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Transforming the Activation of Clinical Trials.
Watters, Julie T; Pitzen, Jason H; Sanders, Linda J; Bruce, Virginia Nickie M; Cornell, Alissa R; Cseko, Gary C; Grace, Janice S; Kwon, Pamela S; Kukla, Andrea K; Lee, Michael S; Monosmith, Michelle D; Myren, John D; Kottschade, Rebecca S; Shaft, Marc N; Weis, Jennifer Jenny A; Welter, Jane C; Bharucha, Adil E.
Clin Pharmacol Ther ; 103(1): 43-46, 2018 Jan.
Article in English | MEDLINE | ID: mdl-29105757

ABSTRACT

The Institute of Medicine and US Food and Drug Administration (FDA) recognize that activating clinical trials in the United States is lengthy and inefficient. Downstream consequences include increased expense, suboptimal accrual, move of clinical trials overseas, and delayed availability of treatments for patients. An in-tandem processing initiative is here highlighted that transformed the activation of clinical trials (TACT), reduced the activation time by 70%, and offers a paradigm for enhanced translational readiness.


Subject(s)
Clinical Trials as Topic , Drug Approval/methods , Translational Research, Biomedical , Clinical Trials as Topic/methods , Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/standards , Evaluation Studies as Topic , Humans , Organizational Innovation , Quality Improvement , Translational Research, Biomedical/organization & administration , Translational Research, Biomedical/standards , United States , United States Food and Drug Administration/organization & administration
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