A digital health platform is looking for partners to work on HORIZON-JU-IHI-2024-08-04-two-stage

Last update: Sep 4, 2024

To apply for this call to your existing account or an account for free.

Last update: Sep 4, 2024 Last update: Sep 4, 2024

Details

Deadline: Oct 10, 2024 Deadline for applications has passed

Organization:Monsenso mHealth

Project locations: EU 27

EU 27

Sectors: Health, Information & Communication Technology, Research

Health, Information & Communication Technology, Research

Partner types: Academic institution, Consulting organization, Government agency, NGO, Other financing mechanism

Academic institution, Consulting organization, Government agency, NGO, Other financing mechanism

Partner locations: EU 27, Europe Non EU 27

EU 27, Europe Non EU 27

Attachments

No documents to display

Description

Monsenso is a digital health platform to collecting extensive real-world data from patient reported outcomes, ecological momentary assessments, smart phone sensor data, wearable data as well as clinical reported data. Monsenso has been involved in more than 20 research projects with more than 70 peer-reviewed articles published on the technology and its use. We have a heritage in mental/behavioral health but have now also expanded to other disorders like obesity, ulcers, migraine and sclerosis.

Patient-Centred Clinical-Study Endpoints Derived Using Digital Health Technologies

TOPIC ID: HORIZON-JU-IHI-2024-08-04-two-stage

Type of grant: Call for proposals

Topic description

ExpectedOutcome:

The action under this topic must contribute to all of the following outcomes:

organisations and institutions involved in the development of therapies for the treatment and management of chronic disease have access to a unifying framework and consensus-based recommendations for:
- using a combination of patient preference information (PPI), clinical outcome assessments (COAs), and digital health technology (DHT)-derived measures to demonstrate the importance to patients of what is being measured by DHT-derived clinical-study endpoints;
- determining, from the patient perspective, what constitutes a minimal clinically important difference (MCID) in a patient-centred, DHT-derived clinical-study endpoint.
new methods for analysing PPI and COA data collected using DHT and for combining data from PPI, COA, and DHT-derived measures are available to researchers;
a consistent framework for engagement regarding the development and use of patient-centred, DHT-derived clinical-study endpoints is available to industry and stakeholders;
acceptance of the use of PPI, COAs, and patient-centred DHT-derived measures in addition to or in combination with traditional clinical-study endpoints to provide a robust view of the benefits of a therapy to patients;
acceptance of the use of patient-centred DHT-derived measures for clinical-study endpoints as reliable evidence for the evaluation of the clinical and economic benefit of therapeutic medicinal products and medical technologies among stakeholders including, but not limited to, patient groups, regulatory bodies, and health technology assessment (HTA) bodies (including the EU Member State Coordination Group on HTA), indicated by a qualification opinion, endorsement, adoption or other approval by each relevant stakeholder group;
patient-centred, DHT-derived endpoints are implemented along with traditional clinical-study endpoints in clinical studies of therapies to treat chronic diseases, and data from DHT-derived clinical-study endpoints are used in regulatory and reimbursement decision-making.

Please, visit the following page to get more information regarding this call: https://www.developmentaid.org/grants/view/1324764/patient-centred-clinical-study-endpoints-derived-using-digital-health-technologies?useNavigation=true