Harmonization of Ethics Policies in Pediatric Research

2011 ◽  
Vol 39 (1) ◽  
pp. 70-78 ◽  
Author(s):  
Valarie Blake ◽  
Steve Joffe ◽  
Eric Kodish
Keyword(s):  
United States ◽  
European Union ◽  
Human Study ◽  
The United States ◽  
New Drugs ◽  
European Medicines Agency ◽  
The European Union ◽  
Drug Marketing ◽  
Technical Requirements ◽  
Recent Initiative

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation.

scholarly journals A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0248222
Author(s):  
Martin Demarchi ◽  
Pierre Coliat ◽  
Philippe Barthelemy ◽  
Roland Schott ◽  
Meher BenAbdelghani ◽  
...  
Keyword(s):  
United States ◽  
European Union ◽  
United States Of America ◽  
Human Study ◽  
Vital Signs ◽  
The United States ◽  
Volume Of Distribution ◽  
The European Union ◽  
Double Blind ◽  
Geometric Means

Purpose This first-in-human study was designed to evaluate the pharmacokinetic (PK) equivalence between HD204 and the European Union (EU)-sourced bevacizumab, between HD204 and the United States of America (US)-sourced bevacizumab, and between EU-sourced and US-sourced bevacizumab (NCT 03390673). Methods In this randomized, double-blind, 3-way parallel group, single-dose comparative PK study, healthy male subjects were randomized to receive a single 1 mg/kg intravenous dose of HD204, EU-sourced bevacizumab or US-sourced bevacizumab. PK parameters were calculated using non-compartmental methods. PK equivalence was determined using the pre-defined equivalence margin of 0.8–1.25 in terms of AUC(0-∞) for the pairwise comparisons. Findings Baseline demographics for the 119 randomized subjects were similar across the three groups. The 90% CIs for the ratio of the geometric means of HD204 to US-sourced bevacizumab, HD204 to EU-sourced bevacizumab, and EU-sourced to US-sourced bevacizumab were all within the interval of 80% to 125% for AUC0-inf, thus demonstrating equivalency in the PK properties for all three treatment groups. Similarly, the ratio of the geometric means for AUC0-last and Cmax were all within the 80% and 125% margins, supporting the robustness of the primary findings. All other PK parameters, including the half-life (t1⁄2) clearance (CL), volume of distribution (Vd) and time of maximum concentration (tmax), were comparable. There was no difference between the 3 treatment arms in terms of vital signs, laboratory tests and adverse events. None of the subjects treated with HD204 had positive ADA results. Implications HD204 demonstrates equivalent pharmacokinetic profiles compared to those of both US-sourced and EU-sourced bevacizumab. (NCT 03390673).

Effectiveness of HCC treatments in real-world experiences.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 61-61 ◽  
Author(s):  
Glen I. Misek ◽  
Mark Keckeisen ◽  
Venkata K Jayanti
Keyword(s):  
United States ◽  
European Union ◽  
Real World ◽  
Late Stage ◽  
The United States ◽  
New Drugs ◽  
The European Union ◽  
Sorafenib Treatment ◽  
One Year ◽  
The Impact

61 Background: The global incidence of HCC is over 700,000 patients making it the sixth leading cancer. Recently new drugs have been approved to treat HCC. Nevertheless, prognosis is poor with a 5 year survival of 11%. Hence, it is important to understand if there are differences in OS in the Real World (RWE) based on patient demographics, comorbidities and whether current treatments are effective. Methods: A robust global database of HCC patients was constructed from patient chart data with nearly 4,000 unique patient records from the United States, the European Union, and Asia in 2011. Several hypotheses were tested including the impact of ethnicity, presence of Hep B or C or cirrhosis, stage at diagnosis and/or if current treatments used could predict PFS and /or OS. CART and CHAID analyses were conducted to help determine patient segments and treatment flows in conjunction with Kaplan-Meier plots to understand the differences in survival based key patient and treatment attributes. Results: One year survival appears to be associated with geography as it is significantly lower in China/ Korea compared to the United States and the European Union. Significantly higher one year survival rates are observed for HCC patients in the European Union and the United States receiving TACE compared with patients receiving sorafenib first line. However, in Asia there are no differences. Across all three regions sorafenib use does not effect OS in Stage IV patients. Further, no significant differences in one year survival are seen in patients with Hep C or B or cirrhosis compared to those with no history of liver disease. Sorafenib treatment duration in China appears to be substantially lower. Finally, Child-Pugh C patients had lower survival compared to Child-Pugh A or B patients. Conclusions: Early diagnosis, intervention and treatment of HCC appear to be important predictors of survival. Stratifying groups by type of drug treatment including sorafenib use does not appear to have a measurable effect on OS. Efforts aimed towards screening, early detection and treatment initiation during early stages to improve RWE for HCC patients may be more effective than expanding treatment with sorafenib in late stage patients. Given the lack of significance in OS for late stage patients treated with sorafenib across the globe, serious thought should be given its use for late stage patients.

Russian Federation and the United States of America: geostrategic directions to manage the Ukrainian crisis

2019 ◽  
pp. 123
Author(s):  
Attarid Awadh Abdulhameed
Keyword(s):  
United States ◽  
European Union ◽  
National Security ◽  
Russian Federation ◽  
United States Of America ◽  
The United States ◽  
The European Union ◽  
The Usa ◽  
Ukrainian Crisis ◽  
Zero Sum

Ukrainia Remains of huge importance to Russian Strategy because of its Strategic importance. For being a privileged Postion in new Eurasia, without its existence there would be no logical resons for eastward Expansion by European Powers.  As well as in Connection with the progress of Ukrainian is no less important for the USA (VSD, NDI, CIA, or pentagon) and the European Union with all organs, and this is announced by John Kerry. There has always ben Russian Fear and Fear of any move by NATO or USA in the area that it poses a threat to  Russians national Security and its independent role and in funence  on its forces especially the Navy Forces. There for, the Crisis manyement was not Zero sum game, there are gains and offset losses, but Russia does not accept this and want a Zero Sun game because the USA. And European exteance is a Foot hold in Regin Which Russian sees as a threat to its national security and want to monopolize control in the strategic Qirim.

COMPARATIVE ANALYSIS OF THE CURRENT FRENCH FOREIGN POLICY ACTIVITY

2019 ◽  
Vol 22 (2) ◽  
pp. 74-79
Author(s):  
Nargiza Sodikova ◽  
◽  
◽  
Keyword(s):  
United States ◽  
European Union ◽  
Foreign Policy ◽  
International Security ◽  
The United States ◽  
Foreign Affairs ◽  
Modern Time ◽  
The European Union ◽  
National Interests ◽  
French Foreign Policy

Important aspects of French foreign policy and national interests in the modern time,France's position in international security and the specifics of foreign affairs with the United States and the European Union are revealed in this article

Ocena antykryzysowej polityki gospodarczej Stanów Zjednoczonych i wybranych państw członkowskich Unii Europejskiej w latach 2005–2014

2016 ◽  
pp. 26-46
Author(s):  
Marcin Jan Flotyński
Keyword(s):  
United States ◽  
European Union ◽  
Financial Markets ◽  
Global Economy ◽  
Global Financial Crisis ◽  
The United States ◽  
The European Union ◽  
High Volatility ◽  
The Global Financial Crisis ◽  
Domestic Products

The global financial crisis in 2007–2009 began a period of high volatility on the financial markets. Specifically, it caused an increased amplitude of fluctuations of the level of gross domestic products, the level of investment and consumption and exchange rates in particular countries. To address the adverse market circumstances, governments and central banks took actions in order to bolster the weakening global economy. The aim of this article is to present the anti-crisis actions in the United States and selected member states of the European Union, including Poland, and an assessment of their efficiency. The analysis conducted indicates that generally the actions taken in the United States in response to the crisis were faster and more adequate to the existing circumstances than in the European Union.

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