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The Clinical Research Profession: Workforce Insights from the FDA

with guest David Burrow, FDA Director, Office of Scientific Investigations

Christine Senn:

If Dave Burrow from the FDA is speaking at any conference I'm at, I am there; I'm clearing my schedule to be at that session, and he does not disappoint. He is with us today and actually for two parts because he was so fantastic that I kept having questions for him. So please enjoy this first installment with Dave Burrow from the FDA.

I've been interviewing leaders in our industry as a way to hopefully teach people about career opportunities in clinical research and to educate people already in the field about what other people do and think. You're in a pretty unique position to provide FDA insights on the clinical research workforce. So where do you think we are as an industry in terms of clinical research as a profession?

Dave Burrow:

You know, I have to laugh because in the series of sessions here, it has to be like: One of these things is not like the other. I'm the FDA representative. And we're coming at this from a little bit different kind of perspective as a government entity, a regulator. We might be one of those roles that you would ordinarily think of as a traditional clinical research role, but that might not necessarily be true. And that's kind of part of our regulation as a global industry leader as well. We see a line of sight that you might not ordinarily see with a regulated industry generally. You see all different types of practices of sponsors, of CROs and vendors and every different blend of herbs and spices that might come between, just in the global ecosystem here.

I think one of the really interesting conversations about the clinical research industry and clinical research as a profession right now is the scope of what we might consider being a clinical research professional. I think that's changed, or at least it's changing at this point in time. You have all different kinds of roles and backgrounds, different types of entities, and it calls us into this conversation in a way to be open-minded – and I think more so now than we've ever seen before, because the opportunities really are limitless. It's not just about medical professionals or study staff, and it's not just about CRCs or CRAs or anything like that. When you start to talk about the clinical research industry as a whole - globally - and all the different types of things that are front and center in all of our conversations these days, you hear things like decentralized clinical trials and digital health technologies and real-world evidence and real-world data, and e-systems and vendors, and EHR and ePRO and the different wearables, remote monitoring, and risk-based quality management systems. It includes all those other tie-ons like data analysis and computer systems apps, artificial intelligence and machine learning.

And everyone -- every single person in any role involved in any of those vendors or CROs or sponsors or sites, that entire ecosystem from IT and contracts and budgeting and logistics and translation services, all the way back to our core clinical research workforce of the study staff and the community physicians -- we are all clinical research professionals. Everyone involved in every role across that spectrum of companies and organizations are all clinical research professionals regardless of whether they have that direct connection to individual research subjects. My key moment of clarity here is that this is really an industry that is continuing to evolve. It's in an evolutionary growth cycle right now, changing over time.

Just like evolution generally, you see some creatures, some organizations, some people that are really fit for survival, while others need to kind of change to fill a different niche in the ecosystem. Or even dare I say, die out, become extinct. Because evolution really is the perfect metaphor for the clinical research workforce right now. The environment just generally. You have some roles, some types of organizations that didn't even exist 10 years ago, so the clinical research workforce, I think, is in a position to really grow and evolve with the ecosystem just generally. And so the skills needed, the types of backgrounds, those all change too. The great value of this type of conversation is to kind of normalize that state of change and ask ourselves how we might take that next great leap in evolution as an industry generally.

Christine Senn:

I love that. I really had to hold back laughing too, because you always are so colorful in the way you speak, so here I am picturing hashtags going up everywhere as you're talking. Your entire transcript will end up being an SEO delight, by the way, on the marketing side. So <laugh>, we in marketing thank you.

We've heard about challenges in hiring for the clinical research ecosystem. How are you saying seeing this play out in your role at the FDA?

Dave Burrow:

Well, the term really is that there's a “workforce crisis” now, right? That's a consistent message we've heard across all different types of organizations, different practice settings, different types of roles: hiring and retention of good talent, exceptional professionals. It's a real challenge and it's one where you're not alone, where we are not alone. We see that being true at the site level, small, medium, large organizations, regional, nationally, even global, international organizations. And it's all different types of roles – with those within a medical practice, being a medical practitioner, is the primary consideration, as well as those where being a clinical research professional and running research studies is really a primary consideration that the challenge in hiring is one that really transcends everything. We've got to reflect back on that idea of being really open-minded.

The shift for us, I think, is in driving the focus into being really skills-driven and knowing what the call is to us in this profession. What was true in the clinical research ecosystem of yesterday is probably not necessarily as true today. The skills that were necessary 20 years ago are probably not the exact same as the skills that are necessary to thrive in the workforce today. So let's not be rigid; let's be flexible and evolve. When we talk about the workforce of today, the workforce of tomorrow, we have to ask ourselves: What are we going to use to call people towards clinical research as a profession and not have people just running from one position to the next over the course of their career? What's the call towards something?

I think the very best example that we could ever imagine is what we just had with the COVID-19 pandemic. What I like to talk about there is really the metaphor of steel, which is that the strongest steel is forged in the hottest fire. Those blades are sharpened through friction. What we've seen in the clinical research workforce over the course of the last 3-plus years is a tremendous fire. The crucible of the pandemic in medical practice and clinical research – and, I think, the workforce - is all the better for it. We're coming out on the other side of the COVID-19 pandemic stronger for having been forged in that fire and sharpened through the friction of what we had to go through here. Taking the metaphor a little too far here is that that edge is probably ready to carve out a new identity for the clinical research workforce in industry generally.

Christine Senn:

That would be amazing. Something I'm really striving for so much is to see this as a profession that people do go towards like you're saying. I would love a point of clarity. You've mentioned being open-minded a couple of times. I want to make sure I understand that, and especially what you're talking about in being skills-driven. Are you thinking about being agile and nimble in the way we think of certain roles?

Dave Burrow:

Yes, and I also think we have an opportunity in the context of diversity in clinical research for the diversity of roles, diversity of thought, and the idea that we as professionals shouldn't get so deeply rooted in being one type of position, one title, or one set of backgrounds. We hear all the time about the experience necessary to perform certain functions and having that be a really rigid criterion. I think we have the opportunity to explore that with a sense of curiosity and just asking ourselves what is necessary for this position and how we might we appropriately match a really interested up-and-coming go-getter candidate to a role. Just ask yourself what's needed to be able to perform that, to be open-minded in the fact that we have a deep need for technologically savvy communication skill sets, things like that, and not necessarily so formally driven in the number of years of experience or a certain degree or certification program. You know, trying to fill the need for the profession as a whole, in whatever way that might manifest.

To learn more about the clinical research workforce crisis, be sure to read:


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