scholarly journals FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results

2018 ◽  
Author(s):  
Nicholas J. DeVito ◽  
Seb Bacon ◽  
Ben Goldacre
Keyword(s):  
Clinical Trials ◽  
Relevant Information ◽  
Reporting Requirements ◽  
Practical Support ◽  
The Us ◽  
Us Government ◽  
Results Reporting ◽  
And Performance ◽  
Legal Frameworks ◽  
Clinical Trial Results

AbstractIntroductionNon-publication of clinical trials results is an ongoing issue. In 2016 the US government updated the results reporting requirements to ClinicalTrials.gov for trials covered under the FDA Amendments Act 2007. We set out to develop and deliver an online tool which publicly monitors compliance with these reporting requirements, facilitates open public audit, and promotes accountability.MethodsWe conducted a review of the relevant legislation to extract the requirements on reporting results. Specific areas of the statutes were operationalized in code based on the results of our policy review, publicly available data from ClinicalTrials.gov, and communications with ClinicalTrials.gov staff. We developed methods to identify trials required to report results, using publicly available registry data; to incorporate additional relevant information such as key dates and trial sponsors; and to determine when each trial became due. This data was then used to construct a live tracking website.ResultsThere were a number of administrative and technical hurdles to successful operationalization of our tracker. Decisions and assumptions related to overcoming these issues are detailed along with clarifications directly from ClinicalTrials.gov. The FDAAA TrialsTracker was successfully launched in February 2018 and provides users with an overview of results reporting compliance.DiscussionClinical trials continue to go unreported despite numerous guidelines, commitments, and legal frameworks intended to address this issue. In the absence of formal sanctions from the FDA and others, we argue tools such as ours - providing live data on trial reporting - can improve accountability and performance. In addition, our service helps sponsors identify their own individual trials that have not yet reported results: we therefore offer positive practical support for sponsors who wish to ensure that all their completed trials have reported.

scholarly journals Magyar klinikai vizsgálatok sajátosságai egy nemzetközi adatbázis elemzése alapján

2017 ◽  
Vol 158 (9) ◽  
pp. 345-351
Author(s):  
Tamás Tóth ◽  
Péter Pollner ◽  
Gergely Palla ◽  
Elek Dinya
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Data Cleaning ◽  
Free Text ◽  
Research Organizations ◽  
The Us ◽  
Us Government ◽  
International View ◽  
Significant Data

Abstract: Intorduction: The ClinicalTrials.gov website, which is operated by the US government, collects data about clinical trials. Aim: We have processed data related to Hungary by downloading from the website as XML files. Method: Most of the data describe trials performed after 2000, so we got an overview about the clinical research of the last 10 to 15 years. As the majority of the data fields are collected as free text, significant data cleaning was needed. Results: The database contained 2863 trials related to Hungary from 189 settlements. Only 20 per cent of the actual research organizations could have been identified as many times only an “id” number or a general name was given, thus this information was anonymised in many cases. Conclusion: Besides the analysis of the information obtained from this database, our study points out the relevant issues that may influence the international view of the Hungarian clinical research. Orv. Hetil., 2017, 158(9), 345–351.

Symbolic power in the US Government Counterinsurgency Guide: US security, (non-) combatant civilians, and the refugee-in-place

2020 ◽  
pp. 092137402093514
Author(s):  
Stefanie A Jones
Keyword(s):  
Pierre Bourdieu ◽  
Symbolic Order ◽  
Performance Theory ◽  
Symbolic Power ◽  
Power Differentials ◽  
The Us ◽  
Us Government ◽  
And Performance

Framed by symbolic power as a theory of performance, this essay takes as its subject the state’s use of performance transience for oppressive ends. For Pierre Bourdieu, the symbolic field is about group misrecognition of existing power differentials as legitimate distinctions. Building from this theory, I examine the 2009 US Government Counterinsurgency Guide’s work in the symbolic field. At once a military, social, and performance theory, the Guide creates categorization schemas that differentially define states and people based off of performances of loyalty to US interests. Through the concept of the “non-combatant civilian,” these hierarchies position non-US populations as always already threatening, and acquire social authorization through the threat of further violence. By generating roles for groups of people and framing the means of enforcing those roles, the Guide uses performance transience to structure a symbolic order with deeply racializing consequences.

Relation of Statistically Significant, Abnormal, and Typical WAIS-R VIQ-PIQ Discrepancies to Full Scale IQs

2000 ◽  
Vol 16 (2) ◽  
pp. 107-114 ◽  
Author(s):  
Louis M. Hsu ◽  
Judy Hayman ◽  
Judith Koch ◽  
Debbie Mandell
Keyword(s):  
Graphical Method ◽  
The United States ◽  
Full Scale ◽  
True Score ◽  
Absolute Value ◽  
Normative Population ◽  
The Us ◽  
The Mean ◽  
And Performance ◽  
Quadratic Models

Summary: In the United States' normative population for the WAIS-R, differences (Ds) between persons' verbal and performance IQs (VIQs and PIQs) tend to increase with an increase in full scale IQs (FSIQs). This suggests that norm-referenced interpretations of Ds should take FSIQs into account. Two new graphs are presented to facilitate this type of interpretation. One of these graphs estimates the mean of absolute values of D (called typical D) at each FSIQ level of the US normative population. The other graph estimates the absolute value of D that is exceeded only 5% of the time (called abnormal D) at each FSIQ level of this population. A graph for the identification of conventional “statistically significant Ds” (also called “reliable Ds”) is also presented. A reliable D is defined in the context of classical true score theory as an absolute D that is unlikely (p < .05) to be exceeded by a person whose true VIQ and PIQ are equal. As conventionally defined reliable Ds do not depend on the FSIQ. The graphs of typical and abnormal Ds are based on quadratic models of the relation of sizes of Ds to FSIQs. These models are generalizations of models described in Hsu (1996) . The new graphical method of identifying Abnormal Ds is compared to the conventional Payne-Jones method of identifying these Ds. Implications of the three juxtaposed graphs for the interpretation of VIQ-PIQ differences are discussed.

Der Aufschwung des Katastrophen-Kapitalismus

2006 ◽  
Vol 36 (143) ◽  
pp. 177-183
Author(s):  
Naomi Klein
Keyword(s):  
Natural Disaster ◽  
International Monetary Fund ◽  
Bush Administration ◽  
The Us ◽  
Us Government ◽  
The International Monetary Fund

Fitting to its doctrine of preventiv war, the Bush Administration founded a bureau of reconstruction, designing reconstruction plans for countries which are still not destroyed. Reconstruction after war or after a “natural disaster” developed to a profitable branch of capitalist investment. Also the possibilities to change basic political and economic structures are high and they are widely used by the US-government and institutions like the International Monetary Fund.

Pathways to Legalization: Undocumented Mexican Immigrants in the US/Mexico Borderlands, 1942–1956

2015 ◽  
Vol 2 (2) ◽  
Author(s):  
Ana Elizabeth Rosas
Keyword(s):  
United States ◽  
Family Relationships ◽  
Mexican Immigrants ◽  
Extended Family ◽  
The United States ◽  
Mexican Immigrant ◽  
Agricultural Laborers ◽  
The Us ◽  
Us Government ◽  
Contract Laborers

In the 1940s, curbing undocumented Mexican immigrant entry into the United States became a US government priority because of an alleged immigration surge, which was blamed for the unemployment of an estimated 252,000 US domestic agricultural laborers. Publicly committed to asserting its control of undocumented Mexican immigrant entry, the US government used Operation Wetback, a binational INS border-enforcement operation, to strike a delicate balance between satisfying US growers’ unending demands for surplus Mexican immigrant labor and responding to the jobs lost by US domestic agricultural laborers. Yet Operation Wetback would also unintentionally and unexpectedly fuel a distinctly transnational pathway to legalization, marriage, and extended family formation for some Mexican immigrants.On July 12, 1951, US president Harry S. Truman’s signing of Public Law 78 initiated such a pathway for an estimated 125,000 undocumented Mexican immigrant laborers throughout the United States. This law was an extension the Bracero Program, a labor agreement between the Mexican and US governments that authorized the temporary contracting of braceros (male Mexican contract laborers) for labor in agricultural production and railroad maintenance. It was formative to undocumented Mexican immigrant laborers’ transnational pursuit of decisively personal goals in both Mexico and the United States.Section 501 of this law, which allowed employers to sponsor certain undocumented laborers, became a transnational pathway toward formalizing extended family relationships between braceros and Mexican American women. This article seeks to begin a discussion on how Operation Wetback unwittingly inspired a distinctly transnational approach to personal extended family relationships in Mexico and the United States among individuals of Mexican descent and varying legal statuses, a social matrix that remains relatively unexplored.

Functioning of Ukrainian Bureau in Washington D. C. (March 1939 – May 1940)

2019 ◽  
pp. 142-157
Author(s):  
Danylo Kravets
Keyword(s):  
New York ◽  
The United States ◽  
College Degrees ◽  
The Us ◽  
Us Government ◽  
General Functioning ◽  
History Of ◽  
Governmental Institutions ◽  
History Of Journalism ◽  
The Military

The aim of the Ukrainian Bureau in Washington was propaganda of Ukrainian question among US government and American publicity in general. Functioning of the Bureau is not represented non in Ukrainian neither in foreign historiographies, so that’s why the main goal of presented paper is to investigate its activity. The research is based on personal papers of Ukrainian diaspora representatives (O. Granovskyi, E. Skotzko, E. Onatskyi) and articles from American and Ukrainian newspapers. The second mass immigration of Ukrainians to the US (1914‒1930s) has often been called the «military» immigration and what it lacked in numbers, it made up in quality. Most immigrants were educated, some with college degrees. The founder of the Ukrainian Bureau Eugene Skotzko was born near Western Ukrainian town of Zoloczhiv and immigrated to the United States in late 1920s after graduating from Lviv Polytechnic University. In New York he began to collaborate with OUN member O. Senyk-Hrabivskyi who gave E. Skotzko task to create informational bureau for propaganda of Ukrainian case. On March 23 1939 the Bureau was founded in Washington D. C. E. Skotzko was an editor of its Informational Bulletins. The Bureau biggest problem was lack of financial support. It was the main reason why it stopped functioning in May 1940. During 14 months of functioning Ukrainian Bureau in Washington posted dozens of informational bulletins and send it to hundreds of addressees; E. Skotzko, as a director, personally wrote to American governmental institutions and foreign diplomats informing about Ukrainian problem in Europe. Ukrainian Bureau activity is an inspiring example for those who care for informational policy of modern Ukraine.Keywords: Ukrainian small encyclopedia, Yevhen Onatsky, journalism, worldview, Ukrainian state. Keywords: Ukrainian Bureau in Washington, Eugene Skotzko, public opinion, history of journalism, diaspora.

Repurposed Antiviral Drugs for the Treatment of COVID-19: Syntheses, Mechanism of Infection and Clinical Trials

2020 ◽  
Vol 21 ◽  
Author(s):  
Subha Sankar Paul ◽  
Goutam Biswas
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Molecule ◽  
Mode Of Action ◽  
Antiviral Drugs ◽  
Public Health Emergency ◽  
Advanced Stage ◽  
Clinical Trial Results

: COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.

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