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Transforming the Activation of Clinical Trials.

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.

SUBMITTER: Watters JT

PROVIDER: S-EPMC5774626 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Transforming the Activation of Clinical Trials.

Watters Julie T JT Pitzen Jason H JH Sanders Linda J LJ Bruce Virginia Nickie M VNM Cornell Alissa R AR Cseko Gary C GC Grace Janice S JS Kwon Pamela S PS Kukla Andrea K AK Lee Michael S MS Monosmith Michelle D MD Myren John D JD Kottschade Rebecca S RS Shaft Marc N MN Weis Jennifer Jenny A JJA Welter Jane C JC Bharucha Adil E AE

Clinical pharmacology and therapeutics 20171106 1

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 enhance ...[more]

PMID: 29105757

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