Patient Narratives: Writing Process & Example with Key Components
Patient narratives are brief summaries of specific events experienced by patients during the course of a clinical trial. They are a required component of clinical study reports (CSRs) and pharmacovigilance activities and aid in the evaluation of the safety profile of a drug. Here we will briefly review the narrative writing process and provide a patient narrative example.
Patient Narrative Writing Process
The narrative writing process, including the creation, authoring, and completion of patient narratives, requires the efforts of programming/biostatistics, pharmacovigilance/safety reviewers, clinical teams, and writers to produce quality documents that meet regulatory requirements. These functional groups must collaborate to determine, secure, and synthesize details including:
- Narrative content format
- Review cycles
- Medical/clinical input
The narrative writing process can become cumbersome and can quickly lead to increased costs and extended timelines as a result of the time it takes to receive final data and complete reviews, misalignment between multiple and/or contract reviewers, and/or missing or incomplete data, often requiring additional drafts and reviews. Consequently, patient narratives often delay the completion of CSRs.
A narrative is written primarily from the clinical data, which may be provided in the form of listings, patient profiles, or case report forms (CRFs). Supplemental information from the safety data (typically provided as CIOMS or MedWatch forms) is manually added to provide a complete, concise clinical picture as applicable. Additionally, information from other sources, such as adjudication forms or adverse events of special interest summaries, may be included when relevant/applicable.
Patient Narrative Example
Here we provide a low-complexity patient narrative example and briefly describe key components from a regulatory perspective. Additional information may be included as deemed relevant by the sponsor or requested by regulatory agencies depending on the drug class, population, and/or potential safety signals.
Narrative Writing Solutions
A sound narrative writing process is integral to success in producing consistent, high-quality patient narratives without unnecessary increases in cost and threats to timelines. Leveraging our thirty plus years of experience leading, authoring and reviewing large narrative projects, Synchrogenix has evolved and streamlined these efforts by focusing on behavior, process and technology.