Epoch Ontological Framework to support Clinical Trial Management - PowerPoint PPT Presentation

Epoch Ontological Framework to support Clinical Trial Management Ravi Shankar Stanford Medical Informatics Stanford University

Overview � Clinical trials are used to determine whether new drugs or treatments are both safe and effective. � Complex clinical trials involve collaboration among many groups using different software applications. � Lack of standardization and reduced efficiency leads to poor productivity. � We are building an ontological framework called Epoch to improve semantic interoperability among clinical trial management applications.

The Immune Tolerance Network � ITN is an international collaboration designed to accelerate the development of immune tolerance therapies � Funds, plans, implements, monitors, and assesses investigator-initiated clinical trials of novel tolerance-promoting therapies in Autoimmune diseases • Transplantation • Allergy and Asthma • � Provides services to undertake comprehensive mechanistic studies that complement each trial

Schedule of Events

Constraint Temporal Anchor Time Annotation Visit Schedule of Events Activity Period

Specimen Table

Processing Instruction Assay Specimen Specimen Table Workflow Specimen Container Mechanistic Study

Specimen Workflow RT PCR Core 1 x 0.5 cryovial 1 x 0.5 cryovial (kidney RNA) (kidney RNA) RNA Processing 1 x 0.5ml cryovial 1 x 0.5ml cryovial Core (kidney RNA) (kidney RNA) 1 x cryomold 1 x cryomold 1 x cryovial 1 x cryovial (kidney) (kidney) (kidney) (kidney) Barcode Suffix –E21 –E21 Barcode Suffix – E22 Barcode Suffix – E22 1 x cryovial 1 x cryovial Kidney (kidney) (kidney) Lab Fisher Core 1 x cryomold 1 x cryomold (kidney) (kidney) Specimen Specimen Disposal Collection Point Point

Specimen Workflow Core RT PCR lab Core 1 x 0.5 cryovial 1 x 0.5 cryovial (kidney RNA) (kidney RNA) RNA Processing 1 x 0.5ml cryovial 1 x 0.5ml cryovial Core (kidney RNA) (kidney RNA) Site 1 x cryomold 1 x cryomold 1 x cryovial 1 x cryovial Lab (kidney) (kidney) (kidney) (kidney) Barcode Suffix –E21 –E21 Barcode Suffix – E22 Barcode Suffix – E22 1 x cryovial 1 x cryovial Kidney (kidney) (kidney) Lab Fisher Core 1 x cryomold 1 x cryomold (kidney) (kidney) Bio- Repository Specimen Specimen Specimen Container Disposal Collection Point Point

Challenges in Trials Management � Knowledge about protocols, assays, and specimen flow is captured in documents and spreadsheets Plan Implement Monitor Assess CRF Core Tracking

What is in a visit name? Visit 0, v0, v 0, 0, Day 0, Transplant

What is in a visit name? Visit 0, v0, v 0, 0, Day 0, Transplant Assay 0 Group Protocol 0 Group Specim en Table Schedule of Events

What is in a visit name? Visit 0, v0, v 0, 0, Day 0, Transplant CRO Day 0 , Transplant CRF Assay 0 Group Protocol 0 Group Specim en Table Schedule of Events

What is in a visit name? Visit 0, v0, v 0, 0, Day 0, Transplant Day 0 , Transplant CRO CRF Assay 0 Group Protocol 0 Group Specim en Table Schedule of Events Operations v 0 Group Tube Table

What is in a visit name? Visit 0, v0, v 0, 0, Day 0, Transplant Day 0 , Transplant CRO CRF Assay 0 Group Protocol 0 Fisher v 0 Group Specim en Table Kit Report Schedule of Events Cim arron v0 , Visit 0 Operations v 0 Group I m m unoTrak Tube Table

What is in a visit name? Visit 0, v0, v 0, 0, Day 0, Transplant Day 0 , Transplant CRO Core v0 CRF Labs Assays Assay 0 Group Protocol v 0 0 Fisher Group Specim en Table Kit Report Schedule of Events Cim arron v0 , Visit 0 Operations v 0 Group I m m unoTrak Tube Table