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ACRIN Annual Meeting 2010
Mitchell Schnall MD, PhDProfessor of RadiologyUniversity of PennsylvaniaACRIN Network Chair
State of ACRIN : Working to secure our future
ACRIN Annual Meeting 2010
Review of ACRIN Scientific Strategy
1. Develop and evaluate strategies for imaging surveillance of populations at high risk for cancer.
2. Develop and validate imaging biomarkers to predict and monitor therapy response.
3. Evaluate the effectiveness of imaging directed therapy on improving patient management and associated outcomes. This includes comparative effectiveness studies of existing imaging methods.
ACRIN Annual Meeting 2010
ACRIN Organizational Chart
Institutional Participants CommitteeVice Chair
Chris Comstock, MDMemorial Sloan Kettering
Institutional Participants CommitteeVice Chair
Chris Comstock, MDMemorial Sloan Kettering
Media / Publications and
DisseminationCommitteeVice Chair
Laurie Fajardo, MDUniversity of Iowa
Media / Publications and
DisseminationCommitteeVice Chair
Laurie Fajardo, MDUniversity of Iowa
Special PopulationsElizabeth Patterson, MD
Special PopulationsElizabeth Patterson, MD
Research AssociatesWendy Smith, RT
Rhode Island Hospital
Research AssociatesWendy Smith, RT
Rhode Island Hospital
Quality ControlMitchell Schnall, MD, PhDUniversity of Pennsylvania
Quality ControlMitchell Schnall, MD, PhDUniversity of Pennsylvania
Patient AdvocacyBarbara LeStage, MHP
Patient AdvocacyBarbara LeStage, MHP
Outcomes & Economics Core
LaboratoryWilliam Black, MD
Dartmouth Medical School
Outcomes & Economics Core
LaboratoryWilliam Black, MD
Dartmouth Medical School
Advisory PanelDaniel Sullivan, MD
Duke University
Advisory PanelDaniel Sullivan, MD
Duke UniversityLeadership Council
Mitchell Schnall, MD, PhDUniversity of Pennsylvania
Leadership CouncilMitchell Schnall, MD, PhD
University of Pennsylvania
Biostatistical & Data Management Center
Chair Constantine Gatsonis, PhD
Brown University
Biostatistical & Data Management Center
Chair Constantine Gatsonis, PhD
Brown University
Steering Committee
Network ChairMitchell Schnall, MD, PhD
University of Pennsylvania
Deputy Chairs Anat/Fxn ImagingDenise Aberle, MD
UCLA
Molecular ImagingBarry Siegel, MD
Washington University
Steering Committee
Network ChairMitchell Schnall, MD, PhD
University of Pennsylvania
Deputy Chairs Anat/Fxn ImagingDenise Aberle, MD
UCLA
Molecular ImagingBarry Siegel, MD
Washington University
AbdominalTerri Wong, MDDuke University
AbdominalTerri Wong, MDDuke University
Head/Neck/CNSGreg Sorensen, MD
Massachusetts General Hosp
Head/Neck/CNSGreg Sorensen, MD
Massachusetts General Hosp
BreastConnie Lehman, MD
University of Washington
BreastConnie Lehman, MD
University of Washington
ThoracicCaroline Chiles, MDWake Forest University
ThoracicCaroline Chiles, MDWake Forest University
GynecologicalSusanna Lee, MD
Massachusetts General Hosp
GynecologicalSusanna Lee, MD
Massachusetts General Hosp
Disease SiteCommittees
Scientific SupportCommittees
Experimental ImagingDavid Mankoff, MD
University of Washington
Experimental ImagingDavid Mankoff, MD
University of Washington
InformaticsDaniel Rubin, MDStanford University
InformaticsDaniel Rubin, MDStanford University
Core Laboratory
PET/Nuc MedicineBarry Siegel, MD
Washington University
MR/CTMark Rosen, MD, PhDUniversity of Pennsylvania
Core Laboratory
PET/Nuc MedicineBarry Siegel, MD
Washington University
MR/CTMark Rosen, MD, PhDUniversity of Pennsylvania
Ultrasound Working Group
Barry Goldberg, MDThomas Jefferson University
Ultrasound Working Group
Barry Goldberg, MDThomas Jefferson University
NCIJim Tatum, MD
Cancer Imaging Program
NCIJim Tatum, MD
Cancer Imaging Program
Network AdministrationCharles Apgar
ACR Philadelphia
Network AdministrationCharles Apgar
ACR Philadelphia
Data & Safety Monitoring Committee
Daniel Sargent, PhDMayo Clinic
Data & Safety Monitoring Committee
Daniel Sargent, PhDMayo Clinic
SupportCommittees
Organization
Cardiovascular Pam Woodard, MDWashington University
Cardiovascular Pam Woodard, MDWashington University
ACRIN PAMitch Schnall, MD, PhD
University of Pennsylvania
ACRIN PAMitch Schnall, MD, PhD
University of Pennsylvania
NeuroscienceGreg Sorensen, MD
Massachusetts General Hosp
NeuroscienceGreg Sorensen, MD
Massachusetts General Hosp
ACRIN ProjectsMitch Schnall, MD, PhD
University of Pennsylvania
ACRIN ProjectsMitch Schnall, MD, PhD
University of Pennsylvania
Non NCI Disease SiteCommittees
ACRIN FoundationJim Thrall, MD
MGH
ACRIN FoundationJim Thrall, MD
MGH
ACRIN Annual Meeting 2010
Progress over Past year Have 12 studies open to accrual
3 ACRIN PA (4005 accrued 663 to date) 9 ACRIN CORE (Modest Accrual)
4 concepts approved, preparing to open, 4 concept submitted
Cancer Center imaging qualification initiative under way
Successfully competed for a grant from AHRQ CER of CTA vs SPECT in the initial evaluation of stable
angina (10 million)
ACRIN Annual Meeting 2010
Open Studies
4003/4004: Evaluation of a Novel PET Radiopharmaceutical to Identify Patients with Alzheimer’s Disease
4005: CT Coronary Angiogram vs Traditional Care for Low-Risk ED Pts with Potential Acute Coronary Syndromes
6671: Cervical and Endometrial Cancers: Staging with PET/CT 6678: Lung Cancer: Evaluation of Treatment Response with PET 6682: Cervical Cancer:64Cu-ATSM PET/CT Assessment of
Tumor Hypoxia 6684: Newly Diagnosed Glioblastoma: Assessment of Tumor
Hypoxia with FMISO PET, DCE MRI and MRS 6685: Staging of Head and Neck Cancer: Assessment of FDG-
PET/CT and the Impact on N0 Neck Surgical Treatment
ACRIN Annual Meeting 2010
Open Studies Cont.
6686: Newly Diagnosed Glioblastoma: Substudy of Tumor Assessment with Advanced MRI
6687: 18F-Fluoride PET as a Biomarker for Prostate Cancer and Bone Metastases
6688: Phase II Study of FLT PET in Invasive Breast Cancer 6689:Newly Diagnosed Glioblastoma: Substudy of Tumor
Assessment with FLT PET and DCE MRI and MRS
ACRIN Annual Meeting 2010
Unique ACRIN Accrual Challenges
Studies of markers for clinical trials associated with less immediate impact on care, reducing site/patient enthusiasm
Complex studies Operational challenges at site level (scheduling!) Funding limitations The “VEN” diagram problem
Clinical Imaging
ACRIN Annual Meeting 2010
Approaches
More emphasis on site / patient accrual in review
Reduce study complexity Earlier involvement of RA committee and
advocates Collaboration with treatment groups Complement portfolio with clinical
diagnostic studies (6685/6690) Accrual Strategy Session: Friday 1:00-2:30
ACRIN Annual Meeting 2010
Nearing preparation for the next grant cycle IOM report calling for reorganization and consolidation
of the groups OEWG implements hard timelines Change in leadership at NIH, NCI and CIP Clinical effectiveness of imaging relative to cost and
exposure being challenged Funding opportunities changing (NLST, ARRA ending;
CER/PCORI starting)
Critical Time for ACRIN
ACRIN Annual Meeting 2010
OEWG Guidelines
Concept Review
Concept revision/ review cycles
Protocol development
Protocol review
Protocol revision/review cycles
Forms development
0 30 90 180 210 300
Timeline pauses if industry negotiations cause delay
If registration trial, FDA review in 30 days
Time (days)
ACRIN Annual Meeting 2010
Other Notable OEWG Activities
Cost effectiveness sub-study funding now available through the BIQSFP mechanism
Imaging Steering committee to be established
Medidata license Financial analysis of cooperative groups
complete
ACRIN Annual Meeting 2010
Requested by NCI to address several issues regarding the NCI clinical trials program The infrastructure has not evolved to adequately
incorporate the rapid pace of scientific discovery The process is inefficient (delays, incomplete trials) Government oversight overly complex Funding is inadequate Industry trials are moving overseas Biomarker driven selection of appropriate treatment will
enhance outcomes (at increased cost)
IOM Study
ACRIN Annual Meeting 2010
Key Recommendations Increase speed and efficiency of study
development and conduct Consolidate “Front office” through peer review Consolidate “Back office”/improve operations Streamline regulation International Coordination/Collaboration
Innovation in science and design Central tissue (imaging) repositories Innovative trials including biomarkers National standards for imaging procedures and
biomarker tests
ACRIN Annual Meeting 2010
Key Recommendations
Improve trial prioritization, selection, and support Evaluate role of NCI Increase accrual volume
Increase funding to cooperative group program
Incentivize participation Support investigators Cover cost of patient care in clinical trials
ACRIN Annual Meeting 2010
Next Steps
NCI considering response Input from NCAB expected Discussed at CTAC
• 50% of the costs of trials are contributed by “volunteerism” some related to group association
• Consolidation unlikely to reduce cost
Cooperative group leadership developing proposal
Multiple professional societies etc weighing in (generally in support of groups)
ACRIN Annual Meeting 2010
Leadership Transition
New leadership of NCI comes from a bench science background
Focused on removing barriers to translation of genomics (and other “omics”) to medical care
Highlight value of correlative science in clinical trials
Transition of leadership at CIP Paula Jacobs to serve as interim Associate Director Lalitha Shankar Chief of the Clinical Trials Branch
ACRIN Annual Meeting 2010
Positioning of ACRIN
Unique niche in trials system We are collaborative: RTOG, GOG, ACOSOG, NCCTG, SWOG,
CALGB, QARC, ABTC, ECOG
Biomarkers are important part of NCI vision However:
Can we accrue these trials? Whose science is it?
• Strategic alliances with treatment groups Is there support for trials of contemporary questions in
radiology practice?
• AHRQ/PCORI to support CER research
• Compete for CER research funding (RESCUE model)
ACRIN Annual Meeting 2010
Challenges for 2011
Accrue / publish open studies Simplify studies to increase chances for
success Continue to nurture international
collaborations Develop strategic partnerships with therapy
groups around marker development Harmonize data management and IT with the
rest of the cooperative groups Continue to diversify funding sources