Representativity of women and racial/ethnic minorities in randomized clinical trials on bempedoic acid: Positive efforts and lacking data

2021 ◽  
Author(s):  
Federica Fogacci ◽  
Davide Gori ◽  
Arrigo F.G. Cicero
Keyword(s):  
Clinical Trials ◽  
Ethnic Minorities ◽  
Randomized Clinical Trials ◽  
Racial Ethnic

scholarly journals Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies

Cells ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 476 ◽  
Author(s):  
Flavia Franconi ◽  
Ilaria Campesi ◽  
Delia Colombo ◽  
Paola Antonini
Keyword(s):  
Clinical Trials ◽  
Environmental Factors ◽  
Gender Gap ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
Sex And Gender ◽  
Key Factors ◽  
And Gender ◽  
Scientific Value ◽  
Racial Ethnic

There is a clear sex–gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed over recent years. Despite this change, a gap still exists. This gap is linked to biological factors (sex) and psycho-social, cultural, and environmental factors (gender). These multidimensional, entangled, and interactive factors may influence the pharmacological response. Despite the fact that regulatory authorities recognize the importance of sex and gender, there is a paucity of research focusing on the racial/ethnic, socio-economic, psycho-social, and environmental factors that perpetuate disparities. Research and clinical practice must incorporate all of these factors to arrive at an intersectional and system-scenario perspective. We advocate for scientifically rigorous evaluations of the interplay between sex and gender as key factors in performing clinical trials, which are more adherent to real-life. This review proposes a set of 12 rules to improve clinical research for integrating sex–gender into clinical trials.

scholarly journals P15-30 LB. An evaluation of prescreen recruitment data: enrolling racial/ethnic minorities in Phase I HIV vaccine clinical trials

Retrovirology ◽  
2009 ◽  
Vol 6 (S3) ◽  
Author(s):  
D Johnson ◽  
Y Merino ◽  
N Berkowitz ◽  
O Vasilenko ◽  
B Larkin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Ethnic Minorities ◽  
Hiv Vaccine ◽  
Racial Ethnic

scholarly journals An Analysis of the Inclusion of Women, Older Individuals, and Racial/Ethnic Minorities in Rehabilitation Clinical Trials

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Julie K. Silver ◽  
Laura E. Flores ◽  
Antonio Mondriguez González ◽  
Walter R. Frontera
Keyword(s):  
Clinical Trials ◽  
Ethnic Minorities ◽  
Older Individuals ◽  
Racial Ethnic

scholarly journals Conducting Research with Racial/Ethnic Minorities: Methodological Lessons from the NIDA Clinical Trials Network

2011 ◽  
Vol 37 (5) ◽  
pp. 324-332 ◽  
Author(s):  
A. Kathleen Burlew ◽  
Jerren C. Weekes ◽  
La’Trice Montgomery ◽  
Daniel J. Feaster ◽  
Michael S. Robbins ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ethnic Minorities ◽  
Conducting Research ◽  
Racial Ethnic

scholarly journals Racial/ethnic representation in randomized clinical trials referenced in ACOG practice bulletins

2022 ◽  
Vol 226 (1) ◽  
pp. S363
Author(s):  
Ipsita Ghose ◽  
Ellen Crowe ◽  
Angelique Turner ◽  
Caroline C. Zhang ◽  
Irene A. Stafford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Ethnic Representation ◽  
Racial Ethnic

Abstract 17202: Racial/Ethnic Minority Underreporting and Underrepresentation in Guideline-Driving Blood Cholesterol Clinical Trials

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Ashish Sarraju ◽  
Areli Valencia ◽  
Joshua Knowles ◽  
David J Maron ◽  
Fatima Rodriguez
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Census Data ◽  
The United States ◽  
Blood Cholesterol ◽  
Trial Participation ◽  
Atherosclerotic Cardiovascular Disease ◽  
The Us ◽  
Us Census ◽  
Racial Ethnic

Introduction: Cholesterol management is the cornerstone of atherosclerotic cardiovascular disease prevention. Diverse racial/ethnic participation in high-impact cholesterol trials is essential for the generalizability of trials and guidelines across the United States (US). Methods: We analyzed randomized clinical trials (RCTs) cited in the 2018 American Multi-society Guideline on the Management of Blood Cholesterol for reporting and representation of racial/ethnic minorities. We extracted participant level racial/ethnic data, including non-Hispanic White (NHW), Black, Hispanic, or Asian groups. For each race/ethnicity, we pooled trial data to assess overall representation compared to the general US population based on 2010 US Census and 2019 US Census American Community Survey estimates. Results: Among 71 cited RCTs from 1984 - 2017, 59.1% reported racial/ethnic data. NHW participation was reported in 58%, Black in 34%, Hispanic in 27%, and Asian in 17% (Figure). Four trials disaggregated Hispanic patients and none disaggregated Asians. Black trial representation was significantly lower than the US population per 2010 and 2019 Census data (trial: 5.5%, 2010: 12.6%, 2019: 13.4%, P <0.001). Hispanic trial representation was significantly lower compared to the US population (trial: 10.6%, 2010: 16.3%, 2019: 18.3%, P <0.001). NHW trial participation was lower compared to the US population (trial 69.2%; 2010: 72.4%; 2019: 76.5%, P <0.001), but with smaller relative differences compared to Black and Hispanic representation. Asian participation was higher than US census representation. Conclusion: Among guideline-driving cholesterol RCTs, Black and Hispanic participants are significantly underrepresented compared to the general U.S. population. Few studies disaggregate major racial/ethnic subgroups. These findings represent a source of systemic bias that may limit the generalizability of trials and guidelines and potentiate health inequities.

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