A European Proactive Adaptive Clinical Trials Network within EU-Response

Información del proyecto

PROACT EU-Response

Identificador del acuerdo de subvención: 101156304

DOI

10.3030/101156304

Fecha de la firma de la CE 6 Diciembre 2024

Fecha de inicio 1 Enero 2025

Fecha de finalización 31 Diciembre 2029

Financiado con arreglo a

• Health

Coste total

Sin datos

Aportación de la UE

€ 17 042 172,16

Coordinado por

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

Documents, reports (15)

Set of recommendations and adaptations based on sponsor hurdles

Report detailing resources and adaptations on study documents, ethical and logistical aspects to support sponsor to rapidly move to another phase of the platform

Set-up the Patient Advisory Group (PAG)

Patient Advisory Board and Patient Engagement Process document

EU-SYNDACT-1 SAP

Statistical analysis plan for EU-SYNDACT-1

Data sharing framework

Set-up of the data repository and templates for legal agreements for data sharing

Conference pre-program

Thems and speaker identification

EU-SYNDACT-1 clinical trial Protocol development

Completion of trial protocol for EU-SYNDACT-1. Del co-lead UCL & ULB.

Safety instructions and SOP

Report including safety instructions and safety SOPs according to the trial protocol

Capacity building strategic plan

Comprehensive capacity building strategy to promote and disseminate the results and the messages of the PROACT EU-Response project.

Communication and dissemination strategy

Comprehensive Communication strategy to promote and disseminate the results and the messages of the PROACT EU-Response project.

Evidence map

A searchable evidence map/database summarizing the findings of the AI-supported systematic search

PROACT EU-Response site evaluation tools developed to assess Capacity and Capability

Comprehensive report detailing the tools developed to assess the capacity and capability of clinical trial sites to conduct EU-SYNDACT-1, EU-SYNDACT-2, and Pandemic/Epidemic Trials. Del co-lead UCL & ULB.

Systematic review report

A comprehensive report detailing the outcomes reported in randomised controlled trials and systematic reviews of antiviral treatments for respiratory infections.

Meeting charters (TSC, TMT & DSMB)

Report including meeting charters for the TSC, TMT and DSMB describing tasks, responsibilities and connections with other governing bodies

Survey report CFM M18

The findings from the survey sent to Social Media influencers will be summarized in a report.

Survey report

The survey findings will be summarized in a report.

Data Management Plan (1)

Data Management Plan v1

Document describing the data collection, management, annotation, storage, analysis and reuse v1

Websites, patent fillings, videos etc. (1)

Website and visual identity

Creation of the PROACT EU-Response website and its visual identity.

Publicaciones

Peer reviewed articles (1)

PLoS ONE

Autores: Declan Devane; Matthias Briel; Sanjay Bhagani; Nadine Boesten; Stephanie Buchholz; Estefania Callejas De Luca; Jeremie Guedj; Anastasia Koryakina; Kavita Kothari; Karine Lacombe; Patrick W. Mallon; Clément R. Massonnaud; Joanne O’Dwyer; Inge Christoffer Olsen; K. M. Saif-Ur-Rahman; Johannes M. Schwenke; James Thomas; Yazdan Yazdanpanah; Lina Zgaga; Julia Louw
Publicado en: PLOS One, Edición 20(09), 2025, ISSN 1932-6203
Editor: Public Library of Science (PLOS)
DOI: 10.1371/JOURNAL.PONE.0330288