Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials

2021 ◽  
pp. 1-8
Author(s):  
Neha Siddiqui ◽  
Ryan G. Chiu ◽  
Ravi S. Nunna ◽  
Georgia Glastris ◽  
Ankit I. Mehta
Keyword(s):  
Clinical Trials ◽  
Native American ◽  
Gender Diversity ◽  
Chi Square ◽  
Clinical Patient ◽  
New Device ◽  
Before And After ◽  
Device Applications ◽  
Us Fda ◽  
And Gender

OBJECTIVE The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its effectiveness in the participant diversity of neurosurgical device trials. METHODS The FDA premarket approval (PMA) online database was queried for all original neurosurgical device submissions from January 1, 2006, to December 31, 2019. Endpoints of the study included racial and gender demographics of reported effectiveness trials, which were summated for each submission. Chi-square tests were performed on both endpoints for before and after years of FDASIA passage and implementation. RESULTS A total of 33 device approvals were analyzed, with 14 occurring before SIA implementation and 19 after. Most trials (96.97%) reported gender to the FDA, while 66.67% reported race and 63.64% reported ethnicity. Gender breakdown did not change significantly post-SIA (53.30% female, p = 0.884). Racial breakdown was significantly different from the 2010 US Census for all races (p < 0.001) both pre- and post-SIA. Only Native American race was significantly different in terms of representation post-SIA, increasing from 0% to 0.63% (p = 0.0187). There was no significant change in ethnicity. CONCLUSIONS The FDASIA, as currently written, does not appear to have had a significant impact on the racial or gender diversity of neurosurgical device clinical trial populations. This may be due to the noncompulsory nature of its guidance, or a lack of more stringent regulation on the composition of clinical trials themselves.

Abstract TP409: Reporting of Key Demographic Characteristics in Neurological Trials Registered on ClinicalTrials.gov

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kush Fansiwala ◽  
Lauren Southwick ◽  
Emily Goldmann ◽  
Nina S Parikh ◽  
Joy Madubuonwu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Race And Ethnicity ◽  
Neurological Diseases ◽  
Demographic Characteristics ◽  
Mandatory Reporting ◽  
Trial Participation ◽  
Limited Participation ◽  
Chi Square ◽  
Before And After ◽  
Race Ethnicity

Introduction: To increase the transparency of clinical trial information, U.S. Congress passed the Food and Drug Administration (FDA) Amendments Act of 2007, which expanded prior legislation to mandate inclusion of specific trial characteristics, such as funding source and gender demographics, in a new basic results section on ClinicalTrials.gov. Few studies have examined the extent to which key demographic characteristics such as sex and race/ethnicity are reported for neurological trials on ClinicalTrials.gov. Methods: As part of the National Initiative for Minority Involvement in Neurological Clinical Trials (NIMICT), we systematically identified neurological clinical trials on ClinicalTrials.gov (for stroke, epilepsy, Alzheimer’s Disease [AD]) and examined the proportion that reported sex, race, and ethnicity (Hispanic/Latino or not) of study participants. We used the website’s advanced search feature to evaluate demographic information reported from trials conducted between 1999 and 2015. We first calculated frequencies of trials reporting these characteristics, then assessed differences in reporting of each characteristic (yes/no) by condition (stroke, epilepsy, AD) and between trials conducted before and after the basic results section update (pre- and post-2008) using chi-square tests. Results: Our sample comprised 251,847 subjects across 393 trials (147 stroke, 127 epilepsy, 115 AD). Overall, sex was reported for nearly all trials (99.0%), while reporting of race and ethnicity was low (ethnicity: 14.0%, race: 19.8%). Reporting of these characteristics did not differ significantly across the three conditions or between periods preceding and following the FDA act. Conclusion: While ClinicalTrials.gov mandates reporting of sex, it does not require reporting of race/ethnicity, and few trials report these characteristics. This lack of information prevents understanding of neurological trial participation and how interventions might impact patients differently by race/ethnicity. Mandatory reporting of race/ethnicity would enhance transparency and increase awareness of the limited participation of racial/ethnic minorities-who suffer disproportionately from neurological diseases-in neurological trials.

Thinking about ethnicity and gender diversity in children and young people

2018 ◽  
Vol 24 (2) ◽  
pp. 291-303 ◽  
Author(s):  
Nastasja M de Graaf ◽  
Ilham I Manjra ◽  
Anna Hames ◽  
Claudia Zitz
Keyword(s):  
Young People ◽  
Identity Development ◽  
Gender Identity ◽  
Gender Diversity ◽  
Age Groups ◽  
Chi Square ◽  
Children And Young People ◽  
And Gender ◽  
The Uk ◽  
Ethnicity Data

Background: Little is known about how social and cultural variants interact with gender identity development. This article aims to identify the ethnicities of children and young people referred to the United Kingdom’s national Gender Identity Development Service (GIDS), and compare the ethnicity data with the UK child population and referrals to Child and Adolescent Mental Health Services (CAMHS). Methods: GIDS referrals made between April 2012 and April 2015 for children and young people were retrieved. Ethnicity data were obtained by the ‘16 + 1’ ethnicity list. Chi-square and t-tests were performed on the demographics. Results: Less than 10% of the 995 referrals at GIDS were from Black and minority ethnic (BME) groups – an underrepresentation as compared with both the national population and CAMHS figures. No significant differences in ethnic representation were found between the demographic birth-assigned sexes, across age groups, or year of referral. Conclusions: Hypotheses proposed for this underrepresentation take into account both the potential barriers to accessing services and the possibility of cross-cultural variations in the conceptualisations of gender, gender roles and gender diversity. Ethnicity, culture and religion, and their overlapping relationship with gender need further exploration.

scholarly journals Effectiveness of a Program to Improve Attention towards Affective-Sexual, Bodily and Gender Diversity in University Students

2021 ◽  
Vol 11 (4) ◽  
pp. 1205-1220
Author(s):  
Francisco Manuel Morales-Rodríguez
Keyword(s):  
Gender Diversity ◽  
Perceived Usefulness ◽  
Gender Violence ◽  
Sexual Diversity ◽  
Negative Attitudes ◽  
Teaching Innovation ◽  
Ex Post ◽  
Before And After ◽  
Ex Post Facto ◽  
And Gender

It is necessary for the university environment to contribute to the improvement of the attention paid to affective-sexual, bodily, and gender diversity. This research deals with how, by means of a teaching innovation program, competences for affective-sexual diversity were developed. Specifically, negative attitudes towards diversity, knowledge, and degree of empathy on these issues before and after the implementation of the program are compared. The degree of satisfaction, perceived usefulness, and fulfillment of the objectives proposed in the program were also evaluated. An ex post facto design was used. The participants in this study were 129 students belonging to Educational Sciences and Psychology, out of 2400 who benefited from the innovation program. The results showed an increase in competences related to the attention to diversity, with the improvement of attitudes and knowledge about affective-sexual diversity after the application of the program. It is concluded that this type of innovation program, with quality training, contributes to the improvement of coexistence and the prevention of gender violence in university classrooms, eliminating stereotypes and negative attitudes towards diversity.

Understanding scientific collaboration: Diversity of collaborators and sequences in publication bylines

2020 ◽  
Author(s):  
Zaida Chinchilla-Rodríguez
Keyword(s):  
Scientific Collaboration ◽  
Collaborative Work ◽  
Gender Diversity ◽  
Career Stages ◽  
Future Research ◽  
Scientific Career ◽  
Scientific Publications ◽  
Before And After ◽  
And Gender ◽  
The Relationship

Comparing distinct dimensions of diversity and author order in publications could improve the understanding of collaborative work and help to identify opportunities for and risks of evaluation of collaborative work in different scientific career stages. Thus, the aim of this paper is to better understand the contextual dynamics of evaluating collaborative work by investigating the relationship between the sequence of authors in the publication bylines and the diversity of their collaborators. The diversity of collaborators is quantified with three separate dimensions, namely topic, impact, and gender diversities. Using the ArnetMiner dataset containing ACM-indexed publications in computer science, we find that the following three patterns relate to higher-impact scientific publications: (1) greater (less) topic diversity of collaborators plus more (less) tendency to work as first or last authors; (2) less (greater) impact diversity of collaborators plus more (less) tendency to work as first authors; and (3) greater gender diversity of collaborators plus more tendency to work as last authors. We also detect different patterns of authors’ first-, middle-, last-authored publications before and after their Ph.D. graduation and find that there are some differences for topic and impact diversities but not many differences for gender diversity in terms of Ph.D. students and researchers in their later stages of careers. Some implications are described, and a brief description of the limitations and future research are provided.

Graduate Students' Perceptions of Ethnic and Gender Diversity

2013 ◽  
Author(s):  
Diana Zarb ◽  
Ryan F. Birch ◽  
David Gleave ◽  
Winston Seegobin ◽  
Joel Perez
Keyword(s):  
Graduate Students ◽  
Gender Diversity ◽  
And Gender

The Influence of Age and Gender on Mandibular Indices among the Libyan Population

2019 ◽  
Vol 3 (2) ◽  
Keyword(s):  
Negative Correlation ◽  
Bone Mineralization ◽  
Age Groups ◽  
T Test ◽  
Chi Square ◽  
Age And Gender ◽  
Significant Difference ◽  
Chi Square Test ◽  
And Gender ◽  
Libyan Population

Radiographic Mandibular Indices serve as easy and relatively cheap tools for evaluating bone mineralization. Objectives: To examine the effect of age and gender on three mandibular indices: the panoramic mandibular index (PMI), the mandibular ratio (MR) and the mandibular cortical index (MCI), among Libyan population. Methods: The three indices were measured on 317 digital (OPGs) of adult humans (155 males, 162 females). The sample was divided into six age groups (from 18-25 years through 56-65 years). The measurements were analyzed for interactions with age and sex, using SPSS (Statistical Package for Social Studies) software version no. 22. The tests employed were two way ANOVA, the unpaired T-test and chi-square test. Results: The mean PMI fluctuated between 0.37 s.d. 0.012 and 0.38 s.d. 0.012. among the sixth age groups. One-way ANOVA statistical test revealed no significant of age on PMI. On the other hand gender variation has effect on PMI, since independent sample t-test disclosed that the difference between the male and female PMI means statistically significant. ANOVA test showed that the means of MR among age groups showed a negative correlation i.e. MR mean declined from 3.01 in 18-25 age groups to 2.7 in 55-65 age groups. In contrary, the gender showed no effect on MR according two sample t-test at p> 0.05. In regards with MCI, statistical analysis showed that it affected by age that is C1 was decreasing by age while C2 and C3 were increased by age. Using chi square test the result indicated that there is a significant difference among the different age group and the two genders in MCI readings. Conclusion: PMI was influenced significantly by age but minimally by the gender. MR is not affected by gender but has a negative correlation with age. MCI is affected by both age and gender

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