Lean medical writing

The American Medical Writers Association (AMWA) ran a global survey seeking the views of health authority assessors on the regulatory documents they review. Excessive length, repetition, and verbosity emerged as the leading criticisms [1]. The report made a compelling argument for weaving a story rather than dumping data; effectively brevity over ‘infobesity’ [2, 3]. In the evolving landscape of pharmaceutical and clinical research, the demand for clear, concise, and efficient documentation has never been greater. Regulatory documents, such as clinical study reports (CSRs), protocols, and investigator brochures, are pivotal assets in the drug development process. However, its clear that they often suffer from excessive length and complexity, hindering their effectiveness. Enter the concept of lean medical writing (LMW).

Lean medical writing draws inspiration from Lean Six Sigma methodologies, emphasizing the elimination of waste and the enhancement of value in processes [4]. A common misunderstanding of lean writing is that it just points at the data source. The lean medical writing (LMW) principles provide a solution to concise and precise writing, promoting clarity and efficiency without compromising the integrity of the information presented. This translates into producing documents that are ‘as informative’ as necessary while being brief, detailed and readable. The goal is to shift from a data-dump approach to a more narrative-driven style that highlights the significance of the data in a clear and structured manner, aiming to reduce the cognitive load on readers, particularly regulatory reviewers, who often face tight deadlines and voluminous submissions.

Key principles of LMW include:

• Clarity and brevity: Using straightforward language and avoiding unnecessary jargon to make documents accessible to a broader audience.
• Structured organisation: Employing clear headings, subheadings, and logical flow to guide readers through the document.
• Purposeful content: Including information that directly supports the document’s objectives and omitting extraneous details.
• Visual aids: Utilising tables, figures, and bullet points to present data succinctly and enhance comprehension.

Benefits of lean medical writing

Lean writing does not just mean writing as little as possible [5], instead authors provide the right amount of data to give sufficient context without overloading the text [6]. Advantages to be gained include:

1. Enhanced readability: Documents become more accessible, allowing reviewers to quickly grasp essential information [7].
2. Improved efficiency: Streamlined content reduces the time required for both writing and reviewing, accelerating the overall regulatory process [8].
3. Consistency and quality: Standardised templates and writing approaches promote uniformity across documents, minimizing errors and discrepancies [9].
4. Resource optimisation: By focusing on essential content, organizations can allocate resources more effectively, reducing costs associated with excessive revisions and prolonged review cycles [10].

Implementing lean medical writing

Delivering LMW doesn’t emerge from a vacuum. It relies on authors adhering to a robust delivery processes. Niche set up its internal quality management system for its medical writing services after working with SmithKline Beecham’s visionary ‘Regulatory Document Management System’ (RDMS) in the 1990’s. As such, we were early adopters of the principles of LMW (though we didn’t know it at the time), which put us in good stead to contribute to the development of GlaxoWellcome’s quality document system in the late 90’s. We adopted and continued to build on the learnings to create the Niche team into a lean, mean writing machine. Sharing from our experience, to effectively apply LMW principles, medical writers must adopt the following strategies:

• Pre-writing planning: Develop a clear outline based on the document’s objectives, ensuring that each section serves a specific purpose [11].
• Audience awareness: Tailor content to the knowledge level and needs of the intended audience, whether they are regulatory reviewers, clinicians, or patients [12].
• Iterative review: Regularly revise drafts to eliminate redundancy, clarify ambiguous statements, and ensure alignment with the document’s goals [13].
• Use of templates and style guides: Employ standardized formats to maintain consistency and facilitate easier navigation [7].
• Standard operating procedures (SOPs): Set up well defined SOPs, processes and guides that meet required regulatory standards and describe the delivery process to follow.
• Incorporation of visual elements: Present complex data through the appropriate use of charts, graphs, and tables to enhance understanding, communicate meaning clearly and enhance retention [14].

It is critical to ensure that project team members are trained on documents templates, style guides and the writing/reviewing process [6]. Effectively, this underlines the importance of including a well-trained medical writer adhering to a robust quality system in your team [1].

Large language models and LMW

The rise of Large Language Models (LLMs) presents new opportunities and challenges in medical writing. Large Language Models, such as GPT-4, have demonstrated remarkable capabilities in generating human-like text, offering potential benefits in medical writing. These models can assist in drafting sections of regulatory documents, summarizing research findings, and even suggesting edits for clarity and conciseness [15].

However, the integration of LLMs into medical writing must be approached with caution:

• Accuracy and reliability: LLMs may produce plausible-sounding but incorrect information. Human oversight is essential to verify the accuracy of generated content.
• Contextual understanding: While LLMs can process vast amounts of data, they may lack the nuanced understanding required for complex medical concepts and regulatory requirements.
• Ethical considerations: Ensuring that LLMs do not inadvertently introduce biases or compromise patient confidentiality is paramount.
• Data confidentiality: No intellectual property data, confidential materials or information on clinical trial participants should ever be shared with an LLM.

Despite these challenges, when used judiciously, LLMs can serve as valuable tools to enhance productivity and support the application of LMW principles.

Conclusion

For many years, the prevailing belief was that “the data speak for themselves”—that we should present data in its raw form, allowing its meaning to be self-evident. In reality, data does not interpret itself. It’s the responsibility of authors, using experience, analytical skills and collective expertise, to interpret the data and place it in context. This explains why three different people might draw different conclusions from the same dataset: each brings a unique perspective, shaped by their individual knowledge and experience. That’s precisely why a collaborative team approach like we employ at Niche (www.niche.org.uk) is so valuable—we bring diverse viewpoints together to discuss, align, and synthesise a shared understanding of the data’s meaning. It is this consensus interpretation, the totality of the evidence as we understand it, that we must communicate clearly to regulatory assessors, enabling them to evaluate and judge the data from an informed position.

Medical writers must extract that deeper understanding of all the nuances in the data from the project team [8].We also need to remember that we are writing scientific documents, not elegant works of literature. The goal is not to demonstrate how creatively you can describe the data. The faster an assessor can find the information they are looking for and get a clear understanding of the sponsor’s interpretation, the faster they can build their own opinion about a product. Lean documents not only take less time to write (when medical writers have been trained appropriately) they also burn fewer internal resources during review and quality control. This equates to shorter production times.

Though the benefits are clear and the concept of LMW has been around for decades, its adoption has been slow. Organisations and individuals used to more traditional writing practices resist using new, leaner approaches. Sponsors often fail to understand exactly what is needed and feel it’s safer to do it the way it was done last time. Everyone needs to learn and master lean writing principles and, more importantly, understand why this is so important.

The integration of LMW principles with LLMs represents a promising frontier in regulatory documentation that extends beyond the wildest dreams of the creators of RDMS in the 1990s. By focusing on clarity, efficiency, and purpose-driven content, medical writers will produce high-quality documents that meet the stringent demands of regulatory bodies. Simultaneously, the judicious use of LLMs will augment the writing process, offering new avenues for innovation and productivity. As the pharmaceutical industry continues to evolve, embracing these approaches will be crucial in ensuring that regulatory documents are not only compliant but also effective in communicating vital information.

References

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