During the pandemic, sponsors and biotechs started running decentralised clinical trials (DCTs) to keep research going when patients had less face-to-face access to clinicians, with the added benefit that they could be more sustainable.
At the time, it was thought that DCTs would be the future, however, five years on, while they have not disappeared entirely, sponsors seem to be adopting more hybrid clinical trial models.
Go deeper with GlobalData
GlobalData’s Pharmaceutical Intelligence Center shows a slight uptick in 2024 for DCT adoption compared to 2023, but the numbers remain low compared to 2021. You can follow the Clinical Trials Arena’s DCT Adoption Tracker to view more DCT trends.
GlobalData is the parent company of Clinical Trials Arena.
While DCTs mean that patients do not have to travel to sites as frequently, and there is less paperwork, some questions have been asked about whether they are more sustainable for the environment. With the use of technology comes the problem of e-waste, and while patients do not need to visit sites for monitoring, visits by a home nurse or data storage from wearables may be just as bad for the carbon footprint of a trial.
The global not-for-profit Pistoia Alliance, in collaboration with the Sustainable Healthcare Coalition, is launching the next phase of its project to measure and reduce the carbon footprint of clinical trials. This initiative follows three years of research into all clinical trial models. Now, investigators are specifically looking into DCTs and digital health solutions (devices, apps), compared to traditional, paper-based approaches.
The project hopes to establish a standardised methodology for evaluating the use of digital tools in DCTs. This methodology will be used to create a Carbon Calculator, so ClinOps teams and others who contribute to clinical trial design will be able to accurately compare the sustainability of digital versus non-digital trial approaches.
Speaking to the Clinical Trials Arena, Thierry Escudier, portfolio lead at the Pistoia Alliance, said that creating a methodology to evaluate a footprint has been more challenging than anticipated. This interview has been edited for length and clarity.
Abigail Beaney (AB): How is the alliance evaluating whether a DCT is sustainable?
Thierry Escudier (TE): Our aim three years ago at the Pistoria Alliance was to assess the impact of decentralised trials, but we had to understand first whether we get the basic data from any type of trial. So, all the data we have been collecting so far has been mainly on the classic, traditional way of doing clinical research, where all patients go to the hospital or see their GP at their practice in a classical way.
Now, we are going to work specifically on use cases of DCTs from our members who have experience in using all or part of the technology used in DCTs such as shifting from classical paper consent to e-consent, or paper-based patient-reported outcome (PRO) to e-PROs.
A fully decentralised clinical trial doesn’t seem to be the model that the industry has chosen but one that has been forced due to the Covid pandemic, but once everyone was back at the office and back at the hospital, it shifted back a bit. Now the more classic model is a relatively standard trial design but with a few elements of DCT models.
AB: What kind of technology are you evaluating?
TE: That’s where we are starting the journey. If you think about those tools that might be used, it’s complex. If you start to evaluate from the production of those devices, for example, a smartphone or tablet, are you looking to offer the patient a new device or an already used device or are you asking for a patient to bring their own device? Based on conversations I have had with pharma members who are already using these tools, it’s very much dependent on the provider.
We also need to consider if those technology provider vendors are already assessing the carbon footprint of the production or not, so that adds a level of complexity, but we will try to have a common methodology with these. Some technologies are used more than others like the e-PRO so have a lower footprint overall.
There is also the use of wearables to collect data. On top of the device itself, you also must consider the impact of both the data collection and the data storage. Over the years that I have been involved in the industry, there has always been a trend to try to collect more data because it might be useful. With the facility that may offer digital tools, including wearables, data is coming as a permanent flux. Therefore, we should also question, whether is it a need to have, or nice to have. Beyond that, there is also a need to be more transparent with the patient and investigators as to why we are collecting this data.
We also need to consider direct-to-patient shipments from a central pharmacy to the patient’s home. Even though this is not pure technology, it is using digital tools. This itself is a much more recent advancement and is very much country-specific. This can be difficult because we don’t know how much data we are going to be able to collect about this.
AB: Big pharma has already made pledges for net zero. Do you think this is also a feasible target for small and medium-sized biotech/biopharma?
TE: That’s a very good question. There’s an overall responsibility whether you are working in a small or big corporation. For small companies that have fewer resources, that is part of the reason why the Pistoia Alliance is doing this research. The calculator will be free to access on the Sustainable Healthcare Coalition website which also demonstrates that we are committed to making this accessible. However, companies must go beyond the use of the tool because it is just to provide information. These changes can be reducing the number of visits to patients or the number of samples collected.
We also want to mix sustainability while still allowing profitability. Sustainability should not be a way to prevent profitability – in fact, it should be the opposite. If you are more sustainable, there is more chance that you will be able to still run your business more efficiently because you will have less waste. You will focus more on what is important, and therefore you will be in a better position to run your own business.
AB: How does patient opinion factor into this?
TE: When we think about sustainability, it must also be reasonable. There is technology available to offer nearly every approach you could dream of. However, when you are starting to discuss these options with patients, the industry needs to understand that there are different types of patients.
The pharma industry tends to consider whether a patient will be technology savvy or not or whether they need to speak to someone physically on a one-to-one basis. There are some indications which may require less personal interaction, for example, a more active type of population who must go to work so being involved in clinical research might have an impact on their daily schedule more than people who are potentially older who need more contact with a researcher. That also adds complexity.
I guess one day, the goal would be to offer a different model to every patient depending on what they would prefer. It’s still complex because we need to have the standardisation that allows good quality data, but maybe one day we could hope to have more confidence in having a personal approach. As we know in our industry, not all drugs work for everyone, so surely this means that not all study designs work for everyone.
