Strategies for Improving Enrollment of Diverse Populations with a Focus on Lipid-Lowering Clinical Trials

Ogungbe, Oluwabunmi; Grant, Jelani K.; Ayoola, Adeoluwa Segilola; Bansah, Eyram; Miller, Hailey N.; Plante, Timothy B.; Sheikhattari, Payam; Commodore-Mensah, Yvonne; Turkson-Ocran, Ruth-Alma N.; Juraschek, Stephen P.; Martin, Seth S.; Lin, Michael; Himmelfarb, Cheryl R.; Michos, Erin D.

doi:10.1007/s11886-023-01942-2

Cited by 3 publications

(2 citation statements)

References 130 publications

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“…To promote the inclusion of Black men in clinical trials, it is imperative for researchers to engage this community meaningfully by addressing well-noted barriers such as mistrust and research literacy. In addition to recognizing the importance of racial concordance within the research team, it is equally vital to embrace diversity among team members and participants, acknowledging that inclusivity does not necessitate homogeneity in race, but rather a commitment to diverse perspectives and experiences [56]. Engagement is best supported by academic-community-governmentindustry partnerships that thoughtfully share decision-making responsibilities, working toward a shared goal [55].…”

Section: Discussionmentioning

confidence: 99%

More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities

Metlock,

Addison,

McKoy

et al. 2024

IJERPH

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Background: Black Americans remain significantly underrepresented and understudied in research. Community-based interventions have been increasingly recognized as an effective model for reckoning with clinical trial participation challenges amongst underrepresented groups, yet a paucity of studies implement this approach. The present study sought to gain insight into Black male participants’ perception of clinical trials before and after participating in a community-based team lifestyle intervention in the United States. Methods: Black Impact, a 24-week community-based lifestyle intervention, applied the American Heart Association’s Life’s Simple 7 (LS7) framework to assess changes in the cardiovascular health of seventy-four Black male participants partaking in weekly team-based physical activities and LS7-themed education and having their social needs addressed. A subset of twenty participants completed an exit survey via one of three semi-structured focus groups aimed at understanding the feasibility of interventions, including their perceptions of participating in clinical trials. Data were transcribed verbatim and analyzed using a content analysis, which involved systematically identifying, coding, categorizing, and interpreting the primary patterns of the data. Results: The participants reported a positive change in their perceptions of clinical trials based on their experience with a community-based lifestyle intervention. Three prominent themes regarding their perceptions of clinical trials prior to the intervention were as follows: (1) History of medical abuse; (2) Lack of diversity amongst research teams and participants; and (3) A positive experience with racially concordant research teams. Three themes noted to influence changes in their perception of clinical trials based on their participation in Black Impact were as follows: (1) Building trust with the research team; (2) Increasing awareness about clinical trials; and (3) Motivating participation through community engagement efforts. Conclusions: Improved perceptions of participating in clinical trials were achieved after participation in a community-based intervention. This intervention may provide a framework by which to facilitate clinical trial participation among Black men, which must be made a priority so that Black men are “more than just a number” and no longer “receiving the short end of the stick”.

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Section: Discussionmentioning

confidence: 99%

More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities

Metlock,

Addison,

McKoy

et al. 2024

IJERPH

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“…The controversy about whether women benefit to the same extent as men from lipidlowering treatment is mainly attributable to a relative lack of information about the effects on women from individual clinical trials [24]. This bias is secondarily due to sampling errors that led to the enrollment disparity difference between the proportion of women with prevalent ASCVD and the proportion of women enrolled in the studies [25].…”

Section: Discussionmentioning

confidence: 99%

Sex X Time Interactions in Lp(a) and LDL-C Response to Evolocumab

Fogacci,

Yerlitaş,

Giovannini

et al. 2023

Biomedicines

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The aim of this study was to evaluate whether there were significant sex x time interactions in lipoprotein(a) (Lp(a)) and low-density lipoprotein cholesterol (LDL-C) response to treatment with the Proprotein Convertase Subtilisin/Kexin type 9 inhibitor (PCSK9i) Evolocumab, in a real-life clinical setting. For this purpose, we pooled data from 176 outpatients (Men: 93; Women: 83) clinically evaluated at baseline and every six months after starting Evolocumab. Individuals who had been on PCSK9i for less than 30 months and nonadherent patients were excluded from the analysis. Over time, absolute values of Lp(a) plasma concentrations significantly decreased in the entire cohort (p-value < 0.001) and by sex (p-value < 0.001 in men and p-value = 0.002 in and women). However, there were no sex-related significant differences. Absolute plasma concentrations of LDL-C significantly decreased over time in the entire cohort and by sex (p-value < 0.001 always), with greater improvements in men compared to women. The sex x time interaction was statistically significant in LDL-C (all p-values < 0.05), while absolute changes in Lp(a) were not influenced by either sex or time (all p-value > 0.05). Our data partially reinforce the presence of differences in response to treatment to PCSK9i between men and women and are essential to gain a better understanding of the relationship between LDL-C and Lp(a) lowering in response to PCSK9i. Further research will clarify whether these sex-related significant differences translate into a meaningful difference in the long-term risk of ASCVD.

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Lipoprotein(a)

Schwartz

2024

Journal of the American College of Cardiology

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Strategies for Improving Enrollment of Diverse Populations with a Focus on Lipid-Lowering Clinical Trials

Cited by 3 publications

References 130 publications

More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities

More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities

Sex X Time Interactions in Lp(a) and LDL-C Response to Evolocumab

Lipoprotein(a)

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