1. ACRIN Fall Meeting 2010 BDMC Report and Perspective Constantine Gatsonis, PhD ACRIN Biostatistics and Data Management Center Brown University

2. ACRIN Fall Meeting 2010 1.Developing and launching new studies:  Cancer: 6681, 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 4006  Cardiovascular: 4005, 4701 2.Analyzing data for primary and secondary papers and abstracts:  6652, 6654, 6657, 6660, 6661, 6664, 6665, 6666, 6667, 6668, 6673, 6677, 6683 AHRQ funding for RESCUE 3.Pursuing new research and funding opportunities: AHRQ funding for RESCUE BDMC 2009-2010: Highlights

3. ACRIN Fall Meeting 2010 1.Deciphering the link of tests to outcomes  CT Angiography vs usual care ( 4005 and 4701- the RESCUE study)  Pre-op MRI for breast cancer (6694, with ACOSOG ) 2.Accuracy in diagnosis and staging  DCE-CT vs DCE-MRI for HCC (6690)  PET/CT for H&N cancer (6685) 3.Imaging-based biomarkers for predicting response and long term outcomes. Themes of new studies

4. ACRIN Fall Meeting 2010 1.Methodologic challenges Building the outcomes enterprise: ACRIN in the CER era Dx information Outcomes CER calls for illuminating the complex path: The main pathway goes through therapy

5. ACRIN Fall Meeting 2010 2.Randomized studies  address many of the methodologic difficulties  but can be large, lengthy, and costly.  ACRIN has unique scientific expertise, practical experience and infrastructure to pursue them Building the outcomes enterprise: ACRIN in the CER era Dx information Outcomes

6. ACRIN Fall Meeting 2010 3.Observational studies  Registries (e.g. NOPR)  Linkage of clinical trial data and secondary databases (CMS, EMR)  Important opportunities for ACRIN  Area for current GO grant (Dartmouth, Brown, NOPR, Tufts EPC), built around ACRIN’s Outcomes Committee and NOPR Building the outcomes enterprise: ACRIN in the CER era Dx information Outcomes

7. ACRIN Fall Meeting 2010 4.Modeling studies  To assess the impact on outcomes using the findings from ACRIN trials ( DMIST, NLST, NCTCC, 6666)  To combine information from ACRIN trials with others from the literature (CISNET )  Area for to develop, with leadership from ACRIN’s Outcomes Committee Building the outcomes enterprise: ACRIN in the CER era Dx information Outcomes

8. ACRIN Fall Meeting 2010 The scope of ACRIN research (if we can ensure appropriate funding !) CER era Dx information Outcomes