Transforming the Activation of Clinical Trials

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 treatmen...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2018-01, Vol.103 (1), p.43-46
Main Authors: 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.
Format: Article
Language:English
Subjects:
Clinical Trials as Topic - methods
Clinical Trials as Topic - organization & administration
Clinical Trials as Topic - standards
Drug Approval - methods
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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Summary: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.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.898