FDA analysis: Demographic trends in bladder and renal cancer trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18144-e18144
Author(s):  
Laura L Fernandes ◽  
Zhantao Lin ◽  
Lola A. Fashoyin-Aje ◽  
Shenghui Tang ◽  
Rajeshwari Sridhara ◽  
...  

e18144 Background: Many publications report under representation of minorities in certain subgroups, which may limit the generalizability of clinical trial (CT) results. This analysis, investigates and reports enrollment trends in CTs submitted between 2006-2017 in support of marketing applications for drugs indicated for the treatment of urothelial (UC) and renal cancer carcinoma (RCC), and compares them to incidence rates of these diseases by Surveillance, Epidemiology, and End Results (SEER) registry and the US census bureau. Methods: We identified all marketing applications for the treatment of UC and RCC that provided the primary evidence of safety and efficacy and aggregated the demographic data across trials and disease. Using these two pooled datasets, we compared the patient proportions enrolled in each of the race, sex and age categories to the corresponding rates in US cancer population estimated based on the corresponding incidence rates reported by SEER and the US census bureau using a Chi-squared test. Results: The pooled seven UC and 14 RCC CTs provided 2035 and 6757 patients respectively. The results are summarized below for the 939 (46%) UC and 1489 (22%) RCC patients enrolled in the US. Conclusions: Our findings indicate that majority of the patients were enrolled outside of the US. There were lower proportion of Black patients (4% vs 8%), older patients, age ≥ 75 years (30% vs 48%) and males (74% vs 80%) enrolled in UC population in the US. Higher proportions were observed in both White (89% vs 85%) and Asian (4% vs 2%) patients in UC and in White (90% vs 79%) patients in RCC.[Table: see text]

2019 ◽  
Vol 109 ◽  
pp. 397-402 ◽  
Author(s):  
John M. Abowd ◽  
Ian M. Schmutte ◽  
William N. Sexton ◽  
Lars Vilhuber

When Google or the US Census Bureau publishes detailed statistics on browsing habits or neighborhood characteristics, some privacy is lost for everybody while supplying public information. To date, economists have not focused on the privacy loss inherent in data publication. In their stead, these issues have been advanced almost exclusively by computer scientists who are primarily interested in technical problems associated with protecting privacy. Economists should join the discussion, first to determine where to balance privacy protection against data quality--a social choice problem. Furthermore, economists must ensure new privacy models preserve the validity of public data for economic research.


1991 ◽  
Vol 11 (4) ◽  
pp. 357-398 ◽  
Author(s):  
Michael L. Cohen

ABSTRACTThe census is a social fact, the outcome of a process that involves the interaction of public laws and institutions and citizens' responses to an official inquiry. However, it is not a ‘hard’ fact. Reasons for inevitable defects in the census count are listed in the first section; the second section reports efforts by the US Census Bureau to identify sources of error in census coverage, and make estimates of the size of the errors. The use of census data for policy purposes, such as political representation and allocating funds, makes these defects controversial. Errors may be removed by making adjustments to the initial census count. However, because adjustment reallocates resources between groups, it has become the subject of political conflict. The paper describes the conflict between statistical practices, laws and public policy about census adjustment in the United States, and concludes by considering the extent to which causes in America are likely to be found in other countries.


Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
Heidi Mochari-Greenberger ◽  
Amytis Towfighi ◽  
Lori Mosca

Background: Early treatment is associated with better clinical outcomes in stroke, but women must recognize the warning signs of a stroke to reduce delays in treatment. The purpose of this study was to evaluate contemporary knowledge of stroke warning signs and intent to call 9-1-1 first if warning signs occur, among a nationally representative sample of women, overall and by race/ethnic group. Methods: A study of cardiovascular disease awareness and knowledge was conducted by the American Heart Association in 2012 among English speaking US women > 25 years identified through random digit dialing (N=1,205; 54% white, 17% black, 17% Hispanic, 12% other). Demographic data, including race/ethnic group, were evaluated using standardized categorical questions. Knowledge about warning signs of stroke, and what to do first if experiencing signs of a stroke, was assessed by standardized unaided questions. Data were weighted to reflect the US population of women based on the US Census Bureau’s March 2011 Current Population Survey, overall and within ethnic strata. Results: In 2012, half of women surveyed (51%) identified sudden weakness/numbness of face/limb on one side as a stroke warning sign; this did not vary by race/ethnic group. Loss of/trouble talking/understanding speech was identified by 44% of women, and more frequently among white versus Hispanic women (48% vs. 36%; p<.05). Fewer than one in four women identified sudden severe headache (23%), unexplained dizziness (20%), or sudden dizziness/loss of vision (18%) as warning signs, and one in five (20%) did not know one stroke warning sign; these results did not vary by race/ethnicity. The majority of women said that they would call 9-1-1 first if they thought they were experiencing signs of a stroke (84%), and this did not vary among black (86%), Hispanic (79%), or white/other (85%) women. Conclusions: Knowledge of stroke warning signs was low among a nationally representative sample of women, especially among Hispanics. In contrast, knowledge to call 9-1-1 when experiencing signs of stroke was high. These data suggest effort to improve recognition of the warning signs of stroke has potential to reduce treatment delay and improve outcomes among women.


Author(s):  
Paul Schor

This chapter discusses changes in the categories of ethnicity and immigration in the US census. From the beginning of the twentieth century to the 1930s, statistics on immigration and ethnicity took first place in schedules, published reports, and public policy. Not only did census figures establish immigration quotas, but census statisticians, with their methods and their culture, constructed the mechanism for exclusion by national origin. However, after 1928 there was a retreat from measuring ethnicity, which became evident in the 1930 and 1940 censuses by a marked lack of interest in questions of place of birth, mother tongue, and degree of assimilation. The history of the categories that made it possible to measure ethnicity is a complex one, involving three main groups of actors: advocates of immigration restriction, representatives of immigrant populations, and Census Bureau statisticians, with each group attempting to respond to contradictory demands and to defend their own interests.


Author(s):  
Marina Deuker ◽  
L. Franziska Stolzenbach ◽  
Claudia Collà Ruvolo ◽  
Luigi Nocera ◽  
Zhe Tian ◽  
...  

Abstract Objective Relative to urban populations, rural patients may have more limited access to care, which may undermine timely bladder cancer (BCa) diagnosis and even survival. Methods We tested the effect of residency status (rural areas [RA < 2500 inhabitants] vs. urban clusters [UC ≥ 2500 inhabitants] vs. urbanized areas [UA, ≥50,000 inhabitants]) on BCa stage at presentation, as well as on cancer-specific mortality (CSM) and other cause mortality (OCM), according to the US Census Bureau definition. Multivariate competing risks regression (CRR) models were fitted after matching of RA or UC with UA in stage-stratified analyses. Results Of 222,330 patients, 3496 (1.6%) resided in RA, 25,462 (11.5%) in UC and 193,372 (87%) in UA. Age, tumor stage, radical cystectomy rates or chemotherapy use were comparable between RA, UC and UA (all p > 0.05). At 10 years, RA was associated with highest OCM followed by UC and UA (30.9% vs. 27.7% vs. 25.6%, p < 0.01). Similarly, CSM was also marginally higher in RA or UC vs. UA (20.0% vs. 20.1% vs. 18.8%, p = 0.01). In stage-stratified, fully matched CRR analyses, increased OCM and CSM only applied to stage T1 BCa patients. Conclusion We did not observe meaningful differences in access to treatment or stage distribution, according to residency status. However, RA and to a lesser extent UC residency status, were associated with higher OCM and marginally higher CSM in T1N0M0 patients. This observation should be further validated or refuted in additional epidemiological investigations.


2020 ◽  
pp. tobaccocontrol-2020-055976
Author(s):  
Aryn Z Phillips ◽  
Jennifer A Ahern ◽  
William C Kerr ◽  
Hector P Rodriguez

IntroductionIn September 2014, CVS Health ceased tobacco sales in all of its 7700 pharmacies nationwide. We investigate the impact of the CVS policy on the number of cigarettes smoked per day among metropolitan daily and non-daily smokers, who may respond to the availability of smoking cues in different manners.MethodsData are from the US Census Bureau Tobacco Use Supplement to the Current Population Survey 2014–2015 and the Blue Cross and Blue Shield Institute Community Health Management Hub. Adjusted difference-in-difference (DID) regressions assess changes in the number of cigarettes smoked per day among daily smokers (n=10 759) and non-daily smokers (n=3055), modelling core-based statistical area (CBSA) level CVS pharmacy market share continuously. To assess whether the policy had non-linear effects across the distribution of CVS market share, we also examine market share using tertiles.ResultsCVS’s tobacco-free pharmacy policy was associated with a significant reduction in the number of cigarettes smoked by non-daily smokers in the continuous DID (rate ratio=0.985, p=0.022), with a larger reduction observed among non-daily smokers in CBSAs in the highest third of CVS market share compared with those living in CBSAs with no CVS presence (rate ratio=0.706, p=0.027). The policy, however, was not significantly associated with differential changes in the number of cigarettes by daily smokers.ConclusionThe removal of tobacco products from CVS pharmacies was associated with a reduction in the number of cigarettes smoked per day among non-daily smokers in metropolitan CBSAs, particularly those in which CVS had a large pharmacy market share.


2016 ◽  
Vol 14 (2) ◽  
pp. 139
Author(s):  
Laura Siebeneck, PhD

Objective: To develop a vulnerability model that captures the social, physical, and environmental dimensions of tornado vulnerability of Texas counties. Design: Guided by previous research and methodologies proposed in the hazards and emergency management literature, a principle components analysis is used to create a tornado vulnerability index. Data were gathered from open source information available through the US Census Bureau, American Community Surveys, and the Texas Natural Resources Information System.Setting: Texas counties.Results: The results of the model yielded three indices that highlight geographic variability of social vulnerability, built environment vulnerability, and tornado hazard throughout Texas. Further analyses suggest that counties with the highest tornado vulnerability include those with high population densities and high tornado risk.Conclusions: This article demonstrates one method for assessing statewide tornado vulnerability and presents how the results of this type of analysis can be applied by emergency managers towards the reduction of tornado vulnerability in their communities.


2009 ◽  
Vol 36 (1) ◽  
pp. 63-67 ◽  
Author(s):  
MICHAEL M. WARD

ObjectiveTo determine if the incidence of endstage renal disease (ESRD) due to lupus nephritis has decreased from 1996 to 2004.MethodsPatients age 15 years or older with incident ESRD due to lupus nephritis in 1996–2004 and living in one of the 50 United States or the District of Columbia were identified using the US Renal Data System, a national population-based registry of all patients receiving renal replacement therapy for ESRD. Incidence rates were computed for each calendar year, using population estimates of the US census as denominators.ResultsOver the 9-year study period, 9199 new cases of ESRD due to lupus nephritis were observed. Incidence rates, adjusted to the age, sex, and race composition of the US population in 2000, were 4.4 per million in 1996 and 4.9 per million in 2004. Compared to the pooled incidence rate in 1996–1998, the relative risk of ESRD due to lupus nephritis in 1999–2000 was 0.99 (95% CI 0.93–1.06), in 2001–2002 was 0.99 (95% CI 0.92–1.06), and in 2003–2004 was 0.96 (95% CI 0.89–1.02). Findings were similar in analyses stratified by sex, age group, race, and socioeconomic status.ConclusionThere was no decrease in the incidence of ESRD due to lupus nephritis between 1996 and 2004. This may reflect the limits of effectiveness of current treatments, or limitations in access, use, or adherence to treatment.


2015 ◽  
Vol 79 (3) ◽  
pp. 769-789 ◽  
Author(s):  
Katherine Jenny Thompson ◽  
Broderick Oliver ◽  
Jennifer Beck

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