THE IBEAT STUDY SETUP A MODEL FOR PARENCHIMA? Scaling up research - - PowerPoint PPT Presentation

THE IBEAT STUDY SETUP – A MODEL FOR PARENCHIMA?

PARENCHIMA WG3 MEETING UTRECHT 23/04/2018

Scaling up research Consortium-type thinking

The IMI-2 Collaboration & Funding Construct (2014-2024):

2 Project formation process:

• EFPIA consortium suggests project scope to Strategic Governing

Groups

• A call is launched and academic / SME consortia apply
• Full proposal prepared by industry + selected academic consortium

Collaboration project starts after independent review:

• Academic partners are funded
• Industry partners provide in-kind

3.276 billion EUR 1.425 billion EUR 1.638 billion EUR Project budget: 50% efpia + 50% EU

Associated partners

213 million EUR

The BEAt-DKD project

Biomarker Enterprise to Attack Diabetic Kidney Disease (BEAT-DKD), IMI funded (€30M total), sept 2016 – sept 2021. https://www.imi.europa.eu/projects-results/project-factsheets/beat-dkd www.beat-dkd.eu (coming up…)

iBEAT study setup

iBEAT: a Collaborative Study with Central Coordination

• Every site has their own sponsor & local ethics application
• Central site provides protocol, manual of procedures, checklists, QA
• All recruiting sites agree to adopt a standard core protocol
• All recruiting sites take extensive additional data & measurements to address

local ancillary objectives

• Ancillary objectives can be the primary aim with iBEAT objectives secondary
• pt-in procedures

iBEAT: MRI infrastructure – central MR physics site

• Extensive protocol for quantitative MRI (modular) on Philips & Siemens 3T
• Manual of procedures (radiographer, MR physics, MRI processing, QA)
• QA system: on-site and centrally (real-time check within 24hrs)
• Centralised Image Banking (XNAT)
• Centralised Image Processing facility (Leeds)
• Centrally provided support for site setup and qualification
• RedCap instance for storing MRI biomarkers and data integration
• Reference data in healthy volunteers, including reproducibility

iBEAT relevance for PARENCHIMA

iBEAT: a Collaborative Study with Central Coordination

• A model for new collaborative studies funded with separate national

grants?

• Start with small nr of recruiting sites and scale up as funding becomes available
• New sites can apply for local (national) funds to address their ancillary
• bjectives as primary aims
• Will strengthen national funding applications (impact!)
• Can benefit from setup already available – reduces cost, improves confidence,

promotes standardisation

• Requires “multi-centre thinking” when setting up single centre studies

iBEAT: MRI infrastructure – central MR physics site

• Can be scaled up
• Can be made available for other studies
• Happy to share infrastructure and/or experience as needed