Phase V: to ensure data collection by patients

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CIFS embarks on Phase V, to deploy a digital platform for continuous decentralised health data collection. Heavyweights of Danish healthcare join a consortium to develop patient-to-doctors communication tools to evaluate the long termed effects of obesity, diabetic foot ulcers and chronic urticaria treatments, based on indicators related to life quality.

Problems to be solved by Phase V

The project will use new technologies and methods to collect patient data in a clinical trial on established treatments and drugs on the market. Typically, clinical trials are run over a limited period of time at specialized hospitals, which may restrict the enrolled patients to those living nearby the hospitals. After clinical trial termination, the data are analyzed and evaluated, and a new clinical trial can be initiated. Thus, clinical data seem fragmented, in terms of limited time collection on a biased patient population, and only collected at specialized hospitals. In the Phase V project we will test how data can be collected real time and continuously over a long-term period on a broad patient population and involving general practitioner. Finally, we will evaluate if the obtained data enable medical doctors and companies to provide better care to benefit the patients and ultimately the society.

The project will target patients with obesity, diabetic foot ulcers and chronic urticaria, all of which are costly chronic conditions. Annual treatment costs for obesity alone are estimated to exceed DKK 15 billion, covered by local and regional authorities in Denmark. Over 800,000 Danes suffer from obesity, and secondary diseases are very common. Chronic urticaria affects 15-20 percent of the population, and in approximately 1 percent occurs chronically. Urticaria is the cause of a strongly reduced quality of life.

The solution by Phase V

In the Phase V project the participants will develop and deploy an app, which will enable data collection with minimum effort from the user. Each app will target one of the following conditions: chronic urticaria, obesity and diabetic foot ulcers. The app allows the real time data collection to be decentralized (i.e. collected at home) using the patient’s own device. After one year of data sampling the project group will evaluate and document the effectiveness of treatments, to ensure that patients to receive the right treatment during the course of their illness/condition.

The apps and the related studies will aim to:

• Provide insights to patients for better disease handling and improved well-being measuring the impact on the retention
• Provide data after one-year sampling from each study to HCPs and drug manufacturers with a diverse and new type of data
• Evaluations of the three treatments and modalities to improve well-being and optimize public healthcare (HC) spending

The project may establish new standards for documenting the effectiveness of treatments, to ensure that individuals in need of medical assistance to receive the right treatment throughout the patient journey.

‘With Phase V, we move clinical trials into a digital age with the seamless interaction’

Bogi eliasen, cifs health director

‘With Phase V, we move clinical trials into a digital age with the seamless interaction that enables and also the opportunity to give the participants direct health improvement as a part of participating in a trials, says Bogi Eliasen, CIFS Health Director, it opens up for both remote and decentralized way of working, so patients and HCP do not have to use transport more than necessary, it can have much more precise and continuous monitoring and interaction with the patient, and do find the right groups of patients with the necessary diversity’.

Phase V Process

Phase V: Values to stakeholders

PhaseV aims to identify new channels for faster recruitment of patients, to ensure enrollment of a diverse patient population reflecting end-users. New virtual enrollment procedure for a faster and improved consent process will be provided. This will provide specific values to healthcare providers, patients, and the society as a whole.

Value to healthcare providers

• Data will show the long-term effects
• Unique data will allow sponsor to stratify the patients (- higher response better/use reimbursement)
• To optimize use of the drug (shower, activity, meals etc.)
• Ensures that the right drug is used for the right patient
• Treatment can be stopped/initiated at the right time – no over/under treatment

Value to patients

• Continuously real time data collection ensured, i.e. objective measurements of the patient
• Better understanding of disease
• Better understanding to driving factors behind spikes and other unexpected deviations

Value to society

• Data will show the effects of treatments
• Treatment can be stopped/initiated at the right time – no over/under treatment
• Ensures that the right drug is used for the right patient
• Provide new knowledge of disease/treatment

Phase V: background

Phase V was conceived in a discussion by Dr Carsten Obel, Professor at the Public Health School, Aarhus University, John Zibert, an experienced pharmaceutical executive, and Peter Aadal Nielsen, CIFS Special Advisor. They discussed monitoring (or rather the lack of it) of long termed effects of drugs used for treatment of chronic diseases.

The participants to that discussion concluded that new technologies should be employed to get long termed and continuous data from the patients, to get structured data that may give answers to the questions above. It will ensure that the right patients (responders) get the right treatment, and that doctors will be able to detect potential inconveniences.

‘The next step was to collect the very best team to develop and execute the project, and I think we have been very successful in doing this’, says Peter Aadal Nielsen.

Phase V: participants

The consortium behind the project, which is supported by the Innovation Fund (invested EUR6.5M), includes Aarhus University (the Research Unit for General Practice), Aarhus Municipality, Bispebjerg Hospital, Technological Institute, Danish Life Science Cluster, Steno Diabetes Center Aarhus, Copenhagen Institute for Future Studies, Novo Nordisk, Novartis and Monsenso A/S. The participants to the consortium represent major players of the Danish healthcare landscape: the industry, hospitals, and universities.

Bogi Eliasen, CIFS Health Director: ‘Copenhagen Institute for Futures Studies will contribute by bringing the needs of the future health paradigm, that we are developing in many initiatives, to the project’.

Peter Aadal Nielsen, CIFS Special Advisor: ‘I hope we will be able to keep patients in the studies for a year or more and thereby see the long-termed effects of the treatments. Potentially, this will allow outcome-based-reimbursement and patient stratification that enables physicians to identify responders (and non-responders). If we are successful, then we will be able to spend money on the right drugs and treatments of the individual patient. This will be a way to individualize and improve the health of each patient and ensure the drugmakers, an optimized use of their drugs for the benefit of the patients’.

Frederik M. Thayssen, Danish Life Science Cluster: ‘PhaseV must set new standards for demonstrating the effect and safety of new treatments in a scalable manner in the future’.

Thomas Lethenborg, Monsenso CEO: ‘We are building on Monsenso’s platform so that it even more supports decentralized trials across chronic disorders, where behavior and ongoing follow-up play a major role in patients’ quality of life’.

Peter Dridal, Novartis GM Denmark: ‘We must think differently about healthcare because of a lack of resources. By combining public and private partners, this project provides unique opportunities to develop new digital solutions that can improve patient processes and free up staff time’.

Daniél Vega Møller, Novo Nordisk VP Medical & Science Obesity, NASH and Devices: ‘Digitization of the effect of patient treatment can be of decisive importance for our insight into the effects of the treatment of severely overweight people as well as for future clinical studies, where the aim is to make it easier for both patients and healthcare personnel to participate’.

Jens Meldgaard Bruun, clinical professor at Aarhus University and Steno Diabetes Center Aarhus: ‘Obesity causes both direct and indirect costs to society’.

Simon Francis Thomsen, Professor and Chief Physician at Bispebjerg Hospital: ‘Sound data monitoring and effective data collection are crucial for correct and effective treatment in the future’.