A systematic review of ethnic diversity in clinical trial participation in Aotearoa.

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

Mitigating Administrative Risks in Industry-sponsored Clinical Trials

Equitable representation in clinical trials is essential to informing evidence-based treatment and reducing health disparities. No evidence is available about racial, ethnic and sex representation in Tourette's Syndrome (TS) treatment trials. To evaluate racial, ethnic and sex representation in randomized controlled trials (RCTs) of TS medications. We searched CENTRAL, Embase, PsycINFO, PubMed, Web of Science Core Collection and ClinicalTrials.gov for TS RCTs conducted in the US. The primary outcome was participation-to-prevalence ratio (PPR), the proportion of trial participants in racial, ethnic and sex subgroups divided by the proportion of individuals in the corresponding subgroup in the US population. Data were pooled through random-effects meta-analysis. Temporal trends were explored using meta-regression. Overall, 40 RCTs involving 1717 participants were included. All trials reported sex, but only 22 (55%) and 12 (30%) provided race and ethnicity data, respectively. Reporting of race and ethnicity improved over time (meta-regression coefficient (b) 1.80, 95% confidence interval [CI] 0.62-2.98 per decade, P = 0.002). Asian (PPR 0.46, 95% CI 0.29-0.75, P = 0.002), Black (PPR 0.44, 95% CI 0.34-0.57, P < 0.001), Hispanic (PPR 0.41, 95% CI 0.27-0.64, P < 0.001) and female (PPR 0.75, 95% CI 0.65-0.85, P < 0.001) individuals were underrepresented. Only Hispanic enrollment improved over time (b 0.78, 95% CI 0.35-1.20 per decade, P < 0.001). There are disparities in racial, ethnic and sex representation in RCTs of TS medications. Under-enrollment of minority participants may reflect disparities in terms of actual diagnosis of the condition, recruitment of minority individuals for participation in research studies or both.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Background Less than 5% of eligible adult cancer survivors participate in cancer clinical trials. Compared to 1.2% of non-Hispanic Whites, underrepresented minority (URM) survivors are less likely to participate in clinical trials (0.7% of Blacks, P &amp;lt; .001; 0.4% of Hispanics, P &amp;lt; .001). Yet, URMs experience disparities in cancer-related morbidity and mortality. Clinical trials need adequate URM representation in samples to generalize findings for reduction of cancer disparities. There is a critical need to identify interventions that increase URM participation in clinical trials. Common barriers to URM participation are lack of knowledge, lack of access, fear, and mistrust. Thus, educating URM survivors about clinical trials with videos may be an effective intervention. The purpose of this systematic review was to understand the use of video education interventions to increase URM survivor participation in clinical trials. Methods In October 2018, the authors searched Web of Science, Embase, PubMed, Cochrane, PsycInfo, and CINAHL databases for all articles that described or tested video interventions aimed at increasing adult, URM survivor participation in clinical trials. Two authors independently screened articles for inclusion, appraised quality, and abstracted relevant data. All authors synthesized the data into themes. Results The search yielded 2,518 articles. Of these, seven articles describing six distinct interventions met criteria for inclusion. Quality of the included studies appraised as fair to good. Though the six interventions reduced barriers to participation in clinical trials, they reported variable findings on readiness to enroll and/or actual participation of Black and Hispanic survivors of various cancers (largely breast). Five themes emerged: 1) cultural sensitivity application in video development and delivery; 2) video content aimed to educate and change attitudes about clinical trials; 3) video interventions were feasible but lacked power to detect effects; 4) predictors of readiness and participation within URMs were not consistently related to socioeconomic factors; and 5) racially congruent clinical trial coordinators, along with videos, may yield more favorable intervention effects. Conclusions Video interventions are well-received by URM survivors and may improve URM representation in clinical trials, yet they are underutilized. With widening cancer disparities and rapidly changing cancer care, more rigorous studies are needed to establish best practices for video interventions used to increase URM participation in clinical trials. Note: This abstract was not presented at the conference. Citation Format: Timiya S. Nolan, Ya-Ning Chan, Ashley Leak Bryant, Jennifer S. Walker, Ana' M. Bell, Rachel Hirschey. Use of video education interventions to increase underrepresented minority cancer survivor participation in clinical trials: A review [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr B052.

AIDS Clinical Trials Is There Access for All?

Cardiovascular disease (CVD) is the most common cause of death in American women and accounts for a full one-third of all deaths.1 Although the common perception may be that CVD affects mainly men, there is equal prevalence of this disease between the genders by the age of 40, and by the age of 60 more women than men are affected. More women than men have died from CVD causes on a yearly basis since the mid 1980s, and whereas the CVD mortality has steadily declined in men over the past 30 years, it has remained steady in women until very recently when CVD mortality was noted to decrease for both genders.2 See accompanying article on page 277 The impact of cardiovascular disease (CVD) on the health status of American women is gaining more recognition and has become the focus of public education efforts such as the “Go Red for Women” campaign sponsored by the American Heart Association and the “Red Dress” project sponsored by the Department of Health and Human Services, the National Institutes of Health (NIH), and the National Heart Lung and Blood Institute (NHLBI). These programs are, in part, a response to the increasing awareness of cardiovascular disease as a major source of morbidity and mortality in U.S. women. The importance of CVD as a major source of mortality in women was recognized early on by federally funded institutes including the Public Health Service Task Force, which brought attention to concerns about the health information available to women and the historical lack of research focus on women’s health in its 1985 Report of the Public Health Service Task Force on Women’s Health Issues .3 In response to this report, the National Institutes of Health adopted a policy for the inclusion of women in clinical research …

Encouraging participation in cancer clinical trials, one step at a time.

AIDS clinical trials. Is there access for all?

Background: Breast cancer (BC) remains a leading cause of cancer-related morbidity and mortality among women. Despite therapeutic advances, racial and ethnic disparities persist in both clinical outcomes and research participation. Black women have a 40% higher mortality rate than White women despite similar incidence, and BC incidence is rising among Hispanic women. Antibody-drug conjugates (ADCs) have emerged as a transformative therapeutic class for patients with advanced and metastatic BC. As the use of ADCs expands, ensuring equitable representation in the clinical trials that support their approval is critical. This study aimed to evaluate racial and ethnic representation in interventional trials of ADC for BC. We specifically assessed the inclusion of underrepresented populations, the completeness of demographic reporting, and disparities in enrollment relative to the population most affected by the disease. Methods: We analyzed 25 interventional clinical trials investigating ADCs for the treatment of advanced or metastatic breast cancer (Stage III-IV) with publicly available results posted on ClinicalTrials.gov between 2015 and 2025. Trials were included if they investigated ADCs as the primary therapeutic agent and reported demographic data for enrolled patients. Key trial characteristics, including study phase, sponsor type, geographic region, and participant demographic data, were extracted. The primary objective was to assess racial and ethnic representation across trials and evaluate the completeness and consistency of demographic reporting. Descriptive statistics, including mean, median, standard deviation, and 95% confidence intervals, were calculated to summarize participant representation by race and ethnicity. Results: A total of 8,459 participants were included across 25 clinical trials. Most trials (72%, n=18) focused on Stage IV BC; 32% (n=8) also included patients with Stage III disease. All trials (n=25) reported racial demographics, while only 44% included data on ethnicity (n=11). White patients accounted for the highest median representation at 63.9% (n=4,993, 95% CI: 52.2-81.7), followed by Asian individuals at 20.5% (n=2,257, 95% CI: 6.7-40.0). Black patients were markedly underrepresented, with a mean enrollment of 2.2% (n=220, 95% CI: 1.4-3.6). Among the 11 trials that reported ethnicity, Hispanic patients represented a median of 8.1% (n=440, 95% CI: 4.3-17.6). Participants identified as “other” or not categorized represented 5.2% (n=989) of total enrollment. A majority of trials were multiregional (64%, n=16), with North America and Europe hosting most trial locations, 84% (n=21) and 56% (n=14) respectively. South America held only 20% (n=5) of clinical trials, with none in Africa. Most studies (84%, n=21) were industry-sponsored, while 16% (n=4) were led by academic or government institutions. Conclusion: This analysis reveals persistent underrepresentation of Black and Hispanic populations in clinical trials evaluating ADCs for BC, despite their disproportionate disease burden. The limited and inconsistent reporting of ethnicity, alongside broad racial categories that obscure the inclusion of American Indian, Pacific Islander, and multiracial participants further hampers comprehensive equity assessments. As a meta-research study limited to publicly reported data, our findings may underestimate disparities due to incomplete or inconsistent demographic documentation. Nonetheless, these results underscore the urgent need to prioritize representative enrollment and standardized demographic reporting in future ADC trials. Doing so is critical not only for ensuring equitable access to novel therapies, but also for enhancing generalizability of efficacy and safety outcomes across diverse patient populations in oncology. Citation Format: M. Jaramillo, Z. Sarfraz, C. Gillespie, S. Milan, S. Sukie, V. Andion Camargo, F. Akkoc Mustafayev, V. Podder, K. A. Qidwai, M. Ganiyani, M. S. Ahluwalia, R. Mahtani. Racial and Ethnic Representation in Antibody-Drug Conjugate Clinical Trials for Breast Cancer: A 10-Year Review [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-11-18.

620 Creating a culture of clinical research in the clinic: Integrating clinical trials into the care of patients with lupus

Purpose: Thirty years after the NIH Revitalization Act, racial/ethnic minority (REM) patients continue to be underrepresented in oncology clinical trials with disproportionately low rates of participation compared to non-Hispanic whites. Health system, patient, and medical provider factors contribute to this disparity. However, little is known about clinical trial investigator perspectives of REM participation in oncology clinical trials and their contribution to this disparity. To our knowledge there are no published quantitative studies that have investigated this important and actionable topic. Methods: We conducted a cross-sectional, anonymous, pilot survey of medical, radiation, and surgical oncology clinical trial investigators at a large academic center. Over a 5-week period, 107 individuals received a survey. The survey assessed 6 domains regarding disparities in REM participation in clinical trials: investigator knowledge, attitudes, and prior training on the topic, self-efficacy and motivation for improvement in addressing known disparities, and perceived barriers to REM participation in clinical trials. Modified, previously validated items were used when possible. Results: Of 60 respondents (56% response rate), 33 were male (55%). Thirty-six identified as non-Hispanic white (60%), 16 as Asian (27%), 1 as Hispanic/Latinx (2%), and 7 as other/prefer not to state (11%). Respondents included 49 medical (82%), 7 surgical (11%), and 4 radiation oncologists (7%). Average time as a clinical trial investigator was 14 years (2-40). Respondents opened an average of 2 clinical trials as primary investigator in the past year (0-10). A majority (83%) strongly agreed disparities exist in REM clinical trial participation and that the resulting lack of diversity is problematic (75%). However, only 34% strongly agreed they consider ways to achieve racial/ethnic diversity among trial participants when designing clinical trials, or ways to specifically enroll REM patients (28%). Respondents most commonly cited patient rather than health system factors as barriers to REM participation in clinical trials. Notably, nearly half (45%) agreed that lack of REM participation is a problem they cannot directly address. A majority (83%) endorsed wanting to improve their consideration of barriers to REM participation as they design clinical trials and wanted help to improve (86%). Conclusion: Our results suggest there is awareness among clinical trial investigators at our academic center of disparities in REM participation in oncology clinical trials and the problem this poses to cancer care. There is also a pervasive view that primary barriers to REM participation are patient factors, and investigators do not feel they can directly address these. Nonetheless, there is motivation among investigators to improve in their ability to consider barriers to REM participation as they design clinical trials. Interventions that improve investigators’ self-efficacy for addressing barriers to REM participation in clinical trials, especially patient level barriers, are needed. Citation Format: Natalie P. Bransky, Anne M. Walling, John A. Glaspy, Maria Garcia-Jimenez. Exploring the unexplored: Clinical trial investigator perspectives of disparities in racial/ethnic minority participation in oncology clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A078.

Representative enrolment of older adults in clinical trials: the time is now

Representation of lesbian, gay, and bisexual people in clinical cancer trials

Imagine the following: A 58-year-old surgeon recently diagnosed with Stage 4 lung cancer comes to see you for clinical trial options. He is otherwise in excellent health, and he takes no medications. He is highly motivated to receive cutting-edge treatments, has a thorough understanding of the nature of the disease and potential therapies, and states he will be strictly adherent to any recommended treatment regimen. However, he is not eligible for any clinical trial available at your institution due to a history of localized prostate cancer treated surgically three years previously.