The INTEGRATE project: Delivering solutions for efficient multi-centric clinical research and trials

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Highlights

  • Integration of multi-scale biomedical data with post-genomic clinical trials.

  • Ethical and Security Framework for post-genomic clinical trials.

  • Advanced Patient Screening for clinical trials.

  • Collaborative remote environment for pathology review.

  • Cohort selection, qualitative analysis and prediction models for large multi-level patient datasets.

Abstract

The objective of the INTEGRATE project (http://www.fp7-integrate.eu/) that has recently concluded successfully was the development of innovative biomedical applications focused on streamlining the execution of clinical research, on enabling multidisciplinary collaboration, on management and large-scale sharing of multi-level heterogeneous datasets, and on the development of new methodologies and of predictive multi-scale models in cancer.

In this paper, we present the way the INTEGRATE consortium has approached important challenges such as the integration of multi-scale biomedical data in the context of post-genomic clinical trials, the development of predictive models and the implementation of tools to facilitate the efficient execution of postgenomic multi-centric clinical trials in breast cancer.

Furthermore, we provide a number of key “lessons learned” during the process and give directions for further future research and development.

Graphical abstract

INTEGRATE – Closing the loop between clinical research and care in oncology through innovative applications and by improving the information and knowledge flow. The four applications described in this paper leverage our sematic interoperability solution that integrates clinical research and care infrastructures. While CPR and DECIMA impact the care domain and the execution phase of clinical research, Nona and AP address the needs of the clinical researcher, and the definition and design phases of clinical research. The loop is closed by delivering the new data from clinical care and from trials back into the INTEGRATE environment. This solution also helps closing the knowledge loop: new hypotheses lead to new clinical trials and validated trial results become new treatment options.

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Abbreviations

AC
Access Control
AP
Analysis Platform
BC
Breast Cancer
BRIDG
Biomedical Research Integrated Domain Group
CDM
Common Data Model
CDP
Centre for Data Protection
CIM
Common Information Model
CNS
Central Nervous System
CRP
Central Review for Pathology
eCRF
electronic Clinical Report Form
EHR
Electronic Health Record
ER
Estrogen Receptor
FUH
Frankfurt University Hospital
GBG
German Breast Group
HGNC
database of human gene names
HL7
health level 7
INTEGRATE
project acronym for the project with the full title “Driving Excellence in Integrative Cancer Research through Innovative Biomedical Infrastructures”
IJB
Institute Jules Bordet
ISO
International Organization for Standardization
IT
Information Technology
IdPs
Identity Providers
LOINC
Logical Observation Identifiers Names and Codes
MEDDra
Medical Dictionary for Regulatory Activities
PDP
Policy Decision Point
RIM
Reference Information Model
SIL
Semantic Integration Layer
SUS
System Usability Scale
SSO
Single Sign On
STS
Security Token Service
TTP
Trusted Third Party
XACML
eXtensible Access Control Markup Language

Keywords

Innovative biomedical applications
Semantic integration
Post-genomic clinical trials
Collaborative environment
Cohort selection
Predictive models
Quantitative analysis

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