The impact of the globalization of cancer clinical trials on the enrollment of Black patients

Cancer ◽  
2021 ◽  
Author(s):  
Serena Tharakan ◽  
Xiaobo Zhong ◽  
Matthew D. Galsky
Keyword(s):  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Black Patients ◽  
The Impact

Utilization of a multisite financial reimbursement program to promote racial/ethnic diversity and inclusion in therapeutic cancer clinical trials: The iMPACT Study.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 85-85
Author(s):  
Hala Borno ◽  
Sylvia Zhang ◽  
Elena Nieves ◽  
Dana Dornsife ◽  
Robert G. Johnson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Low Socioeconomic Status ◽  
Ethnic Diversity ◽  
Phone Call ◽  
Cancer Clinical Trials ◽  
Impact Study ◽  
Low Socioeconomic ◽  
Diversity And Inclusion ◽  
The Impact ◽  
Racial Ethnic

85 Background: A lack of racial/ethnic diversity among cancer therapeutic clinical trial (TCT) participants remains a critical problem. The significance of costs, both direct and indirect, associated with cancer TCT participation are increasingly understood. Here, we report findings observed in the IMproving Patient Access to Cancer clinical Trials (IMPACT) study, a pilot feasibility study investigating the feasibility and efficacy of offering a financial reimbursement program (FRP) during cancer TCT discussion with or without additional outreach in improving enrollment and diversity. Methods: Participants for this study were recruited at two Comprehensive Cancer Centers (CCCs) from April to September 2019. Patients were randomized 1:1 to receive a brochure about a FRP at time of consent for a TCT or receive brochure and outreach through a scripted follow-up phone call regarding the FRP. Results: No difference in TCT enrollment was observed between study arms. Among 170 patients approached to participate, 132 (78%) provided consent. The participant mean age was 57 years old (std dev = 14 years). Among participants 57% were male and 49% were white. The remaining major racial/ethnic groups were Black (5%) Asian (13%) and Hispanic (26%). The proportion of non-whites was greater among IMPACT study (43%) compared to CCC TCT (28%) participants. Among FRP participants, 24% reported a household income < $25,000 and 14% from $25,001 to $56,000. Conclusions: This study observed that offering an FRP as part of TCT discussion is feasible and effective at CCCs. An outreach phone call is not required in order to influence enrollment in TCT. FRP recipients are racially/ethnically diverse and low socioeconomic status.

Enrollment of Racial Minorities in Clinical Trials: Old Problem Assumes New Urgency in the Age of Immunotherapy

2019 ◽  
pp. 3-10 ◽  
Author(s):  
Bassel Nazha ◽  
Manoj Mishra ◽  
Rebecca Pentz ◽  
Taofeek K. Owonikoko
Keyword(s):  
Clinical Trials ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Predictive Biomarkers ◽  
Trial Participation ◽  
Minority Ethnic Groups ◽  
Black Patients ◽  
New Treatment ◽  
The Impact

Minority U.S. populations are underrepresented in cancer clinical trials. This review appraises the impact of the disparity in clinical trial participation by minority patients in the current era of cancer immunotherapy. Enrollment on pivotal trials leading to U.S. regulatory approval of immune checkpoint inhibitors showed poor representation of minority ethnic groups. Specifically, we found that black patients constitute less than 4% of all patients enrolled across multiple trials that supported the approval of immune checkpoint inhibitors for the treatment of lung cancer. Similar underrepresentation was observed for trials conducted in renal cell carcinoma and other tumor types. Since efficacy of immunotherapy is only observed in a subset of patients, the use of predictive biomarkers to identify responders along with new strategies to expand the benefit to a larger subset of patients are current areas of active investigation. The inadequate representation of minority patients on immunotherapy clinical trials could perpetuate outcome disparity because the unique biology of the host and the tumors from this subpopulation is not accounted for as new treatment algorithms to guide optimal use of immunotherapy are developed for use in the real world.

Increasing participation in breast cancer research: (INSPIRE-BrC).

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 53-53
Author(s):  
Brandi Robinson ◽  
Sandra M. Swain
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Outcome Measure ◽  
Test Method ◽  
Trial Participation ◽  
Lower Survival Rate ◽  
Black Patients ◽  
Clinical Trial Enrollment ◽  
The Impact

53 Background: Increasing black patients’ participation in cancer clinical trials is particularly important because of the population’s lower survival rate. Accrual to clinical trials remains low among the general population (1 to 3%), with recruitment of blacks the lowest of all groups at 0.5 to 1.5%. Clinical trials are key to developing new methods to prevent, detect, and treat cancer. INSPIRE-BrC aims to increase trial participation rates among black patients with breast cancer and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. Methods: A sample size of 123 black patients with breast cancer at five MedStar sites will view a 15 minute, culturally tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. A pre-test/post-test method is used to determine the impact of the video on three variables — likely participation in therapeutic clinical trials; attitudes toward therapeutic clinical trials (assessed based on the 6 barriers); and actual trial enrollment. Expected Findings: We hypothesize that the intervention will increase clinical trial enrollment compared to our 2012 clinical trial enrollment baseline rate of 6% (22/384) for black patients with breast cancer in five MedStar hospitals. The primary outcome measure is the proportion of black patients with breast cancer who agree to participate in a therapeutic clinical trial among those who sign consent to INSPIRE-BrC. Study findings have the potential to increase patient recruitment as a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among black patients with cancer. [Table: see text]

scholarly journals Laboratory eligibility criteria as potential barriers to participation by black men in prostate cancer clinical trials.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 73-73
Author(s):  
Marie Vastola ◽  
David Dewei Yang ◽  
Brandon Arvin Virgil Mahal ◽  
Vinayak Muralidhar ◽  
Christopher S. Lathan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Renal Function ◽  
Black Men ◽  
Racial Differences ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria ◽  
Black Patients ◽  
Incidence And Mortality

73 Background: Eligibility criteria may disproportionately affect black patients and contribute to their underrepresentation in clinical trials. We studied this potential barrier by examining clinical trials in prostate cancer, a disease in which black men face higher incidence and mortality. Specifically, we investigated the use of serum creatinine (sCr) alone instead of race-adjusted measurements for renal function, and the use of an absolute neutrophil count (ANC) threshold that could exclude men with benign ethnic neutropenia, which afflicts 6.7-8% of black patients and could lead to the exclusion of patients despite having healthy immune systems. Methods: We identified 401 interventional prostate cancer clinical trials with an overall survival endpoint. The list of trials was collected on January 16, 2017 from clinicaltrials.gov using the following criteria – study type: interventional studies; conditions: prostate cancer; interventions: drug; outcome measures: overall survival. Characteristics gathered from each trial included sponsor type, phase, accrual goal, start year, and toxicity. Results: Overall, 47.9% (192) of these trials used either sCr alone and/or required participants to have ANC ≥1.5×109 cells/L. Specifically, 25.2% (101) of the trials used sCr alone to determine eligibility, and 41.4% (166) of the trials required patients to have an ANC ≥1.5×109 cells/L. Conclusions: Of clinical trials in prostate cancer, 47.9% used criteria that disproportionately excluded black patients. The reevaluation of these two eligibility criteria could improve minority trial enrollment. First, lowering the ANC cutoff for patients with benign ethnic neutropenia would increase the number of eligible black participants, as 89% of these patients have an ANC ≥1.0×109 cells/L. Second, using race-adjusted equations for renal function would take into account racial differences in creatinine. While adopting race-based differences in trial criteria may add slight logistical challenges when ensuring patients meet trial eligibility, these adjustments would prevent healthy patients from being excluded solely because of benign laboratory differences caused by their race.

The impact of the COVID-19 pandemic on oncology clinical trial recruitment in an Irish cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18756-e18756
Author(s):  
Ronan Andrew McLaughlin ◽  
Valerie Madigan ◽  
Maureen O'Grady ◽  
Thamir Andrew Mahgoub ◽  
Roshni Andrew Kalachand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Treatment Options ◽  
Cancer Clinical Trial ◽  
University Hospital ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Number Of Patients ◽  
The Impact

e18756 Background: The COVID-19 pandemic has created unprecedented disruptions to cancer clinical trial research across the world due to a temporary global suspension of patients’ recruitment to cancer clinical trials. Access to clinical trials permits better treatment options and best clinical practice standards for patients with cancer. We present the impact of the COVID-19 pandemic on cancer clinical trial activity at the Cancer Clinical Trials Unit (CCTU) at the Mid-Western Cancer Centre, University Hospital Limerick (UHL). Over the last 4 years 28 clinical trials, both interventional and translational, have opened here, across a variety of primary disease sites, with 5 trials opened in 2017, 11 in 2018, 7 in 2019 but only 2 in the first 10 months of 2020 until 3 further trials were opened in December. Methods: CCTU records were reviewed to identify the number of patients screened and consented to participate in cancer clinical trials at UHL in 2020, which were compared directly with corresponding numbers for 2019. Results: In 2019, 17 clinical trials were open and recruiting at the CCTU, UHL. During 2020, 19 trials were recruiting although during the 1st surge of the COVID-19 pandemic recruitment was essentially suspended and CCTU staff were redeployed throughout the hospital. 1st Six months 2020 vs 2019 In the six months from January 2020 until the end of June 2020, 99 patients were screened and only 15 (15.2%) signed informed consent to participate in a cancer clinical trial. When these figures are directly compared with the first six months of 2019, there is a 33% reduction in patients screened for participation (147 vs 99) and a 60% reduction in patients consented (37 vs 15) to clinical trials. 12 Months 2020 vs 2019 In total during 2019, 376 patients were screened for inclusion to participate and 49 (13%) patients signed informed consent to participate in a clinical trial within CCTU at UHL. In 2020, 914 patients were screened for participation with 51 patients consented to participate (5.6%). The majority (45/51 (88%)) of patients consented to cancer clinical trials in 2020 at the CCTU, UHL were recruited to translational based studies and only 6 (12%) consented to interventional studies compared with 2019 when 30/49 (61%) consented to translational and 30/49 (39%) to interventional studies. Conclusions: During the COVID-19 pandemic, the percentage of patients consented to participation in a clinical trial reduced significantly, as compared to the previous year (5.6% vs 13%). Fewer interventional studies have recruited patients during 2020. As we enter the third surge of COVID-19 infections in Ireland, we must continue to monitor and identify effective strategies to navigate the ever-changing situation for cancer clinical trials, in an attempt to maintain access to high quality cancer clinical trial opportunities for our patients.

Accrual of Black participants to cancer clinical trials following a five-year prospective initiative of community outreach and engagement.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 100-100
Author(s):  
Carmen E. Guerra ◽  
Vicki Sallee ◽  
Wei-Ting Hwang ◽  
Brenda Bryant ◽  
Armenta L. Washington ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Catchment Area ◽  
Community Outreach ◽  
Fold Increase ◽  
Cancer Center ◽  
Black Communities ◽  
Cancer Clinical Trials ◽  
Black Patients ◽  
Clinical Trial Accrual

100 Background: Accrual of Black participants to cancer clinical trials remains a major challenge across the country. Here, we report the outcomes of a five-year initiative of community outreach and engagement to improve enrollment of adult Black participants to clinical trials at the Abramson Cancer Center (ACC) at the University of Pennsylvania. Methods: Primary metrics were the percentage of Black patients among all cancer cases in our catchment area, the percentage of adult Black patients cared for at the ACC, and the percentage of adult Black participants enrolled on the three types of NCI-defined clinical trials. Results: In 2014, at baseline, Black residents comprised 19% of the population and 16.5% of cancer cases in our catchment area surrounding Philadelphia, but only 11.1% of ACC patients were Black. The percentages of Black participants accrued onto treatment, non-therapeutic interventional, and non-interventional trials were 12.2%, 8.3%, and 13.0%, respectively. We then established a center-wide program with community guidance to address these gaps. Key elements of the program included: 1) culturally tailored marketing strategies for cancer clinical trials; 2) plans for each protocol to facilitate Black participant enrollment; 3) new partnerships with faith-based organizations serving Black communities to conduct educational events about clinical trials; 4) pilot programs with Lyft and Ride Health to address transportation barriers; 5) patient education by nurse navigators regarding cancer and clinical trials; and 6) an improved informed consent process. These efforts reached more than 10,000 individuals in venues including churches, neighborhoods, community parks and centers, and health centers with formats ranging from educational forums to wellness fairs. Reassessing metrics in 2018, we found that the percentage of Black patients seen at ACC had increased to 16.2%, matching the percentage of Black cancer patients among all cancer cases in our catchment area (16.5%). Total cancer clinical trial accrual had increased from 9,308 participants in 2014 to 13,170 in 2018 (41.5% increase). The percentages of Black participants accrued onto treatment, non-therapeutic interventional, and non-interventional trials were 23.9%, 33.1%, and 22.5%, respectively – a 1.7- to 4.0-fold increase in five years and higher than the percentage of Black patients seen at the ACC. Conclusions: Our multifaceted, community-based engagement initiative to encourage clinical trial enrollment was associated with improved accrual of Black participants to cancer clinical trials. These findings also suggest that gaps in access to cancer centers are a key factor driving access to clinical trials. Medicaid expansion occurred concurrently in all states in our catchment area and its impact on accrual merits further research.

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