One of the goals of the innovation project PhaseV is to learn how we strengthen the decentralized clinical studies of the future. The project must gather experience on how we can succeed in involving more users and keep them in the study for several months – and then we must become sharp on how a full clinical study can be carried out virtually.
In the innovation project PhaseV, patients and citizens must participate in a clinical study over an extended period via an app, where the clinician can follow how their treatment is progressing.
One of the big challenges in the project will be to find a solution for how we retain and engage the users so that they continue to use the app, month after month.
The very central thing in PhaseV is to create learning that can be of decisive importance for the clinical studies of the future. This is the opinion of the steering group in the project, which includes the participation of the two global companies Novo Nordisk and Novartis.
See the partners in PhaseV here
– It is crucial for us that we can see the patient’s value in participating in a study. So if we can find a model where even more patients and citizens can create value for clinical studies – and thus contribute to creating new knowledge – then the project has been successful.
– Here we get the opportunity to test different approaches to make a study fully virtual, and we look forward to the learning that will create value for both manufacturers, patients, and clinicians, says Frederik Knud Nielsen, director of Healthcare Partnerships at Novartis.
Collaboration across three different patient groups
PhaseV will develop three apps targeted at patients with costly, chronic conditions. The three apps are developed on top of an existing solution from the company Monsenso A/S and are aimed at citizens with severe obesity, diabetic foot ulcers, and chronic hives.
Part of the project will test how citizens and patients can be recruited and participate 100% digitally in a clinical study.
– The strength of PhaseV is that we collaborate across three very different areas and patient groups. Thereby we get valuable sparring from the other companies, patients, and clinician groups on how patients get the best course in a clinical study. We will hopefully get a better insight into how we adapt a study to a given patient group and which tools work when, says Frederik Knud Nielsen.
Users must experience gaining value
Professor Janus Laust Thomsen is head of the Center for General Medicine at Aalborg University and is part of the steering group in PhaseV. He believes that if we are to expect patients to engage, then they must feel that they are getting something in return.
– In order to retain patients in a course, they must experience that it is relevant and present for them. They must experience that their efforts provide value, and their time consumption must be coordinated. Therefore, we must also focus on giving the patients something in return for their efforts. It can, for example, be in the form of gamification, where, just like in a game, they receive a digital ‘reward’ or recognition when they have entered. Or it can be in the form of the project’s outcome, where they can see that their efforts have helped to create results, explains Janus Laust Thomsen.
From a report from the Knowledge Center for User Involvement, it appears, among other things, that successful user involvement requires that ‘Patients must feel heard’ and that …’ user involvement results in more satisfied patients.’
The project’s learning can have an impact on future studies
Project leader Frederik Mølgaard Thayssen, Alexandra Institute, looks forward to helping to develop the area of clinical studies.
– The model for studies must keep up with the times, and we must adapt to the wishes of the citizens. We can see that more patients in the healthcare system are calling for more digital contact, and clinical studies must naturally follow that trend. PhaseV is the first Danish study to be operated exclusively digitally, and therefore our results can be of decisive importance for future models, predicts Frederik Mølgaard Thayssen.
At Novartis, the learning from PhaseV is also the most important.
– The goal is not that we create a 100% usable new solution – it is equally important that we develop learning that can create stronger methods for clinical studies in the future, says Frederik Knud Nielsen.
PhaseV Health studies are supported by the Innovation Fund.
Discover more about Danish Life Science Cluster:
Danish Life Science Cluster is a Danish national cluster for life science and welfare technology. We connect partners, drive innovation, and create networks between companies, research institutions, and organizations within life science and welfare technology.
