PARENCHIMA WG3 MEETING UTRECHT 23/04/2018 THE IBEAT STUDY SETUP – A MODEL FOR PARENCHIMA?
Scaling up research Consortium-type thinking The IMI-2 Collaboration & Funding Construct (2014-2024) : 1.425 billion EUR 1.638 billion EUR Associated 3.276 billion partners EUR 213 million EUR 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: Project budget: • Academic partners are funded 50% efpia + 50% EU • Industry partners provide in-kind 2
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 opt-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 objectives 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
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