Representation In Clinical Trials Research Articles

The underrepresentation of females in antihypertensive medication over the years: a scoping review

Abstract Background Hypertension is one of the leading global risk factors for cardiovascular disease-related morbidity and mortality. Females have historically been underrepresented in clinical trials resulting in presumed sex-related disparities in antihypertensive treatment effects. The past decade, widespread attention has been paid to this shortcoming aiming at increasing females' representation in clinical trials. Purpose To investigate whether in studies investigating the effect of antihypertensive drugs 1) the representation of females and 2) presentation of sex-stratified data has increased over the past decades. Methods We performed a scoping review after systematically searching PubMed and Embase for studies evaluating the effects of the five major groups of antihypertensive medication from inception (1945) until May 2020. The review was registered in Prospero database. Studies were only included if they 1) investigated one class of the five main groups of antihypertensive medications (beta-blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, and diuretics, 2) human studies, 3) investigated adults ≥18 years of age, 4) were written in English or Dutch. We excluded articles if 1) only abstract was available and full report was not found, 2) unsuitable study design, 3) no reference group included, 4) outcome not related to cardiovascular health, 5) no registration of specific dose and duration information. The primary outcome was the proportion of included females over time, stratified per decade. The secondary outcome was whether sex-stratification was reported. Linear regression analysis with beta coefficient (β) and 95% CI was performed to explore the associations between the percentage of females included in the studies over time. Results The search strategy resulted in 73,867 potential articles. After study selection based on title/abstract and full text, 2,079 original studies were eligible for our study. These included 1,395,264 adults of which the mean percentage of females participating in all included studies was 27.9% (Figure 1, Table 1). The percentage of females participating in antihypertensive studies showed a slight increase each year by 0.4% (95% CI 0.36–0.53, P<0.01). The yearly increase was the highest between 2001 and 2010 being 0.52% (95% CI 0.076–0.954) and in the most recent decade (between 2011 and 2020) 38.7% of included participants were female. Sex-stratification was performed in 76 (3.7%) studies and was the highest between 2011 and 2020 (7.3%). Conclusion Despite yearly increase in female participation in antihypertensive studies, females still only account for only one third of the study population. Moreover, less than 10% of studies report sex stratified data. Considering the global burden of hypertension, more differentiated sex-specific attention remains critically needed. Funding Acknowledgement Type of funding sources: None.

What are the best practices for psychotherapy with indigenous peoples in the United States and Canada? A thorny question.

This conceptual article addresses "best practices" for Indigenous Peoples in the United States and Canada. This topic is "thorny" both pragmatically (e.g., rare representation in clinical trials) and ethically (e.g., ongoing settler colonialism). We outline four potential approaches, or "paths," in conceptualizing best practices for psychotherapy: (a) limiting psychotherapy to empirically supported treatments, (b) prioritizing the use of culturally adapted interventions, (c) focusing on common factors of psychotherapy, and (d) promoting grassroots Indigenous approaches and traditional healing. Lessons from our four-path journey include (a) the limits of empirically supported treatments, which are inadequate in number and scope when it comes to Indigenous clients, (b) the value of prioritizing interventions that are culturally adapted and/or evaluated for use with Indigenous populations, (c) the importance of common factors of evidence-based practice, alongside the danger of psychotherapy as a covert assimilative enterprise, and (d) the need to support traditional and grassroots cultural interventions that promote "culture-as-treatment." A greater commitment to community-engaged research and cultural humility is necessary to promote Indigenous mental health, including greater attention to supporting traditional healing and Indigenous-led cultural interventions. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

How granularity of data matters in understanding and accelerating racial diversity in U.S. clinical trials.

88 Background: Historically, US clinical trials have been shown to recruit disproportionately large percentages of White patients, raising concerns about the generalizability of clinical trial results to underrepresented racial minority patient populations. Because of this, the FDA has recently reiterated its guidance stating that clinical trials need to reflect the demographic distribution of the US. In this research, we sought to understand how participation of Black patients varies by therapeutic area and geography within the US. Methods: Studying patient-level clinical trial data from an industry-leading historical clinical trial data repository of over 8 million patients from 27,000 clinical trials, we assessed the racial composition of US interventional trials across indications from 2010 to 2021 which encompassed 433,822 clinical trial participants across 2,997 trials. We also analyzed participants’ racial composition within the subset of trials from three distinct therapeutic areas (i.e., oncology n = 118,194, cardiovascular n = 12,281, central nervous system n = 35,533) and distinct sites over the same period. Results: The racial distribution of clinical trial participants in the US across all therapeutic areas was 78% White, 15% Black, and 3% Asian. Within the three distinct therapeutic areas, the proportion of Black clinical trial participants varied, with oncology trials reporting 8.5% Black participants, cardiovascular trials reporting 15.3% Black participants, and central nervous system trials reporting 19.9% Black participants. Black participation also varied within a therapeutic area, depending on the indication, as well as by site, with individual sites contributing differently to the racial diversity of trials. Conclusions: Our analysis shows that US interventional trials enroll 15% Black participants, appearing consistent with the 2020 US Census, which estimates that 14.6% of Americans are Black. However, more granular analyses at the level of therapeutic area, indication and site suggest substantial variation in Black participation in clinical trials including a gap in Black representation in oncology trials vs. US Census estimates. This research suggests that aggregate estimates of racial enrollment may mask dramatic variation by other factors like granularity of disease area and geographic location. The study of historic clinical trial data may yield useful insights for accelerating diverse representation in clinical trials.

Race reporting and representation in clinical trials from 2007-2020: An analysis of gynecologic oncology and other gynecology specialties (556)

Objectives: To characterize race and ethnicity reporting and representation in United States (US) gynecologic oncology (Gyn-Onc) clinical trials and compare reporting and representation across gynecology subspecialties. Methods: In this cross-sectional study, we investigated all US-based gynecology clinical trials that reported results on ClinicalTrials.gov from October 2007-March 2020, with a focus on Gyn-Onc. We evaluated two outcomes: (1) reporting of participant race/ethnicity and (2) representation (proportion of trial enrollees of a given race/eth- nicity). We analyzed associations of trial funding and subspecialty with each outcome using descriptive and multivariable logistic regression analyses. We modeled representation using logistic regression with a binary outcome (> or <20% Black, Indigenous, and People of Color [BIPOC] enrollment) controlling for a trial year, phase, and funder. Results: Of 8,515 registered gynecology trials, 3,214 were based in the US. Only 888 of 3,214 (27.6%) reported trial results, of which 505 (56.9%; 190,147 participants) included participant race/ethnicity data. There was a significant increase in race/ethnicity reporting over the study period (p<0.001). Race/ethnicity reporting varied by funder (government/academic 14.2%, industry 19.4%, p<0.001) and subspecialty (Gyn-Onc 13.9%, Benign Gynecology 16.6%, p=0.002), but these reporting differences were not persistent in multivariable analysis. Among trials that reported race/ethnicity, all BIPOC groups were underrepresented relative to their national population representation (Table). No significant difference in representation was seen by funding status. However, differences by subspecialty were noted; in aggregate, Benign Gynecology trials had more than twice as much diversity as Gyn-Onc trials (39.6% vs 17.7% average BIPOC representation per trial). Compared with Gyn-Onc clinical trials, REI (aOR: 2.78, 95% CI: 1.36-6.47), family planning (aOR: 3.68, 95% CI 1.87-8.16), and other benign gynecology trials (aOR: 1.79, 95% CI: 1.26-2.55) all had greater odds of enrolling at least 20% BIPOC participants. No difference was demonstrated between Gyn-Onc and Urogynecology trials. Conclusions: Reporting of race/ethnicity in US gynecology clinical trials is poor but improving. Among trials with race-ethnicity reporting, BIPOC participants were consistently underrepresented. Gyn-Onc trials demonstrated the least diversity of all gynecology subspecialties. This trend excludes BIPOC communities from health innovation conferred through trial participation, biases medical evidence, and worsens disparities in gynecology. Objectives: To characterize race and ethnicity reporting and representation in United States (US) gynecologic oncology (Gyn-Onc) clinical trials and compare reporting and representation across gynecology subspecialties. Methods: In this cross-sectional study, we investigated all US-based gynecology clinical trials that reported results on ClinicalTrials.gov from October 2007-March 2020, with a focus on Gyn-Onc. We evaluated two outcomes: (1) reporting of participant race/ethnicity and (2) representation (proportion of trial enrollees of a given race/eth- nicity). We analyzed associations of trial funding and subspecialty with each outcome using descriptive and multivariable logistic regression analyses. We modeled representation using logistic regression with a binary outcome (> or <20% Black, Indigenous, and People of Color [BIPOC] enrollment) controlling for a trial year, phase, and funder. Results: Of 8,515 registered gynecology trials, 3,214 were based in the US. Only 888 of 3,214 (27.6%) reported trial results, of which 505 (56.9%; 190,147 participants) included participant race/ethnicity data. There was a significant increase in race/ethnicity reporting over the study period (p<0.001). Race/ethnicity reporting varied by funder (government/academic 14.2%, industry 19.4%, p<0.001) and subspecialty (Gyn-Onc 13.9%, Benign Gynecology 16.6%, p=0.002), but these reporting differences were not persistent in multivariable analysis. Among trials that reported race/ethnicity, all BIPOC groups were underrepresented relative to their national population representation (Table). No significant difference in representation was seen by funding status. However, differences by subspecialty were noted; in aggregate, Benign Gynecology trials had more than twice as much diversity as Gyn-Onc trials (39.6% vs 17.7% average BIPOC representation per trial). Compared with Gyn-Onc clinical trials, REI (aOR: 2.78, 95% CI: 1.36-6.47), family planning (aOR: 3.68, 95% CI 1.87-8.16), and other benign gynecology trials (aOR: 1.79, 95% CI: 1.26-2.55) all had greater odds of enrolling at least 20% BIPOC participants. No difference was demonstrated between Gyn-Onc and Urogynecology trials. Conclusions: Reporting of race/ethnicity in US gynecology clinical trials is poor but improving. Among trials with race-ethnicity reporting, BIPOC participants were consistently underrepresented. Gyn-Onc trials demonstrated the least diversity of all gynecology subspecialties. This trend excludes BIPOC communities from health innovation conferred through trial participation, biases medical evidence, and worsens disparities in gynecology.

Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint.

517 Background: Breast cancer is the leading cause of cancer-associated death among Black women, and they are 41% more likely to die from breast cancer compared to White women. Few studies have evaluated if tumor biology differences contribute to this disparity in outcomes. Similar to triple negative breast cancer (TNBC), hormone receptor-positive (HR+) tumors classified as Basal-Type with BluePrint genomic analysis (HR+/Basal) are more aggressive, higher grade, are over-represented among young Black women and have worse clinical outcomes. TNBC is associated with low ACKR1 expression, which encodes the Duffy antigen and correlates with worse breast cancer outcomes. Given the over-representation and worse outcomes among Black women with HR+/Basal tumors, we compared differentially expressed genes (DEGs) by race and subtype. Methods: This study includes 2657 women with Stage I-III breast cancer who received BluePrint testing and are participants of the ongoing BEST study (5R01CA204819) at Vanderbilt University Medical Center or FLEX study (NCT03053193). Of 455 Black women, 315 had Luminal (HR+/Luminal) and 140 had Basal tumors (66 HR+/Basal and 74 HR-/Basal). White women within FLEX (n = 2202) were included as a reference group with HR+/Luminal (n = 1825), HR+/Basal (n = 158), or HR-/Basal (n = 219) tumors. Two-tailed proportional z-test was used to assess differences in subtype proportion by race. Limma R package was used to perform differential gene expression analysis (DGEA) of whole transcriptome data. Significant DEGs had an adjusted p-value &lt; 0.05 and absolute log2 fold change &gt; 1. Results: Black women had a significantly higher proportion of HR+/Basal (15%; p &lt; 0.001) and HR-/Basal (16%; p &lt; 0.001) tumors compared to White women (7% and 10%, respectively). In a multidimensional scaling analysis, HR+/Basal tumors cluster with TNBC rather than with HR+/Luminal tumors. While a DGEA comparing HR+/Basal with HR+/Luminal tumors resulted in over 700 DEGs within Black women, no DEGs were identified when comparing HR+/Basal tumors with TNBC. ACKR1 expression in HR+/Basal tumors was comparable to TNBC in Black women (p = 0.81) and White women (p = 0.46). In contrast, HR+/Basal tumors had significantly lower ACKR1 expression than HR+/Luminal tumors in Black (p &lt; 0.01) and White women (p &lt; 0.01). Conclusions: In this racially diverse cohort, transcriptomic analyses suggest that HR+/Basal tumors are biologically analogous to TNBC, independent of race. Molecular profiling identified racial disparities in the proportion of HR+/Basal tumors and underscores the need for diverse representation in clinical trials. With an over-representation of HR+/Basal tumors in Black women and evidence of worse outcomes, these data suggest that patients with HR+/Basal tumors should not be treated uniformly with HR+/Luminal tumors and highlight the importance of further genomic classification for patients with HR+ tumors. Clinical trial information: NCT03053193.

Racial and ethnic diversity in clinical trials of laser treatments for scars

Patients with skin of color are prone to dyspigmentation and excessive scar cosmesis after laser surgery.1 This poses challenges when using energy-based devices in this cohort, highlighting the need for their representation in clinical trials.2 It remains unclear if trials evaluating laser-treated scar cosmesis equitably represent a diverse population. This study aimed to characterize the racial composition and Fitzpatrick skin types (FSTs) of patients in trials evaluating scar cosmesis after laser surgery.

EP485: Ancestry inference from targeted NGS tests to enable precision medicine and improve racial/ethnic representation in clinical trials

There are well-established racial and ethnic disparities in cancer incidence and outcomes, in part due to structural, socioeconomic, environmental, and behavioral factors. However, some of these differences can be attributed to biological factors, such as the frequency of cancer somatic variants that vary by ancestry. It is well known that diversity in clinical trials is low, with Blacks and Hispanics consistently underrepresented compared to their cancer incidence. Further, race and ethnicity reporting in clinical trials occurs infrequently, and it is missing in up to 50% of patient medical records and genomic profiling tests.

A Framework for Equitable Partnerships to Promote Cancer Prevention and Control in Rural Settings.

Rural populations continue to experience persistent cancer disparities compared with urban populations particularly in cancers that can be prevented or detected early through screening and vaccination. Although the National Cancer Institute and the larger cancer research community have identified rural community partnerships as the foundation for reducing the disparities, we have identified limited application of community-based participatory research in cancer prevention and control research. Guided by the Community-Based Participatory Research Conceptual Model and our collective experience, we provide a framework for a community–cancer center partnership that focuses on promoting health equity. In this commentary, we articulate that the partnership process must foster capacity for communities and cancer centers, strive for rural representation in clinical trials and biobanking, build a pipeline for dissemination and implementation research, and create a bidirectional flow of knowledge between communities and academic institutions. Authentic partnerships with rural communities should be the ultimate goal of cancer centers, and the process described in this commentary can serve as an initial platform to build capacity and continue to strive toward that goal.

Abstract PO-214: Cancer disparities and African American representation in clinical trials involving Accelerated Partial Breast Irradiation Therapy

Abstract Background Radiation therapy is a critical component in the multi-disciplinary care of many breast cancer patients, but traditionally, has necessitated daily treatment visits over several weeks. Accelerated partial breast irradiation (APBI) in appropriately selected patients affords clinical outcomes that rival those achieved with conventionally fractionated whole-breast radiation. In addition to exposing a smaller volume of breast to radiation, APBI also allows reduction in total number of radiation treatment fractions to 1-10. This regimen thus stands to particularly benefit minorities such as Black American patients, who suffer disproportionately from high rates of economic burden in the form of absence from work, lost wages, and transportation costs related to prolonged cancer treatments. Yet, Black Americans have been traditionally underrepresented in clinical trials, threatening the generalizability of new treatments like APBI. In this study, we evaluated the racial makeup of clinical trials evaluating ABPI and the inclusion of Black Americans in these studies. Methods We retrospectively reviewed all published manuscripts involving accelerated partial breast irradiation therapy and analyzed the demographics of their study populations. Studies reported from centers outside the United States were excluded. When race reporting was not available in the published results, this information, where available, was obtained through the NIH Clinical trials registry. Results A total of 130 APBI trials were identified by PubMed search. Out of these, 80 studies were based in the United States. A total of 20 studies investigating APBI provided demographics data, comprising 1735 total patients. Of these, 1488 patients were White (85.7%), 124 were Black (7.1%), 67 were Hispanic (3.9%), and 46 were Asian (2.7%), and 10 patients were classified as multiple or unknown (0.6%). This percentage is lower than the 2019 US Census estimate of 13.4% Black Americans. We compared these results to two APBI trials conducted at our institution investigating 5-fraction and single fraction APBI regimens. Out of a total of 104 patients treated, 17 patients (16.3%) were Black. The higher proportion of Black Americans in our trials is likely due to a unique partnership between Parkland Hospital, a county Hospital that serves a high proportion of minority patients, and UT Southwestern Medical Center, which provides access to technologically sophisticated treatments such as APBI. Conclusion Despite APBI being uniquely positioned to provide increased benefits to racial minorities, Black Americans are underrepresented in clinical trials evaluating APBI, mirroring the broader national trend in all clinical trials. Based on our institutional experience, partnership between academic medical centers, which often have access to novel treatment regimens and county hospitals, which serve a large proportion of minority patients, is needed to reduce racial disparities in clinical trial participation and to eventually narrow and eliminate the racial health disparity gap. Citation Format: Ev Kakadiaris, Brian K Lue, Sherry Gu, Jonathan C. Tyes, Prasanna Alluri. Cancer disparities and African American representation in clinical trials involving Accelerated Partial Breast Irradiation Therapy [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-214.

Abstract PO-078: Introduction of implicit bias training to oncology faculty as a quality improvement initiative

Abstract Background: In a review, Hall (2015) found that implicit bias was significantly related to patient-provider interactions and health outcomes. Implicit Bias Training is a tool to help individuals understand and take corrective action for unfair behaviors. Purpose: Our goal was to assess physician attitudes towards Implicit Bias Training and to measure physician participation in the training when implemented as an NCCN quality measure. Methodology: Implicit Bias Training was offered by the DEI Office at Yale-New Haven Health. This incentivized quality initiative was required for all practicing oncologists. Of 109 physicians, 45 (41.3%) completed this training. The anonymous survey, which included a link to the Harvard Implicit Project's Implicit Association Test (IAT), was emailed to the 45 oncologists prior to participation in the session. There were 21 respondents (46.7% response rate). Results: The self-reported results of the IAT are as follows: 9.5% (n=2) report a strong automatic preference for European Americans (EA) vs. African Americans (AA). 23.8% (n=5) report a moderate automatic preference for EAs vs. AAs 42.9% (n=9) reported little to no automatic preference between AAs vs. EAs. 4.8% (n=1) report a slight automatic preference for AAs vs. EAs. 19% (n=4) did not participate in the IAT. 33.3% (n=7) of physicians report being either extremely or moderately surprised by the result of their IAT, while 33.3% (n=7) report being neither surprised nor unsurprised. 14.3% (n=3) report being moderately unsurprised, and the remainder did not respond. Physicians were asked to report their enthusiasm about Implicit Bias Training on a scale of 0 to 10. The Mean was 6. While physician enthusiasm reports show polarization not apparent by the mean, 57.1% (n=12) of physicians report being hopeful or very hopeful that training would help to improve both collegial and patient-physician relationships. Conclusion: Though this was a mandatory quality initiative that was incentivized, participation was less than 50%. Explanations for the observed participation rate are multifactorial and nuanced. Of the 17 respondents who completed the IAT, nearly one-half (n=7) reported strong or moderate bias for one racial group, and 41% report being surprised by their result. Our findings suggest that unconscious bias was demonstrated in a significant percentage of participants, many of whom were surprised by their results. The results support the need for Implicit Bias Training as part of ongoing oncology quality improvement. 57% of participating physicians were optimistic that the initiative would lead to positive changes. Future Work: We postulate that bias training could increase awareness and result in improved communication with minority patients. Our next project will evaluate the effect of Implicit Bias Training on minority participation in clinical trials. Inclusivity and representation in clinical trials is paramount in efforts to democratize cancer care and our study suggests that bias training could be a valuable tool to achieve this goal. Citation Format: Renee C. Taylor, Andrea Silber. Introduction of implicit bias training to oncology faculty as a quality improvement initiative [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-078.

Abstract PO-084: The pharmaceutical industry in action: 2021 clinical research diversity and inclusion survey

Abstract Development of medicines and vaccines for COVID-19 amplified the need for all US communities to participate in research. This recognition spurred interest in adopting inclusive and equitable research practices across industry and the clinical research ecosystem in general. Between 2018-2021, regulatory bodies, professional organizations, and working groups issued policy and/or recommendations outlining measures that support the conduct of inclusive and equitable clinical trials. We applied previously published multi-themed strategies, multi-stakeholder recommendations, and calls to action by surveying industry to document baseline practices towards equitable clinical trial representation in the US. Research Question: What strategies are industry leaders deploying to increase diversity in clinical trials? Methods: Using a 4-staged approach, we first identified 48 success factors sourced from 12 documents. This analysis included previously documented measures that are both inclusive of diverse populations as well as practices that facilitate insights from diverse communities. Second, a survey tool was developed that organized the individual success factors into 6 categories with one open-ended question on ecosystem changes; survey measures and 4 choices for each factor were “Actively implementing,” “Recommended to be implemented,” “No plans to implement,” and “No answer.” Third, the survey was administered between April 10-30, 2021, to 12 pharmaceutical companies all having a proven external commitment to health equity in oncology and all are represented on the 2021 1Q Biopharma top 25 by Market Cap report. Fourth, responses were anonymized and aggregated; results were provided to respondents. Results: The response rate was 67% (8/12). Responders indicated success factors across two major implementation categories as follows: “actively implemented” (51%); “recommended/planned for implementation” (44%). No responders added any additional success factors via free text. Being “actively implemented” was highest for the 3 categories “site selection” (78%), “general capabilities” (72%), “leadership” (53%). “Recommended/planned for implementation” was highest for the 3 categories “participant focused” (50%), “other factors” (50%), “racial and ethnic minority group data (REMG)” (48%). Conclusions: Pharmaceutical companies reported active implementation of success factors sourced from public documents across all categories. As an example, stakeholders have generally considered thoughtful site selection an important measure to enroll diverse representation in clinical trials as it may mitigate access barriers to participation. In the site selection category, the survey reported 7/8 companies were actively implementing three measures and 5/8 were actively implementing two measures. An approach and analysis should be considered for expansion to more biotech companies and include a process devised for annual fielding and transparently reporting results. Citation Format: Jeanne M. Regnante, Lola Fashoyin-Aje, Ellen Miller Sonet, Quita Highsmith, MBA, Melissa Gonzales, PhD, Sandra Amaro, MBA, Amy Davis, Mary Stober Murray, Maimah Karmo, Barbara Bierer. The pharmaceutical industry in action: 2021 clinical research diversity and inclusion survey [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-084.

Is Our Science Representative? A Systematic Review of Racial and Ethnic Diversity in Orthopaedic Clinical Trials from 2000 to 2020.

Is Our Science Representative? A Systematic Review of Racial and Ethnic Diversity in Orthopaedic Clinical Trials from 2000 to 2020.

Abstract 11893: Women, Ethnic, and Racial Groups Are Underreported and Underrepresented in Atrial Fibrillation Clinical Trials

Introduction: Women, ethnic, and racial group representation in clinical trials is low or uncertain in various fields of medicine. Hypothesis: Ethnic/racial information is underreported in atrial fibrillation clinical Trials. Methods: We systematically reviewed 85 randomized atrial fibrillation clinical trials (RCT), published with results on ClinicalTrials.gov, encompassing 2,546,351 participants from January 2011 to May 2021. We determined the representation of women and ethnic/racial groups, and the frequency of information reporting. Results: All of the studies reported gender information; women represented 33.73% of the participants. Only 56.5% (48/75) reported racial/ethnic data. The distribution of the participants were 87% White and 5.1% Black. Data on Latinx were reported in 38% (33/85) of RCTs and represented 5% of reported samples. Only 3.8% of participants were Asian and reported in 34 studies. Ethnic and racial group underrepresentation and underreporting were observed in trials involving device/procedure as well as drug therapy, with more underrepresentation and underreporting observed in drug therapy trials (Table). Conclusions: Gender reporting is consistent for all RCTs but with women representing only one-third of participants. However, the ethnic and racial characteristics, particularly in drug therapy trials, are underreported. In RCTs that report ethnic and racial data, Black and Latinx patients are underrepresented compared to their proportion in the overall population. These limitations may significantly impact the generalizability of the RCT results.

Ancestry inference from targeted NGS tests to enable precision medicine and improve racial/ethnic representation in clinical trials

Ancestry inference from targeted NGS tests to enable precision medicine and improve racial/ethnic representation in clinical trials

Racial and sex representation in clinical trials: Where are we in abdominal organ transplantation?

Clinical trials have historically failed to reflect the diversity of patients who may ultimately benefit from interventions being studied.1,2 Lack of diversity among trial participants can underestimate the effects of biological variation in treatment effect and further reduce equity and access to evidence-based healthcare for minority patients.3 The NIH and FDA implemented the Revitalization Act of 1993 to address these issues and provide guidelines to promote the inclusion of women and minorities in clinical trials.4.

Female participation in U.S. oncology clinical trials registered on ClinicalTrials.gov from 2008 to 2020.

85 Background: Females are thought to be underrepresented in clinical trials, which may lead to care disparities. We characterized female enrollment trends in U.S. oncology trials registered on ClinicalTrials.gov and identified features associated with accurate representation. Methods: We employed a cross-sectional study design with descriptive, logistic regression, and cox regression analyses. We downloaded 270,172 studies registered on the Aggregate Analysis of the ClinicalTrials.gov database from October 1, 2008 to March 9, 2020, excluding non-interventional and reproductive organ specific trials. We then applied cancer/oncology specific Medical Subject Heading terms and manually reviewed the remaining 27,521 trials for true oncology content. Prevalence-corrected estimates for female participation were calculated as the percentage of females among trial participants divided by the percentage of females in the disease population per U.S. Surveillance, Epidemiology, and End Results Program (SEER) data (participation to prevalence ratio [PPR]), with a range between 0.8 and 1.2 reflecting accurate female representation in the trial. Results: Of 26,894 trials meeting eligibility criteria, 9,059 trials were completed in the U.S., 2,499 trials reported completed study status, and only 1,256 trials reported sex. Among 1,256 oncology trials and 229,056 participants, overall female representation was 46.9% (95% CI, 45.4-48.4%). 43% of trials were industry funded, 29% academic, and 28% U.S. government. Females were underrepresented compared to their disease burden in anal canal (PPR 0.21), thyroid (PPR 0.57), stomach (PPR 0.68), kidney (PPR 0.77), and bone (PPR 0.79) cancer trials. They were accurately represented in head and neck (PPR 0.80), lung (PPR 0.84), bladder (PPR 0.85), skin (PPR 0.88), pancreas (PPR 0.88), colon (PPR 0.90), hematologic (PPR 0.91), liver (PPR 1.01), CNS (PPR 1.03), soft tissue (PPR 1.05), and esophagus (PPR 1.05) cancer trials. Accurate representation was significantly associated with industry funding and pancreas cancer trial focus, but not associated with trial type (medical, surgical, radiation, other invasive, other) (Table). Conclusions: Females are underrepresented compared to their disease burden in many solid tumor clinical trials. Stakeholders can look to industry funded and pancreas cancer trials as models of improvement, but must increase female representation in clinical trials to improve cancer care. [Table: see text]

Access and Representation: A Narrative Review of the Disparities in Access to Clinical Trials and Precision Oncology in Black men with Prostate Cancer

To provide commentary on the disparities in access to clinical trials and precision oncology specific to Black men with Prostate Cancer (PCa) in the United States and lend a general framework to aid in closing these gaps. The ideas, commentaries and data presented in this narrative review were synthesized by utilizing qualitative and quantitative studies, reviews, and randomized control trials performed between 2010 and 2021. We searched PubMed using the key words "Medicaid", "Medicare", "clinical trials", "African Americans", "Black", "underrepresentation", "access", "Prostate Cancer", "minority recruitment", "racial disparities", "disparity", "genomics", "biomarkers", "diagnostic" "prognostic", "validation", "precision medicine", and "precision oncology" to identify important themes, trends and data described in the current review. Keywords were used alone and combination with both "AND" and "OR" terms. Black men with prostate cancer (PCa) in the United States have earlier onset of disease, present with more advanced stages, and worse prostate cancer-specific survival than their White counterparts. Potential causative factors vary from disparities in health care access to differences in tumor immunobiology and genomics along with disparate screening rates, management patterns and underrepresentation in clinical and translational research such as clinical trials and precision oncology. To avoid increasing the racial disparity in PCa outcomes for Black men, we must increase inclusion of Black men into precision oncology and clinical trials, using multilevel change. Underrepresentation in clinical and translational research may potentiate poorly validated risk calculators and biomarkers, leading to poor treatment decisions in high-risk populations. Relevant actions include funding to include minority-serving institutions as recruitment sites, and inclusion of evidence based recruitment methods in funded research to increase Black representation in clinical trials and translational research.

Use of Video Education Interventions to Increase Racial and Ethnic Diversity in Cancer Clinical Trials: A Systematic Review.

Less than 5% of eligible adult cancer survivors participate in cancer clinical trials. Survivors identifying as Black, Indigenous, and people of color (BIPOC) are less likely to participate in clinical trials compared to those identifying as non-Hispanic White. Common barriers to BIPOC participation are lack of knowledge, lack of access, and mistrust. These barriers are all factors in the disparities observed in BIPOC cancer-related morbidity and mortality. Clinical trials need adequate BIPOC representation to garner generalizable findings that can reduce or eliminate cancer disparities associated with the social construct of race. This systematic review examined the use of video education interventions to impact BIPOC survivor participation in clinical trials. Web of Science, Embase, PubMed, Cochrane, PsycInfo, and CINAHL databases were queried for articles that described or tested video interventions aimed at increasing adult, BIPOC survivor clinical trial participation. Two authors independently screened articles for inclusion, appraised quality, and abstracted relevant data. All authors synthesized the data into themes through discussion and consensus. The search yielded 2,512 articles. Seven selected articles described six distinct interventions. Although the six interventions reduced barriers to participation in clinical trials, their findings varied on Black and Hispanic survivors' readiness to enroll and participate in trials. Four themes emerged: (a) cultural sensitivity is needed in video development and delivery; (b) video content should be aimed to educate and change attitudes about clinical trials; (c) video interventions are feasible and acceptable; and (d) video interventions affect outcomes on intention or actual enrollment. Video interventions are well-received by BIPOC survivors and may improve representation in clinical trials. Yet, video interventions are underutilized. More studies are needed to establish best practices for video interventions aimed at diversifying clinical trial participation as widening cancer disparities and rapidly changing cancer care continue to emerge.

Racial representation in clinical trials for dermatological new molecular entities.

Under-representation of ethnic minorities in clinical research has major implications for equality of access to current treatments in the field of dermatology. To determine whether there has been equitable representation of black individuals in the clinical trials for dermatological new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) since 2015, we analysed data from the FDA Drug Trials Snapshots programme from January 2015 to the present. During this period, there was significant under-representation of black participants in clinical trials for NMEs treating acne vulgaris, plaque psoriasis, actinic keratosis and squamous cell carcinoma. These findings highlight the need to prioritize representation of ethnic minorities in clinical trials to enhance clinical practice in the field of dermatology and to improve the care and health of minorities.

AML-406: Age-Based Disparities in Clinical Trials Supporting Food and Drug Administration (FDA) Approval of Therapies for Hematologic Malignancies

Context: The largest proportion of patients diagnosed with hematologic malignancies is older adults, defined as age ≥65. The under-representation of older adults in oncology clinical trials has been previously described; however, data specific to hematologic malignancy trials is sparse. Objective: To evaluate the median age of clinical trial participants and compare it to the real-world age distribution for each respective malignancy. Design: Prescribing information for novel hematologic malignancy therapies first approved for an adult indication between 2015 and 2019 were reviewed for the median age in the evaluable population of the supporting clinical trials. Adult median age estimates for each indication were obtained from the SEER database. Difference in median age (DMA) was calculated by subtracting disease population median age from trial median age. Additional trial protocol details were obtained from FDA package labels. Data are presented using descriptive statistics. Results: Twenty-two hematologic malignancy therapies were approved based on 26 trials, with 6,033 patients in the evaluable populations. Less than half of the trials were phase III (10; 38%) or were randomized with a control group (11; 42%). The median age of the trial participants was younger (mean 3.8 years) than the median age of the disease populations (95% CI: -6.0 to -1.6 years; p Conclusion: The median age of trial participants was nearly 4 years younger than their respective disease populations, despite no age-based exclusions in most protocols. Poor performance status, comorbidities, or organ impairment likely contributed to older patients’ ineligibility. Adequate representation in clinical trials is critical to evaluate the safety and efficacy of new therapies in the patient population who will eventually receive them. Post-approval, real-world research can help understand the effect of these therapies on older adults.