PhaseV

The PhaseV project will develop a new standard for testing and evaluating new treatments. The project will develop a digital platform where patients and clinicians will be motivated to engage in monitoring the effects of treatment over a long period of time. PhaseV will evaluate specific treatments for obesity, diabetic foot ulcers, and chronic spontaneous hives.

Today, life science products are tested in classic randomized trials. Testing of new treatments in phase IV settings is often limited by the fact that they are performed over a limited period of time, data collection is only done via questionnaires, and there are only few clinic visits and often high dropout rates.

However, with digital developments, it is now possible for clinics, hospitals and patients to play a more active role in documenting the effect of treatments through decentralised digital clinical trials. Among other things, so-called ‘real world data’ can now be collected digitally from more technologies such as smartphones and wearables.

Read more about PhaseV on the project’s website

Purpose of the project

PhaseV will bring the monitoring closer to the patient and the citizen and create a 360-degree picture of the patient’s well-being and the effects of the treatment and any side effects over a longer period of time.

In three decentralised clinical studies (obesity, diabetic ulcers and chronic spontaneous hives), we will follow patients for one year and, based on real world data, create an overall picture of the patient. A picture that also describes the patient’s individual life situation.

PhaseV will create value for patients, society and companies because the project develops concrete technological solutions, methods and guidelines for future monitoring of treatment in order to create the best possible personal treatment based on knowledge of the patient’s quality of life and lived life.

Read more: Citizens’ data will improve the clinical studies of the future – and we need to get started now!

The goal of the project

The aim of the project is to show that it is possible to engage and motivate patients and healthcare professionals to collect continuous data from patients over a longer period of time. PhaseV will set new standards for how the efficacy and safety of new treatment options can be documented in a scalable way in the future, so that patients are offered the right treatment.

This allows healthcare professionals and drug manufacturers to gain a better understanding of the impact of long periods of continuous treatment.

Activities in the project

The project will involve:

  • Development of a platform to run PhaseV clinical trials, involving patients, data from remote devices and public registries, so that it will be possible to track the efficacy of marketed medicines, devices and treatments.
  • Long-term patient engagement to identify tools and ways to motivate patients to contribute personal data over the long term.
  • Three different proof of concept cases in obesity, diabetic foot ulcers and chronic spontaneous hives.

Grantor

PhaseV is supported by Innovation Fund Denmark