27 de June, 2023
08 de November, 2023
11:59 PM
Inclusive clinical studies for equitable access to clinical research in Europe-HORIZON-JU-IHI-2023-04-03-two-stage
Investigación
"Escuela de Medicina y Ciencias de la Salud - Escuela de Ingeniería, Ciencia y Tecnología"
Comisión Europea
4.500.000 EUR
This topic aims to develop a multi-faceted, intersectional approach to overcome the multifactorial barriers associated with the recruitment and retention of underserved patient populations in clinical studies and to contribute to transforming the way clinical studies are conducted in Europe.
Expected Impact:
The following impacts are expected:
•Awareness and understanding of what diversity, under-represented and underserved communities look like in geographies across Europe, including barriers and gaps to recruitment and retention in different types of clinical research, such as clinical studies1 on medical products, clinical investigations for medical devices, and performance studies in in vitro diagnostics (IVDs), cohorts, and registries.
•Enhanced representativeness of underserved populations in clinical studies across Europe, through the building of a patient-centric, sustainable infrastructure that improves the recruitment and retention of these patients.
•Increased study data reliability and genetic diversity by including different demographic groups, thereby enhancing patient trust in the evidence generated. More patients benefit from increased access to improved innovative health technologies including medicinal products and medical devices that meet the specific needs and profiles of all patient populations.
•Promoting the implementation of new tools, solutions, approaches, or process models that will reduce the burden of clinical studies and facilitate and increase diverse patient populations’ access to clinical studies.
•Contribution to the Accelerating Clinical Trials in the EU2 (ACT-EU) objectives to proactively deliver inclusive patient-oriented medicines development and delivery across populations.
Proposal page limits and layout: described in Part B of the Application Form available in the Submission System
at stage 1 of a two-stage Call, the limit for RIA short proposals is 20 pages;
at stage 2 of a two-stage Call, the limit for RIA full proposals is 50 pages.
Documents: (Check them on the webside).
IHI JU Evaluation form for Research and Innovation Actions (single and two-stage Calls)
IHI JU Proposal template (RIA/SP) - Part B
•Colombia is eligible as a third country, for this it must participate with the role of partner together with a consortium with at least three entities from different European/associated countries).
OBJETIVO/DESCRIPCIÓN
This topic aims to develop a multi-faceted, intersectional approach to overcome the multifactorial barriers associated with the recruitment and retention of underserved patient populations in clinical studies and to contribute to transforming the way clinical studies are conducted in Europe.
REQUISITOS CLAVE
Expected Impact:
The following impacts are expected:
•Awareness and understanding of what diversity, under-represented and underserved communities look like in geographies across Europe, including barriers and gaps to recruitment and retention in different types of clinical research, such as clinical studies1 on medical products, clinical investigations for medical devices, and performance studies in in vitro diagnostics (IVDs), cohorts, and registries.
•Enhanced representativeness of underserved populations in clinical studies across Europe, through the building of a patient-centric, sustainable infrastructure that improves the recruitment and retention of these patients.
•Increased study data reliability and genetic diversity by including different demographic groups, thereby enhancing patient trust in the evidence generated. More patients benefit from increased access to improved innovative health technologies including medicinal products and medical devices that meet the specific needs and profiles of all patient populations.
•Promoting the implementation of new tools, solutions, approaches, or process models that will reduce the burden of clinical studies and facilitate and increase diverse patient populations’ access to clinical studies.
•Contribution to the Accelerating Clinical Trials in the EU2 (ACT-EU) objectives to proactively deliver inclusive patient-oriented medicines development and delivery across populations.
Proposal page limits and layout: described in Part B of the Application Form available in the Submission System
at stage 1 of a two-stage Call, the limit for RIA short proposals is 20 pages;
at stage 2 of a two-stage Call, the limit for RIA full proposals is 50 pages.
Documents: (Check them on the webside).
IHI JU Evaluation form for Research and Innovation Actions (single and two-stage Calls)
IHI JU Proposal template (RIA/SP) - Part B
•Colombia is eligible as a third country, for this it must participate with the role of partner together with a consortium with at least three entities from different European/associated countries).