Introduction: A Paradigm Shift in Medical Writing
Automation in Medical Writing is poised to bring about a paradigm shift in our approach to the field. By enhancing both speed and quality, automation frees medical writers to focus on intellectual, analytical, and value-enhancing contributions to the document. This is a win-win situation for both medical writers and sponsors/pharmaceutical companies. Medical writers can move beyond the redundancy-laden, repetitive parts of their work and are in turn enthused with the significant contribution they make in an automated document. Sponsors/pharmaceutical companies stand to gain from the enhanced efficiencies and decreased costs.
Approaches to Automation and AI in Medical Writing
Automation can be implemented in several ways. One approach involves integrating data directly into documents from sources (data integration), often through collaboration with statistical programming. For instance, automating patient narratives allows a medical writer to work with a programmer to quickly customize and generate hundreds of narratives in a few minutes. This method reduces development time, eliminates the need for manual quality checks, minimizes human error, and ensures consistency across the package.
Additionally, automation can be done using Artificial Intelligence (AI) and Machine learning (ML) capabilities. Next-generation technologies like Natural Language Processing (NLP) and Natural Language Generation (NLG) may play a critical role moving forward in advancing regulatory medical writing through text mining, processing, and generation. AI and ML can assist in publication writing through methods like extractive summarization and hybrid techniques or by generating downstream documents from precursor documents, such as clinical study reports, summaries of safety and efficacy, and other components of marketing authorization applications
Efficient Writing Techniques for Regulatory Submissions
In tandem with automation technology, focusing on efficient writing techniques is essential. Medical writing is both an art and a science. It’s important not only to ensure that the text flows well, is coherent, and consistent, but also to consider the reader’s needs. For regulatory submissions, which focus on communicating science factually, the presentation should cater to the left side of the brain—where information is processed for practical use. This means using a modular structure, concise vocabulary, and incorporating graphics to ensure quick comprehension and accuracy of information.
In contrast, more emotionally engaging writing—appealing to the right side of the brain—employs narrative styles, varied vocabulary, and diverse sentence structures. While this approach is effective for engaging readers, it is less relevant for regulatory documents.
Health Authorities value submissions that are clear, consistent, and well-structured, which aligns with the left-brain approach. They appreciate consistency in messaging and straightforward communication, which ultimately improves the review process.
The Role of Structured Authoring and Lean Writing
As medical writing continues to evolve, embracing trends such as structured authoring and lean writing becomes increasingly important. The foundation of any submission package is the document itself. To ensure faster and more efficient submissions, it is essential to adopt a style that is both reader-friendly and compatible with IT systems. Structured authoring offers a robust framework for achieving these goals by integrating best practices that enhance both the quality and efficiency of medical writing.
Key practices in structured authoring include:
- Considering the audience when writing
- Ensuring reader-friendliness through logical structure and layout
- Utilizing the inverted triangle approach (placing the most important information at the top)
- Keeping content short and simple (KISS)
- Using plain language and short sentences
- Employing cross-referencing instead of repetition
Structured authoring also emphasizes component authoring principles such as:
- Chunking: Grouping related information and breaking content into small, digestible pieces, each with a single idea
- Relevance: Moving or deleting unrelated content within chunks
- Titling: Assigning meaningful titles to each chunk
- Consistency: Maintaining consistent terms, structures, sequences, formats, and organization throughout the document
These principles facilitate the efficient storage and retrieval of information chunks, allowing IT systems to replicate content across all the various documents of a submission package without manual intervention, thus reducing the risk of human error. If updates are needed, they can be made easily across all affected documents.
Lean writing is another growing trend, driven by the need for clarity and simplicity. Health Authorities require that information be easily accessible to streamline the review process. Hence, lengthy paragraphs and excessive detail are being replaced with more focused, succinct writing that adheres to best practices in medical writing.
Looking Ahead: The Future of Automation in Medical Writing
As automation continues to evolve, medical writing will increasingly leverage technology. Current challenges include ensuring transparency in AI, maintaining patient confidentiality, and managing the need for extensive training sets and models. These challenges are expected to improve over time as global efforts to address them progress. Today’s medical writers who adapt to technological advancements and evolving trends like lean and structured authoring will be well-positioned for a brighter future.
To hear more on this topic, view our recent webinar, “The Changing Paradigm of Regulatory Submissions: Embracing Automation, Gen AI, and Innovation for Faster Approvals”. If you are interested in learning about the use of storyboarding in regulatory submissions, check out this blog, “Strengthen Your Regulatory Submissions Through Strategic Storyboarding”.
At Allucent, we are committed to staying at the forefront of industry trends. We strive to deliver high-quality, efficient, and effective submissions through smart use of automation and best practices in medical writing. Our end-to-end solutions ensure submission-ready documents, helping biotechnology companies enhance quality while reducing time, effort, and cost.
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