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Pharmaceutics 2013, 5(1), 94-106; doi:10.3390/pharmaceutics5010094

Safety Monitoring in Clinical Trials

* ,
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA
* Author to whom correspondence should be addressed.
Received: 6 November 2012 / Revised: 9 January 2013 / Accepted: 10 January 2013 / Published: 17 January 2013
(This article belongs to the Special Issue Drug Safety and Pharmacovigilance)
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Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies. As the industry transitions from passive to active safety surveillance activities, there will be greater demand for more comprehensive and innovative approaches that apply quantitative methods to accumulating data from all sources, ranging from the discovery and preclinical through clinical and post-approval stages. Statistical methods, especially those based on the Bayesian framework, are important tools to help provide objectivity and rigor to the safety monitoring process.
Keywords: clinical trial; safety monitoring; Data and Safety Monitoring Board (DSMB); sequential probability ratio test (SPRT); Bayesian methods clinical trial; safety monitoring; Data and Safety Monitoring Board (DSMB); sequential probability ratio test (SPRT); Bayesian methods
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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Yao, B.; Zhu, L.; Jiang, Q.; Xia, H.A. Safety Monitoring in Clinical Trials. Pharmaceutics 2013, 5, 94-106.

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