Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products is a necessary addition to the library of all researchers who plan to publish their results in top-tier, peer-reviewed journals. ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects and some countries and regions also require this information, as well as timely publication of study results. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results. More than 25 current Web addresses for registries are provided as well as a comprehensive annotated bibliography of papers on the topic of clinical trial registries. This book is a valuable source of information for all sponsors of medicinal products.
Table des matières
Clinical trial registries and publication of results — a primer.- The journal editor’s perspective.- Industry perspective on public clinical trial registries and results databases.- Public and patient usage and expectations for clinical trial registries.- Building a global culture of trial registration.- The Japanese perspective on registries and a review of clinical trial process in Japan.- Transparency and validity of pharmaceutical research.- A project management approach to the planning and execution of clinical trial registries.- Biopharmaceutical companies tackle clinical trial transparency.- In search of “Clinical Trial Register — Version 2.0”.
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