Why Do Clinical Trials Impact The Climate Heavily And What We Can Do About It?

Why Do Clinical Trials Impact The Climate Heavily And What We Can Do About It?

Alexander: [00:00:00] Welcome to another episode of the effective statistician. Today we talk about a topic, which was quite a surprise to me. I never thought about it. And Any who’s our guest today? She’s part of a leadership program that I’m running. And through that we stepped over this topic and those topics are very close to my heart.

But I never saw the connection of them. And so one is clinical research. Especially running clinical trials and the other one is climate change and how the overall pharmaceutical industry or the whole kind of research is having an impact on our CO2 footprint globally. And thanks to Annie, I got the link about it, but before we dive into this, Annie, maybe you can introduce [00:01:00] yourself.

Annie: Hey, yeah. I’m Annie. I’m a first year PhD student based at Imperial College and I work at the Imperial College Clinical Trials Unit. I have a bit of a varied background. I came from doing a pharmacology undergraduate and then swapped to applied statistics. Or, as I worked as a clinical trials statistician for a while, or embarking on a PhD.

Alexander: That is so cool. Yeah. And as you can see, I don’t only have people here on the shows that are 35 years into their career, but also people that are very early in their career. And I really want to have a mix of All these kind of different people, because I think everybody has something to contribute.

And so if you are early in your career, you can actually have a big impact as well. Yeah. Age very often doesn’t matter so much. There’s other things, especially kind of passion, [00:02:00] attitude how you approach things that make a much, much bigger difference. So let’s talk about clinical trials and climate. So where’s the connections there?

Annie: Yeah, I think it’s probably something we don’t think about day to day. I think you think about climate change in terms of like very physical things you can see, like transport you take. But actually, when you break down a clinical trial, there’s like lots of areas which are really increasing your carbon footprint and obviously it’s amazing.

We’ve got loads of clinical trials ongoing. That’s great. We want as much clinical research as possible, but we really do need to think about the impact of that on the environment.

Alexander: Yeah. Do you have any numbers in terms of how big the impact is, let’s say, compared to, to, to Tarzai areas?

Annie: So I guess in clinical trials itself, we’re registering approximately 38, 000 trials every year.

[00:03:00] Amazing, but the actual carbon footprint of these trials is between 80 and 2, 000 tons of CO2, which is quite enormous. And obviously, yeah, we can’t continue in this way, but we want to generate research. Yeah, I think there’s a bit of a push to think about how we drop that and how we do it more considerably.

Alexander: 80 to 200, 000 tons of CO2. How does, that’s, that sounds like a really large number. How does it relate to kind of other areas, that we are a little bit more familiar with?

Annie: Yes, yeah, the global average per person per year is 4. 7 tons of CO2 per person. Even the smallest end of the scale, that’s equivalent to just 42 people. People’s carbon emission.

Alexander: So how does [00:04:00] it. That’s a big number. Let’s put that into perspective.

Annie: Yeah, so if we’re saying that the average carbon footprint of a trial ranges from 2, 000 tons of CO2, this is the equivalent between 17 people to 425 people’s CO2 emissions per year.

We need to like, outweigh the benefit of that with the how good the research output is going to be.

Alexander: I think this is also one of the reasons I think that the whole kind of healthcare pharma industry worldwide actually has quite a significant impact. Impact. Yeah. On CO2. If you look at it, I think it’s even in the same space as kind of air travel.

Yeah. And so just think about this. This is quite a lot. Yeah. And so we as statisticians, design clinical trials on an ongoing basis. Now what kind of [00:05:00] factors mostly in clinical trials affect CO2 footprint?

Annie: It’s probably travel within a trial, which is having a massive impact. That might be travel that a participant’s doing to and from a site. It’s travel that, we are doing to inform our offices. It’s travel that our operational teams are going out to sites today. And also delivery of drug. And if that’s going passing to and from sites before reach the patient.

So it’s these are probably things we can tackle quite easily that probably have quite a big reduction in our carbon footprint.

Alexander: Yeah. I think the so of course, if you have lots of face to face visits, yeah, then each face to face visit requires all the participants to travel to site.

Yeah. Yeah. And of course, yes. Some people will take, the bus to the hospital to streets down the [00:06:00] road, but lots of people will travel quite a lot. Yeah. And so I think if you just think about that and how many visits you have, that increases the thing quite a lot. The other thing that I’ve seen is, all the, clinical trial operational parts in it, monitoring sites initiating sites everything that kind of happens on a by patient or by site level increases drastically with if you have more patients and if you have more sites.

Annie: And I think this is where this idea of decentralization or decentralized trials comes in. Or it’s we’re thinking about trials maybe from a more patient centric view, because they can stay at home. But this also contributes to the greener view, because if we conduct a visit online, because you’re only asking a participant questions, of course we can do that at home, we don’t need to bring them in.

So I think, There are [00:07:00] actually simple changes which can be implemented. It’s maybe just not been at the forefront of our minds because it’s not a very traditional technique.

Alexander: Yeah. Yeah. So what are the typical kind of barriers that you see, for example, for most decentralized studies? So for me, decentralized study is where much more things happen at home.

Yeah. Does it also mean that potentially there’s more sites so that, the travel to each of these sites is less, is that also considered decentralized?

Annie: Yeah. So I guess you can have kind of hybrid decentralization where people might come in for some study visits and some are conducted at home.

I guess you need to think a bit more carefully about your patient population. Not everyone is very. technology literate or doesn’t have the same access to technology at home so that’s [00:08:00] probably quite a big barrier. I think in terms of trial teams we’re conducting a survey on this at the moment but I think people are probably worried about technology failing, how that’s like an extra level of setup, we’re used to just setting up an in trial thing.

But I think as we have a lot of technology now, we conduct a lot of meetings online, it’s not outwith our capabilities, but I think the comfort of what we usually do definitely can outweigh yeah, pushing forward with, I wouldn’t say innovative solutions, because I think we have them, but yeah, being more tech focused.

Alexander: Yeah. I think there is lots of examples already out there of how people use technology to avoid people traveling to sites and that will make things much easier. The other thing also, of course, just the simplicity of slide [00:09:00] of clinical trials. I’ve seen lots of waves of.

initiatives within companies that asked for, let’s simplify our clinical trials. And afterwards, we always have more complex ones because it’s, each and every clinical trial very often takes a lot of burden. Yeah. Just the setting up one study, yeah, with all the governance and also the discussions and also funding and having a team and all these kind of operational things, these one time costs are pretty, pretty significant.

Therefore, very often people on a kind of when they have already this one time costs get as much out of the clinical trial as possible.

Annie: Definitely.

Alexander: So I think one area where people actually need to focus on is decrease this one, one of costs, make it easier [00:10:00] to start a clinical trial.

Annie: I know. And I guess we’re maybe thinking about more of this as we’re creating our funding packages or what we’re asking for, but this.

I know having documentation online is like a big thing and if you can get a package bundle within one funding for that, then you’re more likely to utilize it across all trials and that’s being more efficient. But I guess it’s getting to that place of having the money to do so sometimes the barrier as well.

Alexander: Yeah. Yeah. So as statisticians, we can think about okay, of course, smaller studies usually have these kind of benefits of, let’s say, need less CO2 footprint but less visits for sure. The other areas that I think can have a big impact is all the shipments that we do. Yeah. What’s your experience in that area?

Annie: I think [00:11:00] I’ve worked mainly on vaccine trials, so it’s people having to come in to receive the IMP. But from, I think from speaking to my colleagues, I’ve realised that kind of shipments of the medicinal product, wherever that may be, directly to a participant’s home, is more common than I thought.

And I think that is cutting out a middle partner in this. Maybe we do need to think about how we’re doing this in terms of how much plastic and waste it generates. I know we had a conversation within our unit recently about that and what we’re doing with excess. that hasn’t been used are we recycling that?

Yeah, so for example, some vials that haven’t been used can be come back and used for medical students for training. This is a good way of recycling products that couldn’t go back into hospitals. I think that’s something we need to consider about the waste we generate surrounding a trial.

Alexander: Yeah. That comes from all kinds of different test [00:12:00] kits and lab kits. And, especially if things also need to be, you can’t just put them in a box, but say, there needs to be a temperature controlled and these kinds of things. So difference. Also local versus central labs. Make a big difference.

Annie: Yeah, and I think on the same vein and decentralized trials were saying, okay, We’ll send test kits to people if we want to collect a urine sample or a blood sample, which is great Because they’re not coming into a site, but then Are we thinking about the trade off there in terms of carbon footprint?

Is it actually better to send out this kit, or can they visit a local general practice to have that done, which they can walk to potentially? So there’s good solutions is it the appropriate solution?