# Presentation: 241844

## CCOP, MBCCOP &

**Research Base Meeting**** **
**Lori Minasian, MD**
**Chief, Community Oncology**
**& Prevention Trials Research Group**
**Division of Cancer Prevention**

## 	Meeting Objectives

Information and Updates  
Grant Related Issues 
Program Related Issues
Clinical Trials Related Issues
Feedback on Issues
Format for Discussion

**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

**Electronic Grant Submission**
**Interpreting Notice of Award (NoA)**
**Completing Financial Status Report (FSR)**
**Peer Review Process**

**Community Clinical Oncology Program**

## 	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 

**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**** **

**Community Clinical Oncology Program**

## 	Clinical Trials Topics

CTSU Updates
CTSU Site Advisory Panel
Update on NCI’s CIRB
CMS Clinical Trials Policy
Update on CTWG Initiatives

**CTSU Updates**
**CTSU Site Advisory Panel**
**Update on NCI’s CIRB**
**CMS Clinical Trials Policy**
**Update on CTWG Initiatives**

**Community Clinical Oncology Program**

## State of the CCOP Program

**Community Clinical Oncology Program**

## Rumors....

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

**Community Clinical Oncology Program**

## CCOP & MBCCOP

**Request for Applications (RFA)**

**Community Clinical Oncology Program**

##   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

**Applications Received July 2007**
**Peer Review Scheduled in November 2007**
**Second Level Review to NCAB February 2008**
**Awards in June 2008**

**Community Clinical Oncology Program**

##   CCOP & MBCCOP RFA for FY 2009

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)

**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****)**

**Community Clinical Oncology Program**

##   CCOP & MBCCOP RFA for FY 2009

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

**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**

**Community Clinical Oncology Program**

## Statistics for the CCOP Program

**Community Clinical Oncology 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

**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**

**Community Clinical Oncology Program**

## 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

**Dr. Paul Schwarzenberger**
**Sacred Heart Health System**
**Dr. Glen Mills**
**LSUHSC-Shreveport**
**Dr. William Solomon**
**Suny Downstate Medical Center**

**Community Clinical Oncology Program**

## Participating Physicians (3,565)                                                                  
  2,385 Physicians Accrue Trial Participants
  1,180 Physicians Refer Trial Participants

Participating Hospitals (405) 

**  ****2,385 Physicians ****Accrue**** Trial Participants**
**  ****1,180 Physicians ****Refer**** Trial Participants**
**Participating Hospitals (405)**** **

**Community Clinical Oncology Program**

## Community Clinical Oncology Program

**Community Clinical Oncology Program**

## Community Clinical Oncology Program

**Community Clinical Oncology Program**

## 		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

**Base Budget with Accrual Expectations**
**Restricted Treatment Supplements to CCOP/MBCCOP**
**Restricted Cancer Control (Prevention Supplements) to CCOP/MB-CCOP**

**Community Clinical Oncology Program**

## CCOP

**Organizational Changes**

**Community Clinical Oncology Program**

## CCOP Organizational Changes
i.e., adding/deleting physicians, affiliates/components & research bases
Paper-based process for past 20+ years

**i.e., adding/deleting physicians, affiliates/components & research bases**
**Paper-based process for past ****20+**** years**

**Community Clinical Oncology Program**

## 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

**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**

**Community Clinical Oncology Program**

## Cancer Control Trials

**Cancer Control Trials**

**Community Clinical Oncology Program**

## 	 CCOP Cancer Control Trials

Cancer Control Includes
Cancer Prevention		
Chemoprevention
Surgical Intervention			
Smoking Cessation			
Symptom Management Trials
Continuing Care  
Survivorship
Quality of Life
Other 

**Cancer Control Includes**
**Cancer Prevention****	****	**
**Chemoprevention**
**Surgical Intervention****	****	****	**
**Smoking Cessation****	****	****	**
**Symptom Management Trials**
**Continuing Care  **
**Survivorship**
**Quality of Life**
**Other **

**Community Clinical Oncology Program**

## 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 |

## Number of Newly Activated and Active 

| 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)

**Clinical Trials Working Group (CTWG)**

**Community Clinical Oncology Program**

## 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

**Budget to Fund Specific ****CTWG initiatives**
**High Accruing Site Incentives**
**Incentives to Increase Minority Accrual**
**Correlative Sciences**

**Community Clinical Oncology Program**

## CCCT High Accruing Site Incentive Awards
FY 2007 Budget - $5 million
1⁄4 of Funds Allocated to CCOP Program
Awarded to 10 Highest Accruing (treatment) CCOPS
3⁄4 of Funds Awarded to Cooperative Groups 
For High Accruing Member Sites

**FY 2007 Budget - $5 million**
**1⁄4 of Funds Allocated to CCOP Program**
**Awarded to 10 Highest Accruing ****(treatment)**** CCOPS**
**3⁄4 of Funds Awarded to Cooperative Groups **
**For High Accruing Member Sites**

**Community Clinical Oncology Program**

## 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. |

**Community Clinical Oncology Program**

## 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

**Has a budget to fund specific CTWG initiatives**
**High Accruing Site Incentives**
**Incentives to Increase Minority Accrual**
**Correlative Sciences**

**Community Clinical Oncology Program**

## 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 |

**Community Clinical Oncology Program**

## ? QUESTIONS ?

**Community Clinical Oncology Program**