Opportunity Information: Apply for RFA CA 12 502
Apply for RFA CA 12 502
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Pediatric Phase 1/Pilot Consortium (Limited Competition UM1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395 Cancer Treatment Research.
- This funding opportunity was created on Jan 5, 2012 and posted on Jan 5, 2012.
- Applicants must submit their applications by Mar 20, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,470,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following The eligibility to apply in response to this FOA is limited to the current recipient of the Childrens Oncology Group Phase 1/Pilot Consortium award.
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Opportunity Summary:
The Pediatric Phase 1/Pilot Consortium (Limited Competition UM1) grant opportunity (Funding Opportunity Number RFA-CA-12-502) is a National Institutes of Health initiative led by the National Cancer Institute to continue support for a dedicated clinical trials consortium focused on early-stage pediatric cancer research. The central goal is to keep a specialized, ready-to-operate network in place that can design and run Phase 1 and pilot (early feasibility) clinical studies for children with cancer, so promising new drugs and biologic agents can move into pediatric testing without unnecessary delay. In practical terms, this program exists to speed up "first-in-children" evaluations of new therapies, which is a critical step in determining safe dosing, understanding side effects, and gathering early signals of activity in pediatric populations, where cancers and treatment responses can differ substantially from those seen in adults.
This opportunity uses a cooperative agreement mechanism (UM1), which typically means the funded group works closely with NCI staff as a partner rather than operating in a fully independent grant model. The emphasis is on building and maintaining a strong multi-institutional, multidisciplinary team capable of running complex early-phase trials efficiently across multiple sites. That includes the operational capacity to rapidly develop protocols, manage regulatory requirements, coordinate trial activation, enroll patients, monitor safety, and collect and analyze clinical data. Because the studies involve children, the FOA highlights the need for deep experience conducting research under the ethical and regulatory constraints specific to pediatric clinical trials, including protections for minors and heightened attention to risk-benefit balance, consent/assent processes, and safety oversight.
The expected impact of the program is improved treatment outcomes for children with cancer by ensuring that novel agents can be evaluated and introduced into pediatric oncology in a timely, evidence-based way. By sustaining an established consortium infrastructure, NCI aims to preserve the ability to launch early trials quickly, which can be especially important for rare pediatric cancers where eligible patient populations are small and coordination across institutions is often necessary to complete studies in a reasonable timeframe.
Administratively, this was a discretionary funding opportunity in the NIH cancer treatment research area (CFDA 93.395) with an estimated total funding amount of $3,470,000 and an expectation of one award. It did not require cost sharing or matching. The FOA was posted on January 5, 2012, with an application due date of March 20, 2012, and it was archived on April 20, 2012. Eligibility was limited competition: only the current recipient of the Children's Oncology Group Phase 1/Pilot Consortium award was eligible to apply, meaning the announcement was intended to continue support for an existing, proven consortium rather than establish a new one. For full details, NIH pointed applicants to the official announcement page (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-12-502.html) and provided NIH Office of Extramural Research webmaster contacts for access or linking issues.
Frequently Asked Questions (FAQs)
What is the Pediatric Phase 1/Pilot Consortium (Limited Competition UM1) opportunity?
It is a National Institutes of Health (NIH) funding opportunity led by the National Cancer Institute (NCI) to continue support for a dedicated clinical trials consortium focused on early-stage pediatric cancer research. The program is designed to keep an experienced, ready-to-operate network in place to design and run Phase 1 and pilot (early feasibility) studies in children with cancer.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-CA-12-502.
Which NIH institute is leading this initiative?
The initiative is led by the National Cancer Institute (NCI), under the NIH.
What is the main goal of this program?
The main goal is to maintain a specialized consortium that can quickly design and conduct Phase 1 and pilot pediatric oncology clinical trials, so promising new drugs and biologic agents can move into pediatric testing without unnecessary delay.
Why does the FOA emphasize "first-in-children" evaluations?
The program exists to speed up first-in-children evaluations of new therapies, which are critical for determining safe dosing, understanding side effects, and gathering early signals of activity in pediatric populations. The FOA notes that pediatric cancers and treatment responses can differ substantially from those seen in adults.
What kinds of studies are supported under this consortium?
The consortium is focused on Phase 1 and pilot (early feasibility) clinical studies for children with cancer, particularly early-stage evaluations of new drugs and biologic agents.
What funding mechanism is used?
This opportunity uses a cooperative agreement mechanism (UM1).
What does it mean that this is a UM1 cooperative agreement?
A UM1 cooperative agreement typically means the funded group works closely with NCI staff as a partner, rather than operating under a fully independent grant model. The FOA emphasizes close collaboration with NCI as part of the cooperative arrangement.
What capabilities does the consortium need to maintain?
The FOA emphasizes building and maintaining a strong multi-institutional, multidisciplinary team capable of running complex early-phase trials efficiently across multiple sites. This includes the operational capacity to rapidly develop protocols, manage regulatory requirements, coordinate trial activation, enroll patients, monitor safety, and collect and analyze clinical data.
Why is a multi-institutional network important for this work?
The FOA highlights that coordination across institutions is often necessary, especially for rare pediatric cancers where eligible patient populations are small. A standing consortium infrastructure helps complete studies within a reasonable timeframe.
What pediatric-specific considerations are highlighted?
Because the studies involve children, the FOA highlights the need for deep experience conducting research under ethical and regulatory constraints specific to pediatric clinical trials. This includes protections for minors, heightened attention to risk-benefit balance, consent/assent processes, and safety oversight.
What is the expected impact of this program?
The expected impact is improved treatment outcomes for children with cancer by ensuring novel agents can be evaluated and introduced into pediatric oncology in a timely, evidence-based way. By sustaining the consortium infrastructure, NCI aims to preserve the ability to launch early trials quickly.
How many awards were expected?
The FOA indicated an expectation of one award.
What was the estimated total funding amount?
The estimated total funding amount was $3,470,000.
Was cost sharing or matching required?
No. The FOA stated that it did not require cost sharing or matching.
What was the CFDA number and research area?
The opportunity was in the NIH cancer treatment research area and listed CFDA 93.395.
When was the FOA posted?
The FOA was posted on January 5, 2012.
What was the application due date?
The application due date was March 20, 2012.
Is this funding opportunity still open?
No. The FOA was archived on April 20, 2012.
Who was eligible to apply under this announcement?
Eligibility was limited competition. Only the current recipient of the Children's Oncology Group Phase 1/Pilot Consortium award was eligible to apply.
Was this FOA intended to create a new consortium?
No. The announcement was intended to continue support for an existing, proven consortium rather than establish a new one.
Where can the official FOA details be found?
NIH directed applicants to the official announcement page at http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-12-502.html.
Who was listed as a contact for access or linking issues?
The information provided referenced NIH Office of Extramural Research webmaster contacts for access or linking issues.
What does "discretionary funding opportunity" mean in this context?
Based on the information provided, the FOA was described administratively as a discretionary funding opportunity within the NIH cancer treatment research area. The description does not add further detail beyond that classification.
What operational activities are implied by "ready-to-operate" network?
The FOA describes a ready-to-operate network as one able to rapidly develop protocols, handle regulatory requirements, coordinate trial activation across sites, enroll pediatric patients, monitor safety, and manage clinical data collection and analysis without avoidable delays.
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