Ontology Based Clinical Trial Builder Norbert Graf, Fatima Schera, Gabriele Weiler University of the Saarland, Fraunhofer Institute, Germany Clinical Trial Ontology Workshop May 16-17,
Download ReportTranscript Ontology Based Clinical Trial Builder Norbert Graf, Fatima Schera, Gabriele Weiler University of the Saarland, Fraunhofer Institute, Germany Clinical Trial Ontology Workshop May 16-17,
Ontology Based Clinical Trial Builder Norbert Graf, Fatima Schera, Gabriele Weiler University of the Saarland, Fraunhofer Institute, Germany Clinical Trial Ontology Workshop May 16-17, 2007 " Research and development on innovative ICT systems and services that process, integrate and use all relevant biomedical data for improving health knowledge and processes related to prevention, diagnosis, treatment, and personalisation of health care. " The ACGT Objective: Fighting Cancer The ACGT project sees its mission to develop a GRID platform to support and stimulate further exchanges of both clinic and genetic information. ACGT intends to trigger the emergence of latent clinico-genomic synergies to ensure faster diagnosis and more efficient therapy ACGT targets two major cancer diseases namely, breast cancer (BRCA) and paediatric nephroblastoma (PN) presented by three (running) clinical trials. In addition, in-silico oncology trial scenarios will be run to assess the utility of tumour-growth simulation on both BRCA and PN. The Unknown Reports that say That something hasn't happened Are always interesting to me because, As we know, there are known knowns. There are things we know we know. We also know There are known unknowns. That is to say We know there are some things We do not know. But there are also unknown unknowns, The ones we don't know We don't know. 12th February 2002 Press conference Trial Builder components Trial Outline Builder CRF-Creator Repository SIOP 2001 / GPOH Report / output P P P randomisation P P stratification P pathology AVD surgery P imaging P stratification Diagnosis registration imaging laboratory clinic P P AV-2 AVD HR Follow-up P AV irradiation P Pstop P AV-1 AV / AVD P SAEs / SUSARs Patient diary C timeline SIOP 2001 / GPOH Report / output P S S P P P stratification P C pathology AVD surgery P imaging C P stratification Diagnosis registration imaging laboratory clinic C randomisation P P P S AV-2 AVD HR Follow-up P AV irradiation P Pstop P AV-1 AV / AVD P Patient diary timeline This is the Ontology build in Protegé Clinical View of the Ontology Overview of the Trial Builder TrialBuilder Will support the design phase of a clinical trial Allows a clinician to capture data definition and further design specifications for a clinical trial in a standardized way Allows to create all CRFs for a trial, integrating the ACGT master ontology in a way that the data collected with the CRFs can be later queried in terms of the ontology Integrates a CRF repository for reuse of the created CRFs Clinical Data Management System will be set up by the definitions done in the Trial Builder Web based application that allows to collect the patient data for multicentric clinical trials Functionality of the Clinical Data Management System Patient Management Providing data in terms of the ontology Study Management User Management Roles &Rights Management Security solution Technical Details Web Application Jakarta Struts (open-source framework to develop Java EE web applications), Java Server Pages, Apache Tomcat Webserver Backend Spring Framework (Hibernate) Postgres database XML format for study metadata, clinical data, administrative data and ontology mapping CDISC ODM (will be extended to comprise ontology mapping) Show demonstrator Ontology integration User friendly GUI Clinician‘s View of the Ontology by selecting semantic descriptions the items for the ontology will be created automatically on CRF Tools are fully functioning without Ontology databases are independent from ontology descriptions from ontology are stored in mapping-files Queries with SPARQL in terms of the ACGT master ontology are possible Mapping of all relevant data will be done once Disease Tumor S S R Personal Data R S R Patient Therapeutic Procedure Measurements S R Symptom S R S R Disease Tumor S S R Personal Data R S R Patient Therapeutic Procedure Measurements S S R R Pharmacotherapy Symptom S R Surgical Proc. Radiotherapy S S S R R R Disease Tumor S S R Personal Data R S R Patient Therapeutic Procedure Measurements S S R R Pharmacotherapy Symptom S R Surgical Proc. Radiotherapy S S S R R R Radiotherapy of Lung S Abdominal Radiotherapy R S R Disease Tumor S S R Personal Data R S R Patient Therapeutic Procedure Measurements S S R R Pharmacotherapy S Symptom R Duration SingleDose Surgical Proc. A A TotalDose S Radiotherapy S Begin A S R R R End S R Device S Radiotherapy of Lung A Field A A R Disease Tumor S S R Personal Data R S R Patient Therapeutic Procedure Measurements S S R R Pharmacotherapy S Symptom R Surgical Proc. Radiotherapy Duration SingleDose A A TotalDose Begin S S S R R R A End S R Device S Radiotherapy of Lung A Field A A R Disease Tumor S S R Personal Data R S R Patient Therapeutic Procedure Measurements S S R R Pharmacotherapy S Symptom R Duration SingleDose Surgical Proc. A A TotalDose S Radiotherapy S Begin A S R R R End S R Device S Radiotherapy of Lung A Field A A R Advantages Enables trial chairmen to create reusable CRFs that allow collection of data that are standardized based on an underlying ontology Enables trial chairmen to create trial databases with comprehensive metadata (automatically generated from designed CRFs) data collected in the generated systems can be directly integrated over the mediator with the data in the ACGT environment (no additional mapping is needed) Systems created in this way have built-in semantic interoperability Inferring new knowledge from data entered in the ontology based clinical data management system may be possible according to relationships, axioms and rules specified in the ACGT master ontology