, at some point pivoting to an IIT where there’s more autonomy, there’s more ability to be creative. We’ve used that as a common thread here, but there’s also more responsibility with an IIT. I would start sponsored, then pivot to an IIT when you’re ready, and now you really can do all aspects of research.
Andrew Pucker, OD, PhD, FAAO:
I totally agree with that. I’ve had a couple of companies tell me that they have these investigators who are on sponsored trials, but they don’t yet trust them to do an IIT, because it’s a whole other level of responsibility, as you mentioned.
Chris Lievens, OD, MS, PhD, FAAO:
Yeah. The irony for those listeners who are interested, approximately 10 years ago, I was talking with an industry partner who we had just concluded a few publications in sponsored trials, and we talked about this IIT framework, and that’s where Andrew and I were introduced.
As you mentioned, 10 years later, and a ton of studies later and a ton of work later, we’ve continued this fruitful relationship, but it really did require an introduction of this thematic approach to change gears, but you do have to be ready for it. It does take a lot more preparation, because you are really responsible for, ultimately, the protocol, the protocol design, not just the data collection. That of course a piece, but then also the subsequent data analysis, and then medical writing, and then eventual publication and dissemination.
Andrew Pucker, OD, PhD, FAAO:
What do you think of this question? You have ERA, Eye Research Associates, and you have several doctors. Do you think the best way into having your own IIT is maybe working with some doctors, or being a doctor, who already has an established path, and you hook up with someone who doesn’t? What would you recommend to people?
Chris Lievens, OD, MS, PhD, FAAO:
Yeah, I agree. I mean, partnership and collaboration are keys to life and keys to success. Doing something all by yourself, even for those who are incredibly introverted, is challenging because you’re completely self-reliant on one and only one.
When you can partner and you can collaborate and you can do it jointly, you may be designing a study and you think, based on your design, that this is going to be piece of cake easy. I have a ton of patients that fit the qualities based on the inclusion and exclusion criteria that I’ve designed, that I’m going to have no problem fulfilling the needs of this study in the timeline that I’ve promised. Then, you find lo and behold, “Wow, it’s harder than I anticipated.”
Well, if you’re all by yourself, it’s then left to you and your devices. But with partners in collaboration, now you can partner in the needs, you can share in the needs, and maybe one partner does a little bit more for this study, one does a little bit less. I think that that’s helpful and I think it eases some of the anxiety that you’re feeling because you’re in it together. It’s now not just falling squarely on one pair of shoulders.
Andrew Pucker, OD, PhD, FAAO:
I think that’s a great point. There’s always unexpected things in research. One thing that I keep thinking about, with the work that you and I have done, is we did text messaging and going back many, many years ago, that was a beast to get started. It seems easy, right? I’m just going to send a text message to someone. But it wasn’t, and we’ve now figured that all out, but I don’t think we could have done that by ourselves. We needed help.
Chris Lievens, OD, MS, PhD, FAAO:
Agreed, 100%.
Andrew Pucker, OD, PhD, FAAO:
We talked about what benefits there are to the doctor. What do you think the patients get out of this whole thing?
Chris Lievens, OD, MS, PhD, FAAO:
I think it’s multifaceted. Still on the doctor and the practice, I think many patients see a practice and their provider through a different light when they have the opportunity to participate as subjects in clinical research.
At its most basic level, I think it presents the practitioner and the practice as helping drive new information that, “Wow, my doctor has asked me to participate in a research study that may become published in a year or 2.” That implies, directly or indirectly, that this practice and doctor are on the forefront. They’re on thinking about all the emerging things coming in healthcare, not the has-beens. That helps the practice and the practitioner.
From the patient perspective, in getting involved in clinical research, well, it could be financially beneficial for them because they’re typically paid subjects in IITs, but also they may have the opportunity to be on a treatment that may not be out for a year or 2. If it works for them, certainly they’re going to be keeping their ear to the ground of, “Wow, whenever this thing gets approved, I’m going to be the first patient scheduling an appointment in this practice to be on it, because I already know what it did for me.”
Andrew Pucker, OD, PhD, FAAO:
Yeah, I think that’s a good point. With IITs, we often are the first group to get that product, the first group to have that contact lens, like the first fitting set, or the first few bottles of the drop. It takes time for that to get onto the market. I think that’s a good way for patients to get their potential treatment sooner. I think that’s smart.
Kind of going along with that, how do you come up with your ideas for IITs? Do you think about what’s coming out next year in the drug market, or what do you go with for your ideas?
Chris Lievens, OD, MS, PhD, FAAO:
I think the more research that you do, you invariably start to ask yourself more questions. There’s this inner dialogue that’s constantly going. It’s really bimodal. It’s with things that are already in use. Rather than thinking about, “Well, this is great. I am going to use them as indicated,” okay, that’s wholly appropriate.
But, also asking yourself, “Well, what if I use these as maybe they’re not yet to be indicated? Do they have opportunity to do different things to take care of more patients?” It’s those inner dialogue questions that inevitably lead to things like IITs.
As a researcher, I’m asking those of myself. As the industry employees, I’m presuming their R&D team and marketing team are asking these things about themselves. The perfect match is when they have the same question that I have. Now, through this collaboration of an IIT, now we’re off to the races.
Andrew Pucker, OD, PhD, FAAO:
You may have, for example, a dry eye drug and it’s just approved for general dry eye, but then you’re like, “Hey, I think this works extra good in MGD patients, so I want to look at that subpopulation and get some data.”
Chris Lievens, OD, MS, PhD, FAAO:
Right.
Andrew Pucker, OD, PhD, FAAO:
That sounds kind of like what you’re talking about.
Chris Lievens, OD, MS, PhD, FAAO:
That’s a great example.
Andrew Pucker, OD, PhD, FAAO:
You have an idea like that. How do you decide if it’s worth pursuing? Do you talk to the company first, friends? What’s your thought process on that?
Chris Lievens, OD, MS, PhD, FAAO:
I think both. I think you brought up the whole concept of partnership earlier, which I definitely am a fan of. I think just having informal discussions with your current or former partners in these research endeavors, “Hey, this thought crossed my mind. Have you thought about that before?” Or, “What do you think about that? Do you think that that might have interest?”
Then at some point, if the answers are yes, then have regular ongoing conversations with industry partners to see if they have had similar questions or ideas. If they have had those and they’re interested, great. If they haven’t, well, that’s okay too. Now, you maybe have sparked something of interest in them that they’ll go back and talk to their team, and eventually we may lead to a joint idea, which could be an IIT.
Andrew Pucker, OD, PhD, FAAO:
Yeah, I love that. I kind of go back to when I got started and I was not asking the right questions. An example of that: I wanted to study an allergy drop that had been out for 10 years and the company’s like, “We don’t care. We’ve moved on.”
I think it’s good, like you said, to talk to the companies and start a dialogue. That might be through, what, a medical science liaison or someone in R&D. It probably depends on the company, right?
Chris Lievens, OD, MS, PhD, FAAO:
Sure, it does. One of the common hurdles and challenges that we’ve faced is, let’s say you’re talking to Goodyear about their tire, whatever tire they have. We’ll say it’s called Goodyear Wrangler Tire, and you want to see how it’s driving in the rain. You want to compare it to the leading rain tire, which maybe is the Dunlop rain tire. I’m completely making this up. I don’t even know if they make these things.
You approach Goodyear and say, “Hey, I want to go and design a head-to-head competition between your Goodyear Wrangler, which I think is going to be great in the rain, and compare it to the market leader, which is the Dunlop rain tire.” They say, “Well, yeah, I mean, we think you’re right and we think it has merit, but if we help you fund this design study as an IIT, and lo and behold, it turns out that Dunlop wins, well, now we just spent money on the competitor’s product.”
It does take some nuance and some study design to think about. First, is your data going to come to fruition in a way that’s beneficial to all parties? Then, how are you going to deal with it if it doesn’t? It doesn’t, because in research, you may think 100% that what’s going to happen is going to be results A, B, C, but then you get results X, Y, Z. Well, how are you going to handle that? It’s tricky sometimes.
Andrew Pucker, OD, PhD, FAAO:
I think that’s a super interesting comment. You need to come up with a project that the company will be excited about and also promote their product. As a scientist, that is hard sometimes. Maybe you want to do that randomized trial of tires you mentioned, and then maybe the data’s not going to look the way that the company wants, and they may not want to fund it because maybe it would make their product look bad.
I think part of it is also designing projects to where it’s scientifically meaningful but also is going to be set up in a way that the sponsor’s going to benefit from.
Chris Lievens, OD, MS, PhD, FAAO:
Agreed.
Andrew Pucker, OD, PhD, FAAO:
We just kind of mentioned a couple of mistakes that we potentially have made in the past there. Are there any other mistakes that you’d want to warn people about getting started with?
Chris Lievens, OD, MS, PhD, FAAO:
Well, we’ve touched on being too broad and asking too many questions. Sometimes even if we narrow down to a singular question, we ask it non-specifically, and that can hurt.
I do always think you need to think about the end. Steven Covey used the term, “Begin with the end in mind.”
In this case, when it comes to an IIT, the end result is the manuscript publication. Thinking about when I’ve finished this work, we’ve analyzed the data, we’ve written a paper, where can I publish this, in the highest-level quality journal that we can? Are they, through independent peer review, are they going to take issue with anything about my study design and the question that I’ve asked and the analysis performed? Because if the answer is yes, then we have to stop, pause, and redesign and recreate.
Always thinking about, well, how is this data going to look through the eyes of an independent reviewer? If there’s a potential problem or a pitfall, correct it now, because otherwise it’s too late once you’ve decided and now you’ve started collecting data.
Another error would be sample size. You can’t just come up, “Well, I’m doing this study on a pair of contact lenses or an intraocular lens, and I think, well, 40, 50 patients sounds good.” Well, that sounds good doesn’t necessarily mean appropriate, and statistically powered to make the eventual claim you want to make.
A very simplistic power calculation on the front end, very helpful to eliminate this confusion on the backend. I think deciding on the front end, well, you’re collecting this data. What statistical approach are you going to make to make a claim, to have a conclusion, to be able to have a discussion? Do that on the front end. Don’t collect the data and then go, “Okay, we have all this data. Now how are we going to analyze it?” No, start with that in mind on the front end.
Sometimes, if it’s a complicated study or robust study or one that has lots of patients and subjects, maybe talking to a person who knows more about statistics, to bend their ear and say, “Hey, here’s what I’m thinking. Do you have a different suggestion or is this in line with your thought as well?” Just to double check before you actually start collecting data. Those are some watch-outs, that I would say, that are appropriate to think about right away.
Andrew Pucker, OD, PhD, FAAO:
That’s a perfect lead-in to my next question, which is who should be involved in the development process? You mentioned a statistician. That’s something I think that should be involved in every study at some level. I just don’t want people to think, or optometrists or ophthalmologists to think that they need to be the statistician because most clinicians are not. You probably want to involve one of those people. Who else would you maybe want to have in the mix?
Chris Lievens, OD, MS, PhD, FAAO:
You’re talking to…let’s say you’re doing this in partnership, you’re talking to your partners as well, definitely before data is collected, but ideally even when a protocol is designed, because if you do a study all by yourself, singularly, for the most part, you can trust yourself to do the clinical techniques in the exact same order with the exact same methodology over and over again.
But if you take our advice and to have partners in collaborative efforts in research, you have to then make sure that everybody in the mix is doing the processes exactly in the same order and exactly the same way. Though it sounds rudimentary, it’s not. If we’re studying how Andrew walks from his house to the next block, well, is he walking at the same tempo? Is he putting his right foot out first? Is he swinging his arms the same way? Is his head looking up, straight ahead, or down? Is he wearing shorts or pants or socks or tennis shoes? Walking from point A to point B sounds rudimentary and simplistic, but there’s all kinds of detail in the mix to make sure everything is identical.
Partners are key. You mentioned a statistician consultant, that could be key. We may have ECPs out there who are interested in this, prepared for this, but maybe they’re not confident writers. Maybe talking to a medical writer, so that when you’ve collected all this data, you can have some assistance in actually putting it all together. Maybe somebody who’s going to help you if you’re doing an abstract, not just the writing piece, but maybe if you’re doing a paper, presenting who’s actually going to do the oratory. If there are audiovisuals, who’s putting together something like a PowerPoint, or a visual poster to present? Think of all the things that are needed on the backend that are connected to the study, but maybe somewhat indirectly connected, and make sure all those things are buttoned up.
Andrew Pucker, OD, PhD, FAAO:
Yeah, I love the idea of standardization. You hit on a lot of very important things, but the standardization aspect is huge on a multicenter study. I actually just wrote a trade journal article on this. If you have a metric and say it’s this tear breakup time, a stability measure of the tears, and you increase the standard deviation or the variance between each measured by 1 second, that could maybe double your sample size. It’s a huge impact on some of your outcomes.
Having things standardized, it’s a team effort to do all that…the statistician, the training of the team members, all of that is really, really important.
Chris Lievens, OD, MS, PhD, FAAO:
Yeah, that’s a great point, Andrew. We think that tear breakup time is so basic and everybody does it the same way. Well, they probably don’t, but in research they have to. Things we have to make sure are we using liquid dye or paper impregnated dye and strips? We have to use the same brand. We have to wet them with the same amount of wetting agent. We have to instill this dye in the exact same spots. We can’t have site A put it in on the superior bulbar conjunctiva and site B, the inferior bulbar conjunctiva, or temporal nasal conjunctiva, or palpebral conjunctiva.
We in eye care like to start with the right eye first for some reason. Well, if we’re going to do that, we have to make sure everybody knows we’re starting with the right eye, but then there can’t be too much of a lapse before we go to the left eye. How many seconds did we wait after the dye went in before we look? Do we have the Wratten filter up and the cobalt blue in?
I mean, all the things that we may not think about intentionally in patient care, when it comes to research, we have to be diligent in thinking about everything. If there are different sites, we have to then collaborate and discuss to talk through everything. Otherwise, the data is sloppy and you really can’t make a hill of sense out of sloppy data.
Andrew Pucker, OD, PhD, FAAO:
Yeah, we both have been professors at optometry schools, and we know that people do things differently. You have to really think about standardization and your school taught things differently than my school, and we may think that’s the only way to do it, but actually it’s not. Right?
Chris Lievens, OD, MS, PhD, FAAO:
Right.
Andrew Pucker, OD, PhD, FAAO:
Okay. Say you have this idea; the company loves it. Walk us through how you get that funded. What are the steps that you have to do from the idea to getting the cash at your practice?
Chris Lievens, OD, MS, PhD, FAAO:
Typically, an industry funder will have their own processes in place that we have to then abide by. They may, for example, have a webpage interface by which the preliminary question then be uploaded to their site with maybe a rough idea of the budget. When it comes to designing a budget, that’s difficult as well, because you have to be cognizant of all the costs involved in taking on the responsibility for a study.
You will have to know this will have to be in the United States, and this will have to be approved by an institutional review board to make sure that there’s an independent look at patient safety and patient rights. Typically, there are costs involved with having an IRB approval. Where is this approval going to come from and what is the cost? Is there going to be a cost for creation of your data capture forms? There may be a cost for medical writing that we talked about before. There’s going to be a cost for compensating the subjects for their time.
There’s a cost for you, the investigator, your time, your staff time, your study coordinator time. All these things have costs involved. Creating your budget is tricky, but that’s going to be an initial point of discussion. If you ask for way beyond something that’s reasonable, well, then that agreement’s not going to go anywhere. It has to be reasonable for the funder.
The industry sponsor will typically have a system that these ideas get uploaded to. Then the next step could be a subsequent upload of a formalized protocol and a very detailed budget that they have to then go through their approval to make sure it’s in line.
Oftentimes, there’s some back and forth. This is collaboration. It’s typically not just a yes, no answer. It’s yes, but, conceptually this makes sense for us, but have you thought of this? Or we might like you to, have you considered phrasing your question a little bit differently, or maybe collecting a different piece of information or the same piece of information just via a different technique? There’s going to be some collaboration back and forth, but it’s through this back and forth that we eventually get to approval.
The big call-out is, typically there is some process, whether it’s an online upload or just an email, direct send, of the overarching concept, a rough idea of budget that then leads to a very formal detailed protocol and a very formal detailed budget.
Andrew Pucker, OD, PhD, FAAO:
Okay. Now you have the money, and you need to do the project. What infrastructure do you think is necessary? I know you’re at a university, but you also have the site group, which is private practice, right?
Chris Lievens, OD, MS, PhD, FAAO:
Yes.
Andrew Pucker, OD, PhD, FAAO:
They have less resources than you. What do you think are the key things you need to have, say, at a private practice to get going?
Chris Lievens, OD, MS, PhD, FAAO:
The number 1 key thing, and I’ve had some podcasts on this as well for anybody that wants to flash back, is at minimum you need a study coordinator. It’s a requirement to have an onsite technical staff, support staff, personnel, who are responsible for all the data management in a study. Managing patient appointments, managing some data collection, managing the capture of case report forms, being able to share the data with either internal statistical groups or external statistical groups.
Study coordinator is, first and foremost, the requirement and the biggest need and really the biggest asset for a clinical study. That’s number 1.
Then 2, a decision about, okay, once you have this staff, now you have the investigator, or is there going to be more than 1 investigator, or is it sole? Then collect the data. Then, once all the data is collected, now it’s all about sharing that data, analyzing that data, and then putting it all together.
Andrew Pucker, OD, PhD, FAAO:
Yeah. You can’t do it alone. Even if you wanted to, you probably couldn’t because sometimes you need to do masking. You need to have an unmasked person giving the study drug, and the doctor, who’s probably you, evaluating the subject can’t know anything about that.
Chris Lievens, OD, MS, PhD, FAAO:
That’s a great example. I’m working on starting a study soon where my study staff and coordinators will actually be the ones collecting, pretty much, all the data, or the majority of it, so that I am then completely masked to what that subject has gone through. All I am doing is looking at their eyes to see if they’re improving. I have no idea where their pre-assessments were, what their treatments were, what their interventions were. I’m just looking at them raw and saying, “How do they look?” Without the staff, there’s no way I could do that.
Andrew Pucker, OD, PhD, FAAO:
Awesome. You probably have at least piqued a few people’s interest in doing IITs. What are a couple of things that you would recommend they do to get started?
Chris Lievens, OD, MS, PhD, FAAO:
I’m going to harken back to what we discussed before. I do wholeheartedly suggest that somebody interested in incorporating research into their practice, number 1, it can be done. Number 2, you can do it. This is not a big ask, it’ll take some preparation, but you can do it.
Start small. Start with less responsibility on your shoulders. Start with a completely sponsored trial in which your industry funder has completely designed everything. All you have to do is follow the steps A to Z. They’ve designed the inclusion, the exclusion, so what the subjects have to look like. They’ve designed the protocol. In other words, you know, test A, I do first, then test B, I do second, then test C, I do third. They’ll tell you where to put those results, on paper, on electronic case report form, on some website. They’ll tell you where to put the data.
Then, once you’ve done all that, now you’ve developed the systems in your practice. You have your study coordinator doing what they’re supposed to do. As the investigator, you know what you’re supposed to do. Having done that, then you can slowly grow in size and in complexity. Start with something simple, small amount of subjects, then grow it in complexity. Take on studies with more subject requirements, with more data to be collected.
Then, as you pivot to an IIT, now you have a comfort zone in research. Your practice and your associates know what they’re supposed to do. Everybody understands their role, and now you can take your creative feather out of your hat, and start to write the questions that you might want to answer, that an industry partner might want to fund through collaborative discussions on the front end, and now you can do it more yourself.
This stepwise approach will grow your responsibility in a comfortable way, so that you’re much better suited for success.
Andrew Pucker, OD, PhD, FAAO:
I love the idea of starting simple, and that’s actually inspiration for an upcoming episode on the podcast, which will be starting with survey research. You just have some surveys you hand out to patients and it’s kind of hard to screw that up, but it gets your foot in the door, right?
Chris Lievens, OD, MS, PhD, FAAO:
Yeah. The 1 big takeaway that I want to emphasize is, it’s untapped potential. To people out there: you can do this, number 1, and there is a need and a desire for you to do this. It’s not like you’re raising your hand and nobody’s interested. No, a lot of people will have interest. You start slow, get comfortable, and grow from there.
Andrew Pucker, OD, PhD, FAAO:
Awesome. With that, I’d like to thank Chris for being on the podcast. Thanks for being here, Chris.
Chris Lievens, OD, MS, PhD, FAAO:
My pleasure. Thank you, Andrew. Great seeing you again.
Andrew Pucker, OD, PhD, FAAO:
I’d also like to thank you all for joining us today on Clinical Trials Spotlight. If you enjoyed today’s episode, be sure to subscribe and share the podcast with colleagues and others passionate about advancing ophthalmology research and patient care. Thanks for listening. We’ll see you next time.
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