Research Confidential_James Riddle: Audio automatically transcribed by Sonix

Research Confidential_James Riddle: 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:
James, welcome to the show. It’s so great to have you. Gosh, the last time I’ve seen you, it was probably three or four years ago, is that right?

James Riddle:
Yeah, it was before everybody walked away for COVID. It’s been a while, it’s nice to see your face. I’ve been following your work and thank you very much for inviting me to the podcast.

Joseph Kim:
Of course, so as you know, we’re trying to talk to the larger research community, both from the site perspective and sponsor perspective, but I would be remiss if I didn’t include folks from the IRB. So folks who don’t know James Riddle, he is the vice president of Research Services and Strategic Consulting at Advarra. And before we get into a little bit of how you got to this place, help people understand what is an IRB anyway.

James Riddle:
All right, so if you want to market a new drug in the United States or anywhere else around the world, most of the regulatory agencies will require that you test your new drug on humans to make sure that it’s going to be safe and effective before you get approval to market it to the general public. Seems like a good idea, and as part of that process, the regulators require that the companies producing these drugs and devices get their research testing plans reviewed by an independent medical ethics committee. And here in the United States, where we have the grand tradition of saying gallons and miles, rather than using the metric system, we call these things Institutional Review Board. If you go anywhere else on the planet, they’re called Research Ethics Boards, which is exactly what they are. It’s a group of individuals that get together and they take a look at the research plans that the drug manufacturers and the device manufacturers are putting together, and before they go out and test their drugs on humans, an independent group of people is looking at the plan to make sure that folks who are going to participate in the research are adequately informed about the risks and potential benefits, that the research passes certain ethical hurdles, thus the Research Ethics Board part of the name. But again, here in the United States, we call them institutional review boards or IRBs. So when you hear IRB, just think group of folks looking at a research protocol, watching out for the research participants that are going to enroll in those trials.

Joseph Kim:
So safety of the participant is the number one thing. And who makes up these boards? Is it moms and dads, Boy Scouts, and Girl Scouts? Like what’s the cross-section of people on these review boards?

James Riddle:
Yeah, so the cross-section is defined, first of all, it’s defined in the regulations. So the federal government has regulations that govern how these independent review boards work, and there is a requirement to have a general cross-section. So it can’t be all scientists, it can’t be all non-scientists, it can’t be all one particular demographic group. You have to have people who aren’t associated with the institution that is conducting the research, and of course, here in the United States and in Canada, we have a fair number of independent institutional review boards that are separate from the institutions that are actually conducting the research, and that’s where I work. At Advarra, we provide IRB review services for a lot of places in North America, and we review upwards of 40-50% of all clinical research that occurs in North America.

Joseph Kim:
Wow! That’s, I didn’t know that.

James Riddle:
Through our review boards, and the kinds of people who sit on the boards are indeed moms and dads, folks who are part of clinical research community, we also have clergy, lawyers, homemakers, the broad swath of individuals that can get together, take a look at a research protocol, take a look at what the participants are going to be told about that research protocol through the consent process, and be able to determine, hey, is this a good idea or not? Or more succinctly, if I was the participant and I was going to enroll in this clinical trial, would I be getting enough information that I could make an informed decision about whether to participate or not? And the best group to do that are not necessarily a bunch of scientists sitting around the table in their lab coats. I’m not a scientist, my educational background is in accounting, and so I really appreciate the non-scientist aspect of the Institutional Review Board because they can look at a consent and they can look at the risks that are outlined in that consent form, and I can look at it in a way that a scientist can’t. And so the IRBs have a broad swath, broad cross-section.

Joseph Kim:
Yeah, I think it’s very important. I was doing some research where we were trying to measure nocturnal scratching. And of course, when people go to sleep, you need to give them a blanket. But we had some scientists saying, can we make them sleep without blankets? And while that’s not like a form of torture, it certainly isn’t something that anyone would probably do. So, to your point, scientists don’t always think about the realities of a person, and they had their druthers, they would just design research that, probably no one would want to do on some level.

James Riddle:
Yeah, I can only imagine a consent form in that trial saying there is a risk of coldness while you’re sleeping.

Joseph Kim:
Yeah, right. Let’s go back to your background because like you said, you’re not a scientist by training, and you are actually an accountant with, I think, a concentration in computer science as well, so that’s an interesting background. But, in looking at, further at your background, it looks like being part of these ethics review boards has been kind of part of your identity professionally and amongst other sorts of professions. So just walk me through a brief history of your professional career. Like how did you go from accounting to where you are now at Advarra, who does so much ethical review?

James Riddle:
Yeah, so I think like many in the institutional review board space, if you ask them, did you go to school to learn how to do research ethics, 99 out of 100 would probably say no, I fell into it by accident, fell in love with it and stayed, and that’s really what my story is. I went to school to be an accountant, had an emphasis in computer science. When I got out of college, I started doing computer-based work and in the latter part of the 20th century, my goodness, that seems like a long time ago now, I went to go work for this little organization down in Olympia, Washington, called Western Institutional Review Board, and I went to go work there in their technology department. I didn’t know anything about clinical research or institutional review boards or how they work, but lo and behold, Western Institutional Review Board was founded back in 1968 by Dr. Angela Bowman, and it was the largest independent IRB in the world at the time. And I learned all about how clinical research works, how the drug development process happens, device manufacturing process, and just absolutely was enamored with the idea that there were these groups of individuals who would come together, look at research with a patient protection, and patient safety focus to the review. And I’ve stuck around because if you want to know what’s going on in clinical research, the very best place to be is in the Institutional Review Board, because we get to see everything, all the innovations, all the different techniques, all of the advancements in decentralized clinical trials, which is one of the things that I focus on at Advarra now. Across all of the drug companies, all the device manufacturers, we get to see everything, and it is absolutely amazing to be able to go and work at an organization that is advancing science in the way that we do. You can go work at one organization or you can go work at one device manufacturer and you work on one therapeutic area, or maybe you get a chance to move between different therapeutic areas, but it’s generally focused in a specific type of work. Where if you’re on the research delivery side at the private research clinics or even at institutions that focus on research, you’re still typically looking at the confines of what’s going on at that particular location, where with the ethics board you get to see everything. And it’s really, really been exciting to watch over the last 20-some-odd years, the advancements in how clinical research is conducted. And it’s also mildly discouraging that we haven’t come further in that time period. And I’ll, just a short example, I remember when I first started in the IRB world and we started talking about electronic consent, we were talking about electronic consent in the late nineties. And when I go and visit some clinical research sites today, it is still quill and papyrus in a binder.

Joseph Kim:
Technology that’s thousands of years old.

James Riddle:
Yeah, I mean, granted, quill and papyrus has served us well for 5000 years, but it’s probably time that if you can go to Amazon and click a button, and all of a sudden some obscure object shows up at your house in 24 hours, it seems like as an industry, we could probably figure out how to eliminate some of the manual paper processes that still plague us. And so that’s something maybe we can touch on later on in the podcast.

Joseph Kim:
Sure!

James Riddle:
It has been quite the journey. It has definitely been a fulfilling area to work on and looking forward to continuing to contribute for the next couple of decades, hopefully, if I’m able.

Joseph Kim:
Yeah, well, you’re still young. So you brought up a good point, which I often just forget that you get to see everything, medical device, nutraceuticals, wellness devices, anything that’s being tested on humans that should, I mean, I don’t know how many studies don’t end up going to IRB, which should be zero, but I don’t know how many of them actually do. But you do end up seeing a great cross-section of things: biologics, gene therapy, prosthetics. Gosh, it’s a ton.

James Riddle:
I, pick a therapeutic area, even pick a particular social behavioral area, and at Advarra we see it at some level.

Joseph Kim:
Yeah. So let’s talk first, generally, about what are you looking for? Like, what are some red flags? You see research come across your desk, and I mean, there are obvious things like, I’m going to take your firstborn, right? No, that’s not good. But like within the realm of reasonable submissions, I’m guessing people still are submitting study designs that just don’t pass the test. What are things that pop out to you?

James Riddle:
The encouraging news there is that when the regulations governing IRBs first came out in ’91, as we know them today, it took a little while, probably a decade or more for IRBs to really figure out, and then the pharmaceutical and device companies to really figure out what exactly is it that we’re going to let pass and whatnot. And the FDA was very kind with updated guidance, and the folks from Office of Human Research Protections within the National Institutes of Health, they’ve issued guidance for IRBs. So at this point, it’s pretty rare where we’ll see a protocol and just go like, oh, my gosh, that is never happening. What we do find, though, is protocols will show up and there’ll be something around the edges that needs to be a little refined. And typically that will fall into the category of something involving vulnerable populations, children, economically disadvantaged individuals, folks who may be disadvantaged because of access to healthcare, other areas where folks might be potentially vulnerable, those areas tend to get the most scrutiny from the IRB rather than research protocols that are targeting relatively healthy adults who have the cognitive capacity to provide autonomous informed consent to be in the research for themselves. As far as general trends, there isn’t outside of maybe some very far out there psychedelics type research that may have some questionable track history with risk benefits and things of that nature. From the pharmaceutical industry, we don’t see very many protocols that are just flat-out, oh my gosh, you aren’t going to do this. We do have a fair number of protocols that will come to the IRB and the IRB will go, did you think about this, or we’d like to really understand why you’re doing this particular arm of the study, or is it really necessary to do a complete wash out in order to test this drug if there’s a perfectly agreeable therapy that’s on the market, isn’t there a way to do the study while you still are being able to treat the participants, etc.? So just based on the protocol design, there may be reasons why we need to ask a question, and sometimes it’s very valid scientific reasons to be able to have a protocol go one way or the other, and perhaps the sponsor, they intuitively know it, but maybe they didn’t write it down in a way that the lane member of the IRB, the housewife, the clergy, the lawyer, could understand why we need to do the protocol this way, why do we need to have this particular risk to a participant. And then at its core, that’s really what you want the IRB is looking at, is another set of eyes that are not the scientist, they’re not the sponsor, and it involves a good cross-section of scientists, non-scientists looking at the research and like, is this really okay? Do I understand what’s going on? And are the risks associated with this research really agreeable in relation to the anticipated benefits that we might get, either benefits that might accrue to the individual participant or benefits that might accrue to society at large? So I hope that helps to.

Joseph Kim:
Yeah, so what I’m hearing, what I’m hearing is, a lot of it is, some, not a lot of it, much of it is around just clarity. Like, do I actually understand what I’m getting into? Because if you can’t understand that, then you really can’t have informed consent for sure, which is somebody acknowledging, I understand and I’m going to do this of my own free will. But then certainly there may be, you know, do you ever get to the point of issues around, gosh, it’s a little too invasive, or there’s not enough permissions around what they’re going to do with my data, or are there other sorts of things that you’re seeing patterns around, or is it still kind of a wide variety of issues that might come up?

James Riddle:
It’s still a fairly wide variety of issues. I think one, you mentioned data access or permissions around data. That is a fairly hot topic that we see a bit of at the IRB in the relation to needing to ask questions back to the sponsor, that as sponsors, particularly during COVID, have needed to adopt more decentralized clinical trial technology. Some people call it virtual trial technology, but things like remote monitoring sensors, remote diary capture devices. For myself, I’m isolating because of a COVID exposure. So if I was on a trial, it’d be super handy if I could put my experience into my phone rather than having to go to the clinic in order to get my blood pressure and my diary and everything else taken care of because I actually wouldn’t be able to go to the clinic because I’m isolating, and so all of a sudden my data point in that clinical trial becomes obscured. Well, many sponsors and there’s a lot of device manufacturers that are pushing these technologies now because it’s needed. We have to understand, as a participant, what happens to that clinical trial data that I’m putting into my phone. Where does it go? Who has access to it? What if the device doesn’t work properly? Is that a risk to me in the trial? Where we didn’t have those kinds of concerns when you had the more traditional clinical research participant drives across town to the research clinic, walks through the front door, and meets with the clinical research coordinator in the scrubs to get your measurements taken, and your diary history, and all of that, that’s a more doctor-office-ish sort of relationship. Now we have these decentralized clinical trial technologies where you’re interacting with either telepresence or e-consent or e-pro or e-diaries, e-every, there seems like there’s an E in front of everything.

Joseph Kim:
That’s right.

James Riddle:
And so the IRB needs to really understand how those technologies work. Where does the data go? Can the participant, and this is a big one, can the participant do the research trial if they don’t want to use the virtual trial tech, or is it a requirement? And if it’s a requirement, is it a reasonable requirement? Particularly if you have a later-stage clinical trial where we already have some demonstrated efficacy data, so the drug probably works. Now we’re doing a larger placebo-controlled, pivotal end-stage trial, is it reasonable to have someone not be able to participate in the research if there’s no therapeutic option outside of the research just because they don’t want to have an iPhone in their desk?

Joseph Kim:
Interesting. So there are a couple of things that are properly conflated here, which is like data in general, and then in terms of capturing that data, is it going to actually, A, do they want to have it, but B, will it cost them something, right? Because if you don’t have wi-fi access and things are getting sent to wi-fi, how does a person end up doing that without eating into his or her data plan? Or is there renumeration there to make sure that a patient, if they don’t have the equipment, you can loan it to them or even give it to them if it’s something small and of not great value? So I’ll try and untangle this a little bit, and let’s first talk about renumeration or stipends or reimbursement, however you want to talk about it. And I’ll give you a couple of different examples. And I don’t know if this is sponsors getting to skittish or IRBs actually laying down some precedent that sponsors have been burned by. So, for example, if you give somebody a wearable sensor to wear because they have to wear it over the course of the study, many sponsors will say, well, we have to retrieve them back because it’s going to be seen as too tempting, right? It’s undue influence to the patient. Whereas a reasonable person might say like, listen, I’m not going into this trial to get a fitbit, right? That’s not why I’m doing it.

James Riddle:
Exactly, yeah.

Joseph Kim:
So it’s a really undue influence. So and then maybe in terms of more sort of cash compensation, the effort to participate in research isn’t always that easy. Like you have to take off half a day every Monday for 12 weeks sometimes, that’s a lot. Like, you know, are you going to pay my jurors wage, which is like $36 a day, or what can you do to cover them so it’s not, again, undue influence, right? Too tempting for someone to pass up, particularly given inflation recently and all these other dynamics. So I know I threw a lot at you there, but like let’s talk a little bit about this sort of compensation, undue influence, like what’s too much, what’s reasonable, and what would the average person say?

James Riddle:
We can break that down a little bit because there is a lot there. At its foundation, there are two concepts when it comes to compensating a participant for being in a trial. There’s a concept of coercion, and there is a concept of undue influence, both of which are outlined in the federal regulations, and the IRBs are required to make sure that the consenting process is free from coercion and that undue influence is minimized, not eliminated, but minimized. So coercion is the threat of harm. So it’s really hard to coerce somebody with money unless you’ve got a big bag of it and you threaten to whack them over the head unless they enroll in your trial. That’s how you would coerce somebody with money.

Joseph Kim:
And offer you can’t refuse.

James Riddle:
Exactly, so coercion is what you might imagine. Things like the employer telling the employee, thou shalt enroll in the drug trial or else you’re fired, that’s coercion. And we see almost none of that at the IRB level. That’s, that idea of I’m in a position of authority and I’m commanding you to be in my trial because I have some level of authoritarian rule over you. It’s just not a concept we run into very much in North America anymore.

Joseph Kim:
First of all, thank you for saying that. People misuse that word all the time, and I’m glad you cleared it up.

James Riddle:
Yeah, now, the other concept that was undue influence. Now undue influence is a scale. What might be influential is, I’d like to have that fitbit at the end of the trial. That might be an influence. You know, if I was offered the opportunity to participate in a clinical trial that required me to go to a clinic to get an MRI once a week for 52 weeks, and they offered no remuneration, no reimbursement, no incentive, no nothing, that’s actually the lack of influence. For me, particularly if it is a trial that doesn’t involve my disease condition or a trial that maybe does involve my disease condition, but there’s really no prospect of whether I’m going to get a benefit or not, so you’re asking me out of altruism, which is an influence for some people. Quite practically, folks have lives, they have jobs, they have kids they have to take to school. And there is a place for providing some compensation or remuneration to research participants. Now, when you cross the line and the IRBs have to review this in a very fact-dependent protocol, specific way is if the consenting process or the options that are offered are considered unduly influential. So same study, 52 weeks, I have to go in for an MRI once a week, it’s not possible to do it at my house because you don’t have the MRI truck that you can drive out here, so I have to go somewhere and I have to spend half a day going and getting the MRIs for 52 weeks. If you offer me a 5000-foot square mansion and a couple of cruises and a pile full of gold coins for that, that might be considered unduly influential.

Joseph Kim:
Sure.

James Riddle:
If you offer me some reasonable amount of compensation for my time and travel, the idea that I’m going to have to take off work and forego other income in order to participate in your research trial, that doesn’t seem unduly influential. And for me personally, this is the James Riddle opinion, this is not the official Advarra opinion or FDA opinion or anything else, this is James Riddle opinion from being around in this industry for 20-some-odd years, the sponsors are way too skittish about this. It is very rare, very rare that you hear about us as an IRB or other IRBs or academic IRBs disapproving your research because the sponsor wants to pay too much, that is very rare. More likely what we get is, oh my gosh, the enrollment is low and we aren’t getting enough people in the study. So here we’re going to, here’s, we need to change the compensation model to pay more. Well, and the IRB approves it because it’s still not unduly influential and the sponsor probably should have just paid more in the first place and maybe they would have been attracting more individuals, or maybe the sponsor should make access to the trial a little more flexible. Maybe those MRIs should be on the weekend. Maybe they really should drive the MRI truck, there are such things, right? Maybe they really should drive the MRI truck out to your house, right, so that you don’t have to drive somewhere. And I’m overexaggerating those ideas, but little things like, do I really need to go into the clinic and drive across town and take off work and park and everything else between 8 to 5, Monday through Thursday in order to get my blood pressure taken, a blood draw for my labs, and to meet with the clinical research nurse to go over any adverse event symptoms, or could I have just as easily had a well-defined, validated blood pressure monitor that I did myself in a telepresence call with that same clinical research nurse coordinator and had a portable medic come out and draw my blood at my house on Saturday morning when I didn’t have to take off work and I didn’t have to drive across town? And so those modalities, those decentralized clinical modalities, they exist, and sponsors are starting to adopt them rapidly, but they also do change the compensation structure. So just to bring it back to the compensation for a minute, the IRB will be looking for a compensation plan that doesn’t introduce undue influence for somebody to enroll. Last point, what is unduly influential to me might be different than unduly influential to someone in an economically disadvantaged community that is asked to participate in the same trial. So even with inside the same trial, the IRB does need to consider what’s the target population that is being looked at for this because if you take the, I’m going to pay $100 for a one-hour survey and you take that to a homeless encampment, that might be unduly influential. But if you’re offering that same $100 to the research clinic staff or the principal investigator corps, $100 may not be enough to even incentivize them to take the survey because it doesn’t equate for the value of their time that they’re devoting to the research. So there is a measure of who are we offering this remuneration to as well.

Joseph Kim:
So like, how do you square that? Because if it’s $50 for a visit, which I think is too low, but to your point, I think sponsors are just like, $50 is what the IRB will accept. Let’s say we push it to $250, which might be a tipping point for some, definitely for some, but not for others. You never know who’s going to enroll. So if it’s just Type-1 diabetes, right, that cuts across everyone, would you try and make some sort of sliding scale or you just sort of take the whole gestalt of the patient population and say, okay, you’re not singling any one person out, this is a reasonable amount for the garden variety patient and good to go?

James Riddle:
Yeah, it’s the second thing. There isn’t a regulatory prescribed threshold, so minimum wage is not a prescribed threshold, reasonable average compensation, or medium compensation. I’ve heard folks, some IRBs use living wage concepts depending on where you’re at in the country, and there’s also just the general reasonableness check of the IRB members themselves, because remember, they are housewives, clergy, it’s not a bunch of scientists and white lab coats sitting around the table. What would be reasonable to you? Does this feel unduly influential to you? And if it does, you know, maybe we ought to push back on the sponsor just a little bit. But I would have to say that by and large, James Riddle’s opinion, sponsors don’t offer enough, and they could offer a lot more without testing that unduly influential threshold.

Joseph Kim:
Yeah, sites would agree with you. They’re constantly asking sponsors for just a little bit more. One final question, which is still a hot topic and has been a hot topic for a long time, but it’s gotten less hot because decentralized trials have gotten hot. So I’m kind of sad that people have forgotten about this, and this is the notion of, if you’re going to protect a patient volunteer who’s taking a mystery drug, I would like to think that one of the best ways to protect them after they’re done is to tell them how they did on that mystery drug. At least tell them what the mystery drug they were taking is, or in more technical terms, the return of individual data or at least trial summary results. That’s not something that’s like yet required per se, but if we’re going to talk about protecting patients, like where does that fit in the conversation for an IRB or for an ethicist versus the patient versus the sponsor?

James Riddle:
You’re right, the conversation around returning research results has lost a bit of momentum. During the COVID, everyone has been very much focused on how do we keep clinical research running and more importantly, how do we get the clinical research in order to get the COVID vaccines done, figure it out. I would say that hopefully, it hasn’t completely gone away, the discussion is still being had, and I would just give a nod to the European Union, they, folks over there require a summary of what happened in the trial to be published after the research. We don’t do that here in the United States, I think that’s a big miss on our part, because participants who volunteer their time, their energy, their bodies to advancing science, we ought to be at least reasonable enough to be able to produce a what happened in this trial. Maybe not the, specifically what happened to you in the trial, but here is the general results of what happened in this trial. The drug worked, the drug didn’t work. We expected it to have this level of efficacy, it didn’t have that level of efficacy. Thank you very much for your participation. And some organizations are very forward-thinking on this. A number of sponsors do this voluntarily, and I think that it’s admirable that they do, but it’s not required here in North America. Perhaps someday it will be, I don’t see it on the FDA’s guidance document or guidance docket, excuse me, and so we’ll see what happens. It’s not an IRB requirement, the IRB is not in a position to require such a thing, though, James Riddle’s opinion, the Europeans got it right, we should really do this. Returning individual results back to the patient, that feels a little more like the practice of medicine rather than the conduct of research. I think that if participants are concerned about that, they’re certainly informed about it and the informed consent form on the way in, if they really are concerned about that, their alternative is to not participate in the research and rather participate in the practice of medicine where they may be able to get the drug off label, they may be able to get it through other means, but I mean, that is a participant’s choice. One of the things that you are consciously giving up when you enroll in a clinical trial is that you’re probably not going to know. You’re certainly not going to know if you’re on placebo or study drug, if it’s a blinded trial, and you’re probably not going to know your overall results, right? Because it isn’t the practice of medicine, it’s the conduct of research, and we’re gathering specific scientific data points to be able to prove safety and efficacy of a particular thing. So I don’t know if we’ll ever get to, A, required return of individual participant results, but we certainly owe it to all of the people who participate in a trial to at least say, thank you for participating, here’s what happened. This is what we learned based on your personal sacrifice of being in the trial. Thank you very much, and thank you to all the researchers who did this really wonderful trial. And even if it didn’t work, we still learned something.

Joseph Kim:
Especially if it didn’t work. Yeah, exactly.

James Riddle:
One of my favorite quotes, we have a very, very wonderful chair on one of our committees, and one of his favorite quotes is that, research sometimes is like going down blind alleys just to find out that they’re blind. And if you didn’t know it was a blind alley, you might think it might be an adventurous, wonderful thing until you go down the blind alley and find out it’s blind. And without doing the research, you would have never known. I have elaborated on his quote, so if he’s listening to the podcast, thank you for the little seed there to allow us to elaborate on your quote.

Joseph Kim:
Yeah, I’ve heard something similar, which is if we knew what we were doing, it wouldn’t be called research.

James Riddle:
Exactly, that is very true. If we knew that drug A worked better than drug B or we knew that Molecule X was going to be able to cure this, that, or the other disease condition, there would be no reason to conduct the research.

Joseph Kim:
Right, we’d be practicing it.

James Riddle:
We would move it right to the practice of medicine. And I would just point out they call it the practice of medicine for a reason. It’s the practice of medicine, but it’s the conduct of research. Research is very methodical, very prescribed, and it’s a different experience for the research participant than it is for somebody who’s going to seek medical treatment as a patient. It’s a fantastic world to be in. We have developed and delivered amazing cures for folks over the, just within my short amount of time that I’ve been involved, I have seen amazing cures, particularly in the area of gene transfer and gene therapy where you can fix people rather than treating them. It is just absolutely amazing what we can do and I’m looking forward to the next couple of decades to see what comes next.

Joseph Kim:
Yes, some have said this is a new golden age of medical development and it’s great that you get a front seat to all of the different ideas and interventions coming down the pike.

James Riddle:
Indeed.

Joseph Kim:
James, thank you so much for spending some time with us today. It was great to hear your perspectives. Keep doing what you’re doing. We need good oversight of all this research to make sure that we’re doing things fairly and without undue influence. Thanks for joining us.

James Riddle:
It’s been my pleasure. Thank you.

Joseph Kim:
Thank you for tuning into Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you’d like to debunk a clinical research myth, share some war stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to help@ProofPilot.com. This show was presented by ProofPilot and is powered by Outcomes Rocket.

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