Our Project Organization

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To achieve project objectives GUIDE.MRD is organized in 7 Work Packages (WPs):

WP1: “Project management and coordination”

The goal of WP1 is to establish full synergy, motivation, and effective interactions among GUIDE.MRD Partners with the aim of delivering successful progresses of the Project within the agreed time, cost and quality limits as defined by the Grant Agreement signed with the IHI and the Consortium Agreement signed among the Partners.

WP2: “Development of ctDNA reference materials and analytical benchmarking of ctDNA diagnostics for Minimal Residual Disease (MRD) assessment”

The objectives of WP2 are:

To review available commercial solutions and to select/generate reference materials for different ctDNA features such as mutation and methylation.
To assess, compare, benchmark and rank commercial diagnostic ctDNA tests based on multiple criteria for subsequent clinical validation in WP3.

WP3: “Clinical validation and benchmarking of top performing ctDNA diagnostics”

The goal of WP3 is to assess and benchmark the top performing ctDNA diagnostics identified in WP2 on clinical samples from appropriate time-points in the MRD and surveillance setting. The main objectives of this work package are:

To conduct prospective clinical studies (colorectal, lung, and pancreatic cancer) and to collect plasma at relevant time-points for clinical-decision making (GUIDE.MRD-01-through-03 clinical trials).
To benchmark and assess the potential for clinical utility of the top-performing ctDNA diagnostics from WP2 on the plasma from the GUIDE.MRD-01-through-03 prospective clinical studies.
To assess the clinical utility of the best performing ctDNA diagnostic.
To conduct an interventional randomized clinical trial (GUIDE.MRD-05-RANDOM) to confirm clinical utility of the best performing ctDNA diagnostic, for guiding clinical decision making regarding multi-modal therapies.

WP4: “Data management, governance, statistical and AI analysis”

The aims of WP4 are:

To design and implement a GUIDE.MRD data repository.
To assess the analytical validity of the selected assays against the reference materials and conditions generated in WP2.
To analyze the performance (clinical validity) of the selected tests derived from the ranking in WP2 for prediction of the clinical outcomes in each of the four individual cohorts built in the GUIDE-MRD-01-through-03 clinical studies in WP3.

WP5: “Communication, dissemination and exploitation”

The objectives of WP5 are:

To communicate and disseminate the project results beyond the project Partners to a large audience and potential users of the results, including the clinical/scientific community and the general public with particular emphasis to Open Access and FAIRness.
To reinforce the scientific position of the clinical, academic and private members.
To guarantee the adequate exploitation of project outcomes, seeking the engagement of potential users of results (industry, citizens, other commercial players and policy makers) and ensuring appropriate IPR protection of results facilitating their pre-commercial development
To identify sustainability needs together with all WPs and support the continuation of assets and activities beyond the IHI phase through a workable sustainability strategy.
To translate the achievements and results into new therapeutic approach for clinical use and public health benefit, into useful tools for R&D (pharmaceutical industry) and the healthcare community, thus ensuring the implementation and exploitation of the project results.

WP6: “Stakeholder engagement“

The mains goals of WP6 are:

To ensure that all WPs are supported to build dialogues with relevant stakeholders from the outset of the project, to co-create solutions for better, swifter and more sustainable integration into healthcare systems.
To support all other work packages to be able to effectively engage with external stakeholders (individual advocates, people living with cancer, healthcare professionals, decision-makers) when and where appropriate to understand barriers and obstacles and co-create and propose optimize solutions that will address their (unmet) needs to drive project sustainability.
To engage with regulatory and HTA authorities, with input from other key stakeholders as needed such as the Notified Bodies given their role in the assessment and approval of Companion Diagnostics to facilitate the adoption of evidence and standards.
To help establish the needs and gaps to embed the ctDNA reference framework as a best practice approach for informing decision-making and to deploy across precision medicine for better individual and health outcomes.
To engage key stakeholders and involve them throughout the project to foster alignment and convergence through geographies and stakeholder groups.

WP7: “Ethics requirements“

WP7 sets out the ethics requirements for the Project.

Main inter-relations among GUIDE.MRD WPs

Our objectives

How we work

This project is supported by the Innovative Health Initiative Joint Undertaking (JU) under grant agreement No 101112066.
The JU receives support from the European Union’s Horizon Europe research and innovation programme and EFPIA (including Vaccines Europe), MedTech Europe and LGC Clinical Diagnostics INC.
Funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.