Host 1:
Welcome to Insight Exchange, presented by L.E.K. Consulting, a global strategy consultancy that helps business leaders seize competitive advantage and amplify growth. Insight Exchange is our forum dedicated to the free, open, and unbiased exchange of the insights and ideas that are driving business into the future. We exchange insights with the brightest minds of the day, the most daring innovators and the doers who are right now rebuilding the world around us.
Host 2:
Patient's insights of recruit and enroll patients, change how trials are executed. Year after year, R&D costs incurred by biopharmaceutical companies to bring new therapies to the market are skyrocketing. There is also a lack of appropriate racial representation among study participants. As clinical trial sponsors fail to reach their recruitment targets, these dynamics have led to a greater reliance on clinical trial partnerships for execution. With all that said, let's clarify how sites and participants are changing the way trials are executed and how the necessary changes bring growth to the market, in this episode. Also, we're super excited to bring in Matt Wheeler and Ian Tzeng to share their thoughts. They'll be today's speakers. So hello and welcome, before we get into the podcast, why don't you gentlemen, please introduce yourself and tell us more about yourself.
Ian Tzeng:
Thanks so much. Appreciate the time today. This is Ian Tzeng speaking. Matt and I are both partners with the Boston office of L.E.K. and leaders within our pharma services practice, which is really helping any company that provides services, technologies or products to pharma, to help them in advancing their drugs in their pipeline or selling their drugs or manufacturing their drugs.
Matt Wheeler:
And you have Matt Wheeler here as well. Thanks so much for the time today. I'm excited to do this podcast with you all. I'm a partner in L.E.K.'s Boston office where I spend all of my time in our pharma services practice alongside Ian. Within that, I spend a significant amount of time thinking about the clinical trial ecosystem, how sites, sponsors, CROs, and patients can move drugs through development more efficiently and the different services, tools and technologies that can be deployed as part of that.
Host 2:
Great. Well, thanks to you both for sharing your insights today. Let's get into the conversation. It said that their trends are changing. The trends are changing on how sponsors think about clinical trial sites and patients. Among them are the increasing importance of site sponsor relationships. So sponsors are being viewed as sponsor of choice, as being something that's more important than ever. So can you expand on this sponsor of choice concept?
Matt Wheeler:
Sure. I think that's right. And what we see is that drug development across the board continues to get more competitive, more challenging for biopharmaceutical sponsors. And as they're going through the clinic and trying to find the top sites, the top PIs to run and execute the trials, there's a significant imbalance between the supply and demand of sites and PIs that are available. There are not nearly enough PIs to actually run trials. There are not nearly enough sites to meet the demand that biopharma has, and it really becomes one of the biggest governors to growth for clinical development. So because of that, you see sponsors really thinking in new ways and really putting their money where their mouth is and investing in things that they can do to make themselves, what we call, a sponsor of choice.
And so what is that? That's really a biopharma sponsor that a site is going to want to work with, because they're thinking about a lot of the historical friction points or pain points that sites experience. And they're doing things either through their ways of working or ancillary services and tools that they can offer to sites to help mitigate those and to be seen as quite easy to work with, so that when there are challenges, and when there is back and forth of the site saying, I only have so many spots that I can fill, who do I want to work with? These sponsors really stand out because they're doing a number of important things.
Host 2:
Let's talk some more about standing out. So what does it take to become a sponsor of choice? What factors do they want sponsors to improve on?
Ian Tzeng:
Sure. When sites are thinking about who to work with, you can imagine that it's like any relationship, you want to work with folks who make it easy for you to work with them, there's not a lot of administrative burden. You're interested in similar topics or similar types of therapies. You like the people that you're working with and they provide the necessary support that you're thinking about. So do they provide the resources, the training? Do you feel like you are aligned with them in terms of the patients you're serving? Are they making working with you easy or are they giving you a lot of bureaucratic hurdles and challenging technologies and difficult workflows that you need to implement? Do they kind of toss you in and say sink or swim, or do they actually help you out and coach you? And those types of things really translated into working and pragmatic levels, has to do with being good in terms of transparent and open about negotiating your budget.
It could be about how they support you in enrolling study participants and recruiting those, the technology that you provide for them, and also the site training and the interactions of day-to-day. One of the really key important parts for any site is, if you will, your handler, who is the person that you are interacting with on a regular basis, are they a good person? Are they fun to work with and easy to work with? All these things really impact being a sponsor of choice. And on top of that, with a lot of physicians, especially those who are real specialists in their field, they care very deeply about their patients and advancing therapies. And so they really want to work with folks who are doing innovative things, are showing leadership in that disease state, putting money where their mouth is to really improve the lives of patients.
Matt Wheeler:
I think the other thing, kind of building upon what Ian said is folks have talked about being a sponsor of choice for a while, so why is it different now or why do we see it changing? I think as we look across the ecosystem thinking of our clients on the biopharma side, on the pharma services side, investors who participate in the space and invest in a lot of the innovative companies, we're seeing a real growth and a real, to use Ian's word, putting the money where the mouth is, of investment behind technologies and services very much geared at benefiting the sites. Historically, so much of spend within the clinical process was really geared at optimizing for sponsors and optimizing for CROs. And sites were kind of just left to their own devices, and to a certain extent just told to carry on and make the best of the situation.
And what we're seeing now is sponsors having a renewed interest, in actually investing behind this idea of being sponsor of choice. So it's no longer just lip service that the people say, 'cause it's a nice phrase to say, but we're actually seeing a change in behavior. And because of that, you're seeing a lot of new companies, a lot of new technologies that are gaining adoption and seeing accelerated growth because of that phenomenon. So I think it creates a lot of opportunity across the ecosystem.
Host 2:
Now, Matt, you mentioned technology. So as technology advances, sponsors will progressively adopt distributed locations and trial activities. What do you think about third party services? Can they help or are there any possible challenges for them?
Matt Wheeler:
Yeah, so as we think about what we term as distributed locations, distributed trial activities, the role that technology can play there. I think it's a really important concept to have front and center, as you think through the evolution of clinical research. A lot of folks talk about decentralized trials, DCT, what does that mean? What impact will that have across the industry, and how do sponsors and stakeholders need to adapt to meet the challenges and the new ways of working? I think at L.E.K., when we think through what does decentralized trials mean, where does it create opportunity? Really the way we think about it is on two axes. So one is the different functions that take place throughout the course of a trial, and two is the different sites of care where various functions can occur. And as we think about what DCT means, to us, it's really about distributing functions and distributing activities across different sites of care within a trial.
So we don't see it as a very black and white thing where you'll have virtual trials and you need a technology infrastructure to be able to support that. Rather, what we see is there will be certain activities or parts of the protocol within a trial that can be done in alternative sites of care. So instead of perhaps needing to go to your trial site at an academic medical center for a blood draw, you might be able to do that at a quick clinic, at a local retail pharmacy, perhaps. And so what does that mean for players in the ecosystem and third party services and solutions? It means they need to build tools that are adaptable and flexible and can operate across a range of different sites of care and locations and integrate in a seamless way.
So you think through things like, how do you build flexibility in geography? How do you have the ability to have your technology and service be applicable across various therapeutic areas? How do you think about the target population that you're going against? Technology can help with all of these, but I think the touchstone that we'd come back to is flexibility and adaptability, to be able to give sponsors and other stakeholders in the ecosystem that optionality to have different parts of trial protocols occur at different sites of care.
Ian Tzeng:
I think building on that, there is a need to recognize that services and technology actually do change by the site of care, in terms of how complex it is to manage. If you are shipping supplies for the clinical trial to lots of distributed places or to patients homes versus a centralized site with trained healthcare professionals, it's quite different. So thinking about that, the right mix of services, technology, communications, how those things change because of the location of where you're going, and frankly the training of the people that you're interacting with, potentially even sending nursing services or other capabilities or hardware and equipment. There's a range of things that you need to put more and more out into distributed environments in a lot of ways, with less control. So with less control, with more people involved, you need to make them more and more dummy proof, if you will. And so the technology services and overall workflow really needs to be designed well.
Host 2:
Understood. So you mentioned several things and looks like these things will help to improve, identify more sites, onboard different types of sites and optimize trial locations to each trial's activities. So does this preserve the quality of the data being generated while at the same time ensuring patient compliance and engagement?
Ian Tzeng:
Well, conceptually, yes, but it's probably not yet at a point where people fully hit it out of the park in terms of bringing the whole package together and making it easy. We're really in the early stages of the adoption of more decentralized functions within trials. And with the trial, if you're running a site or whether it's a distributed site or a traditional site, whatever it is, your primary goal, your primary job if you will, is to provide great patients to take part in the trial to generate good data in a timely and cost efficient way. And that's something that becomes harder, the more distributed and less controlled you are in your environment.
So conceptually, the idea with decentralized trials is to remove the barriers to participation and then make it easy for more and more people to participate. And when it matures, I think you're going to see a great democratization, if you will, of trials where more people can access trials, they reduce the burden of participating in the trial in terms of travel or time, and it will help solve the problems related to shortage of participants and the like. So it will take a little bit of time, but it's going to get there and it's a pretty exciting space.
Host 2:
So in regards to this lack of people participating, how do we solve this? Can it be solved?
Matt Wheeler:
I think it can be. And it's exciting to see the different innovations and approaches that many different companies across the ecosystem are taking. I think when we think through the lack of participation in clinical research, it's really staggering, right? It's fewer than 5% of patients and physicians participate in clinical research in the US today, which is crazy when you think about how small of a population that is and how much benefit there is of clinical research, both in terms of progressing science forward, but also just in terms of clinical trials as a form of care for folks who need better support and treatment. When you think about how to move the needle on that and how to get that pool of participants bigger, we typically think through what we refer to as the patient recruitment funnel, because it's a multi-step process and you can make an impact across many different phases of the funnel.
And so at the top we think about patient identification. How do we find the right folks? That's becoming increasingly more challenging as the demands for trial participation are becoming much more specific. As an industry, we're studying more complex and specific diseases and we're putting more targeted and complex therapies against that. And so therefore we need to have patients that meet very strict criteria. And so, not only casting that broad net to find patients, but being really thoughtful about finding ones that meet all the qualification criteria. The next part of the funnel, after you identify the patient, is actually being able to go through and recruit and enroll them. That's a very labor intensive process historically of making sure that you have all the relevant information, that they are qualified to participate in the trial, and that they'll actually provide consent and sign up. And then lastly, and Ian hit on a lot of these points already, is around how do you think about retaining patients?
So once you've done that hard work of identifying them and enrolling them, actually keeping them in the trial is a significant pain point. And there's a lot of dropout because participating in a trial, historically, has not been the easiest things for patients. I believe 70% or so of patients have to drive more than two hours on average to get to their trial site of care, which is a crazy time investment and something that needs to be addressed. And so I think as you understand that full funnel and all the levers that can be pulled from identifying folks, enrolling them, and then retaining them through quality of life, there's opportunities at each of those, and companies are innovating along the way.
Host 2:
Great. Anything else to add there, Ian?
Ian Tzeng:
Yeah, I think when we think about the patients, the patient recruitment challenge, there's a number of things that are driving it and it's the fact that well, more and more trials are being done, that the criteria to qualify for a trial are getting more specific. The need to think about genetic diversity and therefore racial diversity across different types and populations of folks that are out there. Even things like the Russian invasion of Ukraine where a lot of clinical trial participants used to take part. So you're seeing this global shortage of patients with also a greater recognition that we want to target more specific patients, but at the same time diversify our patient bases. In a lot of historical situations, upper middle class Caucasian individuals have the best access to clinical trials, but that's not necessarily representative of the genetic diversity that we have out there.
So a lot of these innovations that people were looking at around decentralized trials, around better patient recruitment, around targeting patients where they are in their community health settings or in their communities directly, regardless of whether it's a health setting, these are the things that are really broadening access for more and more patients to trials. And that really helps the patients in that they get potentially life changing and or lifesaving therapies. But also helps the sponsors, one, reach their targets on time and reduce costs and reduce time, but also provide a better set of data regarding the therapies because now they actually have genetic diversity out there. So it's a really exciting time and we're at a point where you don't have a choice anymore, you have to pull out all the stops to get the patients that you need, and it's so inefficient. So we're really at a point in time where the opportunity is there for those companies who are out there who are really going to help people do this, but it's really to help everyone. And so it's a really exciting time to be in the industry.
Host 2:
All right. Well, thank you, Ian. And let me summarize what you and Matt have covered so far. Companies are not only looking to broaden access to lifesaving therapies by tapping into a diverse pool of patients, but they also realize that widening recruitment efforts through diversity can help mitigate the number one reason trials are halted, which is failure to reach enrollment targets. On the other hand, third party service and solution providers have several opportunities to expand their current offerings to meet the markets evolving needs. And as sponsors continue to look for ways to enhance the trial experience for stakeholders, the service and solution providers that can facilitate specific pain points related to patients and sites will further differentiate themselves and demonstrate their value in this highly fragmented market. So to you both, Ian and Matt, we appreciate each of your insights and for sharing your knowledge with us today. And thank you for joining.
Matt Wheeler:
Thanks for having us.
Ian Tzeng:
Thank you so much.
Host 1:
Thank you, our listeners for joining us today at the Insight Exchange presented by L.E.K. Consulting. Links to resources mentioned in this podcast can be found in the show notes. Please subscribe or follow for future episodes wherever you listen to your podcasts. Also, we encourage you to submit your suggestions for future insights online at LEK.com.
