Enrollment of Racial and Ethnic Minoritized Groups in Gynecologic Oncology Clinical Trials: A Review of the Scope of the Problem, Contributing Factors, and Strategies to Improve Inclusion

Barry, Danika; Steinberg, Jecca R.; Towner, Mary; Barber, Emma L.; Simon, Melissa A.; Roque, Dario R.

doi:10.1097/grf.0000000000000765

Cited by 10 publications

(6 citation statements)

References 91 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This is despite a large literature base identifying numerous barriers to participation at multiple levels, along with numerous recommendations and reports about how mitigating these barriers could lead to increased accrual. 16 , 25 , 51 , 52 , 53 , 54 , 55 Many studies captured in our initial search were eliminated at the abstract phase because their outcome was not accrual into cancer treatment trials or did not provide data that could be used to verify whether an intervention had an effect. No studies were available to determine whether any interventions were more or less effective among patients clinical underrepresented in cancer treatment trials, including people from ethnic and racial minoritized groups, people with low incomes, those who live in rural areas, people who are aged 70 years and older, and adolescents and young adults.…”

Section: Discussionmentioning

confidence: 99%

Strategies for increasing accrual in cancer clinical trials: What is the evidence?

Michaels,

Weiss,

Sae‐Hau

et al. 2024

Cancer Medicine

View full text Add to dashboard Cite

IntroductionDespite the importance of clinical trial participation among cancer patients, few participate—and even fewer patients from ethnic and racial minoritized groups. It is unclear whether suggested approaches to increase accrual are successful. We conducted a scoping review to identify evidence‐based approaches to increase participation in cancer treatment clinical trials that demonstrated clear increases in accrual. Notably, more stringent than other published reviews, only those studies with comparison data to measure a difference in accrual rates were included.MethodsWe searched PubMed/MEDLINE, Embase, CINAHL, and Web of Science for English‐language articles published from January 1, 2012, to August 8, 2022. Studies were included if they were conducted in the United States, described single or multicomponent interventions, and provided data to measure accrual relative to baseline levels or that compared accrual rates with other interventions.ResultsSixteen articles were included: six with interventions addressing patient barriers, two addressing provider barriers, seven describing institutional change, and one describing policy change. Key themes emerged, such as a focus on patient education, cultural competency, and building the capacity of clinics. Few studies provide comparative accrual data, making it difficult to identify with certainty any effective, evidence‐based approaches for increasing accrual. Some patient‐ and system‐level interventions studies showed modest increases in accrual primarily through pre‐post measurement.ConclusionDespite an extensive body of literature about the barriers that impede cancer treatment trial accrual, along with numerous recommendations for how to overcome these barriers, results reveal surprisingly little evidence published in the last 10 years on interventions that increase accrual relative to baseline levels or compared with other interventions. As clinical trials are a primary vehicle through which we improve cancer care, it is critical that evidence‐based approaches are used to inform all efforts to increase accrual. Strategies for increasing participation in cancer clinical trials must be developed and rigorously evaluated so that these strategies can be disseminated, participation in trials can increase and become more equitable, and trial results can become more generalizable.

show abstract

Section: Discussionmentioning

confidence: 99%

Strategies for increasing accrual in cancer clinical trials: What is the evidence?

Michaels,

Weiss,

Sae‐Hau

et al. 2024

Cancer Medicine

View full text Add to dashboard Cite

show abstract

“…The reasons for differential enrollment are multifactorial, including historical factors and socioeconomic, cultural, and systemic barriers. 29 Further research into differential enrollment and strategies to increase diverse accrual is urgently needed to prevent the perpetuation of existing disparities in oncologic outcomes. However, enrollment in a clinical trial alone does not overcome the substantial differences in survival stratified by race, with data from 19,457 patients registered in clinical trials conducted by the Southwestern Oncology Group indicating that African American patients with ovarian cancer have worse survival (HR 1.61, 95% CI 1.18–2.18, P =.02) despite enrollment in phase III trials.…”

Section: Discussionmentioning

confidence: 99%

Association of Clinical Trial Participation With Improved Overall Survival for Recurrent, Platinum-Resistant Ovarian Cancer

Morton

Yao

Chalif

et al. 2023

Obstetrics &Amp; Gynecology

View full text Add to dashboard Cite

OBJECTIVE: To investigate whether clinical trial participation is associated with overall survival in patients with platinum-resistant ovarian cancer. METHODS: An IRB-approved, retrospective, single-institution cohort study was performed in patients with platinum-resistant ovarian cancer from January 1, 2009, to December 31, 2017. Platinum resistance was defined as progression within 6 months after completion of platinum chemotherapy. Patients were divided into two cohorts: 1) clinical trial participants for platinum-resistant ovarian cancer or 2) standard of care. The association of trial participation with overall survival from the date of platinum resistance was assessed with univariate and multivariable models. RESULTS: Of 305 eligible patients with recurrent platinum-resistant ovarian cancer, 46 (15.1%) were clinical trial participants. There were no significant differences in age (61.2 years vs 63.3 years, P=.21), body mass index (27.5 vs 27.6, P=.90), race (P=.61), medical comorbidities (P>.05), or performance status (P=.07) for clinical trial participants compared with those receiving standard of care. The majority underwent primary cytoreduction (76.1% vs 69.1%, P=.34) with no differences in residual disease (P=.43) for clinical trial participants compared with those receiving standard of care. There was no difference in poly-ADP-ribose polymerase inhibitor (21.7% vs 15.1%, P=.26) or bevacizumab (22.2% vs 32.1%, P=.31) use for clinical trial participants compared with those receiving standard of care. On multivariable analysis controlling for comorbidities, stage, and germline mutational status, clinical trial participation was associated with significantly improved overall survival from the date of platinum resistance compared with standard of care (13.8 months vs 10.5 months, adjusted hazard ratio 1.46, 95% CI 1.04–2.05, P=.028). CONCLUSIONS: In this retrospective cohort of patients with platinum-resistant ovarian cancer, clinical trial participation was associated with improved overall survival compared with standard of care therapies. Availability and participation in clinical trials should be prioritized in patients with recurrent, platinum-resistant ovarian cancer.

show abstract

“…Structural barriers (eg, lack of clinical trials in regions with a higher density of minoritized patients) and clinical factors (eg, narrow eligibility criteria that disproportionately affect underrepresented populations) have resulted in lower clinical trial enrollment of racial and ethnic minoritized groups, 4 with evidence that this contributes to poorer survival. [6][7][8][9] In a recent review, Barry and colleagues 10 outlined the extent of racial disparities in clinical trial enrollment of patients with gynecologic cancer. Most of the reviewed studies compared observed enrollment in clinical trials identified through ClinicalTrials.gov with expected enrollment derived from population-based, age-adjusted incidence rates.…”

Section: Introductionmentioning

confidence: 99%

“…In a recent review, Barry and colleagues outlined the extent of racial disparities in clinical trial enrollment of patients with gynecologic cancer. Most of the reviewed studies compared observed enrollment in clinical trials identified through ClinicalTrials.gov with expected enrollment derived from population-based, age-adjusted incidence rates.…”

Section: Introductionmentioning

confidence: 99%

Racial and Ethnic Disparities in Clinical Trial Enrollment Among Women With Gynecologic Cancer

Khadraoui,

Meade,

Backes

et al. 2023

JAMA Netw Open

View full text Add to dashboard Cite

ImportanceRacial and ethnic disparities in clinical trial enrollment are unjust and hinder development of new cancer treatments.ObjectiveTo examine the association of race and ethnicity with clinical trial enrollment among women with endometrial, ovarian, or cervical cancer.Design, Setting, and ParticipantsThis retrospective cohort study used data from the National Cancer Database, a hospital-based cancer registry, and the Surveillance, Epidemiology, and End Results Program (SEER), a population-based cancer registry. Population-based race and ethnicity–specific proportions for each cancer site were derived from SEER. Participants included women with an endometrial, ovarian, or cervical cancer diagnosed from 2004 to 2019. Analyses were performed from February 2 to June 14, 2023.ExposureRace and ethnicity were categorized as American Indian/Alaska Native, Asian, Black, Hispanic (any race), Native Hawaiian/Pacific Islander, White, and other (not defined in the National Cancer Database).Main Outcomes and MeasuresThe primary outcomes were the odds of clinical trial enrollment and representation in clinical trials compared with the US population. Multivariable-adjusted logistic regression was used to estimate odds ratios (ORs) and 95% CIs for associations of race and ethnicity with clinical trial enrollment within the National Cancer Database sample. Participation-to-prevalence ratios (PPRs) according to diagnosis period (2004-2011 vs 2012-2019) were calculated by dividing the race and ethnicity–specific percentage of clinical trial participants in the study sample by the percentage of racial and ethnic groups in SEER.ResultsAmong 562 592 patients with gynecologic cancer (mean [SD] age at diagnosis, 62.9 [11.3] years), 1903 were American Indian/Alaska Native, 18 680 were Asian, 56 421 were Black, 38 145 were Hispanic, 1453 were Native Hawaiian/Pacific Islander, 442 869 were White, and 3121 were other race and ethnicity. Only 548 (&lt;1%) were enrolled in clinical trials. Compared with White women, clinical trial enrollment was lower for Asian (OR, 0.44; 95% CI, 0.25-0.78), Black (OR, 0.70; 95% CI, 0.50-0.99), and Hispanic (OR, 0.53; 95% CI, 0.33-0.83) women. Compared with the US population, White women were adequately or overrepresented for all cancer types (PPRs ≥1.1), Black women were adequately or overrepresented for endometrial and cervical cancers (PPRs ≥1.1) but underrepresented for ovarian cancer (PPR ≤0.6), and Asian and Hispanic women were underrepresented among all 3 cancer types (PPRs ≤0.6).Conclusions and RelevanceIn this cohort of patients with gynecologic cancer, clinical trial enrollment was lower among certain minoritized racial and ethnic groups. Continued efforts are needed to address disparate clinical trial enrollment among underrepresented groups.

show abstract

Enrollment of Racial and Ethnic Minoritized Groups in Gynecologic Oncology Clinical Trials: A Review of the Scope of the Problem, Contributing Factors, and Strategies to Improve Inclusion

Cited by 10 publications

References 91 publications

Strategies for increasing accrual in cancer clinical trials: What is the evidence?

Strategies for increasing accrual in cancer clinical trials: What is the evidence?

Association of Clinical Trial Participation With Improved Overall Survival for Recurrent, Platinum-Resistant Ovarian Cancer

Racial and Ethnic Disparities in Clinical Trial Enrollment Among Women With Gynecologic Cancer

Contact Info

Product

Resources

About