As anticipated last week, returns the column “Tra Scienza e Conoscenza”, and after the summer break we reopen with a new topic: the virtual clinical studies.
We still remain in the medical field and always with an eye to innovation; these virtual clinical studies are nothing more than remote clinical trials, that allow to limit or even to eliminate the need of recruited patients to go physically to the dedicated research centers, using all the technology available, from smartphones, to the most different devices.
Let’s see briefly the development of this reality in the recent years, by analyzing the main steps:
In 2001 the first partially virtual study was carried out by the pharmaceutical company Eli Lilly on a medicine for erectile dysfunction. The patients were invited to visit the reference centres and to complete an online test.
In 2011, another US pharmaceutical company, Pfizer, launched the first fully virtual clinical trial model with an overactive bladder study. One of the main objectives of this study was to compare the virtual approach with the conventional clinical studies, to determine whether the virtual trial project could be a useful model for all the future studies. However, the study faced a lot of challenges, starting, ironically, with the patient recruitment, as the target group of the research in question was mainly formed by olde people with a limited ability to use technological tools in order to give their actual contribution.
In the end, we finally arrive to our days; from 2018 Novartis, a pharmaceutical company, focused on virtual trials, marked an agreement with Science 37, an American clinical research company dedicated to this topic. This company has developed N.O.R.A - Network oriented Research Assistant, a software platform that uses mobile and telemedicine technologies and that allows each patient to offer their contribution, regardless of where they live.
Science 37 has licensed the pharmaceutical company Boehringer Ingelheimto use this platform to conduct clinical trials remotely.
This allows patients to participate in clinical trials in the most user-friendly way for them, and the researchers can interact directly with the patients at all stages. It is a dual possibility, that favors both the research and the cure, because the researcher will always have immediate access to the necessary information and, on the other hand, will be monitored constantly the adherence therapeutic of the patients.
This is therefore an extremely innovative approach, that could completely revolutionize the world of the clinical research. And if for now the use of software as NORA are only available in the United States, the goal is definitely to get to involve all the other countries in the world.