The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials

Geller, Stacie E.; Koch, Abby; Roesch, Pamela; Filut, Amarette; Hallgren, Emily; Carnes, Molly

doi:10.1097/acm.0000000000002027

Cited by 226 publications

(74 citation statements)

References 16 publications

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“…Strict inclusion criteria may also have the unintended consequence of minimizing the impact of the NIH Revitalization Act. Geller et al 6 found that this policy has not increased the inclusion of racial/ethnic minorities in NIHfunded trials. Creative strategies to respond to the greater risk of exclusion will drive meaningful increases in representation and inclusion.…”

Section: Discussionmentioning

confidence: 99%

“…As part of the NIH Revitalization Act of 1993, grant proposals are required to include racial/ethnic minorities as participants, and must indicate their planned distribution of enrollment by race and ethnicity. 5 However, the narrow inclusion/exclusion criteria of RCTs may have the unintended consequence of excluding the most vulnerable participants, 6 such as the medically underserved, those with co-morbidities, or groups who experience disproportionately greater health risks and mortality. As such, findings may have limited generalizability to these subpopulations and have implications for health equity.…”

Section: Introductionmentioning

confidence: 99%

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Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity

et al. 2019

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Objective: The exclusion criteria of tobacco cessation randomized clinical trials (RCTs) may have unintended consequences on inclusion and cessation disparities. We examined racial/ethnic differences in: a) exclusion from a group-based cessation RCT; and b) reasons for exclusion.Design: Quasi-experimental. Inclusion criteria were self-identification as African American/Black, non-Hispanic White, or Hispanic (any race), adults, minimum five cigarettes/day or carbon monoxide reading of ≥ 8 parts per million (ppm), interest in quitting, and spoke/read English. Data were obtained from a parent trial, which is ongoing and will be completed in 2019. Analyses for our present study on participant screening and enrollment were conducted in 2018.Main Outcome Measures: Study ineligibility, and reasons for exclusion (contraindications for nicotine patch use, serious mental illness [SMI, eg, bipolar disorder or schizophrenia], alcohol dependence or illicit drug use, current tobacco treatment, attendance barriers [eg, transportation], and other concerns [eg, aggressive, intoxicated, disruptive, visibly ill]).Results: Of 1,206 individuals screened, 36% were ineligible. The most frequent reasons were SMI (28%), alcohol dependence or drug use (10%), and attendance barriers (7%). Ineligibility was greater among African Americans (42%) and Hispanics (37%), compared with Whites (24%; P<.001). Compared with African Americans and Hispanics, Whites were more likely to be excluded for single reasons, including attendance barriers, and medical conditions (P<.05). African Americans were more than twice as likely as Whites to be excluded for 3 or more reasons (12% vs 5% respectively, P<.05).Conclusions: A notable proportion of smokers were ineligible for this RCT, with SMI as the greatest single cause. Racial/ ethnic minorities were more likely to be excluded, with African Americans deemed ineligible for multiple reasons. Findings have implications for RCT generalizability, addressing tobacco disparities and health equity.Ethn Dis. 2019;29(1):23-30; doi:10.18865/ed.29.1.23.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity

et al. 2019

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“…7 Although the inclusion of females in studies has increased, many preclinical studies still do not include females or analyze sex as a biological variable (SABV). 2,[8][9][10][11] The exclusion of females from research is largely due to the impact of hormonal changes during various stages of the estrous cycle, which could result in high variability. [12][13][14] Levels of estrogen, progesterone, luteinizing hormone, and folliclestimulating hormone fluctuate similarly to humans though the rat estrous cycle is shorter, typically lasting 4-5 days.…”

Section: Introductionmentioning

confidence: 99%

Sex as a biological variable in the rat model of diisopropylfluorophosphate‐induced long‐term neurotoxicity

Gage

Golden

Putra

et al. 2020

Annals of the New York Academy of Sciences

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Sex differences in response to neurotoxicant exposure that initiates epileptogenesis are understudied. We used telemetry-implanted male and female adult rats exposed to an organophosphate (OP) neurotoxicant, diisopropylflourophosphate (DFP), to test sex differences in the severity of status epilepticus (SE) and the development of spontaneous recurrent seizures (SRS). Females had significantly less severe SE and decreased epileptiform spikes compared with males, although females received a higher dose of DFP than males. The estrous stages had no impact on seizure susceptibility, but rats with severe SE had a significantly prolonged diestrus. A previously demonstrated disease-modifying agent, an inducible nitric oxide synthase inhibitor, 1400W, was tested in both sexes. None of the eight males treated with 1400W developed convulsive SRS during 4 weeks post-DFP exposure, while two of seven females developed convulsive SRS. Concerning gliosis and neurodegeneration, there were region-specific differences in the interaction between sex and SE severity. As SE severity influences epileptogenesis, and as females had significantly less severe SE, sex as a biological variable should be factored into the design of future OP nerve agent experiments while evaluating neurotoxicity and optimizing potential disease-modifying agents.

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“…In the French asthma population for example, percentages of women enrolled are higher in women in France in a national academic interventional cohort than in a national industry led early access program to mepolizumab (64.5 and 45%, respectively) [30,31]. Some data suggest that this under-representation of women exists worldwide even in countries where patients might be willing to participate in trials only to have their treatment free of charge [32,33].…”

Section: Discussionmentioning

confidence: 99%

Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?

et al. 2020

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Background: Patient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research. The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results. Methods: This prospective, multicenter survey consisted in the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research (pre or post marketing, sponsored by an academic institution or pharmaceutical company). Logistic regression was used to determine factors contributing to "trust" versus "distrust" group membership and willingness to participate in each category of research. Results: One thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study. 48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female (p = 0.042), inactive in the employment market(p = 0.007), and not-knowing the name of one's disease(p = 0.010) are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.

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The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials

Abstract: NIH policies have not resulted in significant increases in reporting results by sex, race, or ethnicity. The authors recommend strong journal policies to increase compliance with NIH policies.

Cited by 226 publications

References 16 publications

Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity

Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity

Sex as a biological variable in the rat model of diisopropylfluorophosphate‐induced long‐term neurotoxicity

Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?

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