DoD Lung Cancer, Clinical Translational Research Partnership Award | W81XWH 22 LCRP CTRPA

FAQs: DoD Lung Cancer Research Program (LCRP) Clinical Translational Research Partnership Award (CTRPA) - FY22

1) What is the CTRPA and what is it designed to do?

The Lung Cancer Research Program (LCRP) Clinical Translational Research Partnership Award (CTRPA) is a FY22 Department of Defense funding opportunity intended to accelerate promising lung cancer concepts from the laboratory into real clinical use. The purpose is to support a true clinician-scientist partnership that can solve a major lung cancer problem in a way that would be difficult for either investigator to accomplish alone.

2) What disease area does this award support?

This mechanism is specifically focused on lung cancer. Applications that are solely in the area of mesothelioma will not be accepted, so the proposal needs to clearly be a lung cancer project rather than being framed as a mesothelioma project.

3) Who is required to lead the project?

The CTRPA requires two independent, faculty-level (or equivalent) Principal Investigators with complementary expertise. One PI must be a research scientist and the other must be a clinician.

4) What does "true partnership" mean for the two PIs?

The program expects both PIs to make equal intellectual contributions to the project design. The partnership must be more than a convenience arrangement. Projects where the clinician primarily provides access to patients or supplies biospecimens do not meet the intent of this mechanism.

5) Are multi-institutional applications allowed or preferred?

Multi-institutional teams are encouraged but not required. If multiple institutions are involved, the application must address how the collaboration will operate and must include an intellectual property plan.

6) Does at least one PI need prior lung cancer experience?

Yes. At least one member of the partnership must have prior experience in lung cancer research or lung cancer patient care to support feasibility and realistic execution of the proposed work.

7) What types of studies does the CTRPA support?

The CTRPA supports translational, clinically anchored work, with emphasis on pilot studies, proof-of-principle efforts, or early-phase clinical trials paired with correlative science.

8) How does this opportunity define a clinical trial?

A clinical trial is defined as a prospective study in which one or more human subjects are assigned to one or more interventions (including placebo or control) to evaluate effects on biomedical or behavioral health-related outcomes.

9) Are preclinical studies allowed under this award?

Preclinical work may be included, but it must be tightly justified as necessary to inform the clinical trial, interpret clinical trial outcomes, or support associated correlative studies. The preclinical component should not become a separate, stand-alone preclinical project.

10) What level of evidence or readiness is expected in the application?

Applicants are expected to provide a well-justified rationale, convincing preliminary data, and a credible clinical trial methodology and execution plan. The program also requires preliminary lung cancer-relevant data to demonstrate feasibility of the hypothesis and approach.

11) What is meant by "regulatory readiness" for this mechanism?

If the research trajectory would ultimately require FDA oversight (for example through an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE)), the application must demonstrate that the team has practical access to needed clinical-grade reagents (such as the therapeutic candidate) and access to appropriate patient population(s).

12) Is a Regulatory Strategy required for clinical trial submissions?

Yes. Clinical trial submissions must include a dedicated Regulatory Strategy attachment, identified as Attachment 8 in the announcement materials.

13) Is including a consumer advocate required?

Including a consumer advocate is strongly encouraged. The consumer advocate is typically a person diagnosed with lung cancer who is active in a lung cancer advocacy organization.

14) What is the expected role of the consumer advocate?

The advocate is expected to contribute meaningfully rather than symbolically. Described contributions include helping shape the research question, reviewing the design for patient-centeredness and practicality, supporting oversight, improving recruitment approaches, and helping evaluate impact from the perspective of people living with lung cancer or those at risk.

15) What collaboration planning must be described in the application?

Applications must explain how the two PIs (and any participating institutions) will work together day-to-day. This includes communication routines, coordination of progress and results, and plans for how data will be transferred and managed across sites.

16) Is an intellectual property (IP) plan required?

If the project involves multiple institutions, the application must include an intellectual property plan that anticipates potential disputes or institutional barriers and describes how intellectual and material property issues will be handled to keep the collaboration productive.

17) How important is military health relevance in review?

Military health relevance is a major review consideration and is assessed during programmatic review for fit with the Defense Health Program (DHP) and the FY22 LCRP priorities.

18) What are examples of ways to show military health relevance?

Examples described include using military or Veteran populations, biospecimens, or databases; collaborating with DoD or VA investigators; or addressing lung cancer risks and factors especially pertinent to military communities, including non-tobacco environmental exposures that may affect readiness and long-term health.

19) How are the two PI roles structured for submission?

The mechanism is structured around two PIs with distinct roles: an Initiating PI and a Partnering PI. The Initiating PI typically handles most administrative responsibilities tied to submission, while both PIs are expected to play major roles in developing key components such as the Project Narrative and Statement of Work.

20) How are awards made if the application is funded?

If funded, each PI is named on an individual award made to their recipient organization. This structure reinforces the expectation of a balanced partnership rather than a primary award with a typical subcontract relationship.

21) What is the sponsoring agency and the funding opportunity number?

The sponsoring agency is the Department of Defense (Department of the Army, USAMRAA). The Funding Opportunity Number is W81XWH-22-LCRP-CTRPA.

22) What funding instrument types are used?

The posting indicates the instrument type allows for cooperative agreements and grants.

23) What is the activity category and CFDA number?

The activity category is science and technology/research and development. The CFDA number listed is 12.420.

24) Who is eligible to apply?

Eligibility is described as broadly unrestricted unless otherwise clarified in the full announcement.

25) How many awards are expected in this cycle?

The source notice indicates a small number of anticipated awards, listed as two for this cycle.

26) What is the maximum award amount (award ceiling)?

The posting shows an award ceiling of 0, which typically indicates the cap is defined elsewhere in the full funding announcement materials rather than in the summary field.