Abstract
This study describes characteristics of phase 1 trials, frequency of harms, and communication between investigators and research ethics committees about adverse events to characterize the safety and improve the regulatory review of UK phase 1 trials.
MeSH terms
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Clinical Trials, Phase I as Topic / methods
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Clinical Trials, Phase I as Topic / statistics & numerical data*
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Diagnosis-Related Groups
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Humans
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Information Dissemination / methods*
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Pharmaceutical Preparations / administration & dosage*
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Research Design
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United Kingdom
Substances
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Pharmaceutical Preparations