RFA-CA-27-016: The Experimental Therapeutics Clinical Trials Network (ETCTN) Lead Academic Organizations (UM1 Clinical Trial Required)

RFA-CA-27-016: The Experimental Therapeutics Clinical Trials Network (ETCTN) Lead Academic Organizations (UM1 Clinical Trial Required)

This is a historical reference for the National Cancer Institute’s RFA-CA-27-016 NOFO. The application window has closed: the official announcement lists an earliest submission date of May 30, 2026, an application due date of June 30, 2026, and an expiration date of July 1, 2026. The NCI ETCTN program page now describes these RFAs as closed and does not announce a replacement application round. Do not treat this page as an invitation to submit a late application or as evidence that a new cycle is open.

The notice was a reissue of RFA-CA-19-007. It sought institutions that could maintain or establish Lead Academic Organizations (LAOs) in the NCI Experimental Therapeutics Clinical Trials Network (ETCTN). The work is network infrastructure for early-phase cancer drug development, not a single investigator’s stand-alone clinical protocol. Each LAO would design, develop, monitor, conduct, and analyze early-phase trials involving agents under regulatory sponsorship for Investigational New Drug (IND) applications held by NCI’s Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP). LAOs would participate in trials led by their own organization and in trials led by other LAOs.

Closed-cycle status

The official NCI ETCTN page says that the current cooperative-agreement project period began in March 2020 and continues through February 2027. It anticipates a next project period from March 2027 through February 2033, but the page does not publish a new application deadline for that period. RFA-CA-27-016 was the closed competition associated with that anticipated period. The historical flag on this listing is therefore intentional: the real closed-cycle deadline stays in the metadata, while readers are told plainly that no new round has been confirmed.

The official NOFO scheduled scientific merit review for November 2026, advisory council review for January 2027, and an earliest start date of April 2027. Those are award-process milestones from the closed notice, not current application dates.

Key details at a glance

What the NOFO was designed to support

The NOFO was designed around a coordinated clinical research organization. An LAO would provide oversight for scientific, programmatic, financial, and administrative matters for its participating sites. The announcement also required mentorship for investigators early in their clinical research careers. The central question was whether an applicant could operate a reliable early-phase trial portfolio across a lead institution and its rostered sites.

The expected work included:

• design, development, monitoring, conduct, and analysis of phase 0, phase 1, phase 2, pilot, and other experimental therapeutic clinical trials;
• work with DCTD/CTEP on requests for collaborative research under CTEP IND agents, protocol development, trial activation, conduct, and reporting;
• use of the ETCTN Pharmacokinetic Resource Laboratory when appropriate for pharmacokinetic endpoints, drug-drug interactions, cytochrome P450 interactions, pharmacodynamics, and food-effect studies;
• oversight of Lead Academic Organization, Affiliated Organization (AO), and Integrated Component (IC) sites;
• support for accrual, data quality, safety monitoring, regulatory compliance, biospecimen acquisition, molecular characterization, and trial publication; and
• encouragement of appropriate trial requests led by Early Career Clinical Investigators (ECIs), with experienced investigators serving as mentors.

The notice explicitly said that applicants should not propose specific clinical trials as part of this LAO application. The application instead had to show readiness, prior performance, staffing, site governance, trial-development processes, and measurable plans for future ETCTN activity. That distinction matters for anyone using the archive to prepare for a possible successor notice.

The mechanism is a UM1 complex-structure cooperative agreement. It carries substantial federal scientific and programmatic involvement after award. NCI project scientists coordinate activities, review the scope of proposed trials, support protocol and regulatory oversight, participate in network governance, and review site accrual and performance. An applicant therefore needed an operating model that could work with continuing NCI stewardship rather than treating the award as an unrestricted block grant.

Funding and award structure

NCI intended to commit $11.8 million in FY 2027 to fund four to six awards. Application budgets were not limited, but they had to reflect the actual needs of the proposed project. The total requested project period could not exceed 6 years. This was not a promise of $11.8 million per award; it was the aggregate funding intention stated in the notice.

The application was expected to cover three functional components: an Overview with Organizational Structure and Management Core; a Clinical Trial Development and Operations Core; and a Member Site Accrual and Performance Core. Budget planning had to connect personnel, statistical support, data management, regulatory work, site oversight, investigational pharmacy operations, patient accrual, biospecimen handling, and other research-related costs to the proposed network responsibilities.

The notice gave specific budget guidance for clinical-trials research operations and hospital charges. These costs had to be research costs that insurers would not normally reimburse, such as blood and urine collection and shipping, tumor-tissue handling, research biopsies, and research imaging. The announcement expected the annual accrual estimate to be based on at least 80 to 100 patients per year and anticipated an average of 1 to 2 biopsies per patient over a trial. Correlative studies and biomarker assays to enhance specific clinical trials, NCI-provided central support, and treatment costs were not to be included as ordinary LAO budget items.

Eligibility and institutional fit

The notice listed higher education institutions, qualifying nonprofits, for-profit organizations, federal agencies, and other organization types in its general eligible-applicant list. It then narrowed the relevant institutional definition for this application: the applicant had to be an academic center or organization in the United States or Canada that provides direct medical care to patients and is one integral organizational entity under a single financial management system and governance structure. The notice distinguished this from a large medical center whose primary mission is patient care.

The expected academic-care setting also included comprehensive medical training programs, investigational pharmacies, advanced imaging facilities, and preclinical laboratories performing basic research. Canadian institutions were the only non-U.S. entities allowed. Non-U.S. components of U.S. organizations were not eligible, and foreign components and foreign subawards/subcontracts were not allowed under this notice.

Only one application per institution was allowed, normally identified by a unique DUNS number or NIH IPF number. Applicants also had to observe the rule against duplicate or highly overlapping applications. Any proposed Affiliated Organization had to be a distinct legal institution partnering with the LAO, and an AO could be included in only one ETCTN LAO UM1 application.

The PD/PI requirements were equally practical. All PD(s)/PI(s) needed eRA Commons accounts and ORCID registration linked to their eRA Commons profiles. A PD/PI could not serve as PD/PI on another ETCTN LAO application or on the companion RFA-CA-27-017 PK laboratory application. If the contact PD/PI was not a practicing physician, a practicing physician primarily affiliated with the LAO had to oversee clinical trials and patient management.

How the application had to be prepared

The first step was to follow the NIH Research Instructions and the program-specific instructions in this NOFO. The Research Strategy was limited to 30 pages. The application package had to be accessed through NIH ASSIST, an institutional system-to-system route, or Grants.gov Workspace. Paper applications were not accepted.

Required registrations had to be completed before submission: SAM, including a UEI and the applicable CAGE or NCAGE code; eRA Commons; Grants.gov; and PD/PI ORCID linkage. The organization needed a Signing Official and a PD/PI account in eRA Commons, and the application had to use the same unique entity identifier in SAM, eRA Commons, and the submission. The notice warned that registration could take 6 weeks or more and that missing registration was not a valid reason for a late submission.

The application also needed a clear institutional resource description. Facilities and Other Resources had to address early-phase trial infrastructure at the LAO and roster sites, including investigational pharmacies, radiological imaging, radiotherapy delivery, and biospecimen procurement and handling.

The program-specific attachments were central to the submission:

1. OrgChartandRoster: organizational chart, logistical planning, oversight of request letters and protocols, assigned personnel and statisticians, plans for handling development delays, and a roster table covering LAO, LAO IC, AO, and AO IC sites with leaders, CTEP codes where available, expected annual accrual, and expected request-letter volume.

2. Communications: existing meeting routines for safety, trial conduct, progress evaluation, patient monitoring, and timely publication.

3. RegulatoryInformation: how the LAO and AOs would conduct, record, monitor, and report trial activity under protocols, NCI DCTD/CTEP policies, SOPs, Good Clinical Practice, and applicable regulations.

4. ListSOPs: a list of relevant SOPs and organization policies for specimen handling, tumor banking, IRB matters for Canadian sites, assay validation, and related clinical research activities. The NOFO specifically said not to submit the detailed SOPs or investigational-agent management procedures in this attachment.

5. CapabilityPerformance: summary evidence of early-phase trial capabilities, prior trial achievements, molecular characterization, accrual, and operational activation timelines. The notice asked applicants to cover completed trials during 2020 through 2024 and ongoing trials as of February 28, 2025, with specified trial, enrollment, target-size, and NCT information.

The Research Plan also had to include Specific Aims with expected trial counts by phase and participant-accrual benchmarks; a Research Strategy organized by the required functional components; consortium or contractual arrangements for AOs; letters of support from the LAO and each proposed AO; and a Data Management and Sharing Plan. Renewal applicants had an additional progress report covering March 1, 2020 through February 28, 2025.

Clinical operations the proposal needed to demonstrate

The LAO had to show how it would move a request for collaborative research through DCTD/CTEP review, protocol writing, consent development, regulatory review, activation, enrollment, monitoring, amendment, and closeout. The proposal had to explain how it would work with the CTEP Central Protocol Writing Service, NCI central laboratories, the NCI Central Institutional Review Board where applicable, the CTEP common data management system, and other ETCTN infrastructure.

Trial operations had to include patient eligibility and evaluability checks, medical review, safety reporting, data monitoring, accrual recovery plans, protocol amendments, statistical support, and interaction with a Data Monitoring Committee or Data Safety Monitoring Board for applicable trials. Sites also needed capacity for fresh biopsy acquisition, clinical testing, advanced imaging, investigational pharmacy work, and biospecimen transfer and analysis.

The member-site core had to explain how the LAO would recruit and retain qualified staff, improve accrual across roster sites, reach rare-cancer and special populations, maintain site and investigator rosters with the Cancer Trials Support Unit, respond to underperformance, submit data on time, and support presentation and publication of results. These details made clear that the award was for network execution, not simply scientific prestige.

The review criteria stated that no specific clinical trials should be proposed in this application. Reviewers instead assessed the organization’s vision, scientific and operational feasibility, leadership and site structure, trial-development and statistical capability, accrual and performance plans, resource sharing, human-subject protections, inclusion, data and safety monitoring, budget, and period of support. An applicant’s strongest evidence was therefore concrete prior performance and a credible management system.

Submission status and practical interpretation

The June 30, 2026 deadline was firm. All applications were due by 5:00 PM local time of the applicant organization, and the NOFO said no late applications would be accepted. Applicants had to submit electronically, track the application in eRA Commons, view it before the due time, and correct any errors by the deadline. A changed or corrected application submitted after the deadline would be considered late.

Because the cycle is closed, these instructions are useful as an archive of what the next notice may resemble, not as a current submission route. Teams interested in a future ETCTN competition should monitor the NCI ETCTN page and the NIH funding systems for a new notice rather than copying the closed deadline into a new work plan.

FAQ

Is RFA-CA-27-016 still open?

No. The official NCI page calls the RFA closed. The application due date was June 30, 2026, and the expiration date was July 1, 2026. No next application deadline is announced on that page.

What was the funding amount?

NCI intended to commit $11.8 million in FY 2027 for four to six awards. Individual budgets were not capped by a single stated dollar ceiling, but each requested budget had to reflect actual project needs.

Who could apply?

The relevant applicant had to be an academic center or organization in the United States or Canada that provided direct patient care as one integral entity, with the required clinical research infrastructure. Canadian institutions were the only foreign institutions allowed. One application per institution was permitted.

Were specific trial protocols required in the application?

No. The notice required a clinical-trial-capable LAO application, but it stated that applicants should not propose specific clinical trials as part of this application. Applicants had to demonstrate that they could develop and conduct a broad portfolio of future ETCTN trials.

Where can program questions be directed if a successor notice is issued?

The closed NOFO listed the NCI ETCTN RFA contact at 240-276-5930 and NCIETCTNRFA@mail.nih.gov. Those details belong to the archived announcement; verify that they remain current before using them for a future cycle.

Official sources

• Full RFA-CA-27-016 announcement: https://files.simpler.grants.gov/opportunities/78a9c523-d495-4606-a9c2-b67724d68434/attachments/f12fae34-6c5b-4be8-8b35-794d43edbdc4/RFA-CA-27-016-Full-Announcement.html
• NCI ETCTN program page, including the closed-status notice and anticipated project period: https://dctd.cancer.gov/research/networks/etctn

The official announcement is the controlling source for the closed cycle’s deadline, amount, eligibility, application route, required attachments, review process, and contacts. The NCI program page is the source for the current status of the ETCTN competition. Because no replacement deadline is published, this listing keeps the closed June 30, 2026 date as an archive date and does not invent a future one.