Track Your Trial's Carbon Footprint With This Sustainability Calculator
A conversation with Thierry Escudier, portfolio lead, Pistoia Alliance
Clinical trials generate 100 million tonnes of CO₂ annually — the equivalent of Belgium’s carbon footprint, according to the Pistoia Alliance, a cross-collaborating community including 17 of the largest pharma companies, CROs, and service providers.
It and the Sustainable Healthcare Coalition worked together to quantify trials’ environmental impact and now aim to help sponsors, CROs, and other providers reduce it with the creation of its Clinical Trial Carbon Calculator.
The free-to-use tool received its latest update in February with the addition of data for digital and decentralized clinical trial activities. Pistoia Alliance Portfolio Lead Thierry Escudier discusses the project’s progress with the calculator thus far.
Clinical Leader: How has the Pistoia Alliance been working toward a more sustainable future in clinical research?
Thierry Escudier: Three years ago, we decided to partner with a very experienced not-for-profit organization called the Sustainable Healthcare Coalition, well-known in the U.K. because of their work for the NHS. We both had the idea to assess and standardize the way clinical leaders understand what they do when they are running their clinical trials. Before, you ran a life cycle assessment analysis, which is a costly and complex process run by a specific organization.
Our idea was to help clinical leaders who may not have the expertise in sustainability, because they are focused on ethics, cost, data, quality, and safety. Sustainability was never a real concern because we were all thinking we don't do so much bad in terms of the carbon footprint of clinical trials. It's only recently that published papers have said all businesses have a carbon footprint, including clinical trials. When we looked at what already existed, there was not much beyond the existing tools database, where you benchmark your study timelines or study cost analysis. There was nothing for the carbon footprint, so we decided to build the standardized framework.
By building a database and collecting data from Pistoia Alliance members, we created a carbon calculator. It’s a very easy-to-use tool accessible to everyone; you can input the details of your study, in terms of patient visits per patient, number of countries, number of exams, and so on. In doing so, it gives you some sense of the carbon footprint. The idea is to help people think differently about the way they conduct clinical trials.
What's the next step in that project?
There are three main next steps. The first one is to continue to improve the quality, quantity, and therefore the accuracy of the data in the database. That is to say, collect data points that are missing, such as those related to patient travel. It's very tough to understand how much patients travel to the sites because the pharma industry doesn't have that information.
Second, we’ll improve the calculator. And the third is to think about more integration, because it's one additional tool to be used. If we can find ways to help clinical leaders from the pharma companies and the CROs interconnect the calculators with their own systems, like the CTMS, it would be easier to use.
Tell us more about evaluating the use of digital tools and decentralized trials for the calculator.
The focus is to assess the impact of digital and, in particular, decentralized clinical trials. It’s been on our mind, but it is difficult to build the database on sufficient data. At first, we were not able to do it for different tools, such as eConsent versus paper consent and ePRO. versus paper patient-reported outcomes (PROs).
We decided to gather any type of data we can from our members, whatever the type of studies — conventional design models versus more decentralized ones. Now we know what matters —the hot spots in terms of what activity produces the highest impact on the carbon footprint.
Let's take an example: travel. If the pharma and CRO companies are using Zoom or Teams calls for investigator visits with the patient, that matches a patient visit at the hospital. We could replace some of those physical visits with some remote ones and see if there is a positive impact on the carbon footprint.
You mentioned collecting data from sponsor pharmaceutical companies. Is this issue top of mind for them, or do they have to be convinced?
Some of those companies, whether they're on the pharma or the service provider side, are already very much engaged in sustainability as a corporate responsibility. They are already looking at how to improve their situation. Then you have people who have never really thought about it but are easy to convince. And then, you have people who had no clue but also no real understanding of where to find the data. The data may come from different pieces of your organization; it may come from the CTMS or CDMS. Or, it could come from finance, if you are tracking travel expenses. It may come from the IMP database for shipping and the tracking system for blood samples. It was very tough to make sure people who have never done it before understood what are we looking for and where to find it.
On top of that, there was also a question, but it was solved easily, about whether any data we collect can be identified from the origin — the CRO name or the pharma name. Everything is anonymized and not possible to identify.
How complicated can it be to standardize activities?
This has not really been done before, and that means you have to define the meaning of each item. That's why we built an activity-based model. We are looking at the big bricks of study implementation, study monitoring, and study closeout. If you think about a visit, it's somewhat easy, but you have to make sure that you qualify what you are measuring to make sure that the quantification is going to be well done.
For example, we must make sure that what’s conducted in a remote visit is exactly the same as a face-to-face meeting with the investigator. But then, maybe you have to send a nurse to take the blood sample. Doing it remotely, you may have to consider that there are additional activities to track. That's why if we want to compare peer to peer, we have to clarify the meaning of what we are measuring.
Do you ever find yourself going down a rabbit hole? In other words, how far back or how wide do you track an activity?
That's indeed not easy, and we are not claiming that we are absolutely 100% perfect. As soon as you start to think about the processes, even if you think about using a pen to make a note, you can consider the production of the pen and so on. That's the same with the digital tool. In addition, for the digital tool, the manufacturer might not be able to provide information, and so on. That's why we may not have the full view on the carbon footprint, but at least we try to focus, as I said, on the hot spot.
We also take into account whether the trial is providing new digital tools to a site or a patient or asking them to bring their own device. That doesn't add anything. To implement a new app on a device, we consider it almost nothing compared to providing a new tool.
What lessons have you learned since first starting this project that have allowed your team to get better?
The great joy is to see experienced companies share best practices in a pre-competitive space to help those who are new to the field. We have been able to standardize the method so that people who have never done it before can understand it more easily. They can focus on what they are mastering, what they are controlling, and then focus on quick wins.
Now that people know the carbon footprint of clinical trials, they can do something. We can think differently, we can design a study differently, maybe even with a different provider with innovative technology, such as microsampling for blood samples or the way you ship your blood samples with dry ice. The objective is to positively impact the production of carbon and reduce climate change.
The tool is fully ready to use independently, but do you also offer any strategy for how to use it or how to implement changes based on its outcomes?
I’d like to explain to the people: Don't be afraid, have a look, try it, test it, and then you will see it works and you can improve yourself. It's also building what we call a community of practice with all the different companies that volunteer to work together. In this pre-competitive collaborative legal framework, this low-carbon clinical trial community brings the experienced people to the less experienced people to show them it's feasible, that you can think about sustainability efficiently and even save money in doing it. Also, it’s a way to be more patient-centric because it's still tough to get patients engaged and recruited in clinical trials. If we design more patient-centric trials, they will also be more sustainable.
How do those looking to become involved in the Pistoia Alliance’s sustainability efforts do so?
If they are already member of the Pistoia Alliance, they can connect with the community of practice that has been launched by the Sustainable Healthcare Coalition. There will also be webinars during the year.
About The Expert:
Thierry Escudier is a leader in clinical research with over 30 years of experience in corporate R&D within pharmaceutical organizations, dedicated to fostering partnerships between pharma companies and CROs in clinical outsourcing. Since October 2023, Thierry has served as a portfolio lead at the Pistoia Alliance, having been a strategic leader within the organization since January 2022. Thierry brings an extensive background in clinical operations, having worked for Pierre Fabre Medicament for 25 years, with a strong focus on the transformative impact of digital innovation and patient engagement on drug development and the medicinal product life cycle.