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 10/13 1/14 4/14 6/14 10/14 1/15 3/15 3 Responsive X Translation X Capacity Building/Career X Development 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Projects – Solutions • IDEAs – Critical path mapped from beginning • Translational Research Collaboration (TRC) Grants (no longer active)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: Percent of CBCRP Funds Invested in Current Award Types • 11 Grants • Since Cycle 13 invested a total of $9,384,566.00 SRI CRC Fulls • % of total investment 23% 18% CRC Pilots Conference 8% – 4 % of the dollars invested <1% since 1995 Translation 10% IDEAs – 10% of the dollars invested 41% when including only 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 Y N Y Y but N/A audiences limited Overcome barriers N Y Y Y Y Leveraged additional funding N N Y N N/A Moving towards or resulting in Y Y Y! Y N/A products, technologies, interventions, or policies ? ? = 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 on 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 outcomes for women diagnosed with DCIS.
Recommend
More recommend
