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Więcej informacji o Developing a National Registry of Pharmacologic and Biologic Clinical Trials

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Opis

To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry. The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry. The discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.

Szczegóły książki

Kategoria Książki po angielsku Medicine Medicine: general issues Medical equipment & techniques

• Pełny tytuł: Developing a National Registry of Pharmacologic and Biologic Clinical Trials
• Podtytuł: Workshop Report
• Autor: Committee on Clinical Trial Registries, Board on Health Sciences Policy, Institute of Medicine, National Academy of Sciences
• Język: Angielski
• Oprawa: Miękka
• Liczba stron: 124
• EAN: 9780309100786
• ISBN: 030910078X
• ID: 04578387
• Wydawca: National Academies Press
• Wymiary: 229 × 152 mm
• Data wydania: 12. July 2006

Ulubione w innej kategorii

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