scholarly journals Sickle Cell Disease Patients Demonstrate a High Willingness to Participate in Randomized Clinical Trials

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5808-5808
Author(s):  
Volha Mazziotto ◽  
Katrina Mikofalvy ◽  
Alexandra Houck ◽  
Lauren Beck ◽  
Prasad V. Bodas
Keyword(s):  
Clinical Trials ◽  
African American ◽  
African Americans ◽  
Randomized Clinical Trials ◽  
Willingness To Participate ◽  
Participation Rates ◽  
Cell Disease ◽  
African American Population ◽  
The Us ◽  
Reported Data

Abstract Background: African Americans are underrepresented in randomized clinical trials (RCTs). Underrepresentation of this patient group may lead to an inadequate analysis of therapy risks and benefits, and study findings may not be generalizable to a diverse patient population. Moreover, low representation of African Americans in existing clinical trials may discourage future trials focused on this population, as such trials are perceived to be infeasible. Barriers to participation in clinical trials have been extensively studied. Frequently identified factors include: systemic barriers (availability of clinical trials, eligibility barriers, lack of resources), geography (location of the research institution and access to transportation), and individual-level barriers such as low education, poverty, and poor access to healthcare. Willingness to participate has been cited as a major barrier, related to distrust in the US healthcare systemand to cultural and religious beliefs. Yet a dearth of empirical evidence bolsters the assertion that willingness to participate in clinical trials among African Americans is accountable for underrepresentation. We performed a retrospective review of major RCTs focused on sickle cell disease (SCD) in order to measure willingness of African Americans to participate in clinical research. Methods: We systematically identified landmark peer-reviewed RCTs focused on SCD. We analyzed the results of these trials reported in the medical literature and calculated participation and completion rates for each trial. For each study, we identified the number of subjects screened for participation, the number who agreed to participate, and the number who declined. We calculated ratios for study acceptance and study completion. We identified the number of publications which clearly reported data from which acceptance to participate could be directly calculated, the number from which participation could be inferred, or from which reported data were insufficient. Results: We identified 13 RCTs published between 1986 and 2018, representing the major clinically impactful studies in children and adults with SCD. Six of the 13 studies reported sufficient data to infer or calculate participation rates. It is notable that more than half (54%; n=7) of the studies provided insufficient data to calculate study acceptance rates. Our analysis encompassing 2407 patients included in six studies indicates that 82% of subjects with SCD demonstrated willingness to participate in an RCT (range 32-94%), and 95% of clinical trial subjects completed study activities (range 92-98%). Discussion: A minority of publications reported participation data. One of the 13 studies published data on the race of participants, reporting 94% of participants were African American and 3% were Hispanic. However, since SCD predominantly affects African Americans (approximately 90% of those with SCD nationwide are African American and approximately 10% are Hispanic), it is reasonable to estimate that the subjects in our analysis represent a predominantly African American population. We acknowledge that subjects with SCD may not be representative of the US African American population in total. Nonetheless, our findings contradict the assertion that African Americans are less willing to participate in clinical trials, or that African Americans have disproportionately high drop-out rates. Only a minority of publications reported data required to calculate participation rates. Despite this limitation, available empiric evidence suggests that when participation in high-quality clinical trials is made available, African Americans demonstrate a willingness and capacity to enroll and complete study participation. The generalized assertion that African American patients' willingness to participate in research is a major factor in their underrepresentation in clinical trials is false. Researchers should design high-quality clinical trials that include this underrepresented group at the outset, and investigators should be encouraged to collect and report participation data more carefully so that this disparity can be measured and addressed. Disclosures No relevant conflicts of interest to declare.

Emancipation and Free African Americans

2017 ◽  
Author(s):  
Richard Archer
Keyword(s):  
African American ◽  
African Americans ◽  
New England ◽  
Rhode Island ◽  
New Hampshire ◽  
Jim Crow ◽  
African Descent ◽  
American Population ◽  
African American Population ◽  
Free African Americans

Except in parts of Rhode Island and Connecticut, slavery was a peripheral institution, and throughout New England during and after the Revolution there was widespread support to emancipate slaves. Some of the states enacted emancipation laws that theoretically allowed slavery to continue almost indefinitely, and slavery remained on the books as late as 1857 in New Hampshire. Although the laws gradually abolished slavery and although the pace was painfully slow for those still enslaved, the predominant dynamic for New England society was the sudden emergence of a substantial, free African American population. What developed was an even more virulent racism and a Jim Crow environment. The last part of the chapter is an analysis of where African Americans lived as of 1830 and the connection between racism and concentrations of people of African descent.

Consequences of a match made in hell: the harm caused by menthol smoking to the African American population over 1980–2018

2021 ◽  
pp. tobaccocontrol-2021-056748 ◽  
Author(s):  
David Mendez ◽  
Thuy T T Le
Keyword(s):  
Public Health ◽  
African American ◽  
African Americans ◽  
Smoking Initiation ◽  
African American Community ◽  
American Population ◽  
The Public ◽  
African American Population ◽  
Menthol Cigarettes ◽  
Life Years

BackgroundFor many years, national surveys have shown a consistently disproportionately high prevalence of menthol smokers among African Americans compared with the general population. However, to our knowledge, no prior study has quantified the harm that menthol smoking has caused on that population. In this work, we estimate the public health harm that menthol cigarettes have caused to the African American community over the last four decades.MethodsUsing National Health Interview Survey data, we employed a well-established simulation model to reproduce the observed smoking trajectory over 1980–2018 in the African American population. Then, we repeat the experiment, removing the effects of menthol on the smoking initiation and cessation rates over that period, obtaining a new hypothetical smoking trajectory. Finally, we compared both scenarios to calculate the public health harm attributable to menthol cigarettes over 1980–2018.ResultsOur results show that menthol cigarettes were responsible for 1.5 million new smokers, 157 000 smoking-related premature deaths and 1.5 million life-years lost among African Americans over 1980–2018. While African Americans constitute 12% of the total US population, these figures represent, respectively, a staggering 15%, 41% and 50% of the total menthol-related harm.DiscussionOur results show that menthol cigarettes disproportionally harmed African Americans significantly over the last 38 years and are responsible for exacerbating health disparities among that population. Removing menthol cigarettes from the market would benefit the overall US population but, particularly, the African American community.

scholarly journals The Ramifications of Covid-19 Within the African American Community

2021 ◽  
Vol 2 (4) ◽  
pp. 15-26
Author(s):  
Libby Goodman ◽  
Fayetta Lake ◽  
Chinyere Maureen Ndu
Keyword(s):  
African American ◽  
African Americans ◽  
Mortality Rates ◽  
African American Community ◽  
Current Policy ◽  
African American Culture ◽  
African American Population ◽  
General Article ◽  
Perceived Reasons ◽  
Healthcare Leaders

The coronavirus (Covid-19) perplexed many aspects of everyday life. Sadly, Covid-19 took a greater toll on African Americans. As Covid-19 developed, medical professionals, health care authorities, and advocates recognized several day-to-day living situations and intrinsic medical conditions that distressed African Americans with higher mortality rates during the pandemic. It is imperative that healthcare leaders understand the ramifications that have occurred and that may continue to surface from the Covid-19 affliction, which could be utilized to adjust and amend current policy surrounding the adversely affected African American population. We explored several substantial questions regarding this pandemic: the perceived reasons for the vast impact of Covid-19 within the African American culture; and what recommendations are needed to aid healthcare leaders in the fight against Covid-19 within the African American community. There are six ramifications that the authors address in this general article, including- employment, poverty, deaths, mental illness, and distrust. We offer suggestions to implement, prevent, and educate the African American public to circumvent these ramifications for present and future pandemics.

scholarly journals Folk Perception of African American English Regional Variation

2017 ◽  
Vol 5 (1) ◽  
pp. 1-16 ◽  
Author(s):  
David Mitchell ◽  
Marivic Lesho ◽  
Abby Walker
Keyword(s):  
African American ◽  
African Americans ◽  
American English ◽  
African American Vernacular English ◽  
Uniform Structure ◽  
Linguistic Features ◽  
Map Labeling ◽  
Perceptual Dialectology ◽  
Vernacular English ◽  
The Us

Contrary to previous “sociolinguistic folklore” that African American (Vernacular) English has a uniform structure across different parts of the US, recent studies have shown that it varies regionally, especially phonologically (Wolfram, 2007; Thomas & Wassink, 2010). However, there is little research on how Americans perceive AAE variation. Based on a map-labeling task, we investigate the folk perception of AAE variation by 55 participants, primarily African Americans in Columbus, Ohio. The analysis focuses on the dialect regions recognized by the participants, the linguistic features associated with different regions, and the attitudes associated with these beliefs. While the perceived regional boundaries mostly align with those identified by speakers in previous perceptual dialectology studies on American English, the participants consistently identified linguistic features that were specific to AAE. The participants recognized substantial phonological and lexical variation and identified “proper” dialects that do not necessarily sound “white”. This study demonstrates the value of considering African Americans’ perspectives in describing African American varieties of English.

Pegylated Liposomal Doxorubicin (PLD), Vincristine and Reduced-Dose Dexamethasone (DVd) in the Treatment of Predominantly African American Population with Multiple Myeloma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5105-5105 ◽  
Author(s):  
Anshul Bamrolia ◽  
Ahmad Jajeh ◽  
R. Catchatourian ◽  
David Osafo ◽  
Deimante Tamkus ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
African American ◽  
African Americans ◽  
Liposomal Doxorubicin ◽  
Mononuclear Phagocytes ◽  
Disease Stage ◽  
Phospholipid Vesicle ◽  
American Population ◽  
African American Population

Abstract Biologic therapy is emerging as first line therapy for multiple myeloma. However, most patients will require multiple lines of treatments and chemotherapy remains a very good option. In the last few years, there has been an important recognition of potentially different responses to pharmaceuticals based on genetic predisposition, starting with the FDA advisory panel recommending approval of a heart failure drug for African Americans. Liposomal doxorubicin (DOXIL; PLD) is a microscopic pegylated phospholipid vesicle with a core containing conventional doxorubicin. The pegylated coat protects the liposomes from detection by mononuclear phagocytes, increasing blood circulation time (t1/2=55 hours). Due to its prolonged half life, PLD provides a similar effect to using continuous infusion doxorubicin, but administered over 1-hour, transforming the regimen into an outpatient treatment. PLD has also been shown to have a significantly better safety profile than conventional doxorubicin. We evaluated the efficacy and safety of DVd in a predominantly African American population. A phase II trial using DVd was started in October 2000(PLD 40 mg/m2, vincristine 2 mg IVP and dexamethasone 40 mg PO 1-4 d every 4-weeks). Thirty-four patients have received DVd (15 males/19 females: mean age 59 years [range 42–77]) (five patients were off-study but received DVd per protocol). The majority of patients are African American (70%), a patient population not commonly studied. Patients presented with relatively advanced disease (stage II–III). Baseline mean serum albumin level was 3.5 mg/dl (range 1.8 to 4.9), beta-2 microglobulin 4.09 (range 1.0–8.97). Seventeen patients had IgG Kappa, seven patients had IgG lambda, six patients had IgA and four patients had light chain disease. Twenty five patients completed six cycles of therapy, with two patients completing five cycles. Six patients underwent autologous bone marrow transplant following their response to DVd. Response was assessed on the basis of a reduction of the paraprotein in serum or urine that lasted for at least six weeks. A response was achieved in 27 patients of whom 15 had a CR or nCR. 2 patients had stable disease, and disease progressed in four patients based on Blade Response Assessment. One patient died before response could be assessed. Median follow up is 36 months (range 3 months to 5 years). Our median time to progression is approximately 1 year. Twenty four patients are still alive, one patient has been lost to follow up and nine deaths have occurred. Four early deaths were due to disease progression and sepsis. Three of the early deaths had amyloidosis. Two died after one year of therapy due to progressive refractory disease. One died after the second cycle because of sudden cardiac death with sepsis. No episodes of cardiac dysfunction were observed. For African Americans, who have a high incidence of hypertension, renal and cardiovascular disease, a cardiac safer liposomal doxorubicin may be the preferred form of anthracyline.

scholarly journals Understanding Factors That Determine Clinical Trial Enrollment for African American Patients with Lymphoma

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4965-4965
Author(s):  
Gygeria Manuel ◽  
Amy Ayers ◽  
Jonathan Berman ◽  
Shannon Blee ◽  
Claire Sibold ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
African American ◽  
African Americans ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Large B Cell Lymphoma ◽  
Emory University

Abstract Background: Although the incidence of non-Hodgkin lymphoma (NHL) is lower in minority populations, there is a difference in presentation, survivorship and participation in clinical trials (Becnel et al., 2017). African American patients with diffuse large B-cell lymphoma (DLBCL) present with more aggressive features including higher lactate dehydrogenase, increased frequency of B-symptoms, and higher rate of HIV co-infection, while also presenting at a younger age than other patients. (Tiu et al., 2020). Given the association of race with lymphoma presentation and outcomes, minority participation in clinical trials is of vital importance when developing novel therapies. There have been efforts to increase participation of African Americans in cancer clinical trials including patient navigation outreach which resulted in improvement of 9% to 16% of patients approached (Fouad et al., 2016). However, a recent study illustrated that for DLBCL, acute myeloid leukemia, and acute lymphoblastic leukemia, individuals of African descent represented 1.5%, 2.3%, and 6.7% of clinical trial participants, respectively (Gopishetty et al., 2020). We are conducting the current study to identify factors that influence decisions regarding clinical trial participation in African American patients with NHL. Methods: We are identifying African American patients with diffuse large B cell lymphoma and follicular lymphoma who enrolled in a therapeutic clinical trial at Emory University between 2010-2020. We will utilize the electronic medical record to identify patient characteristics such as distance from medical facility, insurance status, type of insurance, comorbidities, education status, type of diagnosis, and race of diagnosing physician. This data will compare African American patients who participated in clinical trials to those who did not participate as part of their initial treatment, specifically comparing baseline characteristics of interest between the groups. Furthermore, the data mention above will be compared between African American and white patients. We are also conducting interviews with a selected group of African American patients that have opted to participate in therapeutic clinical trials to gain a thorough understanding of the barriers and benefits they endured during their experience. The interview questions are based on prior knowledge of clinical trials, distance to facility, religious/ spiritual belief, trust of the physician, additional expenses, and time corresponded to treatment. Patients are asked to rate the importance each factor in their decision to participate and elaborate on points most specific to them. In addition, the interview allows for discussion of possible factors that challenged their participation in clinical trials which may allow for insight on low participation levels nationally. Furthermore, we are going to target patients who enrolled on clinical trials and will subsequently identify patients who did not participate in studies to identify differences in perception of treatment and clinical investigation. This project is partnered with Accounting for the High Enrollment of African Americans in Winship Cancer Institute's Clinical Trials, at Emory University. Conclusions:This study is currently enrolling patients and will answer key questions related to clinical trial participation in African American patients with lymphoma. We aim for the data collected from this study to assist in creating lymphoma clinical trials that better cater to the unique needs and considerations of African Americans. Disclosures Cohen: Genentech, Takeda, BMS/Celgene, BioInvent, LAM, Astra Zeneca, Novartis, Loxo/Lilly: Research Funding; Janssen, Adaptive, Aptitude Health, BeiGene, Cellectar, Adicet, Loxo/Lilly, AStra ZenecaKite/Gilead: Consultancy.

scholarly journals A Pilot Study of a Culturally-Appropriate, Educational Intervention to Increase Participation in Cancer Clinical Trials Among African Americans and Latinos

2021 ◽  
Author(s):  
Jennifer Cunningham-Erves ◽  
Tilicia Mayo-Gamble ◽  
Pamela C Hull ◽  
Tao Lu ◽  
Claudia Barajas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
African Americans ◽  
Educational Program ◽  
Trial Participation ◽  
Willingness To Participate ◽  
Culturally Appropriate ◽  
Clinical Trial Participation ◽  
Medical Researchers ◽  
Town Halls

Abstract Aim: Culturally-appropriate, educational programs are recommended to improve cancer clinical trial participation among African Americans and Latinos. This study investigated the effect of a culturally-appropriate, educational program on knowledge, trust in medical researchers, and intent for clinical trial participation among African Americans and Latinos in Middle Tennessee.Method: Trained community health educators delivered a 30-minute presentation with video testimonials to 198 participants in 13 town halls. A pre-post survey design was used to evaluate the intervention among 102 participants who completed both pre- and post-surveys one to two weeks after the session. Results: Paired-sample t-test showed significant increases in unadjusted mean scores for knowledge (p < .001), trust in medical researchers (p < .001), and willingness to participate in clinical trials (p = .003) after the town halls in the overall sample. After adjusting for gender and education, all three outcomes remained significant for the overall sample (knowledge: p < .001; trust in medical researchers: p < .001; willingness: p = .001) and for African Americans (knowledge: p < .001; trust in medical researchers: p = .007; willingness: p = .005). However, willingness to participate was no longer significant for Latinos (knowledge: p < .001; trust in medical researchers: p = .034; willingness: p = .084).Conclusions: The culturally-appropriate, educational program showed promising results for short-term, clinical trial outcomes. Further studies should examine efficacy to improve research participation outcomes.

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