Measurements in Clinical Trials


1. Introduction

1.3. Safety – What Possible Side Effects Did The Medicine Have?

Participants in a clinical trial are asked to report to the investigator (or trial staff) if anything undesired has happened. The ‘adverse event’ information collected in this way is analysed to give an insight into possible side effects of the medicine, i.e. a possible causal relationship between the trial medication and the observed adverse event. Particular attention is paid to ‘serious’ adverse events – those which are life-threatening or associated with death, hospitalisation or birth abnormalities.