EUROPEAN NUTRITIONAL PHENOTYPE ASSESSMENT AND

DATA SHARING INITIATIVE

Martine Laville

Responsable WP5 : Regulation

Objective

• To deliver: • Open access research infrastructure

• Containing data from a wide variety of nutritional studies

• Including mechanistic/interventions and epidemiological studies

• With a multitude of phenotypic outcomes

• To facilitate combined analyses in the future

Data should be FAIR

• Findable – Easy to find by both humans and computer systems and based on mandatory description of the metadata that allow the discovery of interesting datasets;

• Accessible – Stored for long term such that they can be easily accessed and/or downloaded with well-defined license and access conditions (Open Access when possible), whether at the level of metadata, or at the level of the actual data content;

• Interoperable – Ready to be combined with other datasets by humans as well as computer systems;

• Reusable – Ready to be used for future research and to be processed further using computational methods

‘European Open Science Cloud’ initiative

ENPADASI Consortium

9 countries

Jildau Bouwman ENPADASI

FiND consortium INDIANA NEH-ULg consortium

FORCE-EISBM consortium

JINN-DAT Consortium NutriExp

TNO MNES consortium TUM

NIHD & BioCC

NEXS & UCph

CIBERDEM CIBEROBN IIS La Fe

JINGO

Data sharing in Nutrition (DASH-IN)

Intervention studies (design only)

Intervention studies (incl clean data)

Observational studies (incl clean data)

Observational studies (design only)

Is there a study with similar design? improve power

Is there a study with similar outcome? validate outcome

Are there a studies with specific interventions and outcome

Is there a study with similar design? Extend measures

Infrastructure details

Federated database

Required Actions

• Collect nutritional study data (WP2)

– Observational

– Intervention

• Standardize terminology (WP4)

• Guidelines for ethics, IP, protection, sharing (WP5)

• Develop the system to integrate nutritional studies (WP3)

• Test the integration in study cases (WP2,3,4)

• Train users (WP6)

Acknowledgements

• All ENPADASI partners

• WP2 – Study data (Lars Dragsted)

• WP3 – Database (Corrado Priami)

• WP4 - Integration (Duccio Cavalieri)

• WP5 – Regulation (Martine Laville)

• WP6 – Training (Lorraine Brennan)

See also: test.dbnp.org (user=user password=useR123! )

Ontology workshop

Intervention studies

www.dbnp.org

Collect, harmonize and distribute data

Study Meta-data

Clinical chemistry data

Transcriptomics

Metabolomics

Multi-study analysis and

results

Supplement mix

Placebo

Week 5

-

Supplement mix Group 1

Group 2

Week 10

-

-

Placebo

- Group 3

Group 4

Placebo

-

-

-

-

Supplement mix

Supplement mix

Placebo

Week 15 Week 20

OGTT HF-PPC

OGTT HF-PPC

OGTT HF-PPC

OGTT HF-PPC

Complex design

Complex design

Output possibilities

• For study comparison computer access to software that can analyse your data, e.g. R

• Search option

• Excel export

• Visualisation (Pathvisio, simple graphs)

WP 5: Regulations

• Reuse of data

– Inform consent

– Legal authorities approval: type of investigation

– Personal data protection

– Consortium agreement: IP

Tasks & Time Line

WP 6 : J.Walton, WP 2: K.Nimptsch

Review of existing similar initiatives

• BioMedBridges:

Regulations, privacy and security (W.Kuchinke)

- specific tool for assessment of regulatory and ethical

requirements

- eTricks:

• The Code of Practice on Secondary Use of Medical

Data in Scientific Research (Anne Bahr)

– This Code provides EU harmonized operational solutions to be

compliant with the EU Privacy directive

• Anonymization/De-identification and Pseudonymization

Review of existing similar initiatives

• CORBEL Coordinated Research Infrastructures Building Enduring Life-Science Services (ELIXIR)

– to develop procedures to provide the scientific community with access, to the patient-level data from previous clinical trials for re-analyses, secondary analyses and meta-analyses and to test them in a pilot/demonstrator

• BIOSHARE

– Data Shield: share individual-level analysis without sharing the data

Nos besoins

• Juristes

– Partage de la propriété intellectuelle

• CNIL

– Validation des procédures d’anonymisation