# Presentation: 241850

## John E. Niederhuber, M.D.
Presentation to the                                   National Cancer Advisory Board
September 6, 2006

**John E. Niederhuber, M.D.**
**Presentation to the                                   National Cancer Advisory Board**
**September 6, 2006**

**NCI Community-Based Cancer Centers Pilot Program**

**Notes:**
Note title change to Community-based Cancer Centers Pilot Program (for the presentation; in RFI as NCI Community-based Cancer Centers Program)

You have 45 minutes total time to present and Q&A (11:15 to 12:00)---this will need to be shortened

## NCI-Designated Cancer Centers

**Notes:**
Centers at the forefront of the transition to “personalized medicine” — tests and treatments designed for individuals, based on complete knowledge of their genetics and tumor profile

## Presentation Overview

**Context**
**Program Development**
**Proposed Program Components**
**Program Assessment**
**Research Questions**
**Funding**
**Next Steps**
**Timeline**

## Trends in community-based cancer care

**More well-trained cancer physicians**
**State-of-the-art technology more available**
**Movement to physician offices and “stand-alone” centers**
**Growth in “niche” medical specialty companies**

**Notes:**
A fragmented model that expands availability, but not equally
Generally reduces the coordinated, multi-disciplinary approach to care that is the foundation and hallmark of U.S. cancer care established at the National Comprehensive Cancer Centers

## Realities of treatment

**Economics/insurance**
**Social support systems**
**Qualified cancer specialists**
**Age**
**Reduced toxicity**

**Why most cancer patients are treated in hospitals in their communities:**

## NCI Community Cancer Centers Program

**Mission:**** Enable the provision of state-of-the-art multispecialty care and early-phase clinical trials in community-based locations to meet the needs of the people**

**Notes:**
During the 3-year pilot program of NCCCP, NCI will explore and identify what new models of community-based cancer care can be created to reduce fragmentation of care and create a highly organized, informatics-based system of care available to all, closely linked to — and in support of — NCI’s national clinical research efforts.

## Bringing science to the people where they live

## NCI Community Cancer Centers Program

**(a nationally linked cohort of patients, from screening through treatment of active disease and survivorship)**

**Notes:**
SAIC Notes: 
--It should be made clear that the objective is to subcontract first through the SAIC-Frederick prime contract, then, if appropriate, move into a grant process through an RFA.
--Refer to SAIC as SAIC-Frederick

## Congressional report

***House Appropriations                        subcommittee ’07 report***

## Pilot program development

_**Guiding Coalition**_**:**** John Niederhuber, Mark   Clanton, Anna Barker, Ken Buetow, Norm Coleman, and Donna O’Brien (healthcare consultant)**
_**CRCHD**_**:**** Sanya Springfield, Nada Vydelingum, Ken Chu, Jane Daye, and Barbara Wingrove**
_**DCCPS**_**:**** Bob Croyle, Jon Kerner, Martin Brown, Steve Taplin, Steve Clauser, Rachael Ballard-Barbash, and Julia Rowland**

## Pilot program development

_**DCP**_**:**** Leslie Ford and Lori Minasian**
_**DCTD**_**:**** Jim Doroshow, Michaele Christian, Jeff Abrams, and Frank Govern**
_**OCTR**_**:**** Ernie Hawk, Jaye Viner, and Linda Weiss**
_**OD**_**:**** Rochelle Rollins, Carolyn Compton, and Julie Schneider**

## Program development considerations

**Community sites**
**Early-stage programs with significant outreach to racial/ethnic minorities that address healthcare disparities**
**Well-established programs with successful accrual to clinical trials**
**Programs with strong state funded support**

**Notes:**
NOTE: DO NOT discuss site visits—we conducted “Market Research” to develop the program, and are utilizing the RFI process to solicit further input.

## Program development considerations

**Community sites**
**Public hospital programs that reach  large, uninsured populations**
**Rural programs**

**Notes:**
NOTE: DO NOT discuss site visits—we conducted “Market Research” to develop the program, and are utilizing the RFI process to solicit further input.

## Program development considerations

**NCI-designated Cancer Center Community networks**
**Large physician network focused on research partnership, improving quality of cancer care at community cancer programs, addressing health disparities**
**National health systems to explore knowledge transfer**

**Notes:**
NOTE: DO NOT discuss site visits—we conducted “Market Research” to develop the program, and are utilizing the RFI process to solicit further input.

## Baseline pilot program components

**Community cancer center**
**Clinical trials**
**Disparities & community outreach**
**Information technology**
**Biospecimen initiatives**
**Hospice and palliative care**

## Community Cancer Center

**Community hospital with:**
** ****cancer program in a discrete center**
** ****medical, surgical and radiation oncology**
** ****one administrative/medical program structure**
**Physician director (cancer expertise)**
**Patient navigation support**
**Multi-disciplinary disease specific planning committees**

## Community Cancer Center

**Existing programs for cancer screening**
**Accreditation by the Commission on Cancer of the American College of Surgeons**
**Appropriate staffing, technology, clinical programs, and expertise**

## Clinical trials

**Minimum annual accrual of 25 patients to clinical trials **
**Preference for more than 50 patients**
**Preference for experience with NCI-sponsored clinical trials**
**Established research function to support clinical trials**

## Disparities & community outreach

**Organized, sustainable approach for community health outreach**
**relationships with other community-based organizations**
**Resources for care of the uninsured and underinsured (direct financial and other)**

## Disparities & community outreach

**Partnerships with national, regional and state public health department programs preferred**

## Information technology

**Information technology capacity that includes:**
**plans for an electronic medical record**
**capacity to devote staff time and expertise to assess the benefits, implications, barriers, etc., to implementing relevant caBIG infrastructure and components**

## Biospecimen initiatives

**Commitment and capability to describe and assess implementation requirements for the *****First-Generation Guidelines for NCI-Supported Biorespositories***** for a community-based cancer program**

## Hospice and palliative care

**An organized program for referral to hospice services as appropriate**
**Palliative care programs and survivorship plans are of interest and will be explored during the pilot**

## Special areas of interest during the pilot

**Linkages with NCI Designated Cancer Centers**
**New community-based models to address healthcare disparities**

## Special areas of interest during the pilot

**National health system model in multiple markets**
**to study knowledge transfer methods, rapid replication capability, or rapid diffusion of best practices**
**State funded cancer initiatives**
**Special locations with high incidence/lack of services**

## Special areas of interest during the pilot

**Survivorship plans**
**Experience with payer-supported clinical initiatives**
**Supplemental funding models to accelerate achievement of pilot goals**

**Notes:**
NOTE from SAIC: do not say “co-investment, but “supplemental funding.”

## Special areas of interest during the pilot

**Experience in knowledge exchange networks/activities**
**Successful approaches for multidisciplinary cancer care**
**Successful approaches to increase accruals to NCI-sponsored clinical trials**

**Notes:**
NOTE from SAIC: do not say “co-investment, but “supplemental funding.”

## Pilot program assessment structure

**An external**** — ****and independent ****— ****program evaluator for this demonstration project**
**Year 1****: Infrastructure development; refinement of the pilot program and research questions**
**Colorectal cancer quality-of-care study to be launched for screening, treatment and follow-up care**
**Years 2 and 3****: implementation of the model and evaluation of the metrics/research questions**

## Research questions

**What are the necessary components to insure a comprehensive approach to cancer care?”**
**What methods are effective to increase accrual of patients into clinical trials?**
**How can the benefits of a multi-disciplinary model of cancer care best be demonstrated?**
**Can the NCCCP model improve quality of care?**
**What approaches can reduce healthcare disparities?**

## Research questions

**How can the *****First-Generation Guidelines for NCI-Supported Biorepositories***** be implemented in a community hospital-based cancer program?**
**How can community-based cancer programs effectively participate in caBIG?**
**How can a Knowledge Exchange Network support the advancement of goals for NCI and NCCCP Program?**

## Funding for pilot phase

**It is the intent to support, through the NCI’s prime contract with SAIC-F, multiple sites for a total of $9M over a 3-year period**
**Supplemental funding models to be considered in support of pilot goals (provider, state cancer plan, etc.)**

**Notes:**
SAIC NOTES
--CANNOT say $500K/year/site, but can give an overall amount ($9M over 3 years)
--don’t say “co-investment” but “supplemental funding”

## Funding for pilot phase

**Information technology...  20%**
**Biospecimen initiative.....  20%**
**Clinical trials..................  20%**

## Next Steps

**NCCC Program Development Committee to review comments obtained for Request for Information sent out in mid-August**
**Committee to advise in the drafting of the Request for Proposal**
**Strong communication effort to educate and elicit feedback from the many stakeholders in the cancer community**

## Proposed timeline

**Mid-Aug. 2006...........**

**Release Request for Information/Interest (RFI)**
**RFI responses due**
**Release Request for Proposal (RFP)**
**Pre-proposal conference (if needed)**
**RFP responses due**
**Evaluation of RFP responses completed**

**Mid-Jan. 2007.............**

**Mid-Dec. 2006............**

**Mid-Nov. 2006............**

**Mid-Oct. 2006.............**

**Mid-Sept. 2006...........**

## Proposed timeline

**Mid-March 2007......**

**Site visits (if needed) **
**Pilot selections made and announced**
**Preparations to launch program; finalized pilot requirements/ program elements**
**Launch NCCCP pilot project and program for ongoing review and monitoring during three-year pilot**

**April 30, 2007..........**

**April 2007..............**

**Feb. 2007...............**

## RFI Posted

**FedBizOpps: ****http://www.fedbizopps.gov/**
**SAIC Frederick: ****http://web.ncifcrf.gov/bizopps/**

**Notes:**
These are the sites where the RFI can be accessed.  We have let the following groups know about it, in addition to having it posted on the sites:
	--CCOP PIs
	--Association of Community Cancer Centers

## NCI Community Cancer Centers Program

**Mission:**** Enable the provision of state-of-the-art multispecialty care and early-phase clinical trials in community-based locations to meet the needs of the people**

## Slide 38

## Slide 39