The FDA Sentinel Initiative — An Evolving National Resource

Тhe subject of this study is the young Republic of South Sudan (RSS), the “young” – both in terms of the age of an independent state, and in terms of its demographic potential. RSS, as a member of the United Nations and as a sovereign state, appeared on the world map in 2011, but, possessing super-rich natural resources, has not yet gained sustainable development, moreover, it fell into a deep military-political crisis. Like most countries of the African continent, South Sudan had real demographic capacity, but the authorities were unable to extract any “demographic dividends” from the truly main national resource for the development of the country’s economy, moreover, the number of refugees of young working age is constantly growing. Through the example of South Sudan, which so hard achieved separation of the South from the North and failed to take advantage of the conquered democratic values, the article explores the understudied problem of modification of the consciousness of the younger generation, dictated both by the specifics of the deep historical and cultural tradition of the South Sudanese nationalities and by new trends in global evolutionary processes. Studying the stories from the lives of multi-member families affected during the military-political conflict in the RSS, the author, based on the facts, strongly criticizes the ineffective, even often vicious, youth policy of the South Sudanese government. On the other hand, analyzing the origins, nature, basic traditional moral and sociocultural aspects of child employment in the region, the researcher finds a reasoned explanation of the cause for such a policy of universal child mobilization and tries to define this phenomenon that has not been studied in the scientific literature before. Summarizing the study of the causes of a humanitarian catastrophe in the RSS, the author, in addition to generally accepted factors that influenced the current situation (such as: the intervention of major world financial players in the affairs of a sovereign state, national discord, the struggle for power and resources), also highlights the subjective and not always correct work of the world information agencies and other mass media and, of course, the incompetent state policy of the leadership of the RSS in the Youth Field. Relying on the positive events of the past few months to resolve the conflict in the RSS, the author is still trying to predict in the foreseeable future the time for growth and development of the Republic of South Sudan, with the proviso that it can happen only in case of the inclusion of restraining leverage and expansion of the range of priorities of the main national resource – the youth.

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Computational structural mechanics. From national defense to national resource

IEEE Computational Science and Engineering ◽

10.1109/99.295370 ◽

1994 ◽

Vol 1 (1) ◽

pp. 33-42 ◽

Cited By ~ 7

Author(s):

G.L. Goudreau

Keyword(s):

Structural Mechanics ◽

National Defense ◽

Computational Structural Mechanics ◽

National Resource

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A suggestion for Korean resource productivity management policy with calculating and analyzing its national resource productivity

Resources Conservation and Recycling ◽

10.1016/j.resconrec.2014.07.012 ◽

2014 ◽

Vol 91 ◽

pp. 40-51 ◽

Cited By ~ 6

Author(s):

Il-Seuk Lee ◽

Hong-Yoon Kang ◽

Kyung-hwan Kim ◽

In-Ho Kwak ◽

Kwang-Ho Park ◽

...

Keyword(s):

Management Policy ◽

Resource Productivity ◽

Productivity Management ◽

National Resource

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Exergy-based systems account of national resource utilization: China 2012

Resources Conservation and Recycling ◽

10.1016/j.resconrec.2017.05.011 ◽

2018 ◽

Vol 132 ◽

pp. 324-338 ◽

Cited By ~ 10

Author(s):

Bo Zhang ◽

Zheng Meng ◽

Lixiao Zhang ◽

Xudong Sun ◽

Tasawar Hayat ◽

...

Keyword(s):

Resource Utilization ◽

National Resource

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Strengthening Reciprocity in Study-Abroad Programs

African Issues ◽

10.1017/s1548450500006788 ◽

2000 ◽

Vol 28 (1-2) ◽

pp. 13-19

Author(s):

John Metzler

Keyword(s):

Study Abroad ◽

North American ◽

Project Work ◽

African Language ◽

Study Abroad Programs ◽

High Quality ◽

Area Studies ◽

American Students ◽

Quality Programming ◽

National Resource

The National Consortium for Study in Africa (NCSA) was founded in 1994 by the then 15 National Resource Centers for African Language and Area Studies. The primary agenda of the NCSA is to promote high-quality and accessible study-abroad programs for North American students in Africa. In addressing this agenda the NCSA initial membership had a particular, but not exclusive, interest in programs at African universities for North American students. This particular bias develops out of a long-standing commitment on the part of National Resource Centers to work with peer institutions in Africa. African universities, their faculty, and their students are essential partners in collaborative initiatives in research, teaching, and project work, and in the continuing process of generating knowledge on Africa across the disciplines. Consequently, from its inception the NCSA has viewed its goal of expanding high-quality programming in Africa as a natural outgrowth and expansion of its members’ linkages with African universities.

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FDA-Catalyst—Using FDA’s Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial

Clinical Trials ◽

10.1177/1740774518812776 ◽

2018 ◽

Vol 16 (1) ◽

pp. 90-97 ◽

Cited By ~ 5

Author(s):

Noelle M Cocoros ◽

Sean D Pokorney ◽

Kevin Haynes ◽

Crystal Garcia ◽

Hussein R Al-Khalidi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Transient Ischemic Attack ◽

Oral Anticoagulant ◽

Oral Anticoagulants ◽

Pragmatic Trial ◽

Lessons Learned ◽

Health Plans ◽

Planning Phase ◽

Ischemic Attack ◽

Sentinel Initiative

Background: The US Food and Drug Administration’s Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrastructure. Here, we describe the rationale, feasibility analyses, and lessons learned from the planning phase of the first large pragmatic trial conducted using the Sentinel Initiative’s delivery system capabilities—IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (the IMPACT-AFib trial). Methods: During the planning phase, we convened representatives from five commercial health plans, FDA, study coordinating centers, and a patient representative for protocol development, institutional review board preparation, and other activities. Administrative claims data from the plans were included in a retrospective cohort analysis to assess sample size for the trial. Members ≥30 years old with ≥365 days of medical/pharmacy coverage, ≥2 diagnosis codes for atrial fibrillation, a guideline-based indication for oral anticoagulant use for stroke prevention, and no evidence of oral anticoagulant use in the 365 days prior to the index atrial fibrillation diagnosis in 2013 were included. Exclusions for the analysis included other conditions requiring anticoagulation, history of intracranial hemorrhage, and gastrointestinal bleed. We calculated rates of oral anticoagulant use, transient ischemic attack or stroke, and bleeding in the 365 days following the index atrial fibrillation diagnosis. Results: A total of 44,786 members with atrial fibrillation with no evidence of recent oral anticoagulant use were identified. In total, 87% (n = 38,759) were classified as having a guideline-based indication for oral anticoagulants. Of those, 33% (n = 12,867) had a new oral anticoagulant dispensed during the following year, 15% (n = 5917) were hospitalized for stroke or transient ischemic attack, and 9% (n = 3469) for bleeding events. This information was used to develop the trial protocol including sample size, power calculations, and level of randomization. Conclusion: Sentinel infrastructure generated preliminary data that supported planning and implementation of a large pragmatic trial embedded in health plans. This planning identified unanticipated challenges that must be addressed in similar trials.

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