1. ACRIN BDMC Fall 2011 Biostatistics and Data Management Center Constantine Gatsonis, PhD Department of Biostatistics Center for Statistical Sciences Brown University

2. ACRIN BDMC Fall 2011 1.Developing and launching new studies :  Cancer : 6690, 6691, 6692, 6693, 6694, 6695, 6696, 6697, 6698, 4006, 7151, plus concepts in development  Cardiovascular: 4701- the RESCUE trial 2. Analyzing data for primary and secondary papers and abstracts ( data from 18 protocols) 3.Pursuing new research and funding opportunities: AHRQ funding for RESCUE  AHRQ funding for RESCUE  DOD funding for DCAMP- new consortium to study biomarkers for lung cancer 4.Building the alliance with ECOG BDMC 2010-2011: Highlights

3. ACRIN BDMC Fall 2011 NLST comes to conclusion Radiology, Jan 2011

4. ACRIN BDMC Fall 2011 NLST comes to conclusion NEJ M August 2011

5. ACRIN BDMC Fall 2011 NLST comes to conclusion

6. ACRIN BDMC Fall 2011 NLST comes to conclusion  Study follow-up concluded and database cleaned and locked ( a very large scale effort).  “Omnibus” paper on study published in Radiology.  Key study finding on reduction of lung cancer specific mortality by CT screening announced by NCI Director in November 2010.  Primary paper published in NEJM.  Work underway on a large number of papers, reporting on secondary aims and other aspects of the study.  Access to biospecimens and clinical data has begun.

7. ACRIN BDMC Fall 2011 1.Imaging-based biomarkers for predicting response and long term outcomes ( majority of new studies ) 2.CER for imaging: Linking tests to outcomes  CT Angiography vs usual care ( 4005 and RESCUE)  Pre-op MRI for breast cancer (6694, with ACOSOG)  Two concepts for lung cancer in development. 3.Accuracy in diagnosis and staging  DCE-CT vs DCE-MRI for HCC (6690)  PET/CT for H&N cancer (6685) 4.Screening Themes of current studies

8. ACRIN BDMC Fall 2011 ACRIN studies contribute evidence on the major questions on imaging biomarkers  Preliminaries:  Standardize biomarker measures across machines and institutions  Establish test-retest reproducibility  Clinical care: Establish optimal use of imaging biomarkers in determining therapy and monitoring its effectiveness.  Clinical trials :  Imaging biomarkers used to define endpoints  Imaging biomarkers used to decide on therapy modifications in adaptive designs

9. ACRIN BDMC Fall 2011  NCI supported software system for data collection and management  To be used by all cancer collaborative groups  Transition to Medidata is under way Training staff Piloting implementation in new protocols : Medidata Informatics: Medidata is here !

10. ACRIN BDMC Fall 2011 Biostatistics and Data Management Center of ECOG-ACRIN alliance Planning for the next decades ScreeningPreventionScreeningPrevention DiagnosisStagingDiagnosisStaging TreatmentTreatment ResponseMarkerResponseMarker

11. ACRIN BDMC Fall 2011 Integrated BDMC Goal: ECOG-ACRIN alliance has unified Biostatistics and Data Management Center. Approach:  BDMC makes optimal use of expertise available in group locations in Boston, Providence, and Philadelphia.  BDMC operations rely on an integrated informatics platform and use a common set of SOPs.

12. ACRIN BDMC Fall 2011

13. ScreeningPreventionScreeningPrevention DiagnosisStagingDiagnosisStaging TreatmentTreatment ResponseMarkerResponseMarker