DoD Kidney Cancer, Clinical Trial Award | W81XWH 22 KCRP CTA

Frequently Asked Questions (FAQs): DoD CDMRP Kidney Cancer Research Program (KCRP) Clinical Trial Award (W81XWH-22-KCRP-CTA)

1) What is this funding opportunity trying to accomplish?

This DoD CDMRP KCRP Clinical Trial Award is intended to speed the launch of early-phase kidney cancer clinical trials that could meaningfully change how kidney cancer is treated or managed. The goal is to generate credible, actionable signals and the scientific justification needed to move into larger, efficacy-focused trials later, rather than leaving promising approaches at the preclinical stage.

2) What kinds of trials are in scope?

The opportunity is specifically aimed at phase 0, phase 1, and phase 1/2 kidney cancer clinical trials. The emphasis is on producing results that guide next-step development and justify later, larger trials.

3) Does the project have to be a clinical trial?

Yes. A central requirement is that the funded project must be a clinical trial defined as the prospective assignment of one or more human subjects to one or more interventions (including placebo or control when appropriate) to measure biomedical or behavioral outcomes.

4) Are preclinical or non-clinical studies allowed?

No. This mechanism is not intended for preclinical work. Applicants proposing non-clinical studies are directed to other KCRP funding announcements.

5) What counts as an "intervention" under this award?

The announcement emphasizes flexibility. Interventions may include drugs or biologics, devices, surgical procedures, behavior change strategies, clinical guidance, and other emerging technologies. Placebo or control interventions may be used when appropriate.

6) Can an applicant propose repurposing an existing drug, device, or other intervention?

Yes. The opportunity explicitly welcomes studies that repurpose existing interventions for new kidney cancer indications, which can be faster to translate to patient impact when safety profiles and manufacturing pathways are already established.

7) What are the two FY22 options mentioned, and why would a team use them?

Two new features for FY22 are described:

• Cell Therapy Focus Option: Supports cell therapy trials and recognizes their added needs (manufacturing optimization and intensive correlative science). This option allows a higher funding cap within the allowed performance window, but it requires confirmed access to needed specimens and/or cohort data at the time of application.
• Qualified Collaboration Option: Encourages investigators to partner with established, federally funded consortia or partnerships to use existing trial infrastructure and shared services (for example, data management, database administration, statistics support, and tissue repositories). A letter of collaboration describing concrete commitments and shared services is required, including how the partnership adds value to the government.

8) How quickly does the DoD expect the trial to start after award?

The clinical trial should begin within 12 months of the award date, or within 18 months if the study is FDA-regulated (to account for additional regulatory lead time).

9) What does the program require regarding preliminary data?

Competitive applications must include preliminary data relevant to the proposed clinical trial.

10) What does the program expect for recruitment feasibility?

Applicants must demonstrate they can recruit the needed participants by documenting access to an appropriate patient population, presenting realistic accrual goals, providing a recruitment plan, and addressing inclusion of women and minorities in a way that fits the study objectives.

11) What are the requirements for access to the intervention (drug/device/etc.)?

The application must document access to the intervention for the duration of the trial and document product quality and stability in a manner consistent with applicable FDA manufacturing expectations (such as GMP for drugs/biologics or Quality System standards for devices).

12) Can award funds be used to produce or purchase the investigational product?

Generally, no. The announcement notes a restriction that award funds generally cannot be used to pay for producing or purchasing the intervention itself from a manufacturer. Applicants need a credible plan to obtain the investigational product outside the grant budget.

13) What kind of team expertise and infrastructure does the DoD expect?

Applications are expected to demonstrate real clinical trial execution capacity, including clinical trial expertise, biostatistics, data management, and familiarity with FDA processes when relevant. The DoD also expects a study coordinator function capable of moving the protocol through IRB review and other regulatory approvals, coordinating multi-site activity, and managing participant accrual.

14) What statistical and data management elements are expected in the proposal?

Proposals must include a solid statistical analysis plan, power analysis and sample size justification aligned to the study objectives, and a data management plan that protects data integrity.

15) Are there specific database compliance requirements for FDA-regulated trials?

Yes. If the trial is FDA-regulated, the database must be compliant with 21 CFR Part 11 and use appropriate data standards consistent with FDA expectations.

16) What does the announcement say about acting as the regulatory sponsor?

For trials involving FDA-regulated products, the application should reflect institutional commitment and, when applicable, a willingness and ability to act as the regulatory sponsor and meet sponsor obligations under federal regulations (for example, 21 CFR 312 for drugs/biologics).

17) What are the IND requirements for drug/biologic trials?

If a drug is not FDA-approved for the proposed investigational use, an IND may be required. The applicant is responsible for either providing proof that an IND is not required or submitting the IND to FDA by the application deadline.

18) What are the IDE requirements for device trials?

Similar requirements apply to devices through the IDE pathway. Applicants must provide evidence if an IDE is not required or qualifies for an abbreviated process. If an IDE is required, it must be submitted to FDA by the application deadline.

19) What if the trial includes international sites?

For trials that will run at international sites, applicants must show that submissions to relevant national regulatory authorities have been made by the application deadline.

20) What are the post-award registration and public posting requirements?

After award, the trial must be registered on ClinicalTrials.gov before initiating the study. The informed consent form must also be posted on a publicly available federal website as required by federal human subjects rules.

21) What is HRPO and is it required for this award?

Because this is DoD-funded human research, the USAMRDC Human Research Protection Office (HRPO) must review and approve the study before it can begin. HRPO review is separate from local IRB or Ethics Committee review.

22) Is local IRB approval required at the time of application?

No. Local IRB approval is not required at the time of application submission. However, awardees should plan for the HRPO review timeline, which is often up to around three months once complete documentation is submitted.

23) What additional planning is expected for multi-institutional U.S. trials?

Applications must describe the governance structure, include a plan for single-IRB arrangements, identify the lead institution responsible for the master protocol and consent, and address communication, data transfer, and handling of specimens and imaging products.

24) Are there requirements related to intellectual property or materials for multi-site projects?

Yes. Multi-site projects require an intellectual and material property plan agreed to by all participating institutions.

25) What if the project relies on DoD or VA resources or access to active-duty populations?

If the work relies on DoD or VA resources, databases, or access to active-duty populations, the application must describe how access is secured at submission and how it will be maintained during the project.

26) What type of award instrument will be used (grant vs cooperative agreement)?

This mechanism uses assistance agreements. Awards may be issued as either grants or cooperative agreements depending on how much substantial involvement the DoD anticipates during performance.

27) What is the funding cap for this opportunity?

Budget limits are set in direct costs for the entire period of performance:

• Up to $1.5 million (standard Clinical Trial Award and the Qualified Collaboration Option)
• Up to $2.0 million (Cell Therapy Focus Option)

28) How much total funding and how many awards were anticipated for FY22?

For FY22, CDMRP planned to allocate about $8.0 million total to make roughly three awards (approximately two standard CTA awards and one Cell Therapy-focused award), contingent on federal funds and application quality.

29) What were the key dates listed for this opportunity?

The posting lists an original closing date of October 20, 2022. Awards were to be made no later than September 30, 2023. The posting also notes FY22 funds were expected to remain available for use only for a limited time window, expiring for use on September 30, 2028.

30) What kind of project is this opportunity best suited for?

Overall, it is designed for teams that already have a credible intervention, preliminary supporting evidence, access to patients, and the operational and regulatory experience to launch an early-phase kidney cancer trial quickly, with the goal of generating results that can justify and shape larger confirmatory studies.