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Biostatistics and Data Management Center Constantine Gatsonis , PhD Department of Biostatistics

Biostatistics and Data Management Center Constantine Gatsonis , PhD Department of Biostatistics Center for Statistical Sciences Brown University. BDMC 2010 -2011: Highlights. Developing and launching new studies :

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Biostatistics and Data Management Center Constantine Gatsonis , PhD Department of Biostatistics

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

  2. BDMC 2010-2011: Highlights • 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) • Pursuing new research and funding opportunities: • AHRQ funding for RESCUE • DOD funding for DCAMP- new consortium to study biomarkers for lung cancer • Building the alliance with ECOG

  3. NLST comes to conclusion Radiology, Jan 2011

  4. NLST comes to conclusion NEJ M August 2011

  5. NLST comes to conclusion

  6. 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. Themes of current studies • Imaging-based biomarkers for predicting response and long term outcomes (majority of new studies) • 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. • Accuracy in diagnosis and staging • DCE-CT vs DCE-MRI for HCC (6690) • PET/CT for H&N cancer (6685) • Screening

  8. 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. Informatics: Medidataishere ! • 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

  10. Planning for the next decades Surveillance Diagnosis Staging Biostatistics and Data Management Center of ECOG-ACRIN alliance Screening Prevention Treatment Response Marker

  11. 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. Surveillance Diagnosis Staging Screening Prevention Treatment Response Marker

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