The St. Baldrick’s Foundation-American Cancer Society Childhood Cancer Research Request for Applications
I. Purpose
The St. Baldrick’s Foundation and the American Cancer Society are collaborating to provide funding to advance innovative translational pediatric cancer research conducted within the context of a clinical trial. Studies may include analysis of clinical data and biospecimens collected from children enrolled in a clinical trial.
These investigations should be designed to provide new knowledge regarding mechanisms for novel agents or combination regimens, treatment resistance, novel biomarkers, toxicity, and insights for approaches to precision medicine. We anticipate this funding will stimulate a wide range of new research, stemming from on-going or recently completed patient trials to accelerate progress in childhood cancer.
II. Background
The relatively small numbers of childhood cancer trials limits access to new treatments and can be an impediment to new drug development. Clinical trials have led to more effective treatment in children for many types of pediatric cancer; however, for others, treatment options and survival rates have not improved for decades.
Even in cases where front-line treatment is very effective, children can relapse and develop resistance to those chemotherapies. Additionally, side effects of therapy, early and late, may be daunting. Together, these contribute to a plethora of important, unanswered questions that extend beyond primary objectives of the clinical trial. For example: Why are some cancers more aggressive than others? What distinguishes variable treatment response rates? Why does cancer vary significantly by the age of child? Which children are at high risk for long-term effects of treatment?
To accelerate progress in childhood cancer research, a deeper understanding of the biologic and physiologic mechanisms specific to these diseases and their treatment is needed, as are better ways to personalize care and improve quality of life.
By leveraging the resources and infrastructure of approved clinical trials, we aim to maximize the knowledge we can gain from the data, the biospecimens, and the clinical information collected, to improve outcomes for children more quickly.
III. Focus of RFA: Scope of Research Anticipated to be Generated from the RFA
This Request for Applications (RFA) offers both Pilot Accelerator Awards and Team Accelerator Awards.
Pilot Accelerator Awards are intended to include high risk/high reward research that tests feasibility and generates preliminary data to open new and highly innovative areas of investigation.
Interdisciplinary Team Accelerator Awards are designed to foster innovative, interdisciplinary collaborative research to promote transformational advances in childhood cancer research. High priority will be given to research studies that have the potential for near-term impact on how children with cancer are treated.
Examples of research within the scope of this RFA
Areas of interest: Proposals should focus on research leading to improvements in the care of children with cancer. Potential research areas include:
- Monitoring disease response
- Predicting clinical outcomes
- Analyzing the tumor microenvironment, the role of germline and/or somatic mutations in tumor pathogenesis
- Identifying or validating predictive or prognostic biomarkers
- Developing pre-clinical novel therapeutic targets
- Improving the anti-tumor activity of immunotherapy or other emerging therapies
- Mitigating and managing side-effects
- Improving quality of life
This list is not comprehensive, but research topics of interest include:
- How can a more in-depth understanding of cancer biology in children advance care?
How can the similarities and differences of cancer types by age, gender, race/ethnicity and socioeconomic factors be used to inform care? Are common or newly identified genes and other biomarkers potential targets for prevention, early detection, treatment or indicators of good or poor prognosis or relapse? What is the role of the microbiome and how does that change during treatment or as children age?
- Why are some pediatric cancers unresponsive to treatment?
What biological mechanisms and gene alterations are involved in both intrinsic and acquired resistance to various therapies?
- How can we reduce treatment toxicity?
Explore pathways leading to toxicities of therapies that damage organ systems or impair physical or cognitive development.
- How can we improve the cancer experience for patients and families?
Novel strategies to: evaluate and improve experience of children with cancer and their families, refine or develop more effective patient reported outcomes measures, test strategies to mitigate side effects or improve symptom burden, or use technology to quantify and manage symptoms.
IV. Eligibility
To be eligible, research proposals must be coupled with on-going or recently completed approved pediatric clinical therapeutic trials, such as large/definitive trials conducted in a cooperative group setting.
Pilot Accelerator Awards
Eligible Investigators: Must have a doctoral-level degree and have a full-time faculty position or equivalent at a college, university, medical school, or eligible not-for-profit research organization within the United States. There are no citizenship restrictions.
Eligible Institutions: Applications may be submitted by a college, university, medical school, or other eligible not-for-profit research organization within the United States, its territories, and the Commonwealth of Puerto Rico.
Interdisciplinary Team Accelerator Awards
Eligible Investigators: Must have a doctoral-level degree and have a full-time faculty position or equivalent at a college, university, medical school, or eligible not-for-profit research organization within the United States. There are no citizenship restrictions.
Each team must consist of a minimum of 3 team members:
1. Lead PI
- Role: Lead PI serves as the team leader and primary point of contact for the SBF and ACS Extramural Research Staff. He or She ensures the team complies with the terms of the award. For instance, the lead PI is responsible for the overall scientific and technical direction of the proposed research as well as all reporting, contractual, and financial obligations. Multiple PIs or co-PIs are not allowed. The Lead PI should dedicate at least 10% time and effort to the proposed research. The Lead PI’s institution will oversee all organization assurances and certifications.
- Eligibility Requirements: The Lead PI must be at an institution within the United States. PIs must have more than 5-years of experience as a faculty member (i.e. PIs may not be early-career investigators). An investigator may serve as a Lead PI on only one LOI.
2. Team Principal(s)
- Role: All team principals collaborate with the Lead PI. Principals direct specific areas of the scientific and technical work and lead a component of the research based on their area(s) of expertise. Team Principals should be budgeted at least 10% effort. The Lead PI and all Team Principals share authority for scientific leadership.
- Eligibility Requirements: Team Principals must have more than 5-years of experience as a faculty member (i.e. Principals may not be early-career investigators).
3. Team Investigator(s)
- Role: Team investigators contribute to the proposed research.
- Eligibility Requirements: Investigators within the first 5 years of their initial faculty appointment may serve as a Team Investigator. Teams are highly encouraged to include at least 1 early-career investigator, such as an Instructor or Assistant Professor.
Eligible Institutions: Applications may be submitted by a college, university, medical school, or other eligible not-for-profit research organization within the United States, its territories, and the Commonwealth of Puerto Rico.
V. Award Mechanisms (duration, project period, budget)
Pilot Accelerator Awards
These 2-year awards will focus on establishing feasibility to carry out the proposed translational research.
For example, validation of prognostic or predictive biomarkers, establishing the feasibility of conducting a clinically integrated or integral molecular test in a CLIA/CAP environment, or pilot testing a strategy to improve quality of life.
Award budget and term: $100,000 direct cost, plus 20% indirect cost per year for 2 years
Interdisciplinary Team Accelerator Awards
These 4-year awards will focus on definitive testing of hypotheses related to the actual value of the research proposed in the care of children with cancer.
For example, a definitive testing of a multi-feature “signature” that predicts outcomes in the context of an on-going or recently completed clinical trial, interdisciplinary research focused on the microbiome, or biobehavioral research focused on symptom management.
The successful completion of these projects should result in a practice-changing innovation, such as a new classification or risk stratification scheme for children with a form of cancer or a new diagnostic test that predicts response to an effective therapy or an enhancement to care that reduces symptom burden.
Award budget and term: $200,000 direct costs, plus 20% indirect cost per year for up to 4 years
For either Pilot or Interdisciplinary Team Accelerator Awards, activation of Awards will be dependent upon activation of the clinical trial and approval by the lead PI of the trial.
VI. Intent to Apply
A letter of intent (LOI) process will be used to determine which investigators will be invited to submit proposals.
Letter of Intent Process
LOIs are required and must include the following (maximum of 2 or 3 pages for Pilot or Team Awards, respectively):
- Title of proposed research
- PI Information: Full name, degree(s), title, department, institution name, mailing address, email address, telephone number, administrative assistant’s full name and email address
- Study Team: Names and roles of each member of the study team
- Approved Clinical Trial Information: Title, number and PI name
- Study Overview: Brief background about the research plan, specific aims and hypothesis, data elements required, cohort inclusion/exclusion criteria, study design, data analysis plan, and expected significance and impact
- Attachments (not included in page limit): NIH Biosketches are required for PI and study team
LOI Due Date: July 27, 2020
For LOI Instructions and Templates: See LOI Instructions PDF below. To go straight to the template, go to proposalCENTRAL.
WEBINAR: How to Apply for New Childhood Cancer Grants on August 4, 2020, 2:30 to 3:30 pm EST
Invitation to Apply Date: September 1, 2020
Invitation-to-apply decisions will be communicated to applicants via proposalCENTRAL. That correspondence will include a link to the grant application and instruction materials posted on proposalCENTRAL.
Full Application Due Date: October 22, 2020
Application Review: An independent and competitive peer review of grant applications will be conducted in January 2021. Reviewers will evaluate proposals based on:
- Importance of the scientific or clinical problem and clarity of the hypothesis
- Strength of the experimental design, supportive preliminary data (for team awards), investigator, and scientific environment
- Innovation and creativity in the proposal
- Potential for the work, if successful, to positively influence the care of children with cancer
Award Notification: April 1, 2021
Funds Available for Awards: Funds will support up to 5 Pilot Accelerator Awards and up to 3 Interdisciplinary Team Accelerator Awards. Awarded institutions will contract with ACS using their individual Terms and Conditions.
Interactive Webinar about the Funding Opportunity: By July 6, 2020, the date for a webinar about this RFA will be posted on cancer.org and StBaldricks.org. There will be ample time to ask questions. The webinar will be recorded and made available upon request.
Additional Questions: For questions about this award mechanism, please contact: Chanda Felton at Chanda.Felton@cancer.org and Kimberly Clarke at kimberly.clarke@cancer.org
LOI Instructions for Pilot and Team Awards
Access Electronic Grant Application Process at proposalCENTRAL