Being Prepared for Regulatory Sustainability Requirements in Clinical Research

In a recent video interview with Applied Clinical Trials, Theirry Escudier, Portfolio Lead, Pistoia Alliance, discussed the alliance’s newest initiative to assess the carbon footprint of clinical trials. The initiative aims to answer whether decentralized clinical trials positively or negatively impact carbon footprints. Escudier also discussed how clinical research stakeholders are slowly beginning to adopt more sustainability practices, focusing on reducing waste and costs.

ACT: How will this initiative aid in regulators’ increased demand for sustainability and transparency?

Escudier: In a way, it's beyond, I would say, the regulatory requirement, because, as such, regulatory agencies, that is to say those health regulatory agencies looking for new drug submissions are not yet asking for any data on sustainability itself. This is more of a high-level request from in particular Europe, we have some very ambitious goals to reduce the carbon footprint in order to have less impact on the climate change. Some of the goals have been set up by the European Commission, the European Parliament, the National Parliament, and the national government, so there is, I would say, an overall trend within the industry, not specifically in the pharmaceutical world. Therefore, currently, I don't think there is any requirement from specific regulatory agencies such as the EMA, MHRA, or the FDA. It may come one day or the other, so that's why we have to be prepared, but it's more the voluntary approach from the pharmaceutical industry to consider that they want to also behave even beyond the fact that, as you know, the pharmaceutical industry is working to provide new drugs for saving lives, I would say, reducing the pain, maintaining people in good health, and at the same time, we know that our processes, whatever they are coming from R&D or from the industry, are producing carbon footprint, therefore may have an impact on the climate change, so therefore it's even more important that as an industry as a whole, the pharmaceutical companies are looking to how to reduce the production of carbon in order that in fact, not to offset the benefit of the new drugs, or the drugs we are currently, I would say offering to the to the patient.