ACRIN Annual Meeting 2010 Mitchell Schnall MD, PhD Professor of Radiology University of Pennsylvania ACRIN Network Chair State of ACRIN : Working to secure

ACRIN Annual Meeting 2010

Mitchell Schnall MD, PhDProfessor of RadiologyUniversity of PennsylvaniaACRIN Network Chair

State of ACRIN : Working to secure our future


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 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


Deputy Chairs Anat/Fxn ImagingDenise Aberle, MD

UCLA

Molecular ImagingBarry Siegel, MD

Washington University

Steering Committee

Network ChairMitchell Schnall, MD, PhD


Deputy Chairs Anat/Fxn ImagingDenise Aberle, MD

UCLA

Molecular ImagingBarry Siegel, MD


AbdominalTerri Wong, MDDuke University

AbdominalTerri Wong, MDDuke University

Head/Neck/CNSGreg Sorensen, MD

Massachusetts General Hosp

Head/Neck/CNSGreg Sorensen, MD


BreastConnie Lehman, MD

University of Washington

BreastConnie Lehman, MD


ThoracicCaroline Chiles, MDWake Forest University

ThoracicCaroline Chiles, MDWake Forest University

GynecologicalSusanna Lee, MD


GynecologicalSusanna Lee, MD


Disease SiteCommittees

Scientific SupportCommittees

Experimental ImagingDavid Mankoff, MD


Experimental ImagingDavid Mankoff, MD


InformaticsDaniel Rubin, MDStanford University

InformaticsDaniel Rubin, MDStanford University

Core Laboratory

PET/Nuc MedicineBarry Siegel, MD


MR/CTMark Rosen, MD, PhDUniversity of Pennsylvania

Core Laboratory

PET/Nuc MedicineBarry Siegel, MD


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


ACRIN PAMitch Schnall, MD, PhD


NeuroscienceGreg Sorensen, MD


NeuroscienceGreg Sorensen, MD


ACRIN ProjectsMitch Schnall, MD, PhD


ACRIN ProjectsMitch Schnall, MD, PhD


Non NCI Disease SiteCommittees

ACRIN FoundationJim Thrall, MD

MGH

ACRIN FoundationJim Thrall, MD

MGH


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)


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


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


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


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


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


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)


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



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


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


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


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)


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


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)


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


Challenges for 2011

Continue to build support for ACRIN in imaging and cancer community

Continue to expand internationally Enhance site support Maintain a pipeline of trials in development

Documents

ACRIN Annual Meeting 2010 Mitchell Schnall MD, PhD Professor of Radiology University of Pennsylvania ACRIN Network Chair State of ACRIN : Working to secure