How Workforce Shortages Threaten the Future of Clinical Research

This new recording equipment we have. There's this countdown thing. And if you want to mute while I'm talking, that would be good. Because, I mean, to be honest, the system's really good.

It doesn't really pick up much sound, but just in case you can meet. OK, so you ready? Yes you ready? Yeah I unmuted my like, oh, OK.

Yes, I'm ready. Cool so in 3, 2, 1. How do you evaluate risk in clinical research

this week? Jenny Hecht of this week.

Jenny Hecht of JT h consulting is here to discuss risk in the life science industry. Both current risks as well as those looming on the horizon. During the podcast, we discuss different types of risk, how that playing out and making industry headlines as well as what could happen if some of these risks remain unaddressed. Welcome back, Jeannie.

It's been around a year since your last appearance on the podcast. You came on to discuss sustainability and how trial efficiency can lead to a greener industry approach. What have you been up to in the meantime? Well, it's been a really busy year,

Hannah, so it's good to be back.

And I really appreciate the opportunity to speak with you and your listeners. It seems like the industry as well as myself, continues to work at a breakneck pace. I've been enjoying the journey and supporting a number of different companies as they grow and deal with growth related challenges, opportunities and risks. And I've been following the news, and you think about what's going on in the news right now.

Is there a recession? Is there not? What about what happened with the Silicon Valley Bank and the reverberation that that's going to put across the global economy and probably the sleepless nights of too many ceos, CFOs and investors in small and mid-sized companies within our space. But keep in my ear to the market to look for industry trends that can cause companies to either soar or trip up.

So that's been a lot of what's been keeping me busy these days. Great to hear an update there. So today we're going to discuss the topic of risk in clinical research. Just to start

off, could you explain how risk is evaluated in the industry?

Sure happy to so many companies have a formalized risk management program, and some companies do it more in an informal manner. When I think about my role on many different boards of directors, that is a key function of the board of directors is to be evaluating the risk exposure of an organization as well as opportunities where in the industry risk is creating new paths for growth. When we think about risk management, simply put, a company conducting risk management is looking at risk, which risks they can avoid, which risks they should mitigate or lessen, and which of those risks. They can absorb.

And this all funnels into an organization's annual and probably three year strategic plan. We can look at this with a lens on ourselves and think about those risks we're willing to take versus those we're not willing to take. So, for example, if you've got a big meeting tomorrow, do you want to stay up late tonight watching your favorite TV, TV show or do you want to get a good night's rest so you can do your optimal performance? Many companies in our industry evaluate risks using a matrix, and they rank specific risks based on likelihood of occurrence that rank one degree of impact.

And the categories categorize typically those risks and then a couple different buckets. So financial risk, operational risk, customer risk or regulatory risk, I mean, some might use their own or use different ones. That's typically what I've seen the risks that impact financial metrics or performance of an organization. There are other risks.

There's then there's the risks that affect the company and how it delivers its goods or services to the market. Those are operational risks, risks to customer engagement or customer satisfaction or customer delivery. Those are the risks that typically get bucketed under customer risk and then obviously a risk to regulatory compliance. So if the FDA issues a new regulation, are you following that regulation or are you choosing not to?

And then what are the potential downstream impacts of not following that risk or that regulation? What could that risk lead to? And so that's how companies often look at risks at the corporate level.

Great Thank you for explaining that in greater detail.

If we think about the clinical trials into stroke clinical research industry, are there any specific examples that you can think of that represent how risk can play out in the industry? Well, we'll start first with the one that's at the forefront, which is the Silicon Valley Bank. When you think about what happened with them and overnight, that many companies did not have more than $250,000 in operating cash, that could present a substantial risk to our industry. So that's a lot of biotechs, health care, I.t.,

as well as other types of companies that support our industry, lost their operating cash overnight. So that means how are they going to pay their staff, how they're going to pay their vendors and suppliers? Are they going to keep the lights on? Now, thankfully, those types of risks, which are extremely hard to foresee, are having different types of mitigation strategies with the government stepping in to support it.

When I think about some really specific clinical research risks, there's another one that's kind of front center right now. And a few weeks back, Pfizer announced that they're going to start testing a Lyme disease vaccine in roughly half of the US patients. At this late stage, study patients have been recruited and the company said they were citing it was citing a breach of clinical trial guidelines by a third party contractor. That's a major issue.

And while the information is still coming to light, that's a regulatory risk that one organization chose to perhaps not lessen. They chose to absorb that regulatory risk that then led to now a customer issue and a potential financial risk for that organization, that third party contractor that was recruiting and treating these patients. The you know, this could, you know, impact a large number of patient population and patient participants across the industry. And while this was being delivered, the study was being delivered in a non-traditional a new model, a hybrid model, decentralized model.

In this instance, you know, there is a potential risk then that the market will start to feel as it relates to decentralized or Harvard trials or new models for how operational delivery is being executed at our research sites or the types of partners that are involved might mean that companies customers are less risk tolerant and that they want to continue to stay with traditional models for clinical trial execution. It could also mean that some of the providers that currently support new models of delivery

feel and risks associated with market uptake and therefore revenue generation could be realized and they could start to feel some softness in that area.

So only time will tell. That's one risk that I. Another risk that I see currently impacting the industry. Yes it's interesting because there's been so much talk to centralized trials and people really have different opinions on it.

Yes I mean, clearly they do. I, for one, have always been a supporter of that, because I think of ways in which we can make the clinical trial process easier for the participants that we need to support the advancements of medication and treatment options for patients who need that. Anything we can do to speed up the process and our industry is notorious for taking a long time to implement new technologies, and that often has a direct correlation to the need to take risk to zero. And so I don't want to see this negatively impact our ability to advance new possible ways of delivering clinical trials because there's too many patients that are counting on it.

Another

risk that Springs to mind for me is the risk posed by recruitment problems, both patients and staff. So recently in the UK there's been a review commissioned looking into the decline and trials. There's been a 44% reduction in recruitment from 2017 to 21. And listeners will also know I've had some really interesting conversations recently on the subject of site staff burnout and how to solve it.

This is clearly a huge risk affecting the operation of trials. What are your thoughts on this? You know, whenever an industry has a challenge with work force, it can create substantial issues for the overall industry. And we clearly do.

That the challenges of having an experienced staff who understand the regulations, understand the nuance of engaging a part, a patient who wants to become a participant in a clinical trial. Understanding how the logistics management works of executing a clinical trial successfully at a research site and on up through the various paths within the industry. Any time that person. What I like to call the sharp end is affected or the people down there are affected is the hardest.

It's going to be felt throughout the industry. And when you can't pick up an industry trade journal these days without or attend a conference without hearing firsthand about resource challenges, and it's all over. And I know that AP has been issuing a lot of details and in and reports regarding that. And I spent some time working with Wake Forest University and the University of North Carolina, both here local to me on the kind of business of health and the need to continue to grow resource pools to support this business of health.

I think we're at a real tipping point again. And it's we're either going to have enough resources to continue to deliver and there's enough groups investing in growing and advancing these resources, or we're going to continue to have resource challenges that means that could create other opportunities for other companies. And people have to then make the hard decision. If I don't have enough resources, does that lead to a regulatory risk?

Does it lead to a patient care risk, i.e. an operational risk? Or if it does. Are the risks too great to continue, or are there ways in which I could mitigate the possible likelihood of occurrence or the impact of those risks? Also, as we're seeing, this resource shortage is leading to, you know, trial delays and trial start delays or programs being shelved.

And that, again, has a long term impact on the patients that are counting on you new possible treatment or care options. So again, how can we become more efficient and/or how do we help the industry address and solve this resource challenge that is more than just an issue at Dr. Taylor site or an x, y and z company. Yes is certainly complex.

We've got lots of suggestions in the podcast from some of our guests, so it be interesting to see if

any of those happen or, you know, why wider changes they're implemented in the industry to combat this. So if we think about the biggest risk in the future in clinical research, I know this is kind of a big ask for you to predict the future, but at the same time in your head. There must be some risks that kind of more imminent than others. Yeah I think what I just talked about, the challenge and the risks of a lack of resources is critical.

And think about this in a sense of an agricultural perspective. We don't have enough farmers to tend the lands because of a food shortage. Right and so when we think about our business. We're not in a highly automated.

We don't operate in a highly automated way. We are reticent to bring technology on that could drive efficiency in our processes. We're highly fragmented. Many of our technologies don't talk to one another.

And at that same point in time, there hasn't been a substantial push by and support from the industry to really try to drive the resource challenge at the technical level or the collegiate level or the University level. And as a result, we have challenges with generating this new pool of resources. I mean, there are a couple training grounds, at least in this area, for new research professionals. I mentioned Wake Forest University.

They've got a masters in clinical research program. We have Durham Tech here that supports for the associate degrees program. I know the AP has. There are kind of certification training programs.

There's e-learning companies like proficiency that are centered on a mission to help train competent leaders and really using similar simulation based training and competency based training to do so. We have technology companies like tech row and versatile working to improve efficiency of our clinical research teams at that site level. But again, we for a long time in the industry have ignored the challenges that are affecting at our sites. We just figured that they would overcome them themselves.

And that's the thinking that has to be modified, because it's all books will rise. If we all work together. We can't just try to push problems down within the industry. And we in the industry, I'll put a challenge out there to pharma and biotech.

But we've got this arbitrary ruler about years of experience. And I, for one, know you can take somebody with two years of experience or 20 years of experience. And you might actually find that the person with two years of experience or less is more committed and passionate about the work that they're doing and is more eager to learn and be trained than perhaps somebody with 20 years. That's not a dig a dig on the 20 year person, but it's the fact that we've arbitrarily assumed that somebody is just fresh out of school or only has a year, year and a half or two years of training that they couldn't possibly be as good in a highly regulated, highly controlled environment as somebody who has 20 years of experience.

And I'd like to challenge our thinking on that. If we continue and if we don't, we don't challenge our thinking and we continue to further down that path, we'll continue to see a further decline in the pace of which our trials come to be come to be executed at our research sites. And that will continue to inhibit the availability of possible life altering medications to the patients in need. So since as an industry, we constantly talk about patient centricity,

we should really be looking at the resource challenges that are inhibiting our ability to be actually truly patient centric.

So there's a real message that the industry that needs to be more of an open mind about how many years, people have been working in the business or in the industry. So moving forward, how can we better manage risk generally? Do you have any thoughts on industry wide shifts that need to be implemented? Well, Ken Getz, who I simply adore and his team at tufts, presented some scary statistics last year about the length of process that it takes to do vendor qualifications and also the length of process that it takes to launch new technologies.

And while I know it's harder to tell customers that they need to move faster in that process, I'd like to put a challenge out there that surely we can do better than the

1 plus two, 3 plus years that it's taking to fully adopt or even just implement a new technology. The same point in time. The time it takes and the expense it takes in the vendor qualification process is something I'd love to see the industry make substantial movements on. So those would be what I'd like

to recommend that we focus on next.

Yeah it's kind of strange how fast our world is in every other area. Yet clinical research seems not to have adopted. Yeah I couldn't agree more. I think it's a challenge for each and every one of us not to no longer be OK with the status quo.

We need to constantly be looking within and looking externally to what we and others can be doing better to advance clinical research. Thank you so much for joining me today to discuss the subject of risk in clinical research. It was simply my pleasure. Thanks for having me.