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Personality vulnerabilities and adverse event reporting in phase 1 clinical studies
Joanna Skommer1,2,3, Krish Gunesh4,5, Thomas M Polasek6,7,8
1CMAX Clinical Research, 21 North Terrace, Adelaide, SA, 5000, Australia. Joanna.Skommer@cmax.com.au.
Psychological traits of healthy volunteers in phase 1 clinical trials significantly impact adverse event reporting. Characterizing participants by psychological attributes is crucial for accurate study outcomes.
Area of Science:
- Clinical Pharmacology
- Psychology
- Clinical Trial Design
Background:
- Phase 1 clinical trials require stringent safety monitoring for investigational treatments.
- Healthy volunteers in early-phase trials may possess distinct personality traits compared to the general population.
- Psychological heterogeneity can influence adverse event reporting, especially in trials involving psychoactive substances.
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