Reporting of Imaging-Related Trial Information

1. Reporting of Imaging-Related Trial Information Imaging Face to Face Oct 12, 2007

2. The customer is hungry.

3. Projects Within the Imaging Workspace Image Query Image Retrieval User functionality Annotation and Image Markup (AIM Project) Natural Language Processing (NLP) Imaging Case Report Forms (ICRFs) Assignment of metadata Existing CDEs ACRIN CDEs DICOM CDEs DICOM Ontology ACRIN/CDE Ontology Meta-data “standards” EVS and existing terminology RadLex Playbook RadLex Into EVS Images that undergo structured annotation and markup (e.g., NCIA, RIDER) Images with narrative descriptions (e.g., clinically reported images) Image data = funded project = possible Phase II = possible Phase III = pre-existing

4. JDCJoint Development Committee CCR DCTD Molecular Imaging Program Chemistry Section Clinical Center Drug Development Group DTP Small Animal Imaging Frederick Imaging Drug Group CIP Nanotechnology Characterization Lab Imaging Drug Development @ NCI

5. The Challenge: • Improving Real-time Reporting for Imaging-Related Trial Status information and Images

6. The Challenge • Long-term: • Provide NCI administrators real-time access to imaging clinical trial status information for all NCI-funded trials • Imaging Drug Development & Imaging related clinical trials • Immediate term: • Generate an SOP for soup-to-nuts reporting for clinical trials using caBIG tools • Demonstrate successful implementation in 3 trials

7. 18F-FES – University of Washington predict response to Tx, breast, 18FES (breast) 18F-MISO-University of Washington predict response to Tx, cervix, 18FMISO VEGF – Cancer Inst. Of New Jersey breast DCE-MRI Demonstration Trials Identified

8. Cancer Central Clinical Database(C3D) • Rapid study implementation using a Library of template CRFs based on caDSR CDEs and EVS terminology. • Improved data integrity through elimination of duplicate data entry. • Enhanced data security and patient confidentiality. • Web based remote data entry. • Electronic Case Report Forms in PDF format to easily print completed forms for paper archival. • Automated generation/extraction for electronic submission to monitors and regulators. • Robust data cleaning. • Data entry validation • Post entry discrepancy management

9. C3D Implementation • NCI Clinical Imaging Facility (CC) • 40 Trials have utilized C3D • Extramural Trials: • ~ 8 sites

10. C3D – Implementation Challenges • Imaging – related CRF’s need CDE curation • PI, RAs not able / willing to provide resources • Commercial clinical tools in place already • NCI may not provide complete training and support • Reporting approached as a technical problem rather than a workflow problem.

11. Questions: • caBIG • Imaging – related CDE curation? • How to integrate standardized reporting tools into commercial clinical systems (Oncore, etc) - • Submission of image CRF data to CRO • What tools are there to provide a dashboard of clinical data and images across trials? • CTMS / Imaging Workspace coordination • Process • How to develop training SOP to integrate image CRF reporting into workflow under different conditions? • How to ensure on-site adoption of standard tools for reporting • Do we need to improve access to ACRIN CRFs, CRFs from previous imaging trials

12. Questions (contd): • Provision of Resources • What level of effort/role is needed from C3D service provider to ensure timely reporting? • What level of support/roles can be expected from NCICB? • Workspace • How can IW tools be leveraged? • Ultimately, How to integrate CRF’s into XIP? • At what level can this integrate with “Soup-2-Nuts”