What does a clinical narrative describe?

A clinical narrative specifically provides a detailed description of a patient's experience during a clinical trial, particularly focusing on adverse events or deaths. This narrative captures essential information such as the onset, duration, severity, and outcome of the event, along with any relevant clinical data and context.

The purpose of documenting these cases is to ensure a comprehensive understanding of the patient's experience, which can be critical for evaluating the safety and efficacy of the treatment being studied. Clinical narratives play a key role in regulatory submissions and can help inform healthcare professionals and researchers about the risks associated with a treatment, making them vital for patient safety and trial transparency.

In contrast, other options refer to different aspects of clinical trials: trial findings serve as a summary of the overall results; the hypothesis outlines the proposed question or expectation guiding the study, and statistical methods relate to the analytic techniques used to interpret the data. None of these focus specifically on the individual experiences and events that a clinical narrative addresses.