ACRIN BDMC Fall 2011 Biostatistics and Data Management Center Constantine Gatsonis, PhD Department...

ACRIN BDMC Fall 2011

Biostatistics and Data Management Center

Constantine Gatsonis, PhDDepartment of Biostatistics

Center for Statistical Sciences Brown University


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


NLST comes to conclusion

Radiology, Jan 2011



NEJ M August 2011



· 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.


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


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


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 !


Biostatistics and Data Management Center of ECOG-ACRIN alliance

Planning for the next decades

ScreeningPreventionScreeningPrevention

DiagnosisStaging

DiagnosisStaging TreatmentTreatment

Response Marker

Response Marker

Surveillance


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.


ScreeningPreventionScreeningPrevention

DiagnosisStaging

DiagnosisStaging TreatmentTreatment

Response Marker

Response Marker

Surveillance

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