Latest Trends and Developments in Clinical Trials

Kyle Faget, Partner, Foley & Lardner LLP, and Devin Cohen, Partner, Proskauer Rose LLP, discuss the current legal and regulatory landscape of clinical trials. They cover issues related to changes to the FDA’s regulatory process, research funding, research misconduct, regulation of wellness products and clinical decision support software, and telehealth and decentralization.

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Transcript

SPEAKER_00 0:04

This episode of AHLA Speaking of Health Law is brought to you by AHLA members and donors like you. For more information, visit americanhealthlaw.org.

SPEAKER_01 0:17

Hi, and welcome in, everybody. I am Kyle Figet. I am a partner at Foley and Lardner, and I practice in the healthcare and life sciences space. And today I'm here with my longtime friend and colleague, Devin Cohen, and we are going to talk about clinical trials and challenges facing clinical trials and kind of weave through the myriad of things that come up in that space. So hand it over to Devin so he can introduce himself.

SPEAKER_04 0:47

Thank you, Kyle. I'm Devin Cohen. I am a partner in Proscow's Boston office in the healthcare group, focusing quite a bit on both clinical trials sponsor work, FDA work, as well as provider services. And is a great opportunity to be here to chat with Kyle and kind of go through what's happening and what are the biggest issues for sponsors that they are seeing, in particular in clinical trials.

SPEAKER_01 1:13

I mean, that's probably a great place just to even start. What do you think the biggest challenges are that are facing sponsors today?

SPEAKER_04 1:21

Well, it's a very uh timely conversation. Um, you know, at this time, I think there's been a lot of questions about predictability of the FDA process and um questions about whether there are new anticipations and requirements for standard of care and for ongoing sponsor kind of communications with FDA through a many-year process to roll out a clinical trial so that the process isn't held up at the last minute. Um and I think there's been a couple of instances either in the vaccine space or in other spaces as well, where we've seen um back and forth between the FDA and sponsors given changes in government priorities, um, so that you know we we can avoid ideally type A meetings and the type of kind of conversations between sponsors and the FDA when things start to stall. Um, those those kinds of communications, in my experience, should be happening um collaboratively, early, on a consistent tone and tenor. And there should be no surprises at the end of the day, um, I think for any party of where uh an application is going and what the what the FDA is planning to do with it. Um but though that that that's just my two cents. Um I'm very interested to hear from you, Kyle, on what you're talking about.

SPEAKER_01 2:47

I completely agree with you. I think regulatory uncertainty is a huge issue right now, um, in part driven by a lot of the turnover at FDA. So uh, you know, the sponsors have walked along hand in hand with maybe one individual over time that understands their trial, understands their process, and you know, in comes a new individual that the sponsors, you know, never worked with before and doesn't have the background. Um and that I think that's where I've seen some real issues is that uh regul that turnover of staff. Um and I think there's been a lot of concern that the reduction in force um is has is going to and has had an impact um on timeliness with FDA reviews and approval. So so that's definitely an issue. And I think you know, there's uh there's just this a whole issue of like what is FDA's uh role here, right? Um you know, we see the new voucher program, so FDA is trying to speed up its review, and then FDA is getting involved in some areas that I think it's it's new, at least in my time practicing, I haven't really seen FDA get involved in issues like pricing, for example. Um, and you know, one of the um voucher programs criteria is revolves around pricing. And, you know, in May 2025, there is the executive order that would allow FDA to review and potentially modify or revoke drug approvals if the manufacturers don't comply with the administration's pricing strategy. So we're seeing FDA take kind of a different, uh a different, more active role, I think, in some ways than I than I have seen in my time practicing. So like over the last like 20 years. Um FDA is like pivoting in ways that I think are somewhat new. And I what does that mean for sponsors? It's just lack of predictability, right? Like the FDA has often been known as just, you know, hey, we're moving along, we're moving along in the process, the process is well known. Now you've got different people, different priorities, and I it's not crystal clear what's actually happening just yet.

SPEAKER_04 5:20

I I I I totally agree. And I I want to I want to bifurcate this just a little bit because there's the unpredictable nature of timeliness and staffing and kind of what folks are used to on a many-year billions-of-dollar trial that are trying to push through. And that that's one question, and we cannot minimize it because the outcome to that question I think is deeply important. But I think this uh a related component there is what standards and what processes are the FDA is the FDA actually planning to use for those processes. And and I I think you know, kind of the potential pivot historically, there's been a lot of use of advisory committees. Um, there's been a lot of transparency and requirement that sponsors have visibility into how medical experts and scientific experts sitting on advisory committees are making their determinations. We saw during 2025 in particular, a bit of a pivot for a couple of things, um, particularly towards expert panels. I'm gonna put that in air quotes as much as I can. Um they're a bit more ad hoc, they're they're a bit less transparent, um, and they're really focusing on, you know, I think some of the more emerging issues of our time from talc safety to infant formula to hormone replacement to kind of the new products as they get developed. Um, there is now a question of does a sponsor know what the FDA is going to be looking at and what conversations it's having, or are those conversations being had behind closed doors? And if, you know, I uh the behind closed doors component to the extent that that perpetuates over time, makes it much more difficult to read the tea leaves of how to act for prospective trials and whether pivoting is required for existing trials on the sponsor side.

SPEAKER_01 7:18

Right, right. No, that's a that is a really, really good point. Uh have you ever in your experience or over time seen as much influence by HHS as we see now with RFK and that relationship? Like that to me has been an interesting evolution as well. Um, the back and forth between RFK Junior and FDA.

SPEAKER_04 7:49

Yeah, yeah.

SPEAKER_01 7:50

And and have you ever seen that before?

SPEAKER_04 7:52

I I haven't. Um between the commissioner of the FDA, um, between the vaccine kind of heads, uh, Dr. Prasad at FDA. I I don't think we've seen so much input from an overarching agency head or department head down to the FDA in that regard, um, which which which I think is is also a very interesting development in light of the shift away from kind of chevron deference to Loper Bright deference of predictability. Is that is that maybe there is at least given that there might be a bit more of an open door for challenge and a lack of deference depending on how that process unfolds, whether it goes through federal register or more formal components, and you know, whether the FDA is taking approaches that are dotting the I's and crossing the T's, versus saying we are implementing a new policy determination based upon um, you know, whatever a head of a department might be feeling on a given timeline and how that could impact an ongoing trial. It creates even it exacerbates the uncertainty that I think we were talking about earlier because of um individuals who haven't always had their hands in the pot in that same way taking a more active role.

SPEAKER_01 9:22

Right, right. No, absolutely. And you raise, I think, a really important issue because we're seeing tremendous shifting sands with vaccines. And it's interesting to me, like I keep reading about okay, how is the public reacting? What is our confidence level in vaccines? And have you seen with your clients? Um if you have clients that are in the vaccine development space, um, have you seen any changes in their approach to regulatory strategy, marketing strategy, any of that stuff?

SPEAKER_04 9:59

Um Yeah, I I I I I have worked with a number of clients here, and I I have seen say that they are being more proactive and aggressive, but intentional in what they are trying to do with an understanding of the current administration's view of how vaccine research may overlay onto public health issues. Um, you know, I believe a lot of the sponsors that are investing in this space and have multi-year clinical trials in this space, um, they're not as much taking their foot off the pedal for the research, particularly given the public health importance of it. They are instead trying to identify the most efficient pathway and the most effective documentation to be able to have an active discourse, let's call it, with the FDA or applicable regulators if anyone impedes that process as it does proceed. And I do think there was a fear at the beginning of much of the most recent FDA administration that there could be a chilling effect on this type of research. And I would I would say I've seen less of a chilling effect and more of a very directed approach for sponsors doing the research on how they plan to coordinate with the FDA every step of the way.

SPEAKER_01 11:26

Right. And I think they have to. And I think some of that, so my question when HHS reconstituted the advisory committee for immunization practices, ACIP, which you know makes recommendations about safety and efficacy and clinical need of vaccines to CDC, one of the questions that I have sort of in my background is is the standard for approval for vaccines, is that going to be a moving target over time with FDA? And so to your point about staying in touch with lockstep FDA along the way, I think it's incredibly important because not that I've necessarily even seen the standard for approval change necessarily, but it's just a question in my mind, okay, you know, the experts that are weighing in here are changing the thought around the utility of vaccines is shifting somewhat. So then does that have an impact on approval approval process for vaccines and how you how you get to go with FDA? Um totally.

SPEAKER_04 12:37

And and it's it it and it in theory from a from a statutory interpretation perspective, right? It it shouldn't have that type of impact. The Food, Drug, and Cosmetics Act, it does set forth the safety and efficacy standards. And um and I think the the the kind of tail to the question, which which we haven't seen pressed as much now, but one of the reasons why I thought it was relevant to push on Loper Bright a bit earlier in this conversation, because we don't usually see Administrative Procedure Act type of challenges and standings in this space, both from a reputational and ongoing growth opportunity. Sponsors don't want to uh bite the hand that feeds in some ways. Yep. And second, it it there has been substantial deference historically. So if there is a pivot away from the Food, Drug, and Cosmetics Act kind of guardrails of what should be approved, what shouldn't be, what shows safety, what shows efficacy, I think we're possibly going to see um new avenues or avenues that were less utilized historically by sponsors in order to try to carve a pathway forward.

SPEAKER_01 13:47

Yep, yep, yep, I I can a hundred percent see that. Um, speaking of like another thing that is obviously we couldn't even have this conversation, I think, without addressing grants and what's happening with grants and funding of the actual research required to develop life-saving medications and useful medical devices, et cetera, et cetera. Not that all of the development hinges upon government funding, particularly. Um, certainly private sponsors fund a lot of research, no question about it. But there is a whole bolus of research and development that is contingent upon federal funding for that research. And yeah, so I'll just I'll I'll just throw that throw that out there.

SPEAKER_04 14:36

That's all fall out there. Thanks so much, Kyle. Um I I I I think it it so it it it it's fascinating. And I'm interested if you've seen the same thing, because it it has raised the question of trials that have been so deeply invested, have touched so many subjects and moved it through, let's say, phase two or phase three. And then if there is grant rescision or funding rescission, it you know, that that puts the sponsors to put it, call it between a rock and a hard place is putting it as lightly as you possibly can. But we have also, at least I have seen, um, increased private capital and increased private support when that um rug is pulled out from under folks. Um but that that's a hard balance for sponsors to strike when IP is their great value, the equity in their business is the great value of what drives their their success. To say, do I want to bring in a third-party private capital or funding option in order to support getting this to the end zone? Um and and I don't uh you know it's it's gotten really tough. Have you how what what have you been seeing there?

SPEAKER_01 15:50

So what I've seen more of um, which I 100% yes, there the money has to come from somewhere, right? So if you're not gonna get it from the government, then it's gonna have to come from the private space or the research just isn't gonna happen, right? Like, I mean, that's that's the other potential dubious outcome here. Um, but where I've seen this uh really um impact, which is really not about drug development as much as it is about population type-based research and understanding various communities. And so then when you got the administrative priorities set that really discourage research that includes gender, race, sexual orientation, those kinds of things. Um, and seeing those grants are being terminated or the threat of termination, and a lot of very seasoned researchers that are trying to understand how do these communities function? Like, and this is just a scientific and and it ultimately does matter for drug development, right? Because as we understand communities and community needs, then sponsors can answer to those community needs. But you have to have that underlying um uh you know community population based research occurring, I think, at step one. And obviously it's been very controversial.

SPEAKER_04 17:14

Um it creates such a tension, I would say very specifically in the focus of where grant funding precisions or questions have been arising versus where does clinical need actually sit? If it sits within a very narrow population that happens to be a diverse population, trying to figure out how to balance that with increasing scrutiny on let's call it DEI activities, uh it becomes tenuous at best. Um but but but I I think we can all agree that from a public health perspective, leaving that on the table is not an option.

SPEAKER_01 17:58

Right, right. Well, and so the other thing that was interesting um is when like the entire FDA website was like recast, right? And um and we've talked about and worked with sponsors for years about how to create clinical trials that have a subject population reflective of uh the larger part of the community that the drug is gonna ultimately be used to serve. And it was really, you know, FDA has spilled a lot of ink over time about increasing diversity in clinical trials. And so it's really interesting to see this pivot, like, okay, we can't talk about diversity, we can't deal with diversity, but at the same time, you have to develop drugs that are gonna be safe and effective across, you know, a myriad of populations. So how do you get there without having diverse clinical trials? You can't really, right? Like, and we know that products are performed sometimes differently in different populations. So so that's sort of an interesting thing too that happened, you know, at the very beginning of the administration where we saw this rewrite of diversity in clinical trials. But it was an in it was an elegant piece that I think the administration had to thread that needle a bit because you don't want to release products out in the marketplace that perform differently in different populations without understanding that that's a possibility. I mean, even just from tort like perspective alone. Um, so I think what what I have seen there at any rate is that um I haven't seen sponsors change their approach to putting together clinical trials and the need for diversity in clinical trials. But what I, you know, what I have seen is grant and grant administration population type based research. Does that accord with what you've seen?

SPEAKER_04 19:56

I I think so. Um I I very much think so. Because I think that uh diverse population base is required for comparator data to actually make it through safety and efficacy review with the FTA, right? And and I I've seen kind of thinking of it like a balloon, right? We squeeze one end, but on the other end, I think it's just resulting in more uh focus and more um understanding of nomenclature in the understanding underlying grant applications.

SPEAKER_02 20:27

Right.

SPEAKER_04 20:28

Um, and and very often those applications are coming from academic medical centers with whom private sponsors might partner. And and trying to actually have that collaborative conversation in a way that does not impinge academic freedom at the outset has now become even more important. And we've always that that has always been of utmost importance. So even trying to say more important is hard enough. But um it is taking a real front row to this.

SPEAKER_01 20:55

Yeah, no, fair, fair. I mean, do you think there's is there anything else? I was gonna pivot into a another topic. I mean, we could talk all day about funding and funding mechanisms and so forth, but I know we want to cover a certain amount of ground here. Is there anything else that you want to add to the grant conversation before I pivot?

SPEAKER_04 21:17

Not not on not on my part. Let let's pivot and maybe maybe let me start by asking you a question about what what what what's what's coming down the pipeline here. And and importantly, I I know there's been um a lot of focus on private um academic relationships and research misconduct, um, especially with the changes in the rules and the compliance policies required at the beginning of 2026. How is that impacting what you're seeing with your clients?

SPEAKER_01 21:53

So, what I what I saw right away with those changes is hey, we need to understand these changes. What they are, what they mean. And honestly, I've seen an uptick in research misconduct investigations. There's just there I see the matters come in daily, like with research misconduct. I mean, there's always been a steady flow of those types of matters, but um there's been a real uptick. And I think that there was a renewed conversation about research misconduct, which was probably you know nobody wants to have bad data, bad research, research misconduct. Um, and I think that there have been increased discussions about um, you know, what what and when and how to um deal with issues as they arise in clinical trials, like what kind of transparency is required to NIH, what type of transparency to sponsors. Uh those are the kinds of things that I've seen was there was a renewed conversation and emphasis on research misconduct. What about you?

SPEAKER_04 23:04

No, no, I I agree. And I also think I think that there's been a lot of very public cases, particularly in the academic space, that has put this on um, you know, the general radar of newspapers and and mainstream media that has caught the attention of you know general consumers, patients, and and others. And and and that's not a bad thing, in my view. And to your point of ensuring that the data is actually that that's being used, um, you know, the FDA is going to scrutinize how it's been compiled, the process through which it was, um, the validity of that data. But at the end of the day, um, you know, if someone is and if someone as smart as a principal investigator in some of these institutions is trying to do something that might not be called kosher, that that is going to have its own problems, and the FDA will have more difficulty looking behind the curtain to find that. What I think is a I will say is actually a, from my view, is a benefit of the Part 93 updates of a number of these new developments is we, you know, talking a little earlier on increased academic private collaboration. This has produced a greater impetus on the private industry side and the private sponsor side to really think closely about how they are monitoring research misconduct. Because even if they are not receiving grants or funding directly from HHS, because of their collaboration relationships, they might be pulled into part 93. And and that just that keeps research honest.

SPEAKER_01 24:46

It's a good thing, right? This is not a bad thing at all. Uh so yeah, that's that's interesting. Um you know, one thing that I see occurring in like at lightning speed right now, um, which you know, FDA just released the new guidance around CDS and wellness products. And I feel like we almost have to talk about that.

SPEAKER_02 25:12

Yeah.

SPEAKER_01 25:13

You know, um, and in part because this administration, like you may say a lot of things about this administration, but there is a real commitment, I think, to under the Maha movement, to getting wellness products to market, to um step back from regulating uh products that maybe are not so high risk that they they could be reasonably put out into the marketplace. Um so where FDA could regulate and it's ultimately deciding to exercise deference. Um and I think so, I think we're seeing a bit of deregulation when it comes to wellness products and clinical decision support software. I I have some questions, you know, about in CDS that, you know, when you have outputs that can really potentially impact clinical decision making, I don't know that I have the answer for what not that I always have the answer, and nobody's asking me, but hey, as long as as long as I will say you usually do, Kyle, but like please. As long as we're allowed to opine on high today, um, you know, where where is that fine line for CDS? Like at what point should FDA really be regulating? Because we do have, and this showed up in in one of the guidances along the way, a tendency to rely on output from like sometimes we think computers know know best. Um, and so to the extent that we're getting an output that really can impact clinical decision making, um, you know, at what point should those types of products be regulated and where should FDA step back?

SPEAKER_04 26:59

So, so Kyle, where and where do you see the emergence and the continuing growth of artificial intelligence in this market, specifically in that trend?

SPEAKER_01 27:13

I mean, that's like the million-dollar question. If I had that answer, I wouldn't be sitting here. I mean, we're gonna see AI used so much. It's it's incredible. And you know, maybe this is insane to say, but I think we're about two steps away from having ultimately fully automated clinical decision making.

SPEAKER_04 27:37

I I I agree. I I I don't I don't it might be insane, but count count me in um for the insanity. I think we are we are emerging to that area and and the the the FDA's view of CDS from my perspective has been acknowledging the market trends that are growing with AI. And and and you know, saying that we will encourage AI use under the right circumstances and with the right determinants. However, it can't be done without the adequate safeguards and mitigating factors.

SPEAKER_01 28:16

Right. So here's a philosophical question for you. At what point, to the extent like if we're in agreement, which I think we are, we're headed toward clinical decision making being done electronically and by AI and so forth. Um we're headed there. But so, okay, so FDA regulates in that space because you it's hard to argue that it's not software as a medical device at some level, right? But at what point does that regulation then dip into the practice of medicine?

SPEAKER_04 28:48

It innately has to. Like they're there, you're like right, it does have to. And then we are coming into where I where I think you're going, which is which is dead on, is a federal versus state regulatory construct of the practice of medicine, is not something the FDA, CMS, HHS, they they deal with. That is a state police power, right? And and um I I do have to think that there is developing kind of um a trend as AI and CDS grows in that manner and further kind of overlays into the practice of medicine a question, it's going to be a legislative question rather than an interpretive question of the current Food and Drug Cosmetics Act of, you know, should there be preemptive powers or should there be more authority on the federal side for certain components of the practice of medicine? If the answer is yes, how limited should that be? Even if it is limited, is that still constitutionally permissible? We have all types of those types of questions that we're going to be seeing over the coming years.

SPEAKER_01 29:55

Yeah, I mean, it's gonna be fun, honestly. This is what makes me excited to do the work that I do. It's like this, how we're developing and how medicine and clinical practice is developing, how medical devices are developing. It's it's unbelievable. The the pace at which um we're moving is is incredible. And I the only thing that I can see that could potentially slow it down is the thing that typically slows down innovation, is if there's an actual tragedy along the way of some kind, which has a step back and pause. And obviously, you never want that to happen, but but that's typically where we see um you know pause and pivot. So I I don't know, I don't see anything anything else.

SPEAKER_04 30:41

I I I I agree and I think it I mean it it's also very fascinating in that in that same regard. It's very fascinating because we're asking about where does current FDA regulation overlay with clinical practice and um you know physician decision making, nurse decision making, and otherwise. And then we have the whole kind of telehealth component of where we've been seeing all this, which has been regulated on the federal side, um, I'd say quite extensively, and I would say more recently, um, particularly for compounded medicines and and uh you know there's been some I'd say economic impacts of that on the stock market and otherwise. But uh as we continue proceeding there, um, do you see that kind of raising the same type of tension? Or is it is it that the telehealth development is something that isn't going away as long as it has adequate federal support? And if that is the case, the FDA will have to lean in.

SPEAKER_01 31:45

I think that the FDA is gonna have to lean in. And I mean, we've seen a little bit of FDA leaning in in the research side of this with the guidance about decentralized clinical trials. I think FDA probably needs to lean in more because telemedicine is not going anywhere. If anything, it's gonna become more and more sophisticated. I mean, it grew up as this, like it used to just be about like, you know, very personal types of medications, cash only, like erectile dysfunction, male pattern baldness, like you know, nobody wants to go in and have a conversation in person with their doc. They can hop on telemedicine, get everything taken care of. And you know, it was all cash pay. And now we've really moved into um a model where all of them have payer contracts, like it's just totally, you know, um and and for research, right, it's so obvious that decentralized clinical trials are the way um to move forward, but it's so at odds with state practice standards and licensure. There's there it's it's a it's a messy, messy thicket. Um, and so you know, to that extent, I do wonder if if there will be more federal um involvement, right? Because and even like state, I mean it's interesting, keeps lawyers employed, like there's the you know, 50 state survey after 50 state survey. What can what you know, what can one clinician do in this state? And what, you know, what are the rules of the road? What are the practice standards that are applicable when you're in one state versus another and each state is dealing with telemedicine differently? And you've really got to get your arms around all of that if you want to engage in decentralized clinical trials. And again, if we really want to incentivize innovation, removing some of that state by state mess is probably the way forward, even though you know people hate when there's powers taken away from states or decisions are made at a federal level. Um and there's some balance in there. I don't know, I don't have the answer as to where that is, but I know that if we really are going to leverage telemedicine for all it's worth, particularly in the research space, uh, you know, there's gotta be some national standards.

SPEAKER_04 34:15

I agree. I agree. I agree entirely. And I I would love to hear your thoughts on on you know uh what's not changing, what's not going anywhere? There's there's you know some trends we've had for some time. What are your thoughts there?

SPEAKER_01 34:32

I mean, the muce the minutia of clinical trial contracting, the back and forth, that's not really going anywhere. We're gonna be negotiating indemnification clauses and from now until the end of time, subject to injury now until the end of time, even if we all can agree that if somebody's really hurt in a trial, it behooves a sponsor to go ahead and pay. Like, you don't want to be the sponsor that front of the New York Times, like failed to pay for this terrible injury sustained by whatever. But yeah, you know, again, it it keeps us employed. And I think that clinical trial contracting is there hasn't been a lot of change really over time. I think like there's some shifts in what provisions are accepted, and we've seen a move away from academic medical centers agreeing to indemnify and pushing back on that more and more, where that wasn't as you know, when I first started doing these kinds of negotiations, it was the standard practice to cross-indemnify, and now it it's not as much. So I I don't know that I see that that world there there hasn't been that much. I haven't seen a lot of change in the con clinical trial contracting space. I don't know, what about you? What's what's not going anywhere?

SPEAKER_04 35:49

No, I I I I I do agree. And and I I I think the role of CROs, the roles of SMOs, the vertical integration between CROs and private sites and sponsors in private sites, um, that's going to continue um developing quite quite fast. Um relatedly, I think there is always going to be an increase, uh, a resistance to cross-border transfers during an increasingly international tribal space. Yes. And and the question is where that focus is going to be on a given day. Um the DOJ's kind of focus currently on the PRC is one thing, but I can't tell you that's what it's going to be in two years or three years. And and and that type of tension is an innate component of a globalized system for sponsors. And and as these products and and product trials continue to develop, um, trying to read the tea leaves on where's the next area of scrutiny going to be is really the key rather than asking of whether there will be scrutiny, because there will be. I think we can get behind that.

SPEAKER_01 37:03

Absolutely. I couldn't agree more. I hope that we, I think we covered some some decent ground here, and maybe this is a good place to let our listeners go.

SPEAKER_03 37:12

I absolutely thank you for taking the time, Kyle. I really always love talking to you.

SPEAKER_01 37:17

Absolutely. It's so fun.

SPEAKER_00 37:23

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