Narrative writing: Effective ways and best practices

Address for correspondence: Dr. Samir D. Ledade, Department of Medical Writing, Tata Consultancy Services, Empire Plaza, Lal Bahadur Shastri Marg, Vikhroli West, Mumbai - 400 083, Maharashtra, India. E-mail: moc.liamg@edadel.rimas

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Abstract

A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in turn requires effective management of resources, cost, time, quality, and overall project management. Narratives are included as an appendix to the clinical study report and are submitted to the regulatory authorities as a part of dossier. Narratives aid in the evaluation of the safety profile of the investigational drug under study. To deliver high-quality narratives within the specified timeframe to the sponsor can be achieved by standardizing processes, increasing efficiency, optimizing working capacity, implementing automation, and reducing cost. This paper focuses on effective ways to design narrative writing process and suggested best practices, which enable timely delivery of high-quality narratives to fulfill the regulatory requirement.

Keywords: Clinical study report, narrative writing process, patient narrative, project management, safety narrative

INTRODUCTION

Medical writing is a specialized field in clinical research domain, where scientific documents are prepared for regulatory submissions. These documents require adherence to regulatory guidelines in terms of structure, content, and format. Narrative writing is an integral part of medical writing services. The purpose of writing patient narratives is to provide a concise summary of identified/specific adverse events (AEs) occurring in a patient to conclude causal relationship between the investigational drug and AE. These narratives are submitted along with the clinical study report (CSR). The approximate length of narrative may vary from one to four pages depending on the number of AEs, and data availability for a particular patient/event. In a CSR, the number of narratives could be as huge as 1000, depending on the phase of the trial. Thus, the sponsor may choose to outsource narrative writing activity to effectively manage cost, time, quality, and in turn overall project management. Considering current trends, this article focuses on providing guidance to a medical writer for better understanding of the process, how to drive the narrative writing process (NWP) effectively, regulatory norms, challenges, mitigation strategies, and trends toward automation of narratives.

Patient narrative is a summary of AEs occurring in a clinical trial patient/subject. It is generally written for the following criteria: Death, serious AE (SAE), event(s) of special interest, AE leading to study drug/trial discontinuation, and adjudication event(s). It should be written in a structured way with clear, concise, and logical flow of information. It should follow succinct style and presentation and should provide a medical and scientific context in terms of the event(s) for which it is being written. The logical flow to describe event(s) in a patient narrative is as described below:

Clinical course of the events, with an indication of timing of event corresponding to study drug administration