Increasing operational and scientific efficiency in clinical trials
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چکیده
منابع مشابه
Increasing the efficiency of clinical trials of antimicrobials: the scientific basis of substantial evidence of effectiveness of drugs.
In the United States, drug sponsors must obtain approval from the US Food and Drug Administration before licensure and widespread clinical use of drugs. In this article, I discuss the definition and history of the regulatory requirement for "substantial evidence" of effectiveness from "adequate and well-controlled" clinical trials of drugs. These requirements apply to antimicrobials as they do ...
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The period toward the end of patients' participation in late stage blinded clinical trials is highly resource intensive for the sponsor. Consider first a Phase 3 trial. If the trial is a success, the sponsor has to implement the next steps, which might be filing for approval of the drug with the US Food and Drug Administration (FDA). To shorten the time interval between trial completion and sub...
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Danielle M. Wenner, PhD1,2, Baruch A. Brody, PhD3,2, Anna F. Jarman, BA1, Jacob M. Kolman, MA2,3, Nelda P. Wray, MD MPH1, and Carol M. Ashton, MD MPH1 1The Methodist Hospital Research Institute and Department of Surgery, The Methodist Hospital, 6550 Fannin Street, Houston, TX 77030 2Rice University Department of Philosophy, 6100 Main MS-14, Houston TX 77005-1827 3Center for Ethics, Medicine, an...
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OBJECTIVES (1) To develop an automated eligibility screening (ES) approach for clinical trials in an urban tertiary care pediatric emergency department (ED); (2) to assess the effectiveness of natural language processing (NLP), information extraction (IE), and machine learning (ML) techniques on real-world clinical data and trials. DATA AND METHODS We collected eligibility criteria for 13 ran...
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The Clinical Trials Registery-India is an online, primary register of the WHO's International Clinical Trials Registry Platform. It was launched on 20 July 2007, and is now open to the prospective registration of clinical trials of any intervention conducted in India involving human participants. Registration is voluntary and free, and the register is searchable free of charge. Public disclosur...
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ژورنال
عنوان ژورنال: British Journal of Cancer
سال: 2020
ISSN: 0007-0920,1532-1827
DOI: 10.1038/s41416-020-0990-8