Opportunity Information: Apply for RFA CA 15 501
Apply for RFA CA 15 501
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Limited Competition Revisions to Add Phase 2 Clinical Trials Program to Experimental Therapeutics Clinical Trials Network (ETCTN)(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 Mar 23, 2015 and posted on Mar 23, 2015.
- Applicants must submit their applications by Jun 19, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $7,200,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $560,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education Private institutions of higher education.
- Other Eligible Applicants include the following Only current ETCTN UM1 awardees may submit revision applications invited by this FOA (including Canadian recipients of the ETCTN award). See full announcement for full details.
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Opportunity Summary:
This funding opportunity (RFA-CA-15-501) is a National Institutes of Health (NIH), National Cancer Institute (NCI) initiative designed to strengthen the early development pipeline for experimental cancer therapeutics by combining Phase 2 clinical trial capacity with the existing Experimental Therapeutics Clinical Trials Network (ETCTN). At the time of the announcement, ETCTN was primarily focused on Phase 1 trials under a prior funding mechanism, and NCI's intent here is to bring Phase 2 infrastructure, operational capabilities, and specialized expertise into the same network structure. The practical idea is to reduce friction between stages of clinical development so promising agents can move from initial safety and dose-finding work into early efficacy testing more smoothly, using a unified system for trial activation, oversight, and management.
The FOA uses a cooperative agreement mechanism (UM1), meaning awardees work in close coordination with NCI rather than operating independently as they would under a typical research project grant. The competition is limited: only current ETCTN UM1 awardees are eligible to apply, and they must submit revision applications rather than entirely new standalone applications. The eligibility language also notes that Canadian recipients of the existing ETCTN award may be included among those eligible to submit revisions, reflecting the networked, multi-site nature of the program. Eligible applicant organizations are listed broadly as public/state-controlled and private institutions of higher education, but the limiting factor is ETCTN UM1 award status.
From a programmatic standpoint, the announcement focuses on building out the additional capabilities needed to conduct Phase 2 trials within ETCTN. Phase 2 studies typically require different kinds of infrastructure than Phase 1 alone, including expanded disease-specific expertise, larger and more diverse patient accrual pathways, additional operational support for multi-site trial conduct, and more robust mechanisms to manage endpoints that begin to address activity/efficacy signals rather than only safety and tolerability. By folding these Phase 2 elements into ETCTN, NCI is aiming for a single, integrated early trials network that can manage experimental agents across the Phase 1 to Phase 2 transition without the delays and duplications that can occur when different programs, processes, or administrative structures handle each phase.
The expected outcome emphasized in the FOA is efficiency: more streamlined trial management and a more comprehensive, coordinated approach to early clinical testing. In theory, that increased efficiency should translate into faster decision-making about which therapies should advance, better use of shared infrastructure, and shorter timelines between early-stage trial concepts and the point where the public could benefit from successful new treatments. The opportunity is positioned as an operational and structural enhancement to the national clinical trials ecosystem rather than a call for a specific scientific hypothesis, with the overarching mission of accelerating the delivery of new cancer therapies.
Administratively, the opportunity was posted March 23, 2015, with an original and current closing date of June 19, 2015, and an archive date of July 20, 2015. NCI anticipated up to 10 awards, with an estimated total funding amount of $7.2 million and an award ceiling of $560,000. The listing indicates there is no cost sharing or matching requirement. The CFDA number associated with the program is 93.395 (Cancer Treatment Research). Additional details and the full text of the announcement were provided through the NIH Grants Guide link included in the source data, and NIH Office of Extramural Research (OER) webmaster contacts were listed for access or linking issues.
Frequently Asked Questions (FAQs) - RFA-CA-15-501
What is RFA-CA-15-501?
RFA-CA-15-501 is a National Institutes of Health (NIH), National Cancer Institute (NCI) funding opportunity intended to strengthen the early development pipeline for experimental cancer therapeutics by adding Phase 2 clinical trial capacity to the existing Experimental Therapeutics Clinical Trials Network (ETCTN).
What is the main goal of this funding opportunity?
The main goal is to reduce friction between Phase 1 and Phase 2 stages of clinical development by building Phase 2 infrastructure, operational capabilities, and specialized expertise into the ETCTN. The intent is to support a single, integrated early trials network with unified trial activation, oversight, and management.
Why is NCI adding Phase 2 capacity to ETCTN?
At the time of the announcement, ETCTN was primarily focused on Phase 1 trials under a prior funding mechanism. NCI's intent is to incorporate Phase 2 capabilities so promising agents can move more smoothly from initial safety and dose-finding work into early efficacy testing within the same network structure.
What kind of studies does this initiative emphasize?
The initiative emphasizes building the additional capabilities needed to conduct Phase 2 clinical trials within ETCTN. Phase 2 studies typically require expanded disease-specific expertise, larger and more diverse patient accrual pathways, added operational support for multi-site trial conduct, and mechanisms to manage endpoints that address activity/efficacy signals (not just safety and tolerability).
How does the program expect to improve clinical development?
The expected outcome emphasized in the announcement is efficiency: streamlined trial management, more comprehensive coordination for early clinical testing, faster decision-making about which therapies should advance, better use of shared infrastructure, and shorter timelines between early-stage trial concepts and the point where successful treatments could benefit the public.
Is this funding opportunity focused on a specific scientific hypothesis?
No. It is positioned more as an operational and structural enhancement to the national clinical trials ecosystem rather than a call centered on a specific scientific hypothesis, with the overarching mission of accelerating the delivery of new cancer therapies.
What funding mechanism is used (grant type)?
The funding mechanism is a cooperative agreement (UM1). Under a cooperative agreement, awardees work in close coordination with NCI rather than operating independently as they would under a typical research project grant.
Who is eligible to apply?
Competition is limited. Only current ETCTN UM1 awardees are eligible to apply, and they must submit revision applications (not entirely new standalone applications). The eligibility language also notes that Canadian recipients of the existing ETCTN award may be included among those eligible to submit revisions.
Are new applicants who are not already ETCTN UM1 awardees eligible?
No. Based on the eligibility limitation described, organizations that do not already hold an ETCTN UM1 award are not eligible under this opportunity.
What type of application is required?
Eligible applicants must submit a revision application rather than a new, standalone application.
What organizations are listed as eligible applicant types?
The eligible applicant organizations are described broadly as public/state-controlled and private institutions of higher education. However, the limiting factor is current ETCTN UM1 award status.
How many awards did NCI anticipate making?
NCI anticipated up to 10 awards.
What is the estimated total funding amount for the program?
The estimated total funding amount listed is $7.2 million.
What is the maximum award amount (award ceiling)?
The award ceiling listed is $560,000.
Is cost sharing or matching required?
No. The listing indicates there is no cost sharing or matching requirement.
When was this opportunity posted?
The opportunity was posted on March 23, 2015.
What was the closing date (deadline) for applications?
The original and current closing date listed is June 19, 2015.
When was the opportunity archived?
The archive date listed is July 20, 2015.
Which NIH institute is sponsoring this opportunity?
This opportunity is sponsored by the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH).
What is the CFDA number associated with this program?
The CFDA number associated with the program is 93.395, labeled as Cancer Treatment Research.
Where were additional details provided?
Additional details and the full text of the announcement were provided through the NIH Grants Guide link referenced in the source data.
Who was listed for help with access or linking issues?
NIH Office of Extramural Research (OER) webmaster contacts were listed for access or linking issues.
What is the practical idea behind integrating Phase 2 into ETCTN?
The practical idea is to reduce delays and duplications that can occur when different programs, processes, or administrative structures handle Phase 1 and Phase 2 separately. By integrating Phase 2 elements into ETCTN, trial activation, oversight, and management can be handled through one unified system.
Does the announcement describe what kinds of infrastructure are needed for Phase 2 trials?
Yes. It highlights needs such as expanded disease-specific expertise, larger and more diverse patient accrual pathways, additional operational support for multi-site trial conduct, and more robust approaches to managing Phase 2 endpoints tied to activity/efficacy signals.
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