CCOP, MBCCOP

CCOP, MBCCOP &CCOP, MBCCOP &Research Base MeetingResearch Base Meeting

Lori Minasian, MDLori Minasian, MDChief, Community OncologyChief, Community Oncology& Prevention Trials Research Group& Prevention Trials Research GroupDivision of Cancer PreventionDivision of Cancer Prevention

Meeting Objectives

● Information and Updates ● Grant Related Issues ● Program Related Issues● Clinical Trials Related Issues

● Feedback on Issues● Format for Discussion

Community Clinical Oncology Program

Grant Topics

● Electronic Grant Submission

● Interpreting Notice of Award (NoA)

● Completing Financial Status Report (FSR)

● Peer Review Process


Program Topics

● New CCOP Database● Submission of Organizational Changes● Submission of Accrual Tables

● Evaluation Efforts● Breakout Sessions

● Meant to Foster Constructive Discussion● Research Base PIs/Administrators meeting● Minority Recruitment Session


Clinical Trials Topics

● CTSU Updates● CTSU Site Advisory Panel● Update on NCI’s CIRB

● CMS Clinical Trials Policy● Update on CTWG Initiatives


State of the CCOP Program


Rumors….

….About the CCOP Program’s demise have been greatly exaggerated.


CCOP & MBCCOP

Request for Applications (RFA)


CCOP & MBCCOP RFA for FY 2008

● Applications Received July 2007

● Peer Review Scheduled in November 2007

● Second Level Review to NCAB February 2008

● Awards in June 2008



● Early Start to the Process This Year● Significant Support By the Board of

Scientific Advisors (BSA) for the CCOP/MB-CCOP RFAs

● Anticipate Early Spring 2008 Release

● Submission Process Still Paper-based (i.e., Not yet Electronic)



● Submission of application requires grantee institution & PI to be registered with NIH eRA Commons

● Session on Peer Review● CCOP & MB-CCOP RFA Peer Review

Panels & Lessons Learned


Statistics for the CCOP Program


Funded CCOP Programs in FY 2007

49 CCOPS 29 States

14 MBCCOPS 10 States, DC & Puerto Rico

13 Research Bases

Headquarters in 10 States

Update on Program Funding in FY 2007

● Newly funded● Sacred Heart MBCCOP, Mobile, AL

● LSUHSC-Shreveport, Shreveport, LA

● Suny Downstate Medical Center, Brooklyn, NY

● No longer funded ● Northern New Jersey CCOP● Our Lady of Mercy MBCCOP● University of Michigan Research Base


Welcome to the new MBCCOP PIs

• Dr. Paul Schwarzenberger• Sacred Heart Health System

● Dr. Glen Mills● LSUHSC-Shreveport

● Dr. William Solomon● Suny Downstate Medical Center


Participating Physicians (3,565)

2,385 Physicians Accrue Trial Participants 1,180 Physicians Refer Trial Participants

Participating Hospitals (405)


0123456789

101112

2000 2001 2002 2003 2004 2005 2006 2007Est

CREDITS

Thousa

nds

Treatment

Cancer Control


Funding Levels

$0

$10

$20

$30

$40

$50

2000 2001 2002 2003 2004 2005 2006 2007Fiscal Year

Millions

CCOP MB-CCOP


FY 2007 Notice of Grant Award

● Base Budget with Accrual Expectations

● Restricted Treatment Supplements to CCOP/MBCCOP

● Restricted Cancer Control (Prevention Supplements) to CCOP/MB-CCOP


CCOP

Organizational Changes


CCOP Organizational Changesi.e., adding/deleting physicians, affiliates/components &

research bases

● Paper-based process for past 20+ years


Organizational Changes

● New web-based database developed to Process Organizational Changes Electronically

● New Process more Efficient & Transparent● Implement in a Step-Wise Fashion

● Physicians● Affiliates/Components● Accrual Tables for 6, 9, & 12 month Data● Research Bases


Cancer Control Trials


CCOP Cancer Control Trials

Cancer Control Includes Cancer Prevention

Chemoprevention Surgical Intervention Smoking Cessation

Symptom Management Trials Continuing Care Survivorship Quality of Life Other


Phase III Treatment Trials with HRQOL Endpoints

BREAST 5 6

CNS 4 6

COLORECTAL 2 5

GYNECOLOGIC 2 4

HEAD & NECK 2 2

HEMATOLOGIC 4 4

LUNG 4 4

MELANOMA 0 1

PROSTATE 5 7

TOTAL # TRIALS: 28 39

Symptoms Under Study in Trials Since 1995 Symptoms Number of Studies

Fatigue 12

Pain 12

Hot Flashes 11

Anorexia & Weight Loss 10

Nausea & Vomiting 9

Cognitive Function 8

Mucositis 7

Quality of Life 7

Diarrhea 6

Osteoporosis 6

Infection 5

Prevention of Weight Loss 5

Neuropathy 5

Skin Toxicities 2

Hand & Foot Syndrome 1

Others (e.g., Ascites, Depression, HRT, Sexual Functioning, Stress & Distress, etc…)

28

Calendar Year

Newly Activated Trials

Total Active Trials

Accrual

1995 2 8 122

1996 4 11 186

1997 3 14 577

1998 10 22 1046

1999 7 27 1835

2000 10 26 860

2001 12 31 2214

2002 17 46 3139

2003 18 45 3824

2004 18 59 3300

2005 9 61 3437

2006 19 61 3498

Number of Newly Activated and Active CCOP’S Symptom Management Trials from CY 1995

to 2006

Clinical Trials Working Group

(CTWG)


NCI’s Coordinating Center for Clinical Trials (CCCT)

● Budget to Fund Specific CTWG initiatives

● High Accruing Site Incentives

● Incentives to Increase Minority Accrual

● Correlative Sciences


CCCT High Accruing Site Incentive Awards

● FY 2007 Budget - $5 million

● ¼ of Funds Allocated to CCOP Program

● Awarded to 10 Highest Accruing (treatment) CCOPS

● ¾ of Funds Awarded to Cooperative Groups

● For High Accruing Member Sites


CCCT High Accruing Site Incentive Awards

Principal Investigator CCOP

James N. Atkins, MD Southeast Cancer Control Consort.

Shaker R. Dakhil, MD Wichita

Patrick J. Flynn, MD Metro-Minnesota

Stephen Grubbs, MD Christiana Care

J. Philip Kuebler, MD Columbus

John W. Kugler, MD Illinois Oncology Research Assoc.

Kendrith M. Rowland, MD

Carle Cancer Center

Philip J. Stella, MD Michigan Cancer Research Consort.

Gamini Soori, MD Missouri Valley Cancer Consort.

Robin T. Zon, MD Northern Indiana Cancer Research Consort.


NCI’s Coordinating Center for Clinical Trials (CCCT)

● Has a budget to fund specific CTWG initiatives

● High Accruing Site Incentives

● Incentives to Increase Minority Accrual

● Correlative Sciences


CCCT Enhanced Minority Recruitment Awards

Principal Investigator MBCCOP/CCOP/Non-CCOP

Karen Freund, MD Boston Medical College

Anand P. Jillella, MD Medical College of Georgia MB-CCOP

Ann-Marie Langevin, MD

South Texas Pediatric MB-CCOP

James B. Lockhart, MD

Warren Cancer Research Foundation CCOP

John D. Roberts, MD Virginia Commonwealth Univ. MBCCOP

Steven N. Wolff, MD Meharry Medical College MB-CCOP

Howard A. Zaren, MD Stroger Hospital of Cook County MBCCOP


? QUESTIONS ?


Documents

CCOP, MBCCOP