Results from a Review of CBCRPs Support of Translational Research - - PowerPoint PPT Presentation

Results from a Review of CBCRP’s Support of Translational Research

Priority-Setting Data for the Translation and Dissemination Program Goal October 11, 2013

Overview of 2015 Priority-Setting Process

• 1. Review the CBCRP mission statement and reaffirm the

program’s foundation of long-term outcomes.

• 2. Review and revise the priority criteria; and review and revise

as necessary the data collection questions corresponding to each criterion.

• 3. Gather and analyze pertinent data as indicated by

the priority criteria and data collection questions.

• 4. Identify and make decisions on long-term (5 years) priorities

through a data-driven, group decision-making process.

• 5. Incorporate priority decisions into CBCRP operational plans

and award cycles.

Timeline for the 2015 Priority-Setting Process

6/1 3 10/13 1/14 4/14 6/14 10/14 1/15 3/15 Responsive X

Translation X

Capacity Building/Career Development X Public Health Outcomes X Disparities X Collaboration X California Specific X Innovation X Non-Duplicative X Policy X Decision-making Retreat X

Program Goal

Translation and Dissemination: fund research that is on a critical path for practical application and leads to more effective products, technologies, interventions, or policies and their application/delivery to Californians.

Questions to Consider

• Should CBCRP continue or discontinue the

current Translational Research Award?

• If continued, do any changes need to be made

to the Translational Research Award?

• How are other award types contributing to

CBCRP’s Translation and Dissemination Program Goal?

• Are there other, more effective ways for

CBCRP to support Translational Research?

CBCRP Approaches to Supporting Translational Research

• Translational Research Awards
• CRC awards

– Testing interventions

• SRI Projects

– Solutions

• IDEAs

– Critical path mapped from beginning

• Translational Research Collaboration (TRC) Grants

(no longer active)

Logic Model

Expected short-term (3-5 years) outcomes include:

• Truly translational research

– e.g. effective interventions, new treatments, improved screening

• Involve human subjects or enable a follow-up study in human subjects
• Address funding gaps
• Moved the research topic from one phase on the critical path to the next

phase

• Funded projects will have overcome barriers to translation

Expected longer-term (6-10 years) outcomes include:

• Some projects will have leveraged additional funding to move the project

to the next phase

• Some studies will have begun Phase II or Phase III clinical trials
• Intervention trials will be completed
• Findings from completed and successful studies will be widely

disseminated in the scientific, clinical, advocacy and policy arenas

Information Questions

1. What is the number and distribution of funded Translational Awards in the CBCRP portfolio? 2. What short-term outcomes have been achieved from the translation awards starting in Cycle 13/2007? 3. What types of translational research is CBCRP funding from the CRC mechanism and from the Special Research Initiatives? 4. What are the top 4 pressing issues in breast cancer prevention and care that could be addressed in next 5-10 years? How is CBCRP contributing to finding solutions to these pressing issues/problems?

• 1. What is the number and distribution of funded

Translational Awards in the CBCRP portfolio?

As of October 2013:

• 11 Grants
• Since Cycle 13 invested a total
• f $9,384,566.00
• % of total investment

– 4 % of the dollars invested since 1995 – 10% of the dollars invested when including only current award types

CRC Fulls 18% CRC Pilots 8% IDEAs 41% Translation 10% Conference <1% SRI 23%

Percent of CBCRP Funds Invested in Current Award Types

Translation Award Type Requirements

• Up to 3 years, $750,000 plus indirect costs
• Major impact in the areas of:

– prevention, detection, diagnosis or treatment of breast cancer; – improved quality of life for survivors; – reduction in the community and social burden caused by the disease in California, or – advances in medical practices, health systems changes, health policies or environmental modifications.

• Critical Path: maps how the project fits along a defined

research continuum leading to practical applications.

Topics of Funded Translation Awards

• Tools to accurately predict DCIS outcomes
• Treatment strategies for DCIS (intraductal and soy)
• Tools to accurately predict likelihood of breast cancer

recurrence and to support treatment decisions

• Physician-patient risk assessment and communication
• Improved treatment for HER2 positive breast cancers
• Vitamin D supplementation to improve treatment outcomes

among overweight and obese women

• Development of an innovative database resource to

understand real world treatment decisions and outcomes

• Risk/benefit tool for physicians to recommend Tamoxifen

versus Aromatase Inhibitors

• 2. What short-term outcomes have been

achieved from the translation awards?

Love Ziv Tlsty Kaplan* Wu* Human subjects Y Y Y Y Y Funding gaps Y Y Y Y Y Movement on critical path Y and N Partial Y Y Y Published paper(s) Y Y Y Y N/A Disseminated findings to lay audiences Y N Y Y but limited N/A Overcome barriers N Y Y Y Y Leveraged additional funding N N Y N N/A Moving towards or resulting in products, technologies, interventions, or policies ? Y Y Y! Y N/A

? = unsure/difficult to determine N/A= too early to determine *=No cost time extension. Closing soon.

Feedback from PIs

• Flexibility from CBCRP Important
• 3 years too short

– Takes a lot of time to set up – NCTE

• Important to fund these types of studies

– Women want safe, prevention options

• Army of Women very helpful for recruitment
• Support tissue acquisition and annotation/maintaining

cohorts

• Very hard to get funding for work in prevention/pre-

cancerous

• CBCRP should be prepared that these types of projects

may not always work

• 3. What types of translational research is CBCRP

funding from the CRC mechanism?

• Projects that evaluate intervention programs

aimed at increasing screening rates of marginalized communities.

• Effectiveness of community support groups and

peer navigators *

• Alternatives to traditional support groups:

workbook journal, online vs face-to-face, video conferencing *

• Policy Research –How to implement best

practices within framework of legal protections

• 3. What types of translational research is

CBCRP funding from the SRI?

Chemical Policy

• Design of a chemical

testing scheme.

• Hazard Identification

Approach (HIA) is a recommended method for testing a chemical’s effect

• n a variety of endpoints

in biological processes that, if altered, could affect breast cancer risk.

• Follow-on funding for

dissemination.

SRI Translational Research Projects

Tools for Toxicity Testing- Cycle 17/2011

Biologically Relevant Screening of Endocrine Disruptors

• Shiuan Chen/Beckman Research Institute of the City of Hope

Cell Bioassays for Detection of Aromatase Gene Activators

• Michael Denison/UC Davis

Xenoestrogen-Specific Perturbations in the Human Breast

• Shanaz Dairkee/California Pacific Medical Center Research Institute

Biomarkers for Environmental Exposures in Breast Cancer

• Zena Werb/UCSF

Building on National Initiatives for New Chemicals Screening

• Chris Vulpe/UC Berkeley

CBCRP facilitated meeting planned in December with state and national policy makers to translate funding

• 4. What are the top 4 pressing issues in breast

cancer prevention and care that could be addressed in next 5-10 years?

• DCIS

– Genetic changes in cells surrounding tumors, DCIS and other breast cell structures (West @Stanford) – Origins of DCIS (Greg and Borowsky @UC Davis) – Genetic characteristics of aggressive DCIS (Bose @Cedar-Sinai)

• Safe, effective screening tools

– Handheld laser (Tromberg @UCI) – Salivary test (Zhang @UCLA) – Blood Test (Hoon @ John Wayne Cancer Center)

• 4. What are the top 4 pressing issues in breast

cancer prevention and care that could be addressed in next 5-10 years?

• Chemical Policy (see slide 14)
• Predictive diagnosis for responsiveness to

treatment – Handheld laser (Tromberg @UCI)

– Biologic determinants of response to Paclitaxel and Radiation (Formenti and colleagues/USC) – Targeted therapy for wound-like breast cancers (Chang-

Stanford)

– Targeted treatments for Her2+ breast cancers (Press/USC) – hormone related (resistance to aromatase inhibitors, tamoxifen and/or other estrogen inhibitors) grants

(Vuori/Burnham and Pietras/UCLA)

Conclusions

• CBCRP supports translational research through Translational

Research Award, funding CRC awards, and some SRI projects.

• To date, the Program has funded 11 Translational awards, 3 are

complete, 3 more are about to finish.

• While it may be too early to evaluate the Translational awards,

preliminary assessment of completed Translational awards indicates the funding mechanism is meeting many of the expected outcomes. A formal review is warranted after at least 10 projects have completed.

• Conducting translational research poses additional ethical dilemmas

for investigators.

• The most promising area of translational research supported by

CBCRP has been projects that seek to stratify and accurately predict

• utcomes for women diagnosed with DCIS.

Recommendations

• Continue funding CRC awards and SRI projects with

translational goals.

• Continue funding the Translational Research awards.
• Evaluate the Translational award mechanism after at

least 10 projects are completed. Gather consistent data as projects are completed.

• Consider focusing the topic areas for Translational

Awards (Prevention only?)

• Consider requirements to strengthen PI support for

resolving ethical dilemmas.

• Consider additional ways to support dissemination of

research findings.

– E.g. Open Access requirements