Reporting race/ethnicity in epilepsy clinical trials

2004 ◽  
Vol 5 (5) ◽  
pp. 743-745 ◽  
Author(s):  
Jorge G. Burneo ◽  
Roy Martin
Keyword(s):  
Clinical Trials ◽  
Race Ethnicity

Impact of the Year 2000 Medicare Policy Change on Older Patient Enrollment to Cancer Clinical Trials

2006 ◽  
Vol 24 (1) ◽  
pp. 141-144 ◽  
Author(s):  
Joseph M. Unger ◽  
Charles A. Coltman ◽  
John J. Crowley ◽  
Laura F. Hutchins ◽  
Silvana Martino ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Policy Change ◽  
Positive Impact ◽  
The United States ◽  
Older Patient ◽  
Treatment Trials ◽  
Race Ethnicity ◽  
Method Of Payment ◽  
Medicare Policy ◽  
Year 2000

Purpose A prior analysis by the Southwest Oncology Group (SWOG) showed that women and African American patients were adequately represented on cancer clinical treatment trials but that older patients were substantially underrepresented. Twenty-five percent of patients ≥ 65 years old were enrolled onto SWOG trials from 1993 to 1996, whereas 63% of all patients with cancer were ≥ 65 years old. Recognition of this under-representation led to a change in Medicare policy in 2000 to include coverage of routine patient care costs of clinical trials. We conducted an updated analysis of accrual trends. Methods The proportions of enrollment onto SWOG treatment trials by sex, race/ethnicity, and age (≥ 65 years) were computed for the years 1997 to 2000; corresponding rates in the United States were derived from US Census and National Cancer Institute Surveillance, Epidemiology, and End Results data. Additionally, method of payment data were analyzed over time (1993 to 2003) to assess whether patterns in method of payment changed with the new Year 2000 Medicare policy on clinical trials coverage. Results The results showed continued adequate representation by sex and race/ethnicity. Older patient accrual on SWOG trials increased significantly since 2000, with 31% of patients ≥ 65 years old enrolled from 1997 to 2000 and 38% enrolled from 2001 to 2003 (v 25% from 1993 to 1996). The percentage of patients using Medicare plus supplemental insurance also increased beginning in 2000, whereas the percentage of patients using Medicare alone remained the same. Conclusion Method of payment analyses provided evidence that the Year 2000 Medicare policy change had a positive impact, but only for those patients with supplemental private coverage of coinsurance costs. Improvements in the Medicare payment structure could further increase older patient participation in clinical trials.

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/Ethnicity and the Pharmacogenetics of Reported Suicidality With Efavirenz Among Clinical Trials Participants

2017 ◽  
Vol 216 (5) ◽  
pp. 554-564 ◽  
Author(s):  
Katie R Mollan ◽  
Camlin Tierney ◽  
Jacklyn N Hellwege ◽  
Joseph J Eron ◽  
Michael G Hudgens ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Race Ethnicity

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

scholarly journals Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials

2018 ◽  
Vol 8 (7) ◽  
Author(s):  
Sikander Ailawadhi ◽  
Susanna Jacobus ◽  
Rachael Sexton ◽  
Alexander K. Stewart ◽  
Angela Dispenzieri ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Cooperative Group ◽  
Race Ethnicity

Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities

2003 ◽  
Vol 56 (5) ◽  
pp. 416-420 ◽  
Author(s):  
Giselle Corbie-Smith ◽  
Diane Marie M. St. George ◽  
Sandra Moody-Ayers ◽  
David F. Ransohoff
Keyword(s):  
Clinical Trials ◽  
Health Disparities ◽  
Race Ethnicity

Participation in Surgical Oncology Clinical Trials: Gender-, Race/Ethnicity-, and Age-based Disparities

2007 ◽  
Vol 14 (12) ◽  
pp. 3328-3334 ◽  
Author(s):  
John H. Stewart ◽  
Alain G. Bertoni ◽  
Jennifer L. Staten ◽  
Edward A. Levine ◽  
Cary P. Gross
Keyword(s):  
Clinical Trials ◽  
Surgical Oncology ◽  
Oncology Clinical Trials ◽  
Race Ethnicity

scholarly journals Disulfiram associated with lower risk of Covid-19: a retrospective cohort study

2021 ◽  
Author(s):  
Nathanael Fillmore ◽  
Steven Bell ◽  
Ciyue Shen ◽  
Vinh Nguyen ◽  
Jennifer La ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Retrospective Cohort ◽  
Cox Regression ◽  
Low Cost ◽  
Hazard Ratio ◽  
Comorbidity Score ◽  
Charlson Comorbidity Score ◽  
Race Ethnicity ◽  
Anti Inflammatory ◽  
Test Result

ABSTRACTIn the global COVID-19 pandemic, there is a substantial need for effective, low-cost therapeutics. We investigated the potential effects of disulfiram on the incidence and outcomes of COVID-19 in an observational study in a large database of US Veterans Administration clinical records, the VA Corporate Data Warehouse (CDW). The study is motivated by the unique properties of disulfiram, which has been used as an anti-alcoholism drug since 1948, is non-toxic, easy to manufacture and inexpensive. Disulfiram reduces hyperinflammation in mammalian cells by inhibition of the gasdermin D pore. In a mouse model of sepsis, disulfiram reduced inflammatory cytokines and mortality. Disulfiram also is a low micromolar inhibitor of the Mpro and PLpro viral proteases of SARS-CoV-2.To investigate the potential effects of disulfiram on the incidence and severity of COVID-19, we carried out an epidemiological study in the CDW. The VA dataset used has 944,127 patients tested for SARS-Cov-2, 167,327 with a positive test, and 2,233 on disulfiram, of which 188 had a positive SARS-Cov-2 test. A multivariable Cox regression adjusted for age, gender, race/ethnicity, region, a diagnosis of alcohol use disorders, and Charlson comorbidity score revealed a reduced incidence of COVID-19 with disulfiram use with a hazard ratio of 0.66 and 95% confidence interval of 0.57 to 0.76 (P < 0.001). There were no deaths among the 188 SARS-Cov-2 positive patients treated with disulfiram. The expected number of deaths would have been 5-6 according to the 3% death rate among the untreated (P-value 0.03).Our finding of a lower hazard ratio and less severe outcomes for COVID-19 in patients treated with disulfiram compared to those not treated is a statistical association and does not prove any causative effect of disulfiram. However, the results of this study suggest that there is a pharmacological contribution to the reduced incidence and severity of COVID-19 with the use of disulfiram. Given the known anti-inflammatory and viral anti-protease effects of disulfiram, it is reasonable and urgent to initiate accelerated clinical trials to assess whether disulfiram reduces SARS-CoV-2 infection, disease severity and death.STRUCTURED OUTLINEImportanceIdentifying already approved medications with well characterized antiviral or anti-inflammatory properties supported by real world evidence as candidates for clinical trials for repurposing is an important strategy to manage the pandemic given the ongoing challenges with producing and administering vaccines, the emergence of more infectious viral mutants and the paucity of approved therapies.ObjectiveTo investigate the potential effects of disulfiram on the incidence and severity of COVID-19.DesignRetrospective cohort study from February 20, 2020 to February 1, 2021.SettingVeterans Health Administration. Veterans who had visited a VA primary care provider in the 18 months before their first SARS-CoV-2 test.Participants2,233 Veterans with at least one SARS-CoV-2 laboratory (positive or negative) test result on or after February 20, 2020 and at least one pharmacy record for disulfiram on or after February 20, 2019 and 941,894 Veterans without a pharmacy record for disulfiram.ExposureTreatment with disulfiramMain OutcomePositive test result for SARS-CoV-2ResultsA multivariable Cox regression analysis adjusted for age, gender, race/ethnicity, region, diagnosis of an alcohol use disorder, and Charlson comorbidity score resulted in a reduced hazard of COVID-19 infection with disulfiram use, with a hazard ratio of 0.66 and 95% confidence interval of 0.57 to 0.76 (P < 0.001).Conclusions and RelevanceThe results of this study suggest that disulfiram use contributes to a reduced incidence of COVID-19. Given the known anti-inflammatory and anti-protease effects of disulfiram, its low cost, low side effects, and general availability, it is reasonable and urgent to initiate accelerated clinical trials to assess the effect of disulfiram on infection and the development of advanced disease.

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.

Sign in / Sign up

Export Citation Format

Share Document