ICT Ep: 2.12: Dropping the Baton: Why Clinical Trial Handoffs Keep Failing

In elite sports, races are often won or lost in the transition, and Liam and Ted argue that the same is true in clinical trials. Drawing on the precision of Olympic relay racing, they make the case that the handoff points between sponsors, CROs, and sites are where trials quietly succeed or silently fall apart.

From recruitment referrals that never get followed up, to sites given the green light before they're actually ready, the gaps are rarely dramatic, but the cost adds up. The culprit, more often than not, is assumption over communication.

Tune in to find out why fixing the handoff might be the simplest, and most overlooked way to run better trials.

Transcript

Intro voice: Welcome to Innovating Clinical Trials, the podcast designed for clinical research professionals eager to deepen their understanding of clinical trials through concise, insightful segments. Join your hosts Liam Eves and Ted Trafford as they uncover the core issues in clinical research. Reflect on the industry and challenge conventional wisdom. 

Liam: Ted, good morning. How are you, sir?

Ted: Uh, I'm doing well. How are you?

Liam: I'm good. I'm good. I've got a cup of tea as a traditional English side, so, uh, life couldn't be any better.

Ted: That's amazing. I've been, I've been, uh, binging the Winter Olympics

Liam: Right.

Ted: uh, yeah, just absolutely loving that. Have you been watching.

Liam: I do, you know what? I, I haven't, uh, I really, I, I, I need to get into it. I just. Is getting away from the minute. Have you anything good?

Ted: Well, there's, there's always lots of [00:01:00] drama and, and lots of things that are interesting. And of course, uh, you know, in Canada, winter Olympics are actually pretty popular,

Liam: Yeah.

Ted: It's, you know, the hockey, of course is a, a big focus and, there's been, uh, lots of exciting moments. Lots of, I think, endearing moments.

Ted: Uh. At this Winter Olympics. So it's, it's been, I I, I've really enjoyed watching it. I mean, there's some events that I just dismiss 'cause I

Liam: Yeah.

Ted: boring, but I won't publicly shame them. But, uh, a lot of really interesting, uh, sports, so, yeah. And I was watching the, uh, speed skating relay this week,

Liam: Oh, it's crazy.

Ted: I think it's like 3000 meters

Liam: Wow.

Ted: it's on the, the short track. And like, I just couldn't get over the precision

Liam: Hmm.

Ted: you know, which they made from like one, one, [00:02:00] um, one skater to the next.

Liam: Yeah.

Ted: So, so the it, I mentioned it's a, its a short track. So the, the track is I think something just over a hundred meters in distance for the oval.

Liam: Right.

Ted: And team has four members.

Liam: Right.

Ted: four teams,

Liam: Okay.

Ted: 16 people all skating in this, uh, in this really small, uh, small area.

Ted: And there. There's only like one member of each team that's actually like racing

Liam: Right. Mm-hmm.

Ted: got a handoff. And so the next, so, so all the other skaters, so the 12 other skaters are skating around in the middle of the track getting ready and lined up so that they can do the transition.

Ted: And it's like, looks on the surface like complete chaos.

Liam: Mm.

Ted: there's just so many [00:03:00] people involved in this. They're going so fast, The transitions from one, one person to the next

Liam: Yeah.

Ted: so smooth, and you know, they line things up perfectly. They know exactly what they need to do when they need to do it.

Ted: And just, it's so impressive to me. And so I was thinking about clinical trials and it really made me wish that in clinical trials we handled the handoffs, like between sponsors and CROs and sites, way better.

Liam: I would submit. I thought you were gonna go, I thought you were gonna go a different place there. I thought it might be like we, it would be good if we all while skates or something.

Ted: Oh yeah, no, the tights, Liam, everybody should wear those tights.

Liam: I've got a pair on already.

Ted: Mm. Yeah. I can tell you look really sharp. So, yeah. But it just, it just seems in, in clinical trials, like we tend to stumble

Liam: Yeah,

Ted: at those handoffs thought it [00:04:00] was, it would be worthy of, uh. have a discussion this morning,

Liam: definitely.

Ted: yeah. I don't know if, do any handoffs pop into your mind right away That,

Liam: Oh man.

Ted: do amazing in clinical trials.

Liam: Yeah, I mean, the one that is always, uh, I find fascinating is the, the handoff between, I'm gonna call it the, the enrollment process or the recruitment process in the site, because that, that can be, you know, if it's within site, it's a hell of a lot easier. But then you get these groups right. And things that are handing off patients.

Ted: Right,

Liam: you see this like really interesting dynamic where the sites will often go, well, I'm not taking 'em 'cause they've, they've not been screened and we're gonna have to do a ton of work to see if they're even eligible and there's only a 10% chance that it's actually gonna go, go well. And then the sponsors are getting all, uh, you know, upset because there's patients there, the patients are obviously not being, you know, looked after and things.

Liam: So there's just like, there's, it's just. [00:05:00] Complete confusion. It's like, uh, to your analogy is like you've got a skater that's about to pass a bat on, and then they're just dropping it in the middle of the track and everyone's deciding, okay, well, we'll just kind of casually skate away from this. It's not a problem anymore.

Liam: Uh, that's the one me.

Ted: so, so just to build on that, like,

Liam: Mm.

Ted: a great example because that often is handed handled really poorly

Liam: Yeah.

Ted: and you'll get sites just tune out

Liam: Mm.

Ted: they've gotten too many, you know, uh, referrals that just don't,

Liam: Yeah.

Ted: that just don't look like, you know, they're gonna qualify. So

Liam: Yeah,

Ted: spend the time going through them and.

Liam: yeah.

Ted: Often, even, even in addition to that, uh, I've spent a lot of time reviewing

Liam: Mm.

Ted: a lot of these campaigns,

Liam: Yeah. I.

Ted: and a lot of times the questions that are asked in the pre screeners on the [00:06:00] websites

Liam: yeah, yeah.

Ted: match the protocol. And some nuance to that, and I think some of the advertising agencies don't understand it.

Liam: Yes.

Ted: then the second thing is. When I see the ads, like when I'm on social media, I don't think they really speak to the people that have that condition.

Liam: No.

Ted: I think it's a lot of often technical

Liam: Yeah,

Ted: jargon

Liam: yeah,

Ted: in there

Liam: yeah, yeah, yeah, yeah.

Ted: and, and they maybe didn't get the perspective of people that have the condition

Liam: Yes.

Ted: before they build the campaigns.

Liam: Yeah. Yeah.

Ted: I just,

Liam: It's critical.

Ted: a great example.

Liam: Well, I mean, in some ways, it's one of the things that popped into my head when you were talking about it was I. I wonder how long these speed skaters that are doing these, you know, and it doesn't matter whether any relay, I guess is how long do they then train for that handover,

Ted: Oh, wow. Eh, [00:07:00] yeah.

Liam: do you know?

Liam: And it's like, well actually. How important, like I was thinking, like percentage perspective and say, okay, if the speed skating is 90%, you know, is that you know how fast you can speed, how fast you can race is 90%, is the handover 10% or is it 80 20? And like, what's that? Because to your point is that these things, if you can't hand over a baton, it's pointless doing the race.

Ted: Yep.

Liam: And it's like, I guess what. It's obviously never gonna be binary, but it's a question of asking, I think, for organizations to ask and really to drill into, as you say, those handover points, to see how how much training and effort has actually gone into, you know, passing the button.

Ted: That's a great point because would wager that. It's that transition point [00:08:00] where often the races are won and lost. There was, there was a, a new event that I watched yesterday that I'd never seen before and I think they called it ski mountaineering

Liam: Oh God. Yeah, I saw that.

Ted: Yeah. And so Has to ski uphill for a certain period of time, and then they gotta take their skis off

Liam: Yeah.

Ted: up a

Liam: Yeah.

Ted: steps and then put their skis back on and take the, the skins that they had, uh, on the bottom of the skis.

Ted: They take those off so that they can go downhill. 'cause those skins help 'em go uphill. But they wanna race downhill. And the race I watched last night, person that was in the lead at the beginning of the race, at the end of the first uphill. Lost the race ended up in last just because of the transitions

Liam: Yeah, well.

Ted: and so,

Liam: I mean, we we're [00:09:00] obviously talking about like elite sports where, you know, uh, the difference between winning and losing is, you know, often milliseconds and, but I think it's a really important point because the reality is, is that you can, you've got to think about the entire process and not just.

Liam: How, how fast you can ski in this instance, right? You've got to think at every single point because it's gonna be the weakest, your weakest point in that process. That's ultimately gonna,

Ted: And I think you also need to understand what the next group needs

Liam: yeah. Yeah.

Ted: to make that transition seamless. So for example, the transition between. you know, the, the site startup activities and then the activation of the site and the green light. And I've seen it a lot of times

Liam: Yeah.

Ted: are given the green light and, okay, go

Liam: Yeah,

Ted: sits there and we don't have everything we need to start,

Liam: yeah.

Ted: and they either don't have all the [00:10:00] supplies they need, or just given access to the EDC and haven't been able to create worksheets yet that they need in order to actually collect the data.

Ted: So. It's, it's often the, the sponsor, CRO, not, not understanding what the site needs to succeed and not setting them up for

Liam: Absolutely. Yeah. There's something definitely to be said about, I think as humans, we, I, I can't remember the, that pithy quote, you know, we've got two ears and one, but I think we, um, we, we, we don't spend enough time seeking to understand before we start seeking to be understood. And I think that. Um, it would be in everyone's best interest to, as you say, to take that approach to like, okay, what is it?

Liam: What are all the things that you need and what's important to you? Because it'll be different for each site, uh, as an example for site, you know, going and like some sites will need some things and others [00:11:00] won't, and some sites will need support and others won't. And it's like, it's really tailoring and, and not thinking that these handoffs.

Liam: Because I guess in the, you know, going back to your analogy is that, you know, some people may need a left-handed handoff and some people might need a right-handed handoff, and it's like we have to, it is up to the person who's being handed the bat to tell the other person exactly what in order to optimize that.

Ted: Yeah, the, that was really interesting and it made me think the example I had just given about the sponsor, CRO, not understanding what the site needs to get started in the study. Your point about, you know, taking the time to understand the others, I think there's also a lot of work that sites need to do

Liam: Yes.

Ted: the

Liam: Yeah,

Ted: and CRO processes

Liam: absolutely.

Ted: need in order to get help sites get started,

Liam: Yeah,

Ted: effectively and efficiently.

Liam: definitely.

Ted: I think sites [00:12:00] sometimes approach it thinking, well, the sponsor must know

Liam: Hmm.

Ted: we need this. And maybe there isn't a mechanism of, of really good communication going on

Liam: Yeah, well it's, but it is to that point of like what, 'cause they are just ultimately assumptions, aren't they?

Ted: Yep.

Liam: That, you know, that the, if we are assuming the site, uh, the sponsor knows and they're looking to us, and, you know, we are looking at, everyone's looking at one another. Uh,

Ted: Yeah.

Liam: like who's got the bat behind the bat, guys?

Liam: Uh, and who's passing it to who? Um, I think, I think it is, it, it really is about being as transparent with that communication as possible. Because the reality is, is that you are gonna get a better quality relationship. You are gonna be better served, um. You can, you know, if you are transparent and you do ask.

Ted: Yeah. Absolutely. So the communication's gotta improve

Liam: Yeah.

Ted: on, uh, on everybody's side. And, and I really like the idea of, of the [00:13:00] training. How do we train in clinical trials

Liam: Mm.

Ted: to improve the handoff

Liam: Yeah.

Ted: such a critical juncture.

Liam: Yeah.

Ted: 'cause if the handoff doesn't happen well and the site doesn't start well

Liam: Yeah.

Ted: site motivation.

Ted: And then maybe they turn their attention to a different study 'cause it's.

Liam: Yeah,

Ted: more smoothly, so

Liam: I could agree more.

Ted: yeah.

Liam: I, I, I always love your, uh, analogies, Ted.

Ted: Oh, thanks buddy.

Liam: It.

Ted: Yeah. Well, I'm always thinking about clinical trials for some reason. I don't know. It's a problem. I need to, I need to see somebody about it maybe.

Liam: We'll get you therapy for that.

Ted: Yeah. Thanks buddy.

Liam: Awesome. Love it. Thanks Ted so much.

Ted: Yeah, have a great day.

Liam: You too.