Project number 600932

A clinically-led VPH project developing an

innovative model-driven data and workflow-based

digital repository for paediatrics

Project details

ICT-2011.5.2 - Virtual Physiological Human

+/- 11.800.000 € financing

22 european partners

Started on 1° March 2013 - duration: 48 months

Capitalise the experience of previous EU-funded projects:

Sim-e-Child and Health-e-Child

Project contact and details: http://www.md-paedigree.eu/

Goals

Develop a robust and reusable multi-scale models for more

predictive, individualised, effective and safer healthcare

Support evidence-based translational medicine at the point of care

Establish a worldwide advanced paediatric digital repository

Facilitate collaborations within the VPH community

Main features

Clinically-driven and strongly VPH-rooted

7 world-renowned clinical centres of excellence

improved interoperability of biomedical information, data and

knowledge by developing a set of multi-scale models

scientifically and technologically supported by:

leading industrial actor in medical applications

highly qualified SMEs

some of the most experienced research partners in the VPH

community

Genetic Images Domain Knowledge Data &

Information Sources

Cloud/Grid -Based

Repository

Cloud Platform (Private/Public) & HPC Infrastructure

Patient Knowledge Base (Data, Models)

General Knowledge Base (Ontologies)

Computation Services Storage/Retrieval

Services Knowledge Management

Services

Semantic Data & Knowledge Integration

Lab Values Clinical

Model Integration/Re-Use Knowledge Discovery

Analytics, & Modelling

Layer

Physiome Modelling & Simulation

Diagnosis Prediction Treatment

Population Groups at Risk Individual

Disease Applications & Workflows

Cardiomyopathies Obesity-related

Cardiovascular Disease Juvenile Idiopathic

Arthritis (JIA)

Neurological & Neuromuscular Diseases (NND)

… Gait

Structure

On November 8, 2013 MD-Paedigree was awarded the Best Exhibit Award at ICT2013.

Award

ICT2013 hosted over 200 exhibits and 5500

participants from all over the world (Vilnius, Lithuania 6-8 November 2013).

MD-Paedigree’s governance

ETHICAL AND LEGAL COMMITTEE

Pres. Laura Palazzani

LUMSA

Ethical and Legal Committee

The general function of the Ethical and Legal Committee

inside the project is to “monitor and review project

deliverables authorizing release where ethical questions

arise and monitor for upcoming ethical and legal

implications”

Committee’s Composition

Presindent Laura Palazzani (IT)

• Components:

• Herman Nys (BE)

• Siobhan O’Sullivan (IR)

• Linda Nielsen (DK)

• Maria Luisa Di Pietro (IT)

• Marco Trabucchi (IT)

Ethical and Legal Committee Annual Report

The general ethical and legal criteria for evaluation (specified in

the different medical area) should be:

1. scientific relevance and methodology of the research;

2. inclusion and exclusion criteria of participants;

3. criteria for patient’s enrolment;

4. informed consent and when possible minor’s assent (on the explanation of

the research; foreseen risks/benefits; therapeutic alternatives; voluntary

participation; possibility to withdraw consent);

5. evaluation of benefits/risks of the research

Ethical and Legal Committee Annual Report

General guidelines on two main points:

• Clinical:

1. the collection and storage of biological samples;

2. the collection of clinical data;

• Non clinical:

1. recommends the elaboration of guidelines for the

application of the predictive models

Ethical and Legal Committee Annual Report

Elaboration of guidelines for the application of the predictive

models.

These recommendations should refer to the following points of

ethical relevance:

1. keeping the critical awareness of physicians/clinicians on the fact that

the models are virtual

2. reminding to physicians/clinicians that the model cannot substitute the

real concrete clinical evaluation case by case

3. considering the ethical and qualitative limits of algorithms