Kelvin Health is looking for partners to work on HORIZON-JU-IHI-2024-08-04-two-stage

Kelvin Health is an intelligent solution for detection and monitoring of various abnormalities and inflammation processes in different stages and conditions, using AI analysis applied to mobile-based digital thermal imaging.

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.

Scope:

Three types of patient-centred information related to how a patient feels and functions contribute to the evaluation of outcomes of a therapy:

• patient preference information (PPI);
• clinical outcome assessments (COAs) (including patient-reported outcome (PRO) measures);
• digital health technology-derived (DHT-derived) measures.

Each of these types of measures can be used to understand patient-centred benefits of therapies (i.e., meaningful improvements in how a patient feels or functions).

DHT-derived measures can capture patient-centred information about disease symptoms, physical, cognitive, and emotional functions, and experience with therapy. They can measure the status of a patient’s health in ways that may be related to, but often differ from, COAs. For example, DHTs may measure activity intensity but not specific activities. Likewise, DHT-derived measures may detect changes in patient-centred outcomes - such as function - earlier than a patient may notice such a change. For patient-centred DHT-derived measures (i.e., DHT-derived measures that capture how a patient feels and functions) to be useful as endpoints in clinical studies, they must not only be technically validated, but also demonstrate that they measure functions, activities, symptoms, and other impacts of disease and treatment that are important to patients and measure changes in these outcomes that are meaningful to patients.

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