Quanticate CRO Blog

The Challenges of Writing Patient / Safety Narratives

Posted by Medical Writing Team on Tue, Nov 24, 2015

patient narratives

There are a number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects. This blog describes the scope of narrative projects and outlines the associated challenges and provides some ideas to help you successfully manage narrative projects.

What is the purpose of Patient Narratives?

Patient narratives are written for deaths, serious adverse events (SAEs), or adverse events (AEs) of special clinical interest (eg, AEs associated with the mechanism of action being studied, laboratory results of special interest, regulatory requirements etc.) and those leading to permanent discontinuation from a clinical trial. Patient narratives form an important component of clinical study reports (CSRs) and pharmacovigilance activities (e.g. post marketing safety reports). As per International Conference on Harmonisation (ICH) E3 (Section 12.3.2), a patient narrative should describe:

  • The nature, intensity and outcome of the event
  • Clinical course leading to the event
  • Timing of study drug administration
  • Relevant laboratory measures
  • Counter measures
  • Action taken with the study drug in relation to the event
  • Post mortem findings (if applicable)
  • Investigator’s and sponsor’s opinion on causality

Additionally, patient identifier, age, gender, clinical condition, disease being treated, relevant medical history, concomitant and prior medications should be included.

All this information is extracted from the source files (e.g. Council for International Organisations of Medical Sciences [CIOMS] form, Case Report Form [CRF], MedWatch form, Data Clarification Form [DCF], summary tables, and listings). Sometimes, the CIOMS form can be directly attached as an appendix to the CSR.


Challenges of Narrative Writing

An early challenge, for sponsors, is to identify the approximate number of narratives to be produced, which further determines the narrative format and timing of production (pre- or post database lock). If narratives are written before the data are final, updates are required based on the final clean data. This approach can be time consuming, but is more feasible for projects where a large number of narratives have to be produced and finalised quickly e.g. for a regulatory submission. Medical writers can provide effective guidance to clinical study teams during this process.

The majority of Phase II and Phase IV studies have a large number of patients meeting the narrative criteria as outlined in the narrative plan. Excellent project management skills are essential for tracking such projects where huge volumes of narratives have to be written, often by a team of medical writers. The importance of careful management should not be under estimated; ensuring accuracy and consistency across a large number of narratives is a time consuming and tricky task!

In a Clinical Research Organisation (CRO), completing a narrative project within a pre specified budget and time, whilst maintaining quality can be extremely critical for the writers and the business as a whole. As soon as possible, team agreement on the style and content should be sought; this will reduce the possibility of valuable time being lost due to changes requested by the study team during the project lifecycle.

Narrative writing involves expressing the messages clearly and effectively, whilst collating the relevant information from various sources, and liaising with medical experts. A narrative tells the complete story chronologically and holds together medically. Identifying and relating the ‘relevant’ medical history or laboratory result to the event of interest can be challenging.


Ideas to help you successfully manage narrative projects

Firstly, get upfront team agreement on the style and content. This sounds obvious, but in our experience most narrative projects fall down due to a simple lack of communication at the start. Clear and detailed instructions agreed upfront by the key members of the study team will avoid valuable time being lost later due to changes in scope and will save headaches in trying to maintain consistency across the documents.

The easiest way to do this is to produce an initial batch of 5 10 example narratives for client review as early as possible in the process. Example narratives can be written for those cases where the final data are available (e.g. resolved serious adverse events [SAEs] or discontinued subjects). The in house team can be trained on the client requirements after initial review comments have been received.

Some aspects that you should clarify include:

  • Sentence structures (e.g. some clients prefer to start a sentence with a date)
  • Date formats
  • Which medical history and concomitant medications are considered relevant
  • Inclusion or exclusion of normal ranges for laboratory results
  • Trade or generic names for drugs

A comprehensive template that is flexible enough to suit client requirements whilst maintaining internal consistency can also prove to be a very effective tool.

A lot of re work can be avoided by working and delivering narratives in batches. Periodic delivery in small batches of 5 10 narratives can provide ample time for team review and is considered a pragmatic approach. While sending the narratives for review, it is also advisable to clearly state the timeframe within which all review comments must be returned to avoid unnecessary delays.

Tracking is critical in projects where a large number of narratives have to be written for regulatory submissions. Microsoft Office Excel can be an excellent tracking tool for managing huge volumes of narratives. Important details in the spreadsheet could include key milestone dates, protocol and subject identification numbers, and events of interest.

A narrative project becomes more complex and difficult to manage when multiple writers are involved. In a multi writer project, regular team meetings can help keep everyone on the same page, particularly if changes are requested based on client review. Ensuring that new narratives are written according to the new specifications AND ensuring that previously drafted narratives are updated, can be a challenging task! A useful clinical project management tip is to keep and regularly update a project specific ‘styleguide’ with notification posts sent out to the study team whenever an update is made. All writers working on the narrative project should have access to the latest version of the styleguide.

Quality Control (QC) is an important step in the delivery of a narrative project. One of the most common dilemmas faced by writers is to decide on the stage at which narrative QC should be performed. If time is not a constraint, QC must be performed at both interim (review) and final delivery stages. However, if there are pressing issues (e.g. imminent regulatory filing, timing of production with regards to database lock [e.g. pre database lock], a thorough and independent final QC should suffice.


Patient Safety Narratives


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Tags: Case Report Form (CRF), Adverse Events (AEs), Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report, Serious Adverse Events (SAEs), Patient Narratives, Safety Narratives, Data Clarification Form (DCF), Quality Control