1. All Rights Reserved, Duke Medicine 2007 Duke Cancer Institute caBIG Implementation Strategy Presented to caBIG Architecture WS May 06, 2011 Pankaj Agarwal Duke Bioinformatics Shared Resource Duke Cancer Institute

2. All Rights Reserved, Duke Medicine 2007 Agenda Duke Cancer Institute caBIG Development and Adoption Building Blocks caBIG® Implementation Framework Benefits of caBIG® Adoption Current Pilot Future Plans

3. All Rights Reserved, Duke Medicine 2007 Duke Cancer Institute Duke Hospital is in the top 10 “Honor Roll” hospitals and the top in the South by U.S.News & World Report. Top-Ranked in Cancer Care hospital (12 th ) Significant expansion is underway…

4. All Rights Reserved, Duke Medicine 2007 Duke Cancer Institute 7 floors, including 3 clinic floors 267,000 square feet Construction began: early 2010 Construction complete: early 2012 Estimated project cost: $222 million

5. All Rights Reserved, Duke Medicine 2007 caBIG Development –CTMS Knowledge Center –Cancer Central Participant Registry (C3PR) –caTRIP Many elements part of other caBIG applications –RProteomics –VCDE Mentorship –Architecture Mentorship

6. All Rights Reserved, Duke Medicine 2007 caBIG Adoption –Flagship C3D implementation Many trials in production, many more in development –caAERS (CALGB and Duke) (recommended) –C3PR multi-center pilot –caGRID –RProteomics by June 2011 –caArray

7. All Rights Reserved, Duke Medicine 2007 Data Entity Overview This diagram illustrates data in clinical trials research.

8. All Rights Reserved, Duke Medicine 2007 Program Project (P01)Proposal This flow diagram illustrates the Program Project (P01) Proposal.

9. All Rights Reserved, Duke Medicine 2007 Benefits of caBIG Adoption C3D –Top-shelf CDMS (with CBIIT tech. support) –Regulatory compliant (21 CFR Part 11) –Shared Global Library (parent-child) –caDSR-Direct (local curation ability) –Thousands of Common Data Elements –Development curve Less steep now, new trials up much faster More cluster (brain, breast, etc) replication

10. All Rights Reserved, Duke Medicine 2007 Supported Projects on caBIG Platforms Goal: All Investigator-initiated Clinical Trials Currently ~40 trials in production or development –Single and multi-center –Both IND/IDE and Registry International –Launching first trial with Beijing Cancer Hospital …more to come Funding Mix –Gov’t – NIH (NCI, NINDS, etc) and DoD –Foundation (Komen, etc.) –Industry/Pharma

11. All Rights Reserved, Duke Medicine 2007 Duke-Beijing Abraxane Trial Dike C3D Server CRF’s created for Beijing Study CRF’s accessed by client machine in China First CT collaboration caTissue-based tumor registry Future network in China

12. All Rights Reserved, Duke Medicine 2007 C3PR Multi-center Pilot (Completed) PANVAC multi-center vaccine study –Grid-enabled –Secure –Accessible Dorian GT S CDS webSSO caXchange Key Id P Study Service Registration Service XYZ Cancer Center

13. All Rights Reserved, Duke Medicine 2007 Adoption In Progress caTissue –Pilot implementation underway –Potential for broad institutional adoption caArray –Installed –caGrid enabled DSIC tools (being evaluated) –Primarily to meet data sharing requirement

14. All Rights Reserved, Duke Medicine 2007 Other Projects CCSG Core Grant Supplements CTRP Early Adopter ADOPT RDC Center Deployment Lead caBIG Participant Contracts Architecture (Pankaj Agarwal) VCDE (Sal Mungal)

15. All Rights Reserved, Duke Medicine 2007 Future Plans C3D –Streamline trial start-up with eCRF Harmonization –Exchange data with caAERS –Complete integration with Velos eResearch Expanded use of caARRAY by Bioinf. group China –Set-up local Suite environment in Beijing –Build-out multi-center Chinese network

16. All Rights Reserved, Duke Medicine 2007 Questions? Q & A