The NCI Board of Scientific Advisors approved four new concepts, which includes Requests for Applications, Cooperative Agreements, and Program Announcements.
The board additionally voted to concur with 31 reissue PARs. The NCI receives a large volume of PAR reissues annually, and so, the board has agreed to review these as a group.
The projects, presented at the June 15 meeting of the BSA and National Cancer Advisory Board, are available here.
Implementation Science for Cancer Control in People Living with HIV in Low-and Middle-Income Countries (RFA/Coop. Agr.)
The goal of this RFA/Coop. Agr. is to support the development, adaptation, and testing of implementation strategies to deliver evidence-based interventions, tools, and technologies for cancer control among people living with HIV (PLWH) in low-and middle-income countries (LMICs).
This RFA seeks to support projects tailored to the diverse cancer control needs of PLWH while leveraging existing capacity for HIV care delivery in LMICs.
The project, presented by the Office of the Director, has an estimated total budget of $25 million. Year One (2022) has set aside funds of $5 million, and application budgets are limited to $500,000 in direct costs per year.
The project antitipcates funding through six to eight U01 awards (clinical trial optional).
Opportunities for cancer control in LMICs include:
- Leveraging and building on community infrastructure for HIV treatment and prevention to promote the uptake of evidence-based cancer control interventions.
- Integrating or bundling evidence-based cancer control interventions into HIV treatment and prevention programs that engage remote and vulnerable communities.
- Develop or adapt innovations in telemedicine and mobile health to improve the uptake and reach of evidence-based cancer control interventions in PLWH.
Example research topics are:
- Studies to design, develop, and test theory-informed implementation strategies to improve uptake and integration of evidence-based cancer control interventions for PLWH.
- Studies evaluating the comparative effectiveness and cost-effectiveness of different implementation strategies.
- Studies of policies and other contextual factors that influence the success of dissemination and/or implementation efforts.
- Studies that explore strategies to support the integration of telehealth/telemedicine interventions to deliver evidence-based cancer control.
- Studies to understand how and why implementation efforts are successful (or unsuccessful) in HIV positive populations in LMICs.
Reviewers for this RFA will also be asked to consider the following changes:
- Does the project adequately account for characteristics of the local health systems, and is the proposed implementation approach appropriate for the problem and population proposed?
- Are the research methods relevant, rigorous, and practical in the context of the LMIC setting?
- Does the proposal demonstrate relevant community engagement in the research project including equitable partnership opportunities for the LMIC clinical research community?
- Does the proposal clearly describe potential for scalability and sustainability of the project or intervention within the local LMIC context?
- Does the proposal include an adequate training and dissemination plan involving LMIC investigators, institutions, and stakeholders?
A Multi-Level Approach to Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) (RFA)
The purpose of this RFA (CUSP2CT) is to implement and evaluate multi-level and culturally tailored outreach and education interventions with the primary goal to increase referral of racial/ethnic minority populations to NCI-supported clinical trials.
The project, submitted by the Office of the Director, has an estimated total cost of $18.28 million (over five years).
Up to four U01 grantee sites will be awarded. The project period is for five years, with $450,000 in direct costs ($765,000 total costs) for each award per year. The budget will encompass Fiscal Years 2022-2026.
One U24 grant will be awarded. The project period is for five years, with $350,000 in direct costs ($595,000 in total costs) per year. The estimated total costs per year are $3.67 million.
The CUSP2CT Network is composed of a Data, Evaluation, and Coordinating Center, which connects and coordinates the grantee sites (U01).
Objectives of the project:
- Educate racial and ethnic minorities about NCI-supported clinical trials utilizing community health educators and lay health advisors in the integrated team.
- Engage primary care and referring providers to increase clinical trial awareness to refer racial/ethnic minority populations to NCI-supported clinical trials utilizing community health educators and lay health advisors in the integrated team.
- Enhance referral of racial/ethnic minority populations to NCI-supported clinical trials at the site, provider, and patient levels utilizing community health educators and lay health advisors, in the integrated team.
- Address barriers and facilitators that impede and support pathways by which racial/ethnic minority populations access NCI-supported clinical trials at the site, provider, and patient levels. Identify and disseminate best practices.
Areas of research interest:
- Test the effectiveness of interventions designed to educate racial and ethnic minority communities about clinical trials generally and the importance of inclusion into clinical trials.
- Encourage and facilitate referral of racial and ethnic minorities who are eligible for a specific clinical trial.
- Address implicit bias and strengthen communication skills of primary care and referral providers.
- Develop referral pathways to clinical trials that would require minimal resource investment on the part of healthcare organizations.
- Test the effectiveness of using virtual/technology-driven interventions, initiated during the COVID-19 pandemic, to increase referral, recruitment, and consent of racial and ethnic minority patients to NCI-supported clinical trials.
Components of a competitive application:
- Cancer type and target population,
- Integrated site team,
- Community intervention,
- Provider intervention,
- Referral system; and
- Identification of best practices.
The coordinating center will:
- Receive, store, and analyze data from the U01 grantee sites.
- Identify and/or develop common metrics and measures to be collected by all U01 grantee sites to facilitate a CUSP2CT program evaluation.
- Assist sites in evaluating their specific interventions and making changes as appropriate at the patient, provider, and site levels.
- Develop an overall program evaluation plan and conduct an evaluation of the CUSP2CT network.
- Disseminate results for all implemented interventions within and outside of the CUSP2CT network, with sufficient detail to allow non-grantee sites to replicate the evaluated interventions.
- Encourage the replication and scale up of effective interventions and best practices.
Mechanisms that Impact Cancer Risk after Bariatric Surgery (PAR)
The purpose of this PAR, submitted by the Division of Cancer Prevention, is to promote studies examining the mechanism(s) through which bariatric surgery impacts cancer risk.
The project, which anticipates funding through the R21 and R01 mechanisms, aims to attract talented scientists who understand the dynamic changes caused by bariatric surgery.
The R21 mechanism will allow for early stage or resource development projects (clinical trial not allowed); and the R01 mechanism will accommodate broader scoped or in-depth mechanistic studies (clinical trial optional).
There was no associated budget with this concept.
Currently, very little has been published on the is the mechanistic link between bariatric surgery and cancer risk reduction, either in animal models or in humans.
The focus thus far has been on benefits seen more quickly after surgery, which includes reduction in body weight, reduction in type II diabetes mellitus, reduction in metabolic syndrome, and reduction in cardiovascular risk.
Questions to address:
- Do alterations in risk biomarkers occur before weight loss? If so, in what organ, tissue, or cell type do they originate?
- Is maximum weight loss or long term weight loss more important for cancer risk reduction? If so, how do the two differ at a cellular and/or biochemical level?
- What mechanism(s) explain the evidence that bariatric surgery is more beneficial in cancer risk reduction in women than men?
- Does bariatric surgery increase or decrease the risk of colorectal cancer, and if so, what are the mechanism(s)?
- Which cancers are favorably impacted by bariatric surgery, and what are the mechanism(s) that explain the effect?
Does the specific bariatric surgery procedure influence cancer impact? If so, what are the mechanism(s) driving the difference in impact?
Cancer Prevention and Control Clinical Trial Planning Grant Program (PAR)
The purpose of this PAR, submitted by the Division of Cancer Prevention, is to yield information that is both scientifically necessary and also sufficient to permit final decisions about the design or conduct of the large phase II or beyond clinical trial.
It aims to save time and cost by ensuring future trial success.
There is no set aside budget for a PAR, but the direct costs are expected to be $225,000 per year, which totals $450,000 over the two year project period. If the project includes a feasibility trial, the budget can be up to 600,000 direct costs over three years.
The project anticipates funding through the R34 and U34 grants. The PAR intends to fund four to six applications per year across DCP and DCCPS.
The application must include a summary of the future planned clinical trial. A planning grant is not a prerequisite for an R01 funding clinical trial or a large trial through a network.
Examples of research needs include but are not limited to:
- Identify the appropriate control or comparison group to use in the subsequent clinical trial.
- Standardize and evaluate feasibility of the intervention or outcome across multiple sites.
- Feasibility and plan for development of a placebo
- Validate survey instruments.
- Test effectiveness of training tools.
- Adapt and test an intervention or outcome instrument for a population that differs culturally from the population for which the instrument was originally designed.
- Modeling data to support trial assumptions in the study design.
- Statistical planning and design
Short term metrics for this PAR:
- Number of R34 or U34 projects that identified issues needing correction,
- Modifications in the subsequent trial that resulted from the knowledge gained
- Number that proceeded to a full clinical trial or definitively did not,
- Number of clinical trial applications or protocols approved from R34 or U34 awardees; and
- The publication of results, positive or negative.
Long term metrics for this PAR:
- Frequency of one or more major feasibility issues encountered in full clinical trials conducted by R34 or U34 awardees versus those conducted by non-R34 or U34 awardees.
- Frequency of no-cost extensions or cost overruns, or insufficient accrual, in full clinical trials conducted by R34 or U34 awardees versus those conducted by non-R34 or U34 awardees.
