DoD Prostate Cancer, Synergistic Population and Data Science Award | W81XWH 19 PCRP SPDSA

Frequently Asked Questions (FAQs)

What is the DoD Prostate Cancer Research Program (PCRP) Synergistic Population and Data Science Award (SPDSA)?

The SPDSA is a FY19 funding opportunity from the Department of Defense (DoD) designed to support large, team-based prostate cancer studies that rely on already existing patient datasets and cohorts. The focus is on bringing multiple institutions together to combine and harmonize well-annotated datasets so investigators can answer high-impact questions that a single dataset or institution could not address alone.

What is the main goal of this award mechanism?

The main goal is to enable multi-institution collaboration so teams can pool and harmonize multiple prostate cancer datasets/cohorts and conduct a rigorous, hypothesis-driven retrospective population science or data science study that produces credible, actionable conclusions.

What kinds of projects are a good fit for this award?

Projects that are retrospective, hypothesis-based, and depend on coordinated analysis across multiple existing datasets/cohorts. The work should be designed to address a central question that genuinely requires pooled or harmonized data from multiple sources to achieve adequate scale, statistical power, and significance.

Are prospective studies or clinical trials allowed?

No. Prospective recruitment of human subjects and clinical trials are explicitly not allowed. The opportunity uses a FY19 definition of a clinical trial as a study where human subjects are prospectively assigned to an intervention to evaluate health-related outcomes. Applications must remain on the non-prospective side of that definition to be responsive.

What study designs are acceptable under this opportunity?

Acceptable designs include retrospective case-control studies, cohort studies, and other population/data science approaches, including studies that use biospecimens and information from established retrospective databases.

Does the application need to align with specific PCRP priorities?

Yes. Every application must directly address at least one of the FY19 PCRP Overarching Challenges. The project aims and expected outcomes must clearly connect to a major program priority in prostate cancer.

Who should the research be relevant to?

The work must be relevant to Service members, Veterans, military beneficiaries, and/or the broader American public.

How many institutions are required for eligibility?

At least three institutions are required. The partnership must include three or more institutions working together as a synergistic team.

How many datasets or cohorts must be included?

The project must leverage at least three well-annotated prostate cancer patient datasets or cohorts.

Do we need to prove the datasets are available to the team?

Yes. The proposal must demonstrate that the datasets (and any associated biospecimens, if applicable) are available to the team in sufficient numbers to support strong statistical power and robust significance.

What is meant by funding both "collaboration infrastructure" and "the research itself"?

This award supports (1) building the practical framework needed for multiple institutions to access, manage, share, and analyze the identified datasets in a coordinated way, and (2) using that framework to conduct the hypothesis-driven retrospective study.

What is a "synergistic" research team under this program?

The mechanism is structured around a synergistic team model with a minimum of three Principal Investigators (PIs) across three or more organizations. The intent is a true partnership where multiple PIs materially contribute to both the scientific plan and core application elements.

What is the difference between the Initiating PI and the Partnering PIs?

One investigator serves as the Initiating PI and leads the overall administrative coordination of the application. The remaining investigators are Partnering PIs. While their submission roles differ, all PIs are expected to materially contribute to the scientific plan and key application components such as the project narrative and statement of work.

Does the Initiating PI need specific experience?

Yes. The Initiating PI is expected to have proven experience managing complex, multi-institution research efforts.

Are awards issued as one grant to a lead institution, or as multiple awards?

If funded, each PI receives an individual award made to their home organization. This reinforces that the model is a true partnership rather than a subcontract-only structure.

What expertise does the team need to demonstrate?

The program emphasizes that the team should clearly demonstrate epidemiologic and/or biostatistical expertise appropriate for rigorous large-scale retrospective analyses.

What is a dataset coordination plan, and why is it required?

A detailed dataset coordination plan is required because multi-institution data work can fail without clear operating rules. The application must describe how the team will coordinate decision-making, manage resources, and handle data logistics and harmonization across institutions and cohorts.

What administrative and management details must be included in the coordination plan?

Applications must describe administrative and management processes for decision-making and how resources will be allocated across partners. They must also define key team members and roles and describe communication routines for coordinating progress and sharing results.

What data logistics details does the announcement expect?

The application should explain where data will be stored, how data will be shared among the PIs and institutions, and exactly how the team will harmonize variables and formats across cohorts.

What does the opportunity say about regulatory strategy and IRB coordination?

The application must include a regulatory strategy that addresses coordination of local IRB requirements across participating institutions.

What additional protections are required for human subjects-related research under DoD funding?

When research involves human anatomical substances, human subjects, or human cadavers, DoD-funded work must be reviewed and approved by local IRBs/ethics committees and also by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO) before research can begin.

Is local IRB approval required at the time of application?

No. Local IRB approval is not required at the time of application. However, teams should plan for HRPO review and approval before initiating research activities covered by human subjects protections.

How long should teams plan for HRPO review?

The opportunity notes that HRPO review should be expected to take at least 2 to 3 months, and potentially longer for international components.

What are the expectations around data security and data integrity?

The announcement calls for strong attention to data security and integrity as part of the coordination plan, reflecting the sensitivity and complexity of multi-institution data access, storage, and sharing.

What does the opportunity require regarding intellectual property (IP)?

Applications are expected to address an intellectual property approach as part of the broader plan for multi-institution coordination and dissemination.

Are teams expected to share outputs beyond their consortium?

Yes. The opportunity requests a plan for disseminating information and distributing data products to the broader prostate cancer research community.

Can projects incorporate biospecimens?

Yes, if applicable. The opportunity allows studies that use biospecimens and information from established retrospective databases, and it also expects proposals to demonstrate availability of any associated biospecimens in sufficient numbers where they are part of the planned analyses.

Is there any encouragement to focus on metastatic, advanced, or recurrent cancer?

Applicants are encouraged to consider recommendations from the Congressionally mandated Metastatic Cancer Task Force, particularly ideas that could accelerate clinical and translational progress for advanced or recurrent cancer, as long as the work remains within SPDSA limits and aligns with FY19 PCRP priorities.

What is the maximum funding level for this award?

The anticipated maximum direct costs for the entire project period are capped at $1.5 million.

How many awards were expected to be made, and how competitive is it?

The program expected to allocate about $2.4 million total to fund approximately one award, indicating a highly competitive opportunity.

What is the award type: grant or cooperative agreement?

Awards are issued as assistance agreements, meaning either grants or cooperative agreements. The choice depends on how much involvement the DoD anticipates having during the project. Substantial agency involvement would indicate a cooperative agreement; otherwise, it would be a grant.

When are the final instrument type and start date determined?

The final instrument type and start date are determined during negotiations.

What are the key timing notes mentioned in the opportunity?

Awards were expected to be issued no later than September 30, 2020. The DoD also noted that FY19 funds would expire for use on September 30, 2025, which affects timing and spending windows.

Who is eligible to apply?

Eligibility is described as unrestricted (open to entity types broadly), subject to the detailed requirements in the announcement.

What if the project plans to use DoD or VA populations, resources, or databases?

If a project involves DoD or VA populations, resources, or databases, applicants must describe access plans in the submission and, where required, include letters of support from appropriate authorities.

Does using DoD/VA resources ever require a DoD or VA investigator on the team?

Yes. The announcement notes that some DoD/VA resources may require collaboration with a DoD or VA investigator.

What happens if access to required datasets or resources cannot ultimately be confirmed?

The opportunity states that funding can be withdrawn or revoked if access cannot ultimately be confirmed.