Characteristics and Dissemination of Phase 1 Trials Approved by a UK Regional Office in 2012.
retrospective_cohort · Level III
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- Record sourced from PubMed, PMID 28464134.
- Also identified by DOI 10.1001/jama.2017.1471 and PMC identifier 5815011.
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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.
Medical subject headings
- Clinical Trials, Phase I as Topic
- Information Dissemination
- Pharmaceutical Preparations