Temporal trends in oncology product approvals in the United States, 1986–2005

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6131-6131
Author(s):  
D. B. Ross ◽  
K. D. Weiss ◽  
P. Keegan ◽  
R. Justice ◽  
R. Pazdur

6131 Background: No systematic examination of temporal trends in oncology approvals in the United States (US) has been conducted. Methods: Internal databases at the US Food and Drug Administration (FDA) were queried to determine the number of first-time approvals for New Molecular Entities (NMEs) (both traditional drugs and therapeutic biologics) for oncology indications between the years 1986 and 2005, inclusive; 1986 was the first year for which database records were available for both drugs and biologics. Correlation analysis was used to analyze the data for time-dependent changes in approvals and approval rates. Results: During the period examined, 70 NMEs received first-time approval for an oncology indication ( Table ); 52 (74%) were drugs and 18 were biologics. The median annual number of approvals was 3 (range, 1 to 7); the maximum number of approvals during the period examined occurred in 2004. Statistical analysis showed a weak positive correlation between the number of oncology approvals and time, and between the proportion of applications approved as a percentage of all oncology product applications and time. Conclusions: Available data suggest that the number and rate of oncology product approvals has remained stable in the US over the last two decades. [Table: see text] No significant financial relationships to disclose.

Author(s):  
Sarah L. Jackson ◽  
Sahar Derakhshan ◽  
Leah Blackwood ◽  
Logan Lee ◽  
Qian Huang ◽  
...  

This paper examines the spatial and temporal trends in county-level COVID-19 cases and fatalities in the United States during the first year of the pandemic (January 2020–January 2021). Statistical and geospatial analyses highlight greater impacts in the Great Plains, Southwestern and Southern regions based on cases and fatalities per 100,000 population. Significant case and fatality spatial clusters were most prevalent between November 2020 and January 2021. Distinct urban–rural differences in COVID-19 experiences uncovered higher rural cases and fatalities per 100,000 population and fewer government mitigation actions enacted in rural counties. High levels of social vulnerability and the absence of mitigation policies were significantly associated with higher fatalities, while existing community resilience had more influential spatial explanatory power. Using differences in percentage unemployment changes between 2019 and 2020 as a proxy for pre-emergent recovery revealed urban counties were hit harder in the early months of the pandemic, corresponding with imposed government mitigation policies. This longitudinal, place-based study confirms some early urban–rural patterns initially observed in the pandemic, as well as the disparate COVID-19 experiences among socially vulnerable populations. The results are critical in identifying geographic disparities in COVID-19 exposures and outcomes and providing the evidentiary basis for targeting pandemic recovery.


2021 ◽  
pp. 104973232110321
Author(s):  
Mackenzie D. M. Whipps ◽  
Hirokazu Yoshikawa ◽  
Jill R. Demirci ◽  
Jennifer Hill

What is breastfeeding “success”? In this article, we challenge the traditional biomedical definition, instead centering visions of success described by breastfeeding mothers themselves. Using semi-structured interviews, quantitative surveys, and written narratives of 38 first-time mothers in the United States, we describe five common pathways through the first-year postpartum, a taxonomic distinction far more complex than a success–failure dichotomy: sustained breastfeeding, exclusive pumping, combination feeding, rapid weaning, and grinding back to exclusivity. We also explore the myriad ways in which mothers define and experience breastfeeding success, and in the process uncover the ways that cultural narratives—especially intensive mothering—color those experiences. Finally, we discuss how these experiences are shaped by infant feeding pathway. In doing so, we discover nuance that has gone unexplored in the breastfeeding literature. These findings have implications for supporting, promoting, and protecting breastfeeding in the United States and other high-income countries.


2019 ◽  
Vol 139 (3-4) ◽  
pp. 1379-1384
Author(s):  
Brandon Lawhorn ◽  
Robert C. Balling

AbstractIt is well-documented that the United States (US), along with other mid-latitude land locations, has experienced warming in recent decades in response to changes in atmospheric composition. Among other changes, Easterling (2002) reported that the frost-free period is now longer across much of the US with the first frost in fall occurring later and the last freeze in spring occurring earlier. In this investigation, we explore spatial and temporal variations in all freeze warnings issued by the US National Weather Service. Freeze warning counts are highest in the southeastern US peaking overall in the spring and fall months. Freeze warnings tend to occur more toward summer moving northward and westward into more northerly states. Consistent with the warming in recent decades, we find statistically significant northward movements in freeze warning centroids in some months (December, February) across the study period (2005–2018). Detection of spatial and temporal trends in freeze warnings may be of interest to any number of scientists with applied climatological interests.


Author(s):  
Lihong Chen ◽  
Zhuo Zhao ◽  
Zhen Wang ◽  
Ying Zhou ◽  
Xin Zhou ◽  
...  

AbstractResident physician training is associated with a substantial increase in depression in the United States, with rates increasing from about 4% before internship to 35% at least once during the first year of residency1.Here, we sought to assess whether the rate of depression among residents in China are similar to their US counterparts and identify the common and differential predictors of depression in the two training systems. We assessed 1006 residents across three cohorts (2016-2019) at 16 affiliated hospitals of Shanghai Jiao Tong University and Peking Union Medical College. In parallel, we assessed three cohorts of 7028 residents at 100+ US institutions.At the Chinese institutions, similarly, the proportion of participants who met depression criteria increased from 9% prior to residency to 35% at least once during the first year of residency (P<0.0001), an increase similar in magnitude to residents during internship in US institutions. Among factors assessed before residency, prior history of depression and depressive symptom score at baseline were common factors associated with depression during residency in both China and the US. In contrast, neuroticism and early family environment were strongly associated with depression risk in the US but not in China. Young age was a predictor of depression in China but not in the US sample. Among residency training factors, long duty hours and reduced sleep duration emerged as predictors of depression in both China and the US.To gain insight into whether differences in personal predictors between the residents in China compared to the US residents were driven more by differences between cohorts, or by training system differences, we compared US residents of East Asian descent to other US and Chinese residents. We found that for most predictors (age, Neuroticism, early family environment), US residents of East Asian descent were more similar to other US residents than to the residents training in China.Overall, the magnitude of depression increase and work-related drivers of depression were similar between China and the US, suggesting a need for system reforms, and that the types of effective reforms may be similar across the two systems.


2021 ◽  
Author(s):  
Xiaoping Liu ◽  
A DeVries

Abstract COVID-19 has killed more than 500,000 people in the United States, as of mid-February 2021. Forecasting of COVID-19 spread is helpful for key policy discussions. The transmission coefficient kn of COVID-19 spread varies across time. Accurately forecasting COVID-19 spread is difficult because of the time-dependent kn and becomes more complicated when coronavirus vaccination needs to be considered. In this study, the l-i AIR model was further developed for analyzing COVID-19 spread accompanied by coronavirus vaccinations in the United States. We determined all values of kn prior to January 13, 2021 and calculated the actual number of cumulative infections (In) including asymptomatic infected individuals. We observed 4 plateaus of kn, which corresponded to four national social events. This suggests that events that reduce social distancing and/or percentage of mask wearing played an important role in the acceleration of COVID-19 transmission. Our simulations show that if the American people return to their normal life before 100 million of people are vaccinated, there is likely to be at least one large surge of daily COVID-19 cases. However, if the American people partially return (kn≤0.4) to normal life after 100 million vaccinations, and completely return (kn=1) to normal life after two thirds of the US population are vaccinated in addition to those who have gained some immunity through coronavirus infections, the US may avoid any additional major surge of COVID-19 cases.


2009 ◽  
Vol 5 (1-2 (6)) ◽  
pp. 66-71
Author(s):  
Armine Simonyan

One of the contemporary spheres of modern linguistics is the study of political discourse.For a politician, language is a weapon to win the favours of public at large. The article aims to reveal how American politicians use English to receive the support of the nation. The research is conducted on the debates between the US presidential candidates in 2008 – Hillary Clinton and Barak Obama. The reason for the choice is obvious. Both candidates, as members of the same party, seem to have a lot in common. Both belong to the same party, hence, they should have an audience committed to the same democratic principles whereas, the differences are more than obvious. It is the first time in the history of the United States that the post of the US president has two main candidates that are so different – a woman and a coloured man. The article includes research on the tactics and strategies applied by both the candidates.


Energies ◽  
2021 ◽  
Vol 14 (19) ◽  
pp. 6021
Author(s):  
Palanisamy Manigandan ◽  
MD Shabbir Alam ◽  
Majed Alharthi ◽  
Uzma Khan ◽  
Kuppusamy Alagirisamy ◽  
...  

Research on forecasting the seasonality and growth trend of natural gas (NG) production and consumption will help organize an analysis base for NG inspection and development, social issues, and allow industrials elements to operate effectively and reduce economic issues. In this situation, we handle a comparison structure on the application of different models in monthly NG production and consumption forecasting using the cross-correlation function and then analyze the association between exogenous variables. Moreover, the SARIMA-X model is tested for US monthly NG production and consumption prediction via the proposed method for the first time in the literature review in this study. The performance of that model has been compared with SARIMA (p, d, q) * (P, D, Q)s. The results from RMSE and MAPE indicate that the superiority of the best model. By applying this method, the US monthly NG production and consumption is forecast until 2025. The success of the proposed method allows the use of seasonality patterns. If this seasonal approach continues, the United States’ NG production (16%) and consumption (24%) are expected to increase by 2025. The results of this study provide effective information for decision-makers on NG production and consumption to be credible and to determine energy planning and future sustainable energy policies.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Fadar O Otite ◽  
Priyank Khandelwal ◽  
Amer M Malik ◽  
Seemant Chaturvedi ◽  
Ralph L Sacco ◽  
...  

Background: Data on medical complications following intracerebral hemorrhage (ICH) are sparse. We assessed trends in the prevalence of urinary tract infection (UTI), pneumonia, sepsis, deep venous thrombosis (DVT), pulmonary embolism (PE), acute renal failure (ARF) and acute myocardial infarction (AMI) following ICH in the United States and evaluated their association with in-hospital mortality (IM), cost, length-of-stay (LOS) and home disposition (HD). Methods: Adults admitted to US hospitals from 2004-2013 (n=582,736) were identified from the Nationwide Inpatient Sample. Weighted complication risks were computed by sex and by mechanical ventilation (MV) status. Multivariate models were used to evaluate trends in complication and to assess their association with IM, cost, LOS, and HD. Results: Overall risks of UTI, pneumonia, sepsis, DVT, PE, ARF and AMI following ICH were 14.8%, 7.7%, 4.1%, 2.7%, 0.7%, 8.2% and 2.0% respectively. Risks differed by sex (UTI: females (F) 19.8% vs males (M) 9.9%; ARF: M 10.6% vs F 5.9%; sepsis: M 4.8% vs F 3.4%) and by MV status (pneumonia: MV 17.7% vs non-MV 3.9%; DVT: MV 4.3% vs non-MV 3.2%). From 2004 to 2103, odds of DVT and ARF increased while odds of pneumonia, sepsis and mortality declined over time (figure 1). Each complication was associated with > 2.5-day increase in mean LOS, > $8,000 increase in cost and reduced odds of HD. ARF and AMI were associated with increased IM in all patients; sepsis and pneumonia were associated with increased IM only in non-MV patients while UTI and DVT were associated with reduced IM in all patients. Conclusion and Relevance: Despite IM reduction, ARF and DVT risk following ICH in the US have increased while odds of sepsis and pneumonia have declined over time. All complications were associated with increased cost, LOS and reduced odds of HD but their associations with IM were variable, likely due in part to survival bias. Innovative strategies are needed to prevent ICH-associated medical complications.


1994 ◽  
Vol 9 (0) ◽  
pp. 21-41
Author(s):  
Kyongsoo Lho

The end of the Cold War has precipitated a major rethinking of the United States' international commitments in both the scholarly and policymaking communities. For the first time in nearly half a century, the United States is fundamentally reconsidering both its military and economic relations with the outside world. However, the debate over how to restructure US foreign policy has generally focused on Europe. When analysts have referred to Asia, the emphasis has generally been on economic problems in the region. Similarly, the thrust of these works has tended to remain short-term, looking at the immediate future. This paper challenges these viewpoints. It argues that East Asia is as important as Europe to the United States, for security as well as economic reasons. The paper looks at the long-run as well as short-run trends in East Asia, and argues that the issues the US will face in the future will not arise solely from its traditional adversaries-a major problem will be managing conflicts within alliances.


1959 ◽  
Vol 1 (4) ◽  
pp. 401-401 ◽  

For the first time in its history, the National University of Colombia has a Department of Sociology. Organized temporarily within the Faculty of Economic Sciences, the new department is directed by Orlando Fals Borda, a Colombian sociologist trained in the United States, author of widely known studies of Latin American peasant societies, and since January 1959 Director General of the Ministry of Agriculture. The department starts with fundamental courses and contemplates giving degrees after the fourth year. Fifty-six persons applied for admission in the first year.


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