Transforming Clinical Research in the United States

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 9780309163354
Format: PDF, Docs
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An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Envisioning a Transformed Clinical Trials Enterprise in the United States

Author: Forum on Drug Discovery, Development, and Translation
Publisher: National Academies Press
ISBN: 0309253160
Format: PDF, ePub
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There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

Public Engagement and Clinical Trials New Models and Disruptive Technologies

Author: Forum on Drug Discovery, Development, and Translation
Publisher: National Academies Press
ISBN: 0309219302
Format: PDF, ePub, Mobi
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Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.

Best Care at Lower Cost

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309260736
Format: PDF, Docs
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America's health care system has become too complex and costly to continue business as usual. Best Care at Lower Cost explains that inefficiencies, an overwhelming amount of data, and other economic and quality barriers hinder progress in improving health and threaten the nation's economic stability and global competitiveness. According to this report, the knowledge and tools exist to put the health system on the right course to achieve continuous improvement and better quality care at a lower cost. The costs of the system's current inefficiency underscore the urgent need for a systemwide transformation. About 30 percent of health spending in 2009--roughly $750 billion--was wasted on unnecessary services, excessive administrative costs, fraud, and other problems. Moreover, inefficiencies cause needless suffering. By one estimate, roughly 75,000 deaths might have been averted in 2005 if every state had delivered care at the quality level of the best performing state. This report states that the way health care providers currently train, practice, and learn new information cannot keep pace with the flood of research discoveries and technological advances. About 75 million Americans have more than one chronic condition, requiring coordination among multiple specialists and therapies, which can increase the potential for miscommunication, misdiagnosis, potentially conflicting interventions, and dangerous drug interactions. Best Care at Lower Cost emphasizes that a better use of data is a critical element of a continuously improving health system, such as mobile technologies and electronic health records that offer significant potential to capture and share health data better. In order for this to occur, the National Coordinator for Health Information Technology, IT developers, and standard-setting organizations should ensure that these systems are robust and interoperable. Clinicians and care organizations should fully adopt these technologies, and patients should be encouraged to use tools, such as personal health information portals, to actively engage in their care. This book is a call to action that will guide health care providers; administrators; caregivers; policy makers; health professionals; federal, state, and local government agencies; private and public health organizations; and educational institutions.

12 Rules For Life

Author: Jordan B. Peterson
Publisher: Goldmann Verlag
ISBN: 3641239842
Format: PDF, ePub
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Der Nr.1-Bestseller aus den USA: Wie man in einer von Chaos und Irrsinn regierten Welt bei Verstand bleibt! Wie können wir in der modernen Welt überleben? Jordan B. Peterson beantwortet diese Frage humorvoll, überraschend und informativ. Er erklärt, warum wir Kinder beim Skateboarden alleine lassen sollten, welches grausame Schicksal diejenigen ereilt, die alles allzu schnell kritisieren und warum wir Katzen, die wir auf der Straße antreffen, immer streicheln sollten. Doch was bitte erklärt uns das Nervensystem eines Hummers über unsere Erfolgschancen im Leben? Und warum beteten die alten Ägypter die Fähigkeit zu genauer Beobachtung als höchste Gottheit an? Dr. Peterson diskutiert Begriffe wie Disziplin, Freiheit, Abenteuer und Verantwortung und kondensiert Wahrheit und Weisheit der Welt in 12 praktischen Lebensregeln. »12 Rules For Life« erschüttert die Grundannahmen von moderner Wissenschaft, Glauben und menschlicher Natur. Dieses Buch verändert Ihr Leben garantiert!

Normal

Author: Allen Frances
Publisher: Dumont Buchverlag
ISBN: 3832187111
Format: PDF, ePub, Docs
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1980 hielt man einen Menschen für normal, wenn er ein Jahr lang um einen nahen Angehörigen trauerte. 1994 empfahl man Psychiatern mindestens zwei Monate Trauerzeit abzuwarten, bevor man Traurigkeit, Schlaflosigkeit, Konzentrationsstörungen und Apathie als behandlungsbedürftige Depression einstufte. Mit dem neuen Katalog psychischer Störungen ›DSM 5‹ wird ab Mai 2013 empfohlen, schon nach wenigen Wochen die Alarmglocken zu läuten. Vor einer Inflation der Diagnosen in der Psychiatrie warnt deshalb der international renommierte Psychiater Allen Frances. Er zeigt auf, welche brisanten Konsequenzen die Veröffentlichung haben wird: Alltäg-liche und zum Leben gehörende Sorgen und Seelenzustände werden als behandlungsbedürftige, geistige Krankheiten kategorisiert. Verständlich und kenntnisreich schildert Allen Frances, was diese Änderungen bedeuten, wie es zu der überhandnehmenden Pathologisierung allgemein-menschlicher Verhaltensweisen kommen konnte, welche Interessen dahinterstecken und welche Gegenmaßnahmen es gibt. Ein fundamentales Buch über Geschichte, Gegenwart und Zukunft psychiatrischer Diagnosen sowie über die Grenzen der Psychiatrie – und ein eindrückliches Plädoyer für das Recht, normal zu sein.

Wie Demokratien sterben

Author: Steven Levitsky
Publisher: DVA
ISBN: 3641222915
Format: PDF
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Ausgezeichnet mit dem NDR Kultur Sachbuchpreis 2018 als bestes Sachbuch des Jahres Demokratien sterben mit einem Knall oder mit einem Wimmern. Der Knall, also das oft gewaltsame Ende einer Demokratie durch einen Putsch, einen Krieg oder eine Revolution, ist spektakulärer. Doch das Dahinsiechen einer Demokratie, das Sterben mit einem Wimmern, ist alltäglicher – und gefährlicher, weil die Bürger meist erst aufwachen, wenn es zu spät ist. Mit Blick auf die USA, Lateinamerika und Europa zeigen die beiden Politologen Steven Levitsky und Daniel Ziblatt, woran wir erkennen, dass demokratische Institutionen und Prozesse ausgehöhlt werden. Und sie sagen, an welchen Punkten wir eingreifen können, um diese Entwicklung zu stoppen. Denn mit gezielter Gegenwehr lässt sich die Demokratie retten – auch vom Sterbebett.

Issues in Ophthalmology and Optometry Research and Practice 2011 Edition

Author:
Publisher: ScholarlyEditions
ISBN: 1464963940
Format: PDF, Kindle
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Issues in Ophthalmology and Optometry Research and Practice: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Ophthalmology and Optometry Research and Practice. The editors have built Issues in Ophthalmology and Optometry Research and Practice: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Ophthalmology and Optometry Research and Practice in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Ophthalmology and Optometry Research and Practice: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

The price of innovation new estimates of drug development costs

Author: Christoph Fürleger
Publisher: GRIN Verlag
ISBN: 3640791673
Format: PDF, ePub
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Studienarbeit aus dem Jahr 2010 im Fachbereich VWL - Finanzwissenschaft, Universität Bayreuth, Sprache: Deutsch, Abstract: Die vom Bundesministerim für Gesundheit ausgewiesenen Arzneimittelausgaben in der GKV verzeichneten in den letzten 10 Jahren einen nominalen Anstieg um 54,56 Prozent. Der Anteil an den Gesamtausgaben der GKV stieg in diesem Zeitraum von 14,52 auf 17,57 Prozent (vgl. BMG (2010), S. 1). Für das Jahr 2010 errechnete der Schätzerkreis der gesetzlichen Krankenversicherungen im Oktober 2009 eine Deckungslücke von 7,45 Milliarden Euro zwischen den Einnahmen und Ausgaben im Gesundheitsfond (vgl. BVA Schätzerkreis (2009). Zur Entlastung der Ausgabenseite in der GKV werden daher zahlreiche Maßnahmen u.a. im Bereich der Arzneimittelversorgung diskutiert. Im Fokus stehen dabei im Besonderen patentgeschützte Arzneimittel. Für diese Produkte konnte die Pharmaindustrie bisher die Preise, bis zum Erstattungshöchstbetrag, frei festsetzen. Neben der Kosten-Nutzen- Bewertung und weiteren Faktoren sollen nach der aktuellen Gesetzeslage bei der Festlegung des Erstattungshöchstbetrags auch die Entwicklungskosten von Medikamenten berücksichtigt werden (vgl. § 31 Abs. 2a SGB V).