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.

scholarly journals Race and ethnicity representation in clinical trials: findings from a literature review of Phase I oncology trials

2021 ◽  
Author(s):  
D Ross Camidge ◽  
Haeseong Park ◽  
Karen E Smoyer ◽  
Ira Jacobs ◽  
Lauren J Lee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Predominantly White ◽  
Race And Ethnicity ◽  
Phase I Trials ◽  
Minimal Representation ◽  
Phase I Clinical Trials ◽  
Demographic Representation ◽  
The Usa ◽  
Race Ethnicity

Aim: To provide an assessment of published literature on the demographic representation in Phase I trials of biopharmaceutical oncology agents. Materials & methods: We conducted a rapid evidence assessment to identify demographic representation reported in Phase I clinical trials for biopharmaceutical oncology agents published in 2019. Results: Globally, the population was predominantly White/Caucasian (62.2%). In the USA, the distribution was heavily skewed toward White/Caucasian (84.2%), with minimal representation of Blacks/African–Americans (7.3%), Asians (3.4%), Hispanics/Latinos (2.8%) or other race/ethnicity groups. Conclusion: Our data highlight that Phase I oncology trials do not reflect the population at large, which may perpetuate health disparities. Further research is needed to understand and address barriers to participation, particularly among under-represented groups

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.

scholarly journals A-07 Race, SES, and IQ Test Score Differences: The Case for Social Justice

2020 ◽  
Vol 35 (6) ◽  
pp. 780-780
Author(s):  
L Weiss
Keyword(s):  
African Americans ◽  
Parent Education ◽  
Race And Ethnicity ◽  
Test Score ◽  
Data Sets ◽  
Academic Expectations ◽  
Unequal Distribution ◽  
Iq Test ◽  
Before And After ◽  
Race Ethnicity

Abstract Objective To quantify potential mediators of observed IQ test score differences of Whites with Hispanics and African Americans in the WISC-IV, WISC-V, and WAIS-IV standardization data sets. Method Mediators included parent education, income and academic expectations for children and adolescents; and self-education, income and occupation for adults. Observed IQ score means are presented by race and ethnicity, unadjusted for demographics. A series of regressions quantify the variance in IQ test scores accounted for by race/ethnicity before and after controlling for SES related mediators. Results SES related mediators accounted for substantial portions of IQ score variance in all group comparisons and age ranges, but least for African Americans and adults. Conclusions The critical influence of cognitively enriching and impoverishing environments on the neurocognitive development of children, and the unequal distribution of these influences across social and economic groups are discussed as complementary with interpretations of acculturation and heredity.

scholarly journals Racial and Ethnic Enrollment Disparities and Demographic Reporting Requirements in Acute Leukemia Clinical Trials

2021 ◽  
Author(s):  
Andrew Hantel ◽  
Marlise R. Luskin ◽  
Jacqueline S Garcia ◽  
Wendy Stock ◽  
Daniel J DeAngelo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Native American ◽  
Acute Leukemia ◽  
Race And Ethnicity ◽  
Disease Incidence ◽  
The United States ◽  
Reporting Requirements ◽  
Number Of Patients ◽  
Hispanic Patients ◽  
Race Ethnicity

Data regarding racial and ethnic enrollment diversity for acute myeloid (AML) and lymphoid leukemia (ALL) clinical trials in the United States (US) are limited, and little is known about the effect of federal reporting requirements instituted in the late 2000s. We examined demographic data reporting and enrollment diversity for US ALL and AML trials from 2002-2017 as well as changes in reporting and diversity after reporting requirements were instituted. Of 223 AML and 97 ALL trials with results, 68 (30.5%) and 51 (52.6%) reported enrollment by both race and ethnicity. Among trials that reported race and ethnicity (AML N=6,554; ALL N=4,149), non-Hispanic (NH)-Black, NH-Native American, NH-Asian, and Hispanic patients had significantly lower enrollment compared to NH-white patients after adjusting for race-ethnic disease incidence (AML odds: 0.68, 0.31, 0.75, and 0.83; ALL: 0.74, 0.27, 0.67, and 0.64; all p≤0.01). The proportion of trials reporting race increased significantly after the reporting requirements (44.2 to 60.2%; p=0.02), but race-ethnicity reporting did not (34.8 to 38.6%; p=0.57). Reporting proportions by number of patients enrolled increased significantly after the reporting requirements (race: 51.7 to 72.7%, race-ethnicity: 39.5 to 45.4%; both p&lt;0.001), and relative enrollment of NH-Black and Hispanic patients decreased (AML odds: 0.79 and 0.77; ALL: 0.35 and 0.25; both p≤0.01). These data suggest that demographic enrollment reporting for acute leukemia trials is suboptimal, changes in diversity after the reporting requirements may be due to additional enrollment disparities that were previously unreported, and enrollment diversification strategies specific to acute leukemia care delivery are needed.

Willingness of patients with pancreatic cancer to participate in clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4055-4055
Author(s):  
Pelin Cinar ◽  
Anitra W. Talley ◽  
Jimmy Hwang ◽  
Daniel Paul Dohan ◽  
Margaret A. Tempero
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Trial Participation ◽  
Trial Recruitment ◽  
Chi Square ◽  
Cross Sectional ◽  
Recruitment Methods ◽  
Clinical Trial Recruitment

4055 Background: Recruitment of oncology patients into clinical trials continues to be a challenge as <5% of patients are accrued. Low accrual rates may be due to reduced awareness of trial availability and eligibility by physicians/patients. Our objective was to study the attitudes of patients with pancreatic cancer (PC) regarding clinical trial participation and to identify possible barriers to recruitment. Methods: In this cross-sectional study, we collaborated with Pancreatic Cancer Action Network (PanCAN) and invited patients with PC or their caregivers to complete a survey. The survey that was developed consisted of 22 questions and inquired about patients’ previous clinical trial enrollment experiences and their views on participation. The surveys were collected over a 6-month period via the PanCAN website and regional meetings. Comparison analyses between groups were done by Chi-square and Fisher’s test using STATA software. Results: Of the390 surveys received, 149 were included in the final analyses. 30% of the patients were offered to participate in a trial by their physicians. When asked to participate, 62% of the patients agreed. Of the patients who were not enrolled in a clinical trial, 61% were offered to participate in a trial but did not agree. This suggests that these patients were eligible to participate but declined. Conclusions: Majority of the patients with pancreatic cancer were not offered to participate in clinical trials by their physicians but would have agreed if asked. While low clinical trial recruitment rates for PC may be multifactorial, further research may focus on the important role of physicians in clinical trial recruitment efforts. [Table: see text]

Race and ethnicity: Not factors in the prescribing of hydrocodone- and codeine-containing products in two pediatric emergency departments

2019 ◽  
Vol 15 (3) ◽  
pp. 229-233
Author(s):  
Chris A. Rees, MD, MPH ◽  
Melanie Brooke Bernhardt, PharmD ◽  
Elizabeth A. Camp, PhD ◽  
Jessica S. Lin, BA ◽  
Corrie E. Chumpitazi, MD, MS
Keyword(s):  
Abdominal Pain ◽  
Race And Ethnicity ◽  
Emergency Departments ◽  
Secondary Analysis ◽  
Pediatric Emergency ◽  
P Value ◽  
Chi Square ◽  
Patient Race ◽  
Before And After ◽  
Caucasian Patients

Objective: To describe the prescription of hydrocodone-containing products (HCPs) and codeine-containing products (CCPs) by patient and provider race and ethnicity at two pediatric emergency departments (EDs) before and after the US Drug Enforcement Administration (DEA) rescheduling of HCPs in 2014.Design and setting: The authors performed a secondary analysis of data describing the prescription of HCPs and CCPs for 6 months before and after the DEA rescheduling of HCPs in two academic, urban pediatric EDs.Patients, participants: The authors included all children for whom race and ethnicity data were available and who were prescribed HCPs or CCPs at the time of discharge from the ED during a 12-month period (n = 1,246). The authors sent a three-question survey soliciting name, race, and ethnicity to all providers who prescribed an HCP or a CCP during the study period.Main outcome measures: Chi-square comparisons were made between the number of HCP and CCP prescriptions for primary ED diagnosis and patient ethnicity or race. The number of HCP and CCP prescriptions before and after the DEA rescheduling were compared to patient and provider race and ethnicity using the Breslow-Day test for homogeneity.Results: There were no significant differences in the number of HCP and CCP prescriptions between the pre- and post-DEA rescheduling periods across all racial and ethnic groups. When comparing the number of HCP and CCP prescriptions to patient race, Caucasian patients (84.4 percent) were prescribed more HCPs and CCPs than African Americans (15.6 percent) for abdominal pain (p value = 0.02). Non-Hispanic providers prescribed CCPs more often (n = 38, 55.2 percent) than Hispanic providers (n = 0, 0.0 percent) after DEA rescheduling (Breslow-Day p value = 0.01). Providers of all races wrote similar numbers of HCP and CCP prescriptions before and after the DEA rescheduling (Breslow-Day p value = 0.99).Conclusions: Pediatric patients of all races and ethnicities received fewer HCP prescriptions after the 2014 DEA rescheduling of HCPs. However, Caucasian patients were prescribed HCPs and CCPs for abdominal pain more frequently than African American patients. There were no significant differences in the number of prescriptions of HCPs and CCPs by provider race.

scholarly journals Reporting and availability of COVID-19 demographic data by US health departments, April 2020: Observational Study (Preprint)

2020 ◽  
Author(s):  
Peace Ossom-Williamson ◽  
Isaac Williams ◽  
Kukhyoun Kim ◽  
Tiffany B. Kindratt
Keyword(s):  
Data Collection ◽  
Race And Ethnicity ◽  
Demographic Data ◽  
Health Department ◽  
Washington Dc ◽  
Health Departments ◽  
Before And After ◽  
Quasi Experimental ◽  
Data Points ◽  
Race Ethnicity

BACKGROUND There is an urgent need for the unified and consistent collection of demographic data on coronavirus disease 2019 (COVID-19) morbidity and mortality and the sharing of data in open and accessible ways. Due to lack of consistency and transparency during the initial spread of COVID-19, the Equitable Data Collection and Disclosure on COVID-19 Act was introduced into Congress to require collection and reporting of demographic COVID-19 data on testing, treatments, and deaths by race, ethnicity, sex, age, disability, and socioeconomic status. The bill recommends collecting data on race and ethnicity in line with federal standards, including the Office and Management and Budget’s (OMB) guidelines for collecting race and ethnicity. To our knowledge, no studies have evaluated how all of the aforementioned demographic data points have been collected before and after the introduction of this legislation in April 2020. OBJECTIVE The objective of this study was to evaluate differences in reporting and availability of COVID-19 demographic data by US state health departments and Washington, DC before and after the introduction of Equitable Data Collection and Disclosure on COVID-19 Act in Congress on April 21, 2020. METHODS In this quasi-experimental study, we reviewed health department websites from all 50 states and Washington, DC. We evaluated how each state reported age, gender, and race/ethnicity of cases and deaths and how they made COVID-19 data available (charts and tables only, dashboards, machine-actionable by downloading) before and after introduction of legislation. RESULTS We found statistically significant increases in the number of health departments reporting the age of COVID-19 cases (P=.045) and deaths (P=.0016), gender of deaths (P=.0027) and race/ethnicity of cases (P=.003) and deaths (P=.005). More health departments reported race/ethnicity based on federal requirements (P<.0001), although over half (56.9%) still did not report all racial and ethnic groups based on OMB guidelines. The number of health departments who made their COVID-19 data available to download significantly increased from 7 to 11 (P=.005). CONCLUSIONS Although increased demand for disaggregations has improved reporting of demographics across health departments, there is an urgent need for the introduced legislation to be passed for the US to consistently collect and make characteristics of COVID-19 cases and deaths available to allocate resources to mitigate the spread of this disease.

Comparison of toxicity experienced by elderly (E) and younger (Y) patients in breast cancer (BC) clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9542-9542
Author(s):  
Caroline Joy Mariano ◽  
Mia Ivy Francl ◽  
Howard John Lim ◽  
Janice Pope ◽  
Linda Wong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Trial Participation ◽  
Eligibility Criteria ◽  
Chi Square ◽  
Similar Frequency ◽  
Cancer Agency ◽  
Grade 3 ◽  
Phase Ii And Iii ◽  
Age Range ◽  
Selection Of

9542 Background: E patients (pts), age 65 and older, form a large percent of BC pts, but are under-represented in trials, due to actual/perceived frail health, or actual/perceived greater potential toxicity from therapy (rx). With ethics approval, we examined whether E pts had more toxicity than Y pts (< 65 years) in clinical trials. Methods: All BC phase II and III drug trials open from 1999 to 2012 at British Columbia Cancer Agency Vancouver Center were reviewed, excluding trials with only premenopausal pts. Adverse events (AE) were captured from case report forms and charts. The primary endpoint was meaningful toxicity (MTOX), defined as any grade 3 or 4 AE; any AE with dose delay or reduction; or premature discontinuation of rx. Frequencies of MTOX were compared using chi-square tests, means were compared with T-tests. Results: Among 46 trials enrolling 799 pts, rx types were chemotherapy ([CT], 18% of pts), hormone ([HT] 40%), skeletal ([ST] 14%), targeted ([T] 14%]) and CT + T (14%). Pts were 19% E (age range 65-84) and 81% Y (age range 25-64). E pts were more likely to enroll in HT and ST trials; Y pts were evenly distributed among all rx types. Toxicity data (Table) was available for 778 pts (97%). Conclusions: In non CT trials, E and Y pts had similar frequency and number of MTOX. Few E (5%) enrolled in CT trials, but with no more MTOX than Y pts. Discontinuation of rx was equal in E and Y, considering all rx types. Appropriate selection of E pts by eligibility criteria, self selection, and/or clinician assessment allows safe participation of E pts in BC trials. Fear of increased MTOX should not exclude fit E pts from trial participation. [Table: see text]

scholarly journals Rehabilitation of patients with multiple sclerosis in terms of evidence-based medicine: techniques for digitizing the results

2020 ◽  
Vol 12 (1S) ◽  
pp. 38-43
Author(s):  
S. A. Ryabov ◽  
A. N. Boyko
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Combination Treatment ◽  
Evidence Based Medicine ◽  
Neurological Diseases ◽  
Physical Rehabilitation ◽  
Evidence Based ◽  
Before And After ◽  
Meta Analyses ◽  
Based Medicine

A number of clinical trials, reviews, and meta-analyses have been recently published, which show the effectiveness of rehabilitation in patients with multiple sclerosis (MS). It is necessary to investigate the evidence basis of various rehabilitation methods that have proven to be effective in the combination treatment of other neurological diseases. At the same time, the simple transfer of these methods to the practice of managing patients with MS may not only improve, but even worsen their condition. An important task is to analyze methods for evaluating the effectiveness of physical rehabilitation, which in some cases are not without drawbacks. Owing to up-to-date technologies, there are more accurate, clear, and informative analysis methods as numerical values, the use of which can most objectively evaluate the effectiveness of rehabilitation measures before and after their implementation, which is necessary to standardize rehabilitation algorithms in patients with MS.

Pregnant women readiness to use the Internet to access health information about pregnancy and childbirth: A cross-sectional study (Preprint)

2019 ◽  
Author(s):  
Leila Ahmadian ◽  
Reza Khajouei ◽  
Sudabeh Kamali ◽  
Moghaddameh Mirzaee ◽  
Arefeh Ameri
Keyword(s):  
Pregnant Women ◽  
Health Information ◽  
Demographic Characteristics ◽  
T Test ◽  
Descriptive Statistics ◽  
The Internet ◽  
Chi Square ◽  
Readiness Assessment ◽  
Pregnancy And Childbirth ◽  
Chi Square Test

BACKGROUND Today, the Internet may be a promising tool for interventions for pregnant women. However, these kinds of tools are only helpful if users are ready to use them. OBJECTIVE The present study was conducted with the aim of readiness assessment of pregnant women to use the Internet to access health information about pregnancy and childbirth. METHODS This study was carried out on a sample of 384 pregnant women. Data were collected using a valid and reliable questionnaire. The first section of this questionnaire collected demographic characteristics of the participants. The second part of the questionnaire contains 27 questions covering the following components: infrastructure readiness (6 questions); affordability readiness (3 questions); and skill readiness (12 questions). Data were analyzed with SPSS 19.0 using descriptive statistics, Chi-square test, and T-test. RESULTS This study was carried out on a sample of 384 pregnant women. Data were collected using a valid and reliable questionnaire. The first section of this questionnaire collected demographic characteristics of the participants. The second part of the questionnaire contains 27 questions covering the following components: infrastructure readiness (6 questions); affordability readiness (3 questions); and skill readiness (12 questions). Data were analyzed with SPSS 19.0 using descriptive statistics, Chi-square test, and T-test. CONCLUSIONS The use of the Internet by pregnant women depends on factors such as infrastructure, affordability, and skills readiness. This study showed that speed and the quality of the Internet, hardware and software availability, affordability of the Internet, and access to the Internet training were factors in measuring E-health readiness assessment. CLINICALTRIAL Not applicable

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