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BDMC Report and Perspective. Constantine Gatsonis, PhD ACRIN Biostatistics and Data Management Center Brown University. BDMC 2009 -2010: Highlights. Developing and launching new studies: Cancer : 6681 , 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 4006
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BDMC Report and Perspective • Constantine Gatsonis, PhD • ACRIN Biostatistics and Data Management Center • Brown University
BDMC 2009-2010: Highlights • Developing and launching new studies: • Cancer: 6681, 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 4006 • Cardiovascular: 4005, 4701 • Analyzing data for primary and secondary papers and abstracts: • 6652, 6654, 6657, 6660, 6661, 6664, 6665, 6666, 6667, 6668, 6673, 6677, 6683 • Pursuing new research and funding opportunities: AHRQ funding for RESCUE
Themes of new studies • 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) • Accuracy in diagnosis and staging • DCE-CT vs DCE-MRI for HCC (6690) • PET/CT for H&N cancer (6685) • Imaging-based biomarkers for predicting response and long term outcomes.
Building the outcomes enterprise: ACRIN in the CER era • Methodologic challenges CER calls for illuminating the complex path: Dx information Outcomes The main pathway goes through therapy
Building the outcomes enterprise: ACRIN in the CER era • 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 Dx information Outcomes
Building the outcomes enterprise: ACRIN in the CER era • 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 Dx information Outcomes
Building the outcomes enterprise: ACRIN in the CER era • 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 Dx information Outcomes
The scope of ACRIN research (if we can ensure appropriate funding !) CER era Dx information Outcomes