ACRIN BDMC Fall 2011 Biostatistics and Data Management Center Constantine Gatsonis, PhD Department...
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![Page 1: ACRIN BDMC Fall 2011 Biostatistics and Data Management Center Constantine Gatsonis, PhD Department of Biostatistics Center for Statistical Sciences Brown.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649e625503460f94b5d763/html5/thumbnails/1.jpg)
ACRIN BDMC Fall 2011
Biostatistics and Data Management Center
Constantine Gatsonis, PhDDepartment of Biostatistics
Center for Statistical Sciences Brown University
![Page 2: ACRIN BDMC Fall 2011 Biostatistics and Data Management Center Constantine Gatsonis, PhD Department of Biostatistics Center for Statistical Sciences Brown.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649e625503460f94b5d763/html5/thumbnails/2.jpg)
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· DOD funding for DCAMP- new consortium to study
biomarkers for lung cancer
4. Building the alliance with ECOG
BDMC 2010-2011: Highlights
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ACRIN BDMC Fall 2011
NLST comes to conclusion
Radiology, Jan 2011
![Page 4: ACRIN BDMC Fall 2011 Biostatistics and Data Management Center Constantine Gatsonis, PhD Department of Biostatistics Center for Statistical Sciences Brown.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649e625503460f94b5d763/html5/thumbnails/4.jpg)
ACRIN BDMC Fall 2011
NLST comes to conclusion
NEJ M August 2011
![Page 5: ACRIN BDMC Fall 2011 Biostatistics and Data Management Center Constantine Gatsonis, PhD Department of Biostatistics Center for Statistical Sciences Brown.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649e625503460f94b5d763/html5/thumbnails/5.jpg)
ACRIN BDMC Fall 2011
NLST comes to conclusion
![Page 6: ACRIN BDMC Fall 2011 Biostatistics and Data Management Center Constantine Gatsonis, PhD Department of Biostatistics Center for Statistical Sciences Brown.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649e625503460f94b5d763/html5/thumbnails/6.jpg)
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.
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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
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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
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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
Informatics: Medidata is here !
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ACRIN BDMC Fall 2011
Biostatistics and Data Management Center of ECOG-ACRIN alliance
Planning for the next decades
ScreeningPreventionScreeningPrevention
DiagnosisStaging
DiagnosisStaging TreatmentTreatment
Response Marker
Response Marker
Surveillance
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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.
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ACRIN BDMC Fall 2011
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ACRIN BDMC Fall 2011
ScreeningPreventionScreeningPrevention
DiagnosisStaging
DiagnosisStaging TreatmentTreatment
Response Marker
Response Marker
Surveillance