Minority Accrual Research Articles

Abstract A121: Uncovering research gaps and strategizing future efforts: NCI Think Tank on multiple myeloma and disparities

Abstract One of the National Cancer Institute's (NCI) priority research areas is understanding the underlying causes of cancer health disparities. In recent years, there have been multiple efforts focusing on the disparities that exist within various cancer types, for example, the higher risk of triple-negative breast cancer in black women and prostate cancer in black men. One disease in which disparities are seen prominently is multiple myeloma (MM), the second most common hematologic malignancy, with an estimated 31,000 new cases to be diagnosed in 2018. Despite new treatments significantly improving survival rates, MM remains incurable and incidence rates continue to increase. Furthermore, the burden from MM and its premalignant conditions, monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM), is not shared equally across racial/ethnic groups in the US. Blacks have the highest incidence of MGUS and MM, with a rate 2-3 times higher than non-Hispanic whites. Blacks and Hispanic/Latinos are more likely to experience an earlier age of onset, and blacks are twice as likely to die compared to other racial/ethnic groups, even when matched for socioeconomic and other factors, suggesting that biologic differences may play an important role in the observed disparity. To understand the current state of MM research in the context of disparities, a trans-NCI group organized a one-and-a-half-day Think Tank and Provocative Question (PQ) Session on March 5-6, 2018. Over 35 MM researchers and more than 20 NCI staff from disciplines spanning the cancer continuum attended. The meeting began with the PQ session, which was designed to challenge participants to think creatively about MM and disparities and discuss understudied research questions that, if answered, could move the field forward. The Think Tank uncovered gaps and identified challenges that hinder progress in understanding progression from normal to premalignant conditions to MM in different racial/ethnic populations. The final portion of the day was dedicated to discussing strategies for accelerating the field. The subject matter experts identified several scientific and resource gaps that are barriers to making progress in this area. These included the need for hematologic malignancy models (cell lines and PDX models) from diverse populations, serial biospecimen collection from MGUS, SMM and MM patients of various racial/ethnic groups, and increased clinical trial accrual of minorities. Areas of research that were considered priorities to understand the underlying causes of increased incidence among different populations included biomarker discovery to identify high-risk patients, increased use of multiple ‘omics analysis, and understanding the role of the immune system. Another priority discussed was the need for innovative sensing technology for accurate detection of the premalignant MGUS. The NCI is pursuing several areas that are ripe for further investment to help eliminate the disparities in multiple myeloma. Citation Format: Amy E. Kennedy, L. Michelle Bennett. Uncovering research gaps and strategizing future efforts: NCI Think Tank on multiple myeloma and disparities [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A121.

Abstract A083: Diversifying breast cancer clinical trial accrual: An approach to recruitment at a Comprehensive Cancer Center

Abstract Background: Breast cancer (BC) prevention clinical trials (CTs) play a vital role in the progress of preventative measures and treatments for all races and ethnicities. However, Northern European whites (NE/W) continue to be disproportionally enrolled (e.g., 93.5% were non-Hispanic white in the STAR trial), while minorities such as Asians, blacks, Latinas, and Native Americans (NA) lag in participation. Current studies suggest that minorities are not approached as frequently as NE/W; however, they are just as willing to participate. Here we present a successful recruitment strategy to improving minority accrual in CTs at a Comprehensive Cancer Center located in Duarte, CA. Method: Results from community focus groups suggested the need to mentor local youth who strive to pursue a career in the medical field. Consequently, from February 2016 to July 2018, four bilingual, bicultural clinical research assistants (CRAs) were recruited from the catchment area of City of Hope (CoH). The CRAs, in collaboration with seven surgeons, two radiologists, and one medical oncologist, led the recruitment for three nontherapeutic BC prevention CTs at CoH. Results: All four CRAs were 1) first-generation American, 2) fluent in Spanish or Vietnamese, 3) born and raised in Southern California, and 4) pre-health. Of the 3,148 patients who were screened, 398 were eligible for enrollment, 369 consented, and 58 declined. Primary languages and races/ethnicities of those who declined include the following: 7% Armenian, 9% Chinese, 78% English, 2% Thai, and 5% Spanish; 28% Asian, 3% black, 28% Latina, 2% NA, and 67% white (22% NE, 17% Middle Eastern/North African). Demographics of the consenting population include the following: primary language - >1% Armenian, 4% Chinese, 89% English, >1% Korean, and 7% Spanish; race/ethnicity - 14% Asian, 6% black, 30% Latina, 5% NA, and 75% white (40% NE). Of the white population (n = 277), 11% were Middle Eastern/North African, 53% NE, and 36% Latina. Accrual surpassed both the CoH catchment area (11.3% Asian, 8% black, 24% Hispanic, 1% NA, and 32% NE/W) and the CoH interventional/nontherapeutic CT population (10% Asian/Pacific Islander, 4% black, 21% Hispanic, >1% NA, and 55% NE/W). Conclusion: Contrary to current accrual of CTs, here we show that minorities can have a large representation in CT accrual, as long as they are provided the opportunity. Accrual of Asians, Latinas, and NAs exceeded the catchment area and accrual of other CoH CTs. Interestingly, Chinese-speaking women comprised the highest declination group of the non-English speakers, and Asians and Latinas declined the most outside of non-whites. Cultural competency and bilingualism appear to be characteristics of a CRA that may help in accruing minority women into CTs. Our findings suggest that they are just as willing to participate, and the first step is to simply ask. Citation Format: Tanya A. Chavez, Christine Thai, Angelica Sanchez, Laura L. Kruper, Veronica C. Jones, Sharon Clancy, Amy C. Polverini, Lisa D. Yee, Courtney A. Vito, Noé R. Chávez, Alan Nuñez, Ellen J. Rippberger, Angela K. Wong, Karen Herold, Chidimma M.K. Kalu, Jackelyn A. Alva-Ornelas, Jerneja Tomsic, Krista M. Round, Margarita Robles, Ombeni Idassi, Kendall J. Kennedy, Terry Hyslop, Carola M. Zalles, Christopher Sistrunk, Victoria L. Seewaldt. Diversifying breast cancer clinical trial accrual: An approach to recruitment at a Comprehensive Cancer Center [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A083.

Abstract A045: Increasing minority accrual in breast cancer clinical trials through a multidisciplinary approach

Abstract Breast cancer is the most common cancer in Hispanic/Latina women in the United States (U.S.). Yet, therapeutic cancer clinical trial enrollment among Hispanic/Latina women remains low. Barriers to participation are varied and multifactorial. Health provider and system level barriers at cancer centers in the U.S. include language and cultural discordant communication among providers and patients, transportation (to/from study site), and provider discomfort and skepticism in patient adherence. Recent studies have found that Hispanic/Latina women do not exhibit major concerns related to trust and if adequately informed and invited to participate in therapeutic trials, they are likely to do so. A qualitative study was conducted to understand the factors that influence participation in breast cancer clinical trials among Hispanic/Latina breast cancer patients. We conducted 10 semi-structured in-depth interviews in Spanish with women currently receiving radiation treatment, to identify patient level barriers and facilitators for clinical trial participation. Participants were recruited from the University of California (UC) San Diego Moores Cancer Center and UC Health System-affiliated radiation oncology center. Data were analyzed using a conventional content analysis framework to describe the personal and emotional reactions of Hispanic/Latina women who have been breast cancer patients. The main strength of this approach is to allow ideas and beliefs to emerge from the data to provide new insights that capture key thoughts and values of our participants and their treatment experiences and preferences. The analysis and interpretation were specifically conducted in Spanish to maintain language and cultural concordance with our participants. The final analyses were translated from Spanish to English by bilingual and bicultural study investigators. Preliminary findings reveal that Hispanic/Latina women are more likely to participate in breast cancer clinical trials if study information is delivered in-person, the study location is geographically close to their home, they receive appointment reminders by phone or text, study appointment duration is short, the study uses less invasive medications/treatments, and study personnel deliver a supportive experience (i.e. respectful and professional) during enrollment and throughout the study. Barriers to participation include language concordance, a lack of information about cancer clinical trials, fear of potential risks, a competing focus between their current cancer treatment and clinical trial activity, and a lack of time. Our final in-depth analyses will present detailed thematic results, interpretation, and practice application. These outcomes may guide efforts to improve racial/ethnic minority therapeutic clinical trials enrollment, retention, and related outreach among Hispanic/Latina patients accessing care at comprehensive cancer centers. Citation Format: Valesca Largaespada, Samantha Hurst, Savannah M Bradley, Myriam I Acosta, Jonathan Unkart, Sarah Blair, Jesse Nodora. Increasing minority accrual in breast cancer clinical trials through a multidisciplinary approach [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 A045.

Efficacy of Upfront Docetaxel With Androgen Deprivation Therapy for Castration-Sensitive Metastatic Prostate Cancer Among Minority Patients.

Upfront docetaxel (UD) with androgen deprivation therapy (ADT) has been demonstrated to improve survival outcomes in metastatic castration-sensitive prostate cancer (mCSPC). However, existing studies have included predominantly Caucasian patients. To compare the efficacy of addition of UD to ADT in mCSPC to ADT alone among minority patients. Retrospective study of mCSPC patients. Patients treated with UD and ADT between January 2014 and December 2017 (UD + ADT, n = 44) were compared with those treated with ADT alone between January 2008 and January 2017 (ADT, n = 38); patients of Caucasian ethnicity were excluded. The outcome of interest was progression-free survival (PFS), which was estimated using Kaplan-Meier analysis and Cox proportional hazard analysis. Overall, 63 (76.8%) patients were African American and 16 (19.5%) were Hispanic. Fifty-five (67%) patients had high-volume mCSPC. The median follow-up was 14 months [95% confidence interval (CI): 10.4-16.5] for UD + ADT and 42 months (95% CI: 17-66.9) for ADT. Median PFS did not differ between groups: UD + ADT: 16 versus ADT: 18 months [hazard ratio (HR) for UD + ADT = 0.88, 95% CI: 0.48-1.62; P = 0.70]. In patients with high-volume disease, median PFS remained similar (UD + ADT: 16 vs. ADT: 14 months (HR for UD + ADT = 0.64, 95% CI: 0.33-1.25; P = 0.19). On multivariable analysis, prolonged time to nadir PSA, HR = 0.83 (95% CI: 0.76-0.90), was independently associated with PFS. The most common toxicities in UD + ADT were anemia and fatigue. Major limitations include small sample size and potential for selection bias due to the retrospective study design. In this retrospective review of a minority mCSPC cohort, UD + ADT was not associated with improved PFS compared with ADT alone. Although further study with larger sample size is needed, these results underscore the importance of ensuring accrual of minorities in clinical trials, reflective of the real-world setting.

Operational strategies in US cancer centers of excellence that support the successful accrual of racial and ethnic minorities in clinical trials

BackgroundStudy populations in clinical research must reflect US changing demographics, especially with the rise of precision medicine. However, racial and ethnic minority groups (REMGs) have low rates of participation in cancer clinical trials. MethodsCriteria were developed to identify cancer centers able to accrue a higher than average proportion of REMGs into clinical trials. Comprehensive interviews were conducted with leaders of these cancer centers to identify operational strategies contributing to enhanced accrual of REMGs. ResultsEight US cancer centers reported a REMG accrual rate range in cancer research between 10 and 50% in a 12-month reporting period and met other criteria for inclusion. Fourteen leaders participated in this assessment. Key findings were that centers: had a metric collection and reporting approach; routinely captured race and ethnicity data within databases accessible to research staff; had operational standards to support access and inclusion; developed practices to facilitate sustained patient participation during clinical trials; had strategies to decrease recruitment time and optimize clinical study design; and identified low-resource strategies for REMG accrual. There was also a clear commitment to establish processes that support the patient's provider as the key influencer of patient recruitment into clinical trials. ConclusionWe have identified operational practices that facilitate increased inclusion of REMGs in cancer trials. In order to establish a sustainable cancer center inclusion research strategy, it is valuable to include an operational framework that is informed by leading US cancer centers of excellence.

Abstract LB-012: US cancer centers of excellence coordination of operational strategies contribute to enhanced accrual of racial and ethnic minorities in clinical trials

Abstract Background: Racial and ethnic minority groups (REMGs) have low rates of inclusion in cancer trials. With the rise of precision medicine, it is critical that study populations in clinical research reflect the changing US demographics. Methods: Criteria were developed to identify cancer centers able to accrue a higher than average proportion of REMGs into clinical trials. Comprehensive interviews were conducted with leaders of identified cancer centers to ascertain operational strategies contributing to enhanced accrual of REMGs. Results: Eight representative centers reported a REMG accrual rate range in cancer research between 10-50% in a 12-month reporting period and met other criteria for inclusion, and 14 leaders participated in this assessment. Key findings were that centers: had a metric collection and reporting approach; routinely captured race and ethnicity data within databases accessible to research staff; had operational standards to support access and inclusion; developed practices to facilitate sustained patient participation during clinical trials; had strategies to decrease recruitment time and optimize clinical study design; and identified low-resource strategies for improving accrual. There was also a commitment to establish processes that support the patient’s provider as the key influencer of patient recruitment into clinical trials. Conclusion: Conduct of cancer research requires coordination of an operational framework governed by metrics in order to achieve high accrual of diverse populations in clinical trials. Leading US cancer centers have established key Operational Excellence practices and other notable practices which are critical for optimizing sustained inclusion of diverse populations in cancer clinical research. Citation Format: Jeanne M. Regnante, Nicole A. Richie, Lola Fashoyin-Aje, Laura Lee Hall, Quita Highsmith, J'Aimee A. Louis, Kenneth Turner, Spencer C. Hoover, Simon Craddock Lee, Erin L. Williams, Homer Adams, Coleman Obasaju, Ify Sargeant, Madeline Geday, Marianne Gandee, Rayneisha Watson, Moon S. Chen. US cancer centers of excellence coordination of operational strategies contribute to enhanced accrual of racial and ethnic minorities in clinical trials [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr LB-012.

Language as a barrier to cancer clinical trial accrual: assessing consenting team knowledge and practices for cancer clinical trial consent among low English fluency patients

BackgroundLow English fluency in large culturally diverse institutions may contribute to meager minority accrual. Our objective was to: 1) Assess knowledge of proper consenting procedures among the research team when consenting a low English fluency patient. 2) Assess the enrollment rate of participants in cancer therapeutic trials who identify a preferred language other than English.MethodsAn anonymous web-based survey was distributed at a single institution to investigators, research staff and translator services to assess knowledge of consenting procedures. Patient enrollment data was retrieved from the clinical trials enrollment tracking system from January 2011 – October 2014 and matched to registration data indicating preferred language (N = 1521). The number and type of cancer cases from January 2011–October 2014 were retrieved from the institutional cancer registry and matched to registration data indicating preferred language.ResultsAlthough there are many organizational in-person and web-based trainings focused on the requirements for consenting low English fluency patients, members of the research team responded correctly to only 64.8% (σ = 24.6%) of the knowledge-based portion of the survey. Of the 12,538 index cancer cases indentified, 10% preferred a language other than English. Trial enrollment rates for cancer clinical trials were similar for English (13%), Spanish (11%), and, Armenian (10%) speakers. Populations speaking Russian and Arabic had the lowest participation at 5% each.ConclusionsIn order to increase enrollment into clinical trials, institutions must explore more effective training opportunities for research staff, engage interpreters and adopt recruitment and study materials in different languages.

Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials

Multiple myeloma (MM) is an incurable hematologic malignancy with disparities in outcomes noted among racial-ethnic subgroups, likely due to disparities in access to effective treatment modalities. Clinical trials can provide access to evidence-based medicine but representation of minorities on therapeutic clinical trials has been dismal. We evaluated the impact of patient race-ethnicity in pooled data from nine large national cooperative group clinical trials in newly diagnosed MM. Among 2896 patients enrolled over more than two decades, only 18% were non-White and enrollment of minorities actually decreased in most recent years (2002–2011). African-Americans were younger and had more frequent poor-risk markers, including anemia and increased lactate dehydrogenase. Hispanics had the smallest proportion of patients on trials utilizing novel therapeutic agents. While adverse demographic (increased age) and clinical (performance status, stage, anemia, kidney dysfunction) factors were associated with inferior survival, patient race-ethnicity did not have an effect on objective response rates, progression-free, or overall survival. While there are significant disparities in MM incidence and outcomes among patients of different racial-ethnic groups, this disparity seems to be mitigated by access to appropriate therapeutic options, for example, as offered by clinical trials. Improved minority accrual in therapeutic clinical trials needs to be a priority.

Real world outcomes of upfront docetaxel for hormone naïve metastatic prostate cancer in an ethnically diverse inner-city population.

359 Background: Upfront docetaxel (UD) in castration-sensitive metastatic prostate cancer (CSPC) has improved failure-free and overall survival in the CHAARTED, GETUG-AFU 15 and STAMPEDE trials, resulting in a paradigm shift in practice patterns. However, the impact of docetaxel-based chemotherapy regimens in minorities and in real-world practice remains to be described. The objective of this study is to evaluate tolerability and response to UD in an inner-city ethnically diverse CSPC cohort. Methods: We retrospectively reviewed clinical data for CSPC patients at Cook County Hospital. Patients treated with UD and androgen deprivation (UD, n = 49, 2013-17) were compared to those receiving androgen deprivation alone (ADT, n = 42, 2010-17) using descriptive statistics and Cox Proportional Hazards analysis. Results: Median age was 59 and 60 years in UD and ADT, respectively. African Americans, Hispanics and Caucasians formed 69%, 18%, and 10% in UD and 64%, 9.5% and 26% in ADT. Median PSA at diagnosis was: UD 536 [72-1110] ng/ml, ADT 229 [54-999] ng/ml (p = 0.3). Gleason score > 7 was present in 89.8% [UD] and 92.8% [ADT]. UD and ADT had similar frequency of bone (91% vs. 95%, p = 0.5), visceral (12.2% vs. 11.9%, p = 0.9) and retroperitoneal nodal metastases (55% vs. 45.2%, p = 0.3). UD was initiated a median of 8 weeks from diagnosis. 94% in UD received > 3 cycles of chemotherapy. CTCAE grade > 3 events included anemia (6%); neutropenia (6%); infection (4%); diarrhea (4%); peripheral neuropathy (6%), and fatigue (2%). Median PSA nadir was 3.2 [0.5-40.1] vs. 3.45 [0.1-36.4] ng/ml and time to nadir was 20 [13-27] vs. 41 [19-69] weeks in UD vs. ADT. Biochemical progression was observed in 34.7% [UD] vs. 40.5% [ADT]. Median time to castration-resistance was UD: 39 [31-67] vs. ADT: 65 [34-76] weeks [HR: 0.9; 95% CI 0.4-1.8; p = 0.7]. There were 12 deaths [UD: 4; ADT: 8] during a median follow-up of 46 [23-86, UD] and 111 [68-157, ADT] weeks. Conclusions: In a diverse underserved population with CSPC, UD was well tolerated but was not associated with improvement in time to castration compared to ADT. These results warrant validation and underscore the importance of ensuring accrual of minorities in clinical trials.

Improving the accrual of racial and ethnic minority patients in clinical trials: Time to raise the stakes.

Despite decades of attention and study, racial and ethnic minority accrual to clinical trials remains poor. Serious efforts are needed to incentivize providers to enroll patients and clinical trial sponsors to target enrollment for underrepresented groups.

Abstract IA25: The Cancer Genome Atlas: a primer on 2.5 PB of high quality data

Abstract Although The Cancer Genome Atlas (TCGA) has produced an unprecedented amount of data molecularly characterizing thirty-two tumor types, the usability of the data has been restricted by download model. The Genomics Data Commons (GDC) is a new database for retrieval and query of all NCI genomic-level data, allowing the user to identify areas of interest and download the information on just those segments (BAM slicing). All the data contained in the GDC will be mapped to the genome (aligned) and variations on the sequence called in a uniform fashion. In future releases, the GDC will incorporate a variety of analytical tools, obviating the need to download the raw data in order to analyze it. However, the ethnic diversity represented in the data is sparce; a new initiative by the NCI will try to bridge that deficiency by targeting accrual of minorities (as well as early onset cases) in five different tumor types. Citation Format: Jean C. Zenklusen. The Cancer Genome Atlas: a primer on 2.5 PB of high quality data. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr IA25.

Applying a Conceptual Framework to Maximize the Participation of Diverse Populations in Cancer Clinical Trials.

The underrepresentation of ethnically diverse populations in cancer clinical trials results in the inequitable distribution of the risks and benefits of this research. Using a case study approach, we apply a conceptual framework of factors associated with the participation of diverse population groups in cancer clinical trials developed by Dr. Jean Ford and colleagues to increase understanding of the specific strategies, and barriers and promoters addressed by these strategies, that resulted in marked success in accrual of racially and ethnically diverse populations in cancer clinical research. Results indicate that the studies presented were able to successfully engage minority participants due to the creation and implementation of multilevel, multifaceted strategies that included: culturally and linguistically appropriate outreach, education, and research studies that were accessible in local communities; infrastructure to support engagement of key stakeholders, clinicians, and organizations serving minority communities; testimonials by ethnically diverse cancer survivors; availability of medical interpretation services; and providing infrastructure that facilitated the engagement in clinical research of clinicians who care for minority patient populations. These strategic efforts were effective in addressing limited awareness of trials, lack of opportunities to participate, and acceptance of engagement in cancer clinical trials. Careful attention to the context and population characteristics in which cancer clinical trials are conducted will be necessary to address disparities in research participation and cancer outcomes. These studies illustrate that progress on minority accrual into clinical research requires intentional efforts to overcome barriers at all three stages of the accrual process: awareness, opportunity, and acceptance of participation.

Cultural Competency Training to Increase Minority Enrollment into Radiation Therapy Clinical Trials-an NRG Oncology RTOG Study.

Despite initiatives to increase the enrollment of racial and ethnic minorities into cancer clinical trials in the National Cancer Institute National Cancer Clinical Trials Network (NCCTN), participation by Latino and African American populations remain low. The primary aims of this pilot study are (1) to develop a Cultural Competency and Recruitment Training Program (CCRTP) for physician investigators and clinical research associates (CRAs), (2) to determine if the CCRTP increases cultural competency scores among physician investigators and CRAs, and (3) to determine the impact of the CCRTP on minority patient recruitment into NRG Oncology Radiation Therapy Oncology Group (RTOG) clinical trials. Sixty-seven CRAs and physicians participated in an in-person or online 4-h CRRTP training. Five knowledge and attitude items showed significant improvements from pre- to post-training. A comparison between enrolling sites that did and did not participate in the CCRTP demonstrated a pre to 1-year post-incremental increase in minority accrual to clinical trials of 1.2% among participating sites. While not statistically significant, this increase translated into an additional 300 minority patients accrued to NCCTN clinical trials in the year following the training from those sites who participated in the training.

Experience of the National Cancer Institute Community Cancer Centers Program on Community-Based Cancer Clinical Trials Activity.

A goal of the National Cancer Institute Community Cancer Centers Program (NCCCP) was to improve cancer research capacity in community settings. We examined research capacity development during the pilot phase of the NCCCP within the context of national trends in clinical trial activity with respect to the number and phase of trials, total accrual, and accrual of underserved populations. We examined self-reported data from NCCCP sites during 2007 to 2010, supplemented with data from the National Cancer Institute Cancer Therapy Evaluation Program. Trial availability and accrual improved more quickly at NCCCP sites compared with national trends. Phase III trial availability increased 8% nationally versus 16% across NCCCP sites, and accrual increased 30% nationally versus 133% across NCCCP sites. Accrual of racial and ethnic minorities rose 82%, from 83 to 151 patients, and accrual of patients age ≥ 65 years rose by 221%, from 200 to 641 patients. Change in trial portfolio and accrual differed by sophistication of the site and by prior experience in conducting clinical trials at the site. Despite the short duration, the NCCCP pilot resulted in an increase in the number of open trials as well as patient accrual at a faster rate than that observed nationally. These results, coupled with insights into the relative success of sites with varying sophistication at the outset, provide promise that lessons learned can be applied more broadly to increase research participation.

Hispanic accrual on randomized cancer clinical trials: a call to arms.

Hispanic accrual on randomized cancer clinical trials: a call to arms.

Five National Cancer Institute–designated cancer centers' data collection on racial/ethnic minority participation in therapeutic trials

BACKGROUNDTo ensure that National Institutes of Health‐funded research is relevant to the population's needs, specific emphasis on proportional representation of minority/sex groups into National Cancer Institute (NCI) cancer centers' clinical research programs is reported to the NCI.METHODSEMPaCT investigators at 5 regionally diverse comprehensive cancer centers compared data reported to the NCI for their most recent Cancer Center Support Grant competitive renewal to assess and compare the centers' catchment area designations, data definitions, data elements, collection processes, reporting, and performance regarding proportional representation of race/ethnicity and sex subsets.RESULTSCancer centers' catchment area definitions differed widely in terms of their cancer patient versus general population specificity, levels of specificity, and geographic coverage. Racial/ethnic categories were similar, yet were defined differently, across institutions. Patients' socioeconomic status and insurance status were inconsistently captured across the 5 centers.CONCLUSIONSCatchment area definitions and the collection of patient‐level demographic factors varied widely across the 5 comprehensive cancer centers. This challenged the assessment of success by cancer centers in accruing representative populations into the cancer research enterprise. Accrual of minorities was less than desired for at least 1 racial/ethnic subcategory at 4 of the 5 centers. Institutions should clearly and consistently declare their primary catchment area and the rationale and should report how race/ethnicity and sex are defined, determined, collected, and reported. More standardized, frequent, consistent collection, reporting, and review of these data are recommended, as is a commitment to collecting socioeconomic data, given that socioeconomic status is a primary driver of cancer disparities in the United States. Cancer 2014;120(7 suppl):1113–21. © 2014 American Cancer Society.

Twenty years post‐NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

BACKGROUNDThe National Institutes of Health (NIH) Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all NIH‐funded research. Twenty years after this act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, it is projected that disparities in the cancer burden for minorities will increase.METHODSFor this review article, the authors counted the frequency with which minorities were the primary focus of National Cancer Institute‐sponsored clinical trials, examined citations from the PubMed database focusing on the search terms “NIH Revitalization Act of 1993” and “enhancing minority accrual to cancer clinical trials,” and supplemented the review with their expertise in NIH‐funded research related to minority accrual in cancer clinical trials.RESULTSThe reporting and analyses of data based on minorities in clinical trials remain inadequate. Less than 2% of the National Cancer Institute's clinical trials focus on any racial/minority population as their primary emphasis. The current review of the literature indicated that the percentage of authors who reported their study sample by race/ethnicity ranged from 1.5% to 58%, and only 20% of the randomized controlled studies published in a high‐impact oncology journal reported analyzing results by race/ethnicity. Proportionately greater population increases in minorities, accompanied by their persistent and disproportionate cancer burden, reinforce the need for their greater representation in clinical trials.CONCLUSIONSRenewing the emphasis for minority participation in clinical trials is warranted. Policy changes are recommended. Cancer 2014;120(7 suppl):1091–6. © 2014 American Cancer Society.

An overview of EMPaCT and fundamental issues affecting minority participation in cancer clinical trials: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

This supplement provides an overview of the interventional efforts as well as scientific data regarding the undertaking by the EMPaCT consortium to document the scope of the problem and the results from multiple methods of interventions for increasing minority accrual in clinical trials.

An institutional strategy to increase minority recruitment to therapeutic trials

Participation in therapeutic clinical trials rarely reflects the race and ethnic composition of the patient population. To meet National Institutes of Health-mandated goals, strategies to increase participation are required. We present a framework for institutional enhancement of minority clinical trial accrual. We implemented structural changes on four levels to induce and sustain minority accrual to clinical trials: (1) leadership support; (2) center-wide policy change; (3) infrastructural process control, data analysis, and reporting; and (4) follow-up with clinical investigators. A Protocol Review and Monitoring Committee reviews studies and monitors accrual, and the Program for the Elimination Cancer Disparities leads efforts for proportional accrual, supporting the system through data tracking, Web tools, and feedback to investigators. Following implementation in 2005, minority accrual to therapeutic trials increased from 12.0 % in 2005 to 14.0 % in 2010. The "rolling average" minority cancer incidence at the institution during this timeframe was 17.5 %. In addition to therapeutic trial accrual rates, we note significant increase in the number of minorities participating in all trials (therapeutic and nontherapeutic) from 2005 to 2010 (346-552, 60 % increase, p < 0.05) compared to a 52 % increase for Caucasians. Implementing a system to aid investigators in planning and establishing targets for accrual, while requiring this component as a part of annual protocol review and monitoring of accrual, offers a successful strategy that can be replicated in other cancer centers, an approach that may extend to other clinical and translational research centers.

Minority accrual on a prospective study targeting a diverse U.S. breast cancer population: An analysis of Wake Forest CCOP research base protocol 97609.

6564 Background: Clinical trial accrual rates are lower among minority patients. Wake Forest CCOP RB protocol 97609 designed to accrue 400 non-Hispanic White (NHW) and 600 minority patients to a study evaluating potential genomic single nucleotide polymorphisms as markers for breast radiosensitivty. Methods: Accrual data evaluated from 24 participating CCOPs and numerous CTSU sites. Race / ethnicity self-reported by participants (NHW, non-Hispanic Black, Hispanic/Latino, Asian /Pacific Islander, or American Indian/Alaskan Native) based on ACS reporting criteria. Results: 752 participants accrued in 14.5 mths (11/11-1/13); 402 NHW and 350 minorities. NHW accrual goal reached, 5.9 months (period 1; avg 68.4 participants /month) compared with 54 minority participants (period 1; avg 9.2 participants / month). This 7.4 ratio NHW to minority accrual is higher than expected given incidence. During 8.6 months following closure NHW enrollment (period 2), 296 minority participants accrued (avg 34.3 participants/month). An almost 4-fold increase in minority accrual raises question of accrual disparity. 19 CCOPs open in period 1 and 24 CCOPs in period 2. CTSU contributed both periods, more CTSU sites were added during period 2. Excluding all CTSU sites and five CCOPs open only in period 2, the avg minority accrual:6.8 patients / month period 1 and 10.6 patients / month period 2. The average time of accrual was 4.0 months period 1 and 8.6 months period 2 due to variable opening dates at sites. Taking time into account, the avg minority accrual rate was 0.60 patients / month / site in period 1 and 0.56 patients / site / month in period 2. CCOP minority accrual rates in period 1 vs. 2 increased 11 / 19 sites, decreased 6 / 19, and remained the same in 2 / 19, p = .33. Conclusions: Despite closure of enrollment of NHWs into this study with a specific goal to accrue a large minority population, there was no increase in the rate of minority accrual. The initial appearance of an accrual bias can be attributed to the addition of sites and variable lengths of accrual time at sites. It is unknown whether overall lower minority accrual rate compared to NHWs is participant-, provider-, or population-based. Clinical trial information: NCT01407770.