They are all the data, measures, and statistical analyses generated during that clinical study.
Study results include the following elements:
- Data on how the treatment affected participants (such as survival rates, reduction in symptoms, or improvement in quality of life).
- Safety information (such as reports on side effects, risks, and safety data experienced by participants).
- Statistical analyses collected from studies to evaluate if a new medical treatment works (efficacy) and is safe (safety).
These findings, often detailed in a Clinical Study Report (CSR), determine if a treatment can be approved for general public use by regulatory agencies.
- EUPATI Toolbox. Clinical study results: Publication. https://toolbox.eupati.eu/resources/clinical-study-results-publication/
