Feasibility and Planning Studies for Development of SPOREs

Feasibility and Planning Studies for Development of SPOREs to Investigate Cancer Health Disparities (P 20) Pre-application Webinar April 23, 2019 RFA-CA-19 -034

At a Glance… § RFA-CA-19 -034: Planning Grants for the Development of SPOREs in Cancer Health Disparities (P 20) § Reissue of RFA-CA-17 -033, resubmissions will be accepted o For this issuance, prostate and breast cancer investigations are not responsive. § Purpose: Provide planning support to develop translational research programs focused on cancer disparities. Expectation is that P 20 programs will evolve to become competitive for a full P 50 SPORE, with cancer disparities as a cross-cutting research theme. § Major Components of the P 20 Program: o o Translational research projects, minimum of two with a human endpoint proposed; Administrative Core; Shared Resource Cores (Biospecimen/pathology core is required); Developmental Research Program. § Budget: Maximum of $800 K in direct costs/year for up to 3 years § Application Due Dates: June 19, 2019; October 18, 2019; June 19, 2020; October 18, 2020 2

Specialized Programs of Research Excellence (SPORE) § Currently 52 active SPOREs spanning a diverse range of organ sites. § Supports translational research to improve cancer prevention, early detection, diagnosis, and treatment of cancer § Multi-component, multi-project, specialized center grants (P 50) § SPOREs can focus any of the following: o o An organ-specific cancer; A group of highly related cancers; Cancers related by common biological pathway mutations/alterations; Cross-cutting themes (e. g. cancer health disparities). § No past or active SPOREs exclusively focused on a cancer disparities theme. 3

Important Definitions for P 20 Program Applications 4

Translational Research Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions* in humans AND/OR determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer *The term "intervention" includes any intervention, tool and/or method that is applicable to the prevention, early detection, diagnosis, prognosis, and/or treatment of cancer. These may include: • molecular assays; • imaging techniques; • drugs; • biological agents; • other relevant methodologies. 5

Human Endpoint § A human endpoint must be proposed in each research project: o Population, behavioral, or psychosocial studies addressing biological of aspects cancer; o Discovery/development of biomarkers, only when conducted in human specimens/patients; o Early-phase clinical trials; o IND-directed toxicology studies (conducted following a pre-IND meeting with the FDA). § Cell lines, organoids, xenografts, or patient-derived xenografts (PDX) using primary human tumors are not sufficient as human endpoints § Note: P 50 SPORE applications additionally require a clinical endpoint 6

Cancer Health Disparities (CHDs) § NCI defines CHDs as adverse differences in cancer incidence, prevalence, mortality, survivorship, and/or burden of cancer, or related health conditions, that exist among specific populations. § All activities of the proposed P 20 Programs must address cancer health disparities, using a comparative research design between at least two racial/ethnic populations: § American Indian/Alaska Natives; § Asians; § African Americans; § Caucasians; § Native Hawaiians/Pacific Islanders; § Hispanic/Latinos. § Focus on cancer types for which health disparities are particularly well documented among racial/ethnic minority populations (e. g. colon, liver, lung, multiple myeloma). § For this issuance, prostate and breast cancer investigations are not responsive. 7

Components of P 20 Applications 8

Required Application Components Review “Section IV. Application and Submission Information” for more details § Overall (12 -page limit) § Admin Core: Administrative Core (12 -page limit) § Project: Research Projects (12 -page limit/project) § Core: (12 -page limit/core) o o § Biospecimen/Pathology Core: required; Other Shared Resource Cores (e. g. animal, stat, clinical, outreach): optional. Dev Res Prog: Developmental Research Program (DRP) (12 page limit) 9

Overall (Program Overview) § Overall goals and research strategies of the entire P 20 Program o Uniqueness of the proposal; why this P 20 planning grant and why now? § Potential impact on the field of cancer disparities if all aims are completed successfully § PD/PIs (whether designated as contact or not) must have a minimum effort of 1. 2 person months: o o o Include appropriate Multi-PD/PI Leadership Plan (as attachment) if applicablel PD/PI, Multi-PD/PI, and P 20 Director may be used interchangeably; PD/PI may act as a project co-leader, co-investigator, or core director. § Vision and expectations for a future SPORE application § Cancer Patient Populations o § Include plans for ensuring appropriate racial/ethnic minority populations and/or collected biospecimens accessible. Letters of support from the institution 10

Administrative Core § Leadership and Program Administration: o o o Contact PI/PD should lead the Admin Core; Leadership and succession plan for the P 20 PI/PD; Recommended to include a diagram of the chain of authority. § Integration of P 20 Program Within the Host Institution § Planning and Evaluation Activities: o o § Transition Plan Toward Being Competitive for a SPORE Grant: o o § External Advisory Board (required) and Internal Advisory Board (optional); Scientific collaborations. Timelines, milestones, and evaluation strategies; Recommendation: Review current FOA for SPOREs (PAR-18 -313). Fiscal management: o o o Budget for advisory boards; Travel funds to participate in P 20/SPORE-relevant meetings/workshops; Discretionary funds of up to $50, 000 per year may be requested. 11

Individual Translational Research Projects § Test novel translational ideas in the context of cancer disparities § Minimum of two projects required § Focus on understudied cancer sites, prostate and breast projects are not responsive for this issuance. § Human application/endpoint proposed for each project § § Project co-leaders: o o § In at least one of the proposed specific aims. Basic and clinical/applied scientists (minimum two); Each having minimum effort of 0. 6 person months, not required to be equal commitment. Demonstrate interaction of projects with cores 12

Shared Resource Cores § Core Director(s) recommended to have a minimum effort of 0. 6 person months § Cross-talk between cores and projects § Integration or augmentation with institutional or cancer center cores § Biospecimen/Pathology core (required): o o o § Pathological, clinical, family history information and linkage to databases, etc. ; Pre-analytical (parameters of collection and preservation) and analytical considerations; Priority plan to share biospecimens with others in the scientific community. Other specialized cores (optional), examples of other cores may include: o o o Outreach; Animal; Clinical; Biostatistical; Bioinformatics; Others. 13

Developmental Research Program (DRP) § Purpose is to explore innovative ideas: o o Pilot projects, high risk/high payoff; Collaborative; Focus on cancer disparities; Human endpoint not required. § Outline overarching vision for projects and possible research types (examples of actual projects are not required) § Detail plans for soliciting, reviewing, prioritizing, selecting, and monitoring these projects § Projects may be up to two years in length § DRP Directors are recommended to have a minimum effort of 0. 3 person months § Approximately $50, 000 direct cost per year restricted for DRP, often matched by institutions § Projects may have potential for evolving into full research project in a future SPORE application 14

Additional information on Eligibility, Recommendations, and Review Criteria 15

Eligibility and Responsiveness Applicant and Institution Eligibility: § § Minimum Research Base: At least two investigators with a significant role in the P 20 must have independently funded peer-reviewed grant(s) or serve as an overall/site chairperson on an active NCI-sponsored clinical trial. o Relevant investigators include Research Project Co-Leads, Shared Resource Core Directors, or overall P 20 PI/MPIs; o Include information in LOI and/or describe in leadership plan. Foreign (non-U. S. ) institutions are NOT eligible to apply o § Foreign components are allowed. PDs/PIs on an active SPORE grant (or on a pending SPORE application) cannot be designated as PD/PI on this P 20 application (however can be included as Senior/Key Persons). Responsiveness: § Description of access to appropriate racial/ethnic patient populations; § Inclusion of cancer health disparity theme; § Investigation of cancer sites other than prostate and breast cancer; § Translational Research and human endpoints proposed. Note: Applications not addressing these activities will be considered non-responsive and will not be reviewed 16

Letter of Intent and Pre-application Meetings Letter of Intent: § Highly encouraged, but not required; § 30 days before submission deadline; § Not binding and does not enter into the review. Pre-application meeting: § Encouraged but not required; § Teleconference is acceptable; § Recommended information: o o Diagram of the P 20 structure and leadership; Brief description (1 -2 page) of proposed translational projects; Description of proposed Cores and how they will be organized; Details and/or biosketches on proposed scientific leaders for the P 20. 17

Review Information § Scientific assessment of P 20 applications will be conducted through a peer-review process. § Overall Impact/Priority Score will be assigned to each application. § Funding decisions are made based on overall impact score, availability of funds, and programmatic priorities. § Standard Review Criteria will apply with additional questions specific for the P 20 RFA relating to topics such as (refer to “Section V. Application Review Information” of RFA): o Translational research (impact, feasibility, innovation); o Relevancy to cancer disparities; o Access to appropriate patient populations; o Potential to advance to SPORE. 18

Upcoming Important Dates Letter of Intent Application Receipt Peer Review Council Review Start Dates May 19, 2019 June 19, 2019 September/October 2019 January 2020 April 2020 September 18, 2019 October 18, 2019 March April 2019 May 2020 July 2020 May 19, 2020 June 19, 2020 September/October 2020 January 2021 April 2021 September 18, 2020 October 18, 2020 March April 2020 May 2021 July 2021 19

Contact Information Scientific Research Contact: Tiffany Wallace, Ph. D. (240) 276 -5114 Tiffany. Wallace@nih. gov Financial/Grants Management Contact: Carol Perry (240) 276 - 6282 perryc@mail. nih. gov http: //crchd. cancer. gov @ncicrchd NCI Center to Reduce Cancer Health Disparities (CRCHD) 20

Important Websites § Center to Reduce Cancer Health Disparities (CRCHD): https: //www. cancer. gov/about-nci/organization/crchd § P 20 planning grant RFA: https: //grants. nih. gov/grants/guide/rfa-files/RFA-CA-17 -033. html § Translational Research Program (TRP), home of the SPOREs: http: //trp. cancer. gov § Division of Cancer Treatment & Diagnosis (DCTD): http: //dctd. cancer. gov/ § SPORE Program Announcement: http: //grants. nih. gov/grants/guide/pa-files/PAR-18 -313. html § Office of Extramural Research (OER): http: //grants. nih. gov/grants/oer. htm 21

Important Policy Notices at NIH § Limited allowable appendix materials (NOT-OD-17 -098): o o § Clinical trial and human subjects changes: o o o § New Human Subjects and Clinical Trials Information Form (NOT-OD-17 -119); New Review Criteria for Research Project Applications Involving Clinical Trials (NOT-OD-17 -118); Policy on Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD-16 -094). Genomic data sharing (GDS; NOT-OD-14 -124) o § IRB-approved and draft clinical trial protocols (allowed for SPORE FOA); Blank data collection, survey, and questionnaire forms; Simple lists of interview questions; Blank informed consent/assent forms. Include a GDS plan in Resource Sharing Plan section, if applicable. Updates to Application Instructions and Review Criteria (NOT-OD-18 -228): o o Rigor and Transparency; Inclusion Reporting and Protections for Human Subjects. 22

Questions? Feasibility and Planning Studies for Development of SPOREs to Investigate Cancer Health Disparities (P 20) www. cancer. gov/espanol