Maintaining Regulatory Adherence with Clinical Technology

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: What would you say to stakeholders who are still unsure of implementing more clinical technology?

Escudier: I think it's very much beyond, I would say, the technology itself because, as we can see we are able to speak to each other. I think we have, maybe the Atlantic Ocean between the two of us, and we are still able to interact as we were in the same room, so the technology is there. It's more the question of data privacy in particular, I would say, for patients in using those technologies, we have to ensure that the data privacy is respected. In particular, that for the pharmaceutical sponsor, they shouldn't know anything about the patient identity that should be disclosed and things like this, so there is some of the regulatory, ethics, also difference between, I would say, all countries. Even I would say we have the global ICH E6 that is defining the way clinical studies should be run, but each country may have this their own ethics, let's say mindset, as well as data privacy and therefore, of course, there is sometimes also that fear from the pharmaceutical sponsor side is that, if I'm doing something brand new, is it going to be accepted by the regulatory when I will submit my dossier? That's why, very often the technology is very much, I would say, on line, with the technology of daily life, like even you can look to your bank account, I would say, using the web and so on, and you can interact with friends, but then, as you know, clinical trials are so regulated for the sake of protecting the patient and also the quality of data, that sometimes pharma, I think, is a little bit anxious to move towards those technologies until there is maybe some new guidance. As everyone had to deal with the pandemic crisis, with COVID, of course, there was an increasing speed of trying to adopt some technology, because no one was able to travel anymore, even the patients, they were, I would say, less accepting to travel to the to the sites. The monitors were not able to go anymore to the to the sites to review the source documents, so there was some attempt to try to look to the source documents, but depending on the countries, it might be very difficult. Now that we are back in what I would call a normal situation, after, indeed the very high increase of using technology during the pandemic, there was almost not a shift, but okay, let's come back to what we know, what we master, and let's see how the regulatory will help us, so that's why some of the recent guidance, the one from the EMA and the FDA regarding decentralized components is helping very much the pharmaceutical industry, as well as the CRO service provider and the tech provider to be a little bit more comfortable in the way they can think on implementing those new technologies, but yes, clinical research is a specific word, with a lot of concern for protecting patient data and making sure that you have no deviation, that you have a harmony between standardization across all sides, and of course, depending on the country, it might be very different.