Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability (U01) | RFA CA 17 052

Opportunity Information: Apply for RFA CA 17 052

The grant opportunity "Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability (U01)" (Funding Opportunity Number RFA-CA-17-052) is a National Institutes of Health (NIH) cooperative agreement designed to push cancer clinical trial analytics forward under the Beau Biden Cancer Moonshot Initiative. Its central goal is to speed up research that improves how tolerability is measured and understood in oncology trials by developing better statistical tools for adverse event data. The FOA is tied to a Blue Ribbon Panel (BRP) scientific priority focused on accelerating research that can identify practical approaches to monitor and manage patient-reported symptoms, reflecting a broader shift toward incorporating the patient voice more directly into trial evaluation.

A key emphasis of this FOA is methodological innovation around adverse event data coming from both clinicians and patients, particularly data captured through the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE is used to collect patient-reported symptom information in a structured way, complementing the traditional clinician-graded CTCAE adverse event reporting. The opportunity is specifically aimed at developing descriptive, inferential, and graphical statistical methods that make these data easier to analyze, interpret, and communicate. In practice, that means proposals would be expected to improve how researchers summarize symptom burden over time, compare tolerability profiles between treatment arms, account for missing or irregularly collected symptom reports, and present results in clear visual formats that support decision-making by clinicians, patients, regulators, and trial sponsors.

Because the award mechanism is a U01 cooperative agreement, awardees should expect more active NIH program involvement than in a typical research project grant. Cooperative agreements often imply a collaborative relationship where NIH staff may help shape milestones, coordinate across funded projects, or guide alignment with program goals. The activity category is listed under Education and Health (CFDA 93.395), and the intent is tightly centered on statistical and analytical method development for clinical trials rather than funding a standalone therapeutic trial. The ultimate impact the FOA is aiming for is a more complete and clinically meaningful picture of treatment tolerability, one that better captures what patients actually experience and supports earlier identification and management of troublesome symptoms.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts, as well as public and state-controlled institutions of higher education and private institutions of higher education. The FOA also allows applications from federally recognized Native American tribal governments, public housing authorities/Indian housing authorities, and Native American tribal organizations other than federally recognized tribal governments. Nonprofits are eligible whether or not they have 501(c)(3) status, and both for-profit organizations (other than small businesses) and small businesses can apply as well. The announcement also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Foreign eligibility is restricted in a specific way. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as applicant organizations. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S.-based applicant can include certain types of international collaboration or performance sites if they meet NIH definitions and requirements. This structure supports access to global expertise or datasets while keeping the primary applicant organization domestic.

Administrative details in the source listing include an original closing date of January 17, 2018, and an award ceiling of $425,000. The opportunity was created on September 25, 2017. While the expected number of awards is not specified in the provided excerpt, the overall framing suggests NIH was seeking a set of method-focused projects that, collectively, would modernize the analysis and presentation of clinician-reported and patient-reported adverse event information in cancer trials, improving the ability to interpret tolerability in a way that is both statistically rigorous and meaningful for real-world patient care.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395.
• This funding opportunity was created on 2017-09-25.
• Applicants must submit their applications by 2018-01-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $425,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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