What’s in it for me? : A value assessment of gynecologic cancer clinical trials for Black women

Abstract

Objective:

Underrepresented groups may be dissuaded from clinical trial participation without perceived value. We therefore comprehensively assessed gynecologic cancer clinical trial protocols for the inclusion of items of value most important to Black individuals.

Methods:

ClinicalTrials.gov was queried for NCI-sponsored gynecologic cancer clinical trials in the US between Jan.1994 and Nov.2021. Pre-specified return of value (ROV) items were abstracted from each protocol. Inclusion proportions were calculated for each ROV item and temporal changes assessed with chi-square tests. Temporality of proportional trends was further assessed by slope and departure from linearity calculations.

Results:

279 gynecologic cancer clinical trials were included. Most commonly trials had first accrual in 2001–2007 (37%) and involved ovarian cancer (48%), phase II studies (53%), and chemotherapy (60%) or targeted therapy (34%). Trials often included ROV items in basic information (99%), medical record information (99%), and imaging (82%). 41% of trials included ROV items in biomarker testing, 20% genetic testing, and 20% in patient-reported outcome questionnaires. Over time, there were significant increases in the proportion of trials that included genetic (3% to 51%; p < 0.001) and biomarker testing (14 to 78%, p < 0.001). Information on lifestyle risk factors was rare (1%). No trials included ROV items in ancestry, how to connect with other participants, or remuneration.

Conclusions:

Gynecologic cancer clinical trials include few design elements that provide high value to Black individuals like lifestyle risk factors, ancestry, and remuneration. In any multi-pronged effort to improve diversity in clinical trial enrollment, inclusion of items valued by Black individuals should be considered.

Introduction

Gynecologic cancers represent nearly 12% of cancer cases among US women, with an estimated 115,000 new cases and 32,000 gynecologic cancer-related deaths estimated to occur in 2023.¹ Clinical trials serve an essential role in advancing gynecologic cancer treatments. However, minoritized women, especially Black women, remain underrepresented in gynecologic cancer clinical trials despite being disproportionately affected by worse outcomes of these diseases. Black women enrollment in clinical trials has declined over time.^2–4 In a study of 445 Gynecologic Oncology Group publications between 1985–2013, only 38% (170) of clinical trials reported race. Of the 67,568 enrollees with race data, 8% were Black and 83% were White. Most concerningly, there was a marked 2.8-fold reduction in Black women enrollment between 1994–2002 (16%) and 2009–2013 (5.8%).⁵ The absence of adequate clinical trial representation affects the generalizability of knowledge, insights, and biomedical innovations to populations of Black women and other minoritized cancer patients.⁶

Many individual and systemic factors are associated with the low accrual of Black women into clinical trials.⁷ A patient’s decision to participate in a clinical trial may be determined by what value (worth, usefulness, and benefit) they perceive the clinical trial has to offer. Returning value to participants is a novel concept in which information and results participants perceived as valuable – independent of investigators’ judgments – are returned to individual study participants.⁸

Given the novelty of a return of value (ROV) framework, few studies have characterized what specific populations deem valuable from clinical trials and how such differences may influence enrollment. In a survey of 2,500 diverse US and Puerto Rican adults, who were recruited from two national survey platforms, Wilkins et al. (2019) explored how various people perceive the value of different types of information commonly offered in clinical research designs. Although this study was limited to targeting the general population, rather than those actively considering a clinical trial, most (78.5%) survey respondents indicated that receiving study results would be valuable, and 72.4% of individuals indicated that receiving study results would influence their decision to participate. Furthermore, ranking of ROV components varied among racial and ethnic groups. For Black survey respondents (n = 696 self-identified Black respondents), the single most valuable research results were information on how genetics affect the risk of medical conditions (25%), lifestyle risk factors (15%), and ancestry (10.4%). Additionally, across all racial and ethnic groups, Black individuals were noted to place the highest value on remuneration.⁸

Furthermore, given that much research on recruitment disparities focus on barriers to participation, it is also important to recognize that several of Wilkins et al.’s return of value items can be considered facilitators, which are factors or strategies that aid in clinical trial recruitment, enrollment, and retention of study participants.^3,5,6,9 Research suggests that for Black individuals, important facilitators often include participation benefits like acquisition of health-related knowledge, access to resources, receipt of individual study results, and monetary compensation. Other notable facilitators include a sense of altruism, cultural congruence with research team, trust in research team, and safety assurances.^9–11

Understanding and maximizing value for patients in cancer clinical trials may help facilitate the recruitment, engagement, and retention of Black patients with gynecologic cancers. Whether gynecologic cancer clinical trials are currently designed to provide a return of value to Black patients is unknown. Our objective was to comprehensively assess gynecologic cancer clinical trial protocols for the inclusion of items of value most important to Black individuals as documented in the Wilkins national ROV survey.

Methods

Data Source

We queried the ClinicalTrials.gov registry for eligible trials: therapeutic and non-therapeutic National Cancer Institute (NCI)-sponsored gynecologic cancer (e.g., cervical, uterine, ovarian, vulvar, vaginal, and placental cancers) clinical trials. Clinical trials were open for accrual in the United States between January 1, 1994, and November 15, 2021. Exclusion criteria were non-gynecologic cancer clinical trials, clinical trials not conducted in the US, and clinical trials not opened for accrual between 1994 and 2021. For each clinical trial that met inclusion criteria, study protocols, as listed on ClinicalTrials.gov, were assessed for study characteristics and ROV items as described below.

Return of value items

We evaluated the clinical trial protocols for ROV items contained within Wilkins’ national survey including the following categories: basic participant information (e.g., physical measurements like height, lab panels, survey data), information from the medical record (e.g., procedures), how lifestyle affects the risk of getting a medical condition, genetic ancestry, information on the future use of participant information, information on how to connect with others in the study, and a process for remuneration (Table 1). Trials were additionally evaluated for the presence of health-related quality of life (HRQOL) or patient-reported outcome (PRO) questionnaires, genetic testing, biomarker testing, and imaging tests.

Table 1.

Definitions of return of value items when assessing clinical trials, as adapted from Wilkins et al. (2019)¹¹

ROV Item	Definition
Basic information	Collection of participants’ age, height, weight, lab results, and demographic information
Information from medical record	Use of medical history information including the presence of disease conditions, type and timing of doctor visits and procedures
Health-related quality of life (HRQOL) or Patient-reported outcome (PRO) questionnaires	Administration of questionnaires that seek to determine patients’ views on their symptoms, functional status, and quality of life (e.g., EORTC QLQ-C30)
How lifestyle affects the risk of getting a medical condition	Information about participants’ diet, exercise, sleep, and health-affecting habits such as drinking or smoking
Genetic ancestry	Information that informs participants about what percent of their DNA originates from different geographies of the world (e.g., genetic heritage)
Genetic testing	Genetic studies that help to identify genome variations or mutations that can cause or increase the risk of disease
Biomarker testing	Laboratory studies that measure tumor markers, proteins, and other substances that can provide information about the disease
Imaging test	At least one imaging modality (e.g., computer tomography) was used to evaluate the patient as part of the study
Future use of participant information	Investigators use archived or previously collected samples in the present study and/or are planning to bank samples for future use.
How to connect with others in a study	Connecting clinical trial participants with other study participants through forums or personal stories shared in blog posts or reports
Remuneration process	A process for financial compensation is present for participants that enroll and engage in the clinic trial

Analysis

Key clinical trial characteristics were summarized using descriptive statistics (e.g., year of first accrual, trial status, phase, disease site, and therapeutic modality). The proportion of ROV items included was calculated for each time-period at seven-year increments from 1994 to 2021 (1994–2000, 2001–2007, 2008–2014, 2015–2021). A chi-square test for trends was then used to determine if there were any significant changes by time-period in the proportion of clinical trials that contained ROV items. To further assess the temporality of any trends observed, the slope of the proportion of each ROV item over time was calculated using time as a continuous variable. Departure from linearity was checked using the chi-square statistic for departure. STATA v17.0 (StataCorp, College Station, TX) was used to complete all statistical analyses. A p-value < 0.05 was considered statistically significant. Based on the University of Washington Human Subject Division’s process for determining human subject research, this study did not qualify as human subject research and thus did not require institutional board review.

Results

Clinical trial characteristics

A total of 279 gynecologic cancer clinical trials met the eligibility criteria for inclusion in this study (Table 2). Twenty-one percent of trials had year of first accrual between 1994–2000, 37% between 2001–2007, 28% between 2008–2014, and 15% between 2015–2021. Most trials (65%) were listed under “completed” status, were phase II (53%) studies, and had chemotherapy (60%) as the primary therapeutic/intervention modality. Ovarian (48%), followed by uterine (31%) and cervical (24%) cancers were the disease sites of interest in therapeutic clinical trials.

Table 2.

Characteristics of 279 NCI-sponsored gynecologic cancer clinical trials, 1994–2021

Clinical trial characteristics	No. of Protocolsa N, (%)
Year of first accrual
1994–2000	58 (21)
2001–2007	103 (37)
2008–2014	77 (28)
2015–2021	41 (15)
Current trial status b
Active, Not recruiting	34 (12)
Completed	180 (65)
Terminated	36 (13)
Recruiting	17 (5)
Other (withdrawn, suspended, unknown)	12 (4)
Phase
I	32 (12)
I/II	6 (2)
II	148 (53)
II/III	4 (1)
III	62 (22)
Disease site
Cervix	67 (24)
Ovary	135 (48)
Uterus	87 (31)
Vulva/Vaginal	8 (3)
Placenta	4 (1)
Therapeutic/Intervention modality
Chemotherapy	168 (60)
Endocrine (e.g., hormone)	15 (5)
Immunotherapy	27 (10)
Radiation	23 (8)
Surgery	15 (5)
Targeted therapy	96 (34)
Other	20 (7)

^aSome protocols may include more than one disease site or have a combination of therapeutic intervention modalities in which we account for each phase separately; therefore, N may not total 279 protocols

^bTrial status on ClinicalTrial.gov as of 11/15/2021

Return of value items present within gynecologic cancer clinical trial protocols.

Table 3 details the prevalence of inclusion of ROV items in included clinical trials across all years 1994–2021. Most clinical trial protocols contained ROV items in basic information (99%), information from medical records (99%), and imaging reports (82%). A moderate number of protocols provided ROV items in biomarker testing (41%), genetic testing (20%), and HRQOL or PRO (20%) questionnaires. No gynecologic cancer clinical trial protocols offered ROV items in genetic ancestry, how to connect with others in the study, or a process for remuneration.

Table 3. Frequency of gynecologic cancer clinical trials with the return of value items based on ClinicalTrials.gov protocols, 1994 – 2021 (N = 279).

ROV Item	Example of ROV Inclusion Items from Clinical Trial Protocols	No. of Protocols, N (%)
Basic information	NCT02839707 Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration) Platelets >= 100,000/mcl (within 14 days prior to registration) Hemoglobin (Hgb) >= 8 g/dl (within 14 days prior to registration)	276 (99)
Information from medical record	NCT01039207 Exclusion: Patients with thromboembolic event or ischemic event within the past 12 months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction NCT00028951 No other malignancy within the past 5 years except nonmelanoma skin cancer. No nonhealing ulcer or chronic infection of the lower extremity, including superficial phlebitis. No prior fracture of any portion of either leg.	276 (99)
Health-related quality of life (HRQOL) or Patient-reported outcome (PRO) questionnaires	NCT00262847 Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI). NCT00002568 Objective: Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL.	56 (20)
How lifestyle affects the risk of getting a medical condition	NCT00053261 Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer. NCT00003078 Must complete smoking history questionnaire and provide urine specimen for cotinine analysis. Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis and who smoke at the time of diagnosis versus nonsmokers and those who smoke during radiation therapy versus those who quit.	4 (1)
Biomarker testing	NCT03556839 Secondary Outcome measures: incidence of anti-therapeutic antibodies (ATAs) during the study relative to the prevalence of ATAs at baseline NCT00003384 Evaluate the utility of MN protein, a novel tumor-associated antigen, as a potential diagnostic biomarker for cervical glandular and/or squamous neoplasia in patients with a cytologic diagnosis of atypical glandular cells of undetermined significance NCT01199263 To estimate (and compare) the proportion of patients who respond to the regimen on each arm of the study (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 with measurable patients and by cancer antigen [CA]-125 for those patients with detectable disease only).	114 (41)
Genetic testing	NCT04034927 To explore whether mutations in BRCA1/2 genes or other evidence of homologous repair deficiency (HRD+) is prognostic and/or predictive of response to combined Olaparib and Tremelimumab immunotherapy. NCT03348631 To assess the clinical activity (response frequency) of tazemetostat in patients with recurrent or persistent clear cell ovarian carcinoma with an ARID1A mutation.	57 (20)
Imaging report	NCT00003128 Must have measurable disease consisting of abdominal, pelvic, chest or other masses that can be defined in at least 2 dimensions by palpation, x-ray, MRI, computed tomography or ultrasound. If measured by MRI, computed tomography or ultrasound, the lesion must have a minimal tumor measurement of 1 cm. NCT03738228 Secondary objectives: To assess the predictive value of baseline and on-treatment PD-L1 expression in the tissue in each treatment arm for clinical outcomes using post-treatment PET-CT scan and 2-year DFS as the outcome measures.	229 (82)
Future use of participant information	NCT01012297 Objective: To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research. NCT00551070 Previously collected archived tumor tissue samples are obtained to determine protein levels of p-ERK/ERKERK, DNA isolation and sequencing of BRAF and Ras mutation analysis by immunohistochemistry (IHC).	30 (11)
Genetic ancestry	-----	0 (0)
How to connect with others in a study	-----	0 (0)
Remuneration	-----	0 (0)

Trends in return of value items over time

With the categorization of time from 1994 – 2021, there was a significant increase in the proportion of clinical trial protocols that included HRQOL or PRO questionnaires (increase from 16% to 44% of protocols, p-value < 0.001), genetic testing (increase from 3% to 51%, p-value < 0.001), biomarker testing (increase from 14% to 78% of protocols, p-value < 0.001), and information about future use of participant information (increase from 2% to 20% of protocols, p-value = 0.0026) (Table 4). Most clinical trial protocols across the temporal period contained ROV items in basic information and information from medical records. There was no significant change to the low proportion of clinical trials that contained the ROV item about lifestyle risk factors (p-value = 0.816).

Table 4.

The prevalence of return of value items in gynecologic cancer clinical trial protocols over time, 1994 – 2021 (N = 279)

ROV Item	Number of protocols by time-period, N (%)				p-value for trenda
	1994 – 2000 (N = 58)	2001 – 2007 (N = 103)	2008 – 2014 (N = 77)	2015 – 2021 (N = 41)
Basic information	57 (98)	103 (100)	75 (97)	41 (100)	0.586
Information from medical record	57 (100)	102 (99)	76 (99)	41 (100)	0.516
Health-related quality of life (HRQOL) or Patient-reported outcome (PRO) questionnaires	9 (16)	9 (9)	20 (26)	18 (44)	<0.001
How lifestyle affects the risk of getting a medical condition	1 (2)	1 (1)	2 (3)	0 (0)	0.816
Genetic testing	2 (3)	6 (6)	28 (36)	21 (51)	<0.001
Biomarker testing	8 (14)	30 (29)	44 (57)	32 (78)	<0.001
Imaging test	41 (71)	88 (85)	64 (83)	36 (87)	0.052
Future use of participant information	1 (2)	10 (10)	11 (14)	8 (20)	0.003
Genetic ancestry	0 (0)	0 (0)	0 (0)	0 (0)	---
How to connect with others in a study	0 (0)	0 (0)	0 (0)	0 (0)	---
Remuneration	0 (0)	0 (0)	0 (0)	0 (0)	---

^aA p-value < 0.05 is considered statistically significant.

On further assessment with time as a continuous variable, all ROV items demonstrated linear trends over time. Significant linear trends still held for biomarker testing, genetic testing, HRQOL or PRO questionnaires, and future use of participant information (Figure 1). The linear slopes indicated that there was a 3.3%, 2.7%, 1.5%, and 0.6% increase in the proportion of clinical trials per year that contained, biomarker testing, genetic testing, HRQOL or PRO questionnaires, and information about future use of participant information, respectively. The chi-square statistic for departure from linearity was not suggestive of any significant differences (p-value > 0.05) other than the linear trends observed for all ROV items assessed (data not shown in Fig. 1).

Figure 1.

Trend of return of value items included within gynecologic cancer clinical trials (N = 279) over time. Regression demonstrates the linear relationships between the frequency of return of value items and year. The linear slopes indicate that for every one-year increase, there was a 1.5%, 3.3%, 2.7%, and 0.58% increase in the proportion of clinical trials that included health-related quality of life (HRQOL) or patient-reported outcome (PRO) questionnaires, biomarker testing, genetic testing, and future use of participant information, respectively. Of note, only return of value items with statistically significant trends (p < 0.05) are shown.

Discussion

This study evaluated NCI-sponsored gynecologic cancer clinical trials for the inclusion of information and results highly and most valued by Black individuals. Our study demonstrates that overall gynecologic cancer clinical trials do not return information or contain clinical research facilitators most valued by and important to Black individuals. Over nearly three decades, few studies provided information on lifestyle risk factors, and no clinical trials included information on genetic ancestry or a process for remuneration. The only information type where value was achieved was genetic and biomarker testing in which a moderate number and increasing proportion of clinical trials contained genetic (20%) and biomarker (41%) testing. Our results showing increased genetic and biomarker testing within gynecologic cancer clinical trials likely reflect scientific advancements (e.g., Next Generation Sequencing), the push for personalized medicine, and decreasing costs of these tests.^12,13 Research suggests that Black women look favorably on genetic testing with advantages that include cancer prevention, the ability to act on abnormal results, behavioral changes, and sharing results with family members. Perceived disadvantages of genetic testing by Black women include emotional stress, concerns about confidentiality, stigma, discrimination, and costs.^14–18 Despite Black women finding value in genetic testing, there are disparities in awareness, knowledge, access, and utilization of genetic counseling and testing in the clinical setting.^12,19–22 Engaging Black women in clinical trials that incorporate germline and/or somatic genetic testing may serve as one way to narrow current disparities in access to genetic technologies in cancer care. Increased inclusion of Black women in clinical trials can also increase our scientific knowledge about germline and somatic variants in diverse populations while simultaneously providing information valued by Black participants. Provision of genetic information may also increase enrollment through increased altruism in eligible subjects if they feel their participation may benefit their own community.

Furthermore, although we identified an increase in the proportion of gynecologic cancer clinical trials that utilized genetic testing, no clinical trials included genetic ancestry testing, which Black individuals highly value.^8,23,24 Beyond research utility, ancestry data may provide Black women answers that complete personal and familial narratives that were lost through historical events like the Trans-Atlantic slave trade, provide genealogical and social orientation, and create a sense of identity.²⁵ With the return of any genetic results, counseling and availability of educational resources should be available to explain the results and possible health implications.

There was no explicit evidence or mention of a remuneration process in any clinical trial protocol reviewed. Both non-monetary and monetary remuneration is an important clinical trial design consideration that Black individuals highly value.^8,26–28 On average, Black individuals rated the importance of monetary compensation higher compared to White individuals (6.01 (SD: 1.47) vs 5.32 (SD 1.87) on Likert scale with 1 “not valuable” and 7 “very valuable”). In research, the monetary amount for compensation is often determined using one of several financial models – the market model, the wage model, the reimbursement model, or the appreciation model.²⁹ Regardless of the monetary model utilized, financial compensation is still a highly debated topic within the clinical trial ecosystem. There are legal implications (e.g., Federal Anti-Kickback Statutes) associated with monetary remuneration as remuneration can be coercive and unduly influence patients’ decisions to enroll in a clinical trial despite risks. Meanwhile, an argument can be made that there is an ethical obligation to fairly compensate study participants.^30,31 Research suggests that monetary remuneration for some Black women is valued because it reimburses and compensates for time and effort, provides a source of income, offsets some risks, and helps overcome financial barriers associated with clinical trial participation.²⁷ For clinical trials to be equitable, we must acknowledge the intersectionality of groups that are historically underrepresented in clinical trials including those with limited socioeconomic means as well as those who have and continue to bear the negative social costs and consequences of racism. The expectation that enrollment on the trial alone is enough to account for individual expenses required to participate unfairly biases those with less means who justifiably require more benefit to consider enrollment. Identifying ways to provide remuneration is a potential avenue by which clinical research sponsors could make clinical trial enrollment more equitable for diverse patient populations.

Given that most clinical trials were therapeutic intervention studies of patients with disease, only 1% of cancer clinical trials in our study provided information on lifestyle. However, lifestyle factors were assessed via HRQOL and PRO questionnaires. These questionnaires assess a patient’s physical, functional, social, family, and emotional well-being in relation to treatment effects and also help to facilitate symptom monitoring, prioritization of individual participant problems, patient-provider communication, and assistance with shared decision-making.^32–34 Because therapeutic clinical trials are not designed to include information on lifestyle risk factors, HRQOL and PRO measures and return of this information to participants may be an ROV alternative that may create value for Black women. Currently, many questionnaires used in the cancer setting lack validation in underrepresented racial and ethnic populations, and to our knowledge, none have been validated explicitly in Black populations with gynecologic cancers.^35,36 To ensure value for Black women, these metrics must be validated in underrepresented racial and ethnic populations to optimally capture aspects of diverse treatment experiences and well-being that can be appropriately managed while on a clinical trial.³²

Our findings support current literature suggesting that patient-centered facilitators and interventions can address clinical trial enrollment disparities. Fouad et al. (2016) found that use of African American patient navigators, who provided clinic-based education about clinical trials and supported African American cancer patients enrolled in clinical trials, was associated with significant increases (from 9% to 16%) in clinical trial enrollment of African American cancer patients at an NCI-designated cancer center. Among the African American patients that enrolled in a clinical trial (n = 304), completion rates were higher in those that received patient navigation support relative to those that did not (74.5% vs. 37.5%, p < 0.001).³⁷ Robinson et al. (2017) examined the association between a 15 minute culturally tailored enrollment video and both clinical trial perceptions and enrollment of African American breast cancer patients (n = 200). Positive perceptions about clinical trials increased, and there was a 7.5% increase in clinical trial enrollment after the intervention.³⁸ Nipp et al. (2016) used an interrupted time series design to demonstrate increased clinical trial participation rates when participants, especially those in need, received financial assistance through a cancer care equity program.³⁹ Finally, in the Women Empowered to Live with Lupus (WELL) study, a study designed to assess the efficacy of the Chronic Disease Self-Management Program (CDSMP) in African American women with Systemic Lupus Erythematosus (SLE), researchers used tailored interventions (e.g. scheduling CDSMP on Saturdays, conducting CDSMP at convenient/familiar facilities, and assisting with transportation services) to register 168 African American women into the CDSMP. The researchers credit the 75% CDSMP completion rate to their tailored implementation strategies.⁴⁰ Collectively, these examples show that when intentional study design processes are taken to meet the needs and desires of participants, diverse clinical trial accrual can occur.

Limitations

Wilkins et al.’s work provides an important foundation for population-specific ROV; however, it is still a single study. Concepts of value in gynecologic cancer clinical trials may differ given the unique overlap of reproductive health and cancer thus these items may occur with more or less frequency compared to other clinical trials. Furthermore, our study was limited to only NCI-sponsored clinical trials in the US, which may limit generalizability to industry sponsored or international clinical trials. Our evaluation of trials was, by necessity, limited to only clinical trials identified on ClinicalTrials.gov; therefore, there may be clinical trials not listed on this public domain. In addition, investigators may publish an abbreviated protocol that fails to report some ROV items that were indeed present in the trial. Finally, while this study demonstrated which ROV items are contained within clinical trial protocols, our study was not designed to assess which ROV items were ultimately returned to study participants or to assess participants perceptions of returned information and results.

Conclusion

Clinical trials are an essential component of the cancer care landscape This study seeks to identify whether and to what extent evidence-based items of value to Black individuals are included in gynecologic cancer trials. We use the largest available survey of Black individuals to identify those items of value, and the most comprehensive database of gynecologic cancer trial protocols to determine whether these items were present or absent. In doing this work, we seek to use a specific question to identify evidence-based targets for intervention to improve trial enrollment.

To create equitable clinical trials where Black women enroll, engage, and derive value, evidence-based health equity frameworks can identify a priori likely factors that create inequitable enrollment, thus creating opportunity for targeted intervention. Therefore, specific interventions can be pursued at different levels (e.g., Systemic, Institutional, and Individual-level) to be efficient with resources while doing enough to create change. Research organizations must also include key stakeholders like current/former patients and community members at all steps of a clinical trial, including the design phase. These individuals bring knowledge and experience that may provide insight into what participants perceive as valuable; therefore, helping investigators to create person-centered, community-informed clinical trials.

Future mixed method studies should administer a survey similar to Wilkins et al.’s survey to a cohort of Black women with gynecologic cancers and qualitatively investigate Black women’s perceived value of gynecologic cancer clinical trials. Future studies will also need to examine who should deliver and explain the information to participants and how and when the valued information should be shared within a clinical trial. Lastly, future studies should focus on implementing evidence-based facilitators to enroll and engage Black women with clinical trials.

Highlights.

• Black women are underrepresented in gynecologic cancer clinical trials despite disproportionately worse cancer outcomes

• Survey-based ‘return of value’ items show trial design factors that increase desire to participate among Black individuals

• Gynecologic cancer clinical trials lack facilitators, information, and results Black individuals perceive as most valuable

• Lack of valuable facilitators, information, and results may contribute to low accrual of Black women in cancer research

• The results can be used to create person-centered, community-informed clinical trial design for gynecologic cancer research