Analysis of serious adverse event: Writing a narrative

Address for correspondence: Ms. Indu Nambiar, P. G. Diploma in Dietetics, Registered Dietitian, 1002, Hallmark Business Plaza, Near Guru Nanak Hospital, Near Guru Nanak Hospital Road, Bandra (East), Mumbai - 400 051, Maharashtra, India. E-mail: moc.miehlegni-regnirheob@raibman.udni

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Abstract

One of the reasons that a research molecule undergoes through different phases of clinical trials is to establish the safety and efficacy of the drug. To establish the safety profile of any drug, the most important aspect is to evaluate every adverse event (AE) that a clinical trial individual experiences. This detail is provided by any investigator or sponsor through the narratives that is prepared post the analysis of a serious AE. The purpose of this article is to emphasize the importance of these narratives.

Keywords: Communications, Food and Drug Administration, International Council for Harmonisation, narratives, serious adverse event

INTRODUCTION

With the entire focus of Indian regulations on the safety of human clinical trials participants, serious adverse event (SAE) reporting has become an important obligation, especially for the sites. Medical management and compensation quantum decisions are dependent on the information provided through the SAE forms (in the Schedule Y Appendix XI format). The most relevant section of a SAE form is the narrative, which details about the SAE experience.

What is an serious adverse event?

A SAE is any untoward medical occurrence that at any dose:

An event is considered life threatening if it is suspected that the individual was at substantial risk of dying at the time of the AE

Includes an AE which resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., a significant, persistent or permanent change, impairment, damage or disruption in the individual's body function/structure, physical activities, and/or quality of life

Other important medical events may be considered serious when, based on appropriate medical judgment, they might jeopardize the individual and/or may require medical or surgical intervention to prevent the event from meeting a serious criterion.[1]

Why is the focus on narratives?

Every stakeholder – health-care professionals, patients, regulators, Ethics Committees, policy makers, and health ministry must have access to high quality, up-to-date information, tailored to their abilities and preferences, about medicines and their use, and about health care in general, and about ways to promote health and prevent any adverse effect.[2] Most important aspect is that doctors, nurses, pharmacists, and patients need to know that reporting patients' experience of medicines, and especially adverse effects, will help improve therapy and protect future patients from harm.

Aspects that any safety communication aims to:[2]

Provide timely, evidence-based information on the safe and effective use of medicines and appropriate clinical management of patient treatment

Marketing authorization holders are responsible for collecting, reviewing, and analyzing spontaneous case reports of suspected adverse reactions to medicines by patients and health-care professionals, in scientific literature and elsewhere during postmarketing surveillance of medicines.[3]

When it comes to clinical trial, this communication becomes more important since the “Investigational product” is under experimentation. Hence, narratives become an integral part of every SAE description that is experienced by a trial individual.

What is an serious adverse event narrative?

As per International Conference on Harmonisation (ICH), SAE narrative is a detailed, stand-alone document, which presents a full and clinically relevant, sequential account of the progression of an event or events.[4] It summarizes all relevant clinical and related information including patient characteristics, therapy details, medical history, clinical course of the event(s), diagnosis, and AEs including the outcome, laboratory evidence (including normal ranges), and any other information that supports or alleges an AE.

SAE narrative writing requires a combination of medical and technical writing skills.[5]

Section 12.3.2 of ICH E3 states that “There should be brief narratives describing each death, each other SAE, and those of the other significant AEs that are judged to be of special interest because of clinical importance.”

As per ICH E3 guidelines,[5] a patient safety narrative should describe the following: