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Practical risk management in early phase clinical trials.

Simon Coates,Jörg Täubel,Ulrike Lorch

European journal of clinical pharmacology（2019）

Cited 8|Views7
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Abstract
This work demonstrates how a systematic, objective and consistent approach to risk management of large integrated trials can be simple yet robust, facilitating effective decision making and trial progression whilst safeguarding participant safety.
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Key words
Adverse reactions,Clinical trials,Risk management,Safety,Stopping rules
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