# Presentation: 431278

## Building Patient Access to Science

**Dr. John E. Niederhuber**
- Director, National Cancer Institute

*NIH Director’s Council of Public Representatives*
*April 20, 2007*

## Cancer is a Diseaseof the Genome

**Cancer is a Disease****of the Genome**

**Deletions**
**Amplifications**
**Mutations**
**Translocations**
**Epigenetic changes**

**It arises from changes within the DNA of our cells during their lifespan**

## A Complex Foe

**A Complex Foe**

- Adapted from: Hanahan & Weinberg,
- Cell 100:57 (2000)

**The essential aberrations of cancer**

**Notes:**
Dr. Niederhuber would like to add immunology as one of the essential aberrations to this slide, represented by an antibody symbol  

## Reversing the Curve: Cancer Deaths Decline

**Number of cancer deaths (ACS)**

**Reversing the Curve: Cancer Deaths Decline**

**Rate per 100,000 (NCI)**

**225-**
**220-**
**215-**
**210-**
**205-**
**200-**
**195-**
**190-**
**185-**
**180-**
**175-**

## 
 Transportation/distance
 Economics/insurance
 Social support systems
 Age
 Qualified cancer specialists
 Reduced toxicity of today’s therapy

** ****Transportation/distance**
** ****Economics/insurance**
** ****Social support systems**
** ****Age**
** ****Qualified cancer specialists**
** ****Reduced toxicity of today’s therapy**

**Most cancer patients are treated in the communities where they live**

**Realities of cancer treatment**

**Notes:**
The Realities of Treatment—patients are treated in their local communities.
Two Reasons:
Patient: transportation/distance; economic or insurance reasons, social support systems, or their age

Quality Cancer Care can be given in a community—previously therapies were so toxic that treatments needed to be given in specialized centers;  now there a many qualified cancer specialists in communities, and treatments are less toxic--
A result of this advance is that cancer care has become fragmented—they have surgery in an outpatient facility, got to a clinic for radiation therapy, receive chemotherapy at home, etc.  

## 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.

**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.**

**NCI Community Cancer Centers Program**

**Bringing New Discoveries to Patients Where They Live**

**Notes:**

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

During the pilot, we 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.

Bringing science to the people where they live

## Bringing New Discoveries Closer to Home

**Bringing New Discoveries Closer to Home**

**61 major academic and research institutes making significant contributions each day to advances in the understanding, prevention and treatment of cancer.**

**NCI-Designated Cancer Centers**

**Notes:**
Centers 
--making significant contributions to understand, prevent and treat cancer
--they are 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

## Pilot Goal: Sponsor multiple pilot sites for three years to identify critical factors that define a state-of-the-art community cancer center that will be incorporated into a future program.

**Pilot Goal:**** Sponsor multiple pilot sites for three years to identify critical factors that define a state-of-the-art community cancer center that will be incorporated into a future program.**

**NCI Community Cancer Centers Program**

**Notes:**
For the next three years, ...

## Baseline pilot program components

**Baseline pilot program components**

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

**Notes:**
An extensive group of advisors with expertise from across the Institute worked to develop the program and decided that the core components of the program should be:

--Hospital-based community cancer center, etc

## 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 multidisciplinary model of cancer care best be demonstrated?**
**Can the NCCCP model improve quality of care?**
**What approaches can effectively reduce healthcare disparities?**

**Notes:**
Besides facilitating the formation of the infrastructure, there are a number of research questions to be addressed:

## How can NCI’s biorepository guidelines be implemented in a community hospital-based cancer program?
How can community-based cancer programs effectively participate in caBIG and utilize electronic medical records?
How can a knowledge exchange network support the advancement of goals for NCI and the NCCCP program?

**How can NCI’s biorepository guidelines be implemented in a community hospital-based cancer program?**
**How can community-based cancer programs effectively participate in caBIG and utilize electronic medical records?**
**How can a knowledge exchange network support the advancement of goals for NCI and the NCCCP program?**

## Special areas of interest during the pilot

**Special areas of interest during the pilot**

**Linkages with NCI-designated cancer centers**
**State-funded cancer initiatives**
**Special locations with high incidence/lack of services**
**State or regional health IT initiatives**
**Survivorship plans**
**Supplemental funding models**
**Experience in knowledge exchange networks/activities**
**National health system model in multiple          markets**

**Notes:**
In addition to the core components, there are aspects of community programs that we also want to explore at the pilot sites.

Their:.....

Supplemental Funding Models
---Another key component to the program that I have not discussed yet is to determine the feasibility of the program—NCI is making a modest investment and as part of the pilot goals, the sites must contribute supplemental funding and we hope can demonstrate sustainability in their communities.

## Pilot program assessment structure

**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.**
**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.**

**Notes:**
Since this is a pilot, evaluation of the program is key to determining if the program should go forward in 2010, so we have developed and extensive program assessment structure that will be funded through a separate contract.

## Funding for pilot phase

**Funding for pilot phase**

**Support 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.).**

**Healthcare disparities...... 40%**
**Information technology...  20%**
**Biospecimen initiative.....  20%**
**Clinical trials..................  20%**

**Notes:**
The actual procurement of the services is through a contract mechanism so that we can be active participants in the direction of the pilot, and we are doing this through our prime contract with SAIC-Frederick.

We expect to fund approximately 6 sites for a total of $9M over three years.

Sites must contribute supplemental funding to reach the goals of the pilot.

## Proposed timeline

**Proposed timeline**

**Mid-Aug. 2006****	****................****	****Release Request for****	****	****Information/Interest (RFI)**
**Nov. 1, 2006****	****...................****	****Release Request for****	****	****Proposal (RFP)**
**Jan. 9, 2007****	****....................****	****RFP responses due**
**March 2007****	****.....................Evaluation of responses**
**Early June 2007****	****...............Pilot selections made****	****	****and announced**
**June 25-26, 2007****	****.............****	****NCCCP pilot                                ****	****	****launched**

**Notes:**
For the timeline,
--last summer we went out with a Request for Information to solicit input and comments to the proposal from the community.

--In the fall we released the RFP

--the proposals are currently under review and we hope to announce the sites and have the launch in June.

## “Basic research is a public good, for which social returns may greatly exceed private ones... Even a modest                   1 percent reduction in

**“****Basic research is a public good, for which social returns may greatly exceed private ones...**** Even a modest                   1 percent reduction in**
**cancer mortality would   be worth about                   $500 billion.”**

***Kevin Murphy and Robert Topel              “The Value of Medical Research”    University of Chicago Press, 2003***

## “Access to healthcare will be a greater barrier — a greater determinant of cancer mortality — than scientific advances.”

**J. Niederhuber**

**“****Access to healthcare will be a greater barrier — a greater determinant of cancer mortality — than scientific advances.”**

## www.cancer.gov

**www.cancer.gov**

## Slide 19