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Modernizing Gynecologic Cancer Clinical Trial Eligibility Criteria to Increase Enrollment and Improve Generalizability

Award Number: R01MD021198
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/05/2026
PERIOD OF PERFORMANCE END DATE: 12/31/2030

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Modernizing Gynecologic Cancer Clinical Trial Eligibility Criteria to Increase Enrollment and Improve Generalizability - PROJECT SUMMARY/ABSTRACT Despite the critical importance of clinical trials in advancing cancer treatment, cancer patients from racial and ethnic minority groups are less likely to enroll in clinical trials. Lack of racial and ethnic minority patients in cancer clinical trials threatens generalizability and scientific rigor. Our prior work among gynecologic cancer patients demonstrated that Asian, Black, and Hispanic patients were less likely to enroll in clinical trials. In addition, we identified improved overall survival among those enrolled vs. not enrolled in gynecologic cancer clinical trials (regardless of therapeutic assignment). Therefore, the lower clinical trial enrollment among racial and ethnic minority patients that we have observed is concerning and contributes to lack of generalizability in clinical trials. We lack an understanding of factors that influence racial and ethnic disparities in clinical trial enrollment, preventing meaningful progress in evidence-based intervention development. An exclusive focus on patient-level predictors of gynecologic cancer trial enrollment has not led to effective intervention. Clinical trial design, specifically development of protocol exclusion criteria, is one factor that may be amenable to intervention. National cancer organizations have called for broadening clinical trial eligibility criteria; however, the slow adoption of these recommendations may reflect a lack of empirical data to guide decisions on which exclusion criteria to relax. In lieu of such data, simulation data to forecast changes to the racial and ethnic composition of the trial eligible population and survival outcomes after broadening eligibility criteria may influence clinical trialists’ intentions on this critical aspect of trial design. We propose to examine the extent to which gynecologic cancer clinical trial exclusion criteria mediate racial and ethnic disparities in gynecologic cancer clinical trial enrollment and the potential impact of broadening inclusion/exclusion criteria on enrollment and treatment efficacy. In this proposal, we will leverage the Flatiron Health database and conduct a randomized survey-based experiment of gynecologic oncologists to examine mediation of the race/ethnicity and gynecologic cancer clinical trial enrollment association by routine exclusion criteria (Aim 1); simulate the impact of relaxing gynecologic cancer clinical trial exclusion criteria on the racial and ethnic composition of the trial eligible population and treatment efficacy (Aim 2); and evaluate the impact of an educational intervention on gynecologic oncologists’ intentions to relax clinical trial exclusion criteria (Aim 3). Our focus on restrictive clinical trial exclusion criteria, a modifiable aspect of trial design with potential to increase clinical trial participation and generalizability, will provide critical information for the identification of high-impact solutions to improve cancer outcomes. Moreover, the evaluation of the evidence needed to influence the behavioral intentions of clinicians will lead to more rapid adoption.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $775,836 )
2026	2026	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Minority Health and Health Disparities Research	000	1	8/7/2026	NEW	$775,836
														Subtotal = $775,836

Grand Total All Awards = $775,836

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Modernizing Gynecologic Cancer Clinical Trial Eligibility Criteria to Increase Enrollment and Improve Generalizability

Award Number: R01MD021198

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/05/2026

PERIOD OF PERFORMANCE END DATE: 12/31/2030

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