Perspectives

The Role of AI in Transforming Medical Writing

Technology has always gone hand-in-hand with medical writing in the form of toolbars or tech-enabled templates. In recent years, Artificial intelligence (AI) has become commonplace in many aspects of daily life, and as such, as part of overall life sciences transformation, medical writers need to adapt to using and eventually leveraging these AI tools to improve the writing process. At our recent MMS webinar, ‘Shaping the Future of AI-Enabled Medical Writing,’ our expert panelists Lucy Sutton (Vice President of Account Management, MMS), Teresa Cesena (Executive Director of Regulatory and Medical Writing, MMS), James Newman (Director of Medical Writing, MMS), and Zach Weingarden (Director of AI Technology and Applications, TrialAssure)—shared insights on how AI is transforming medical writing, from automation and pilot implementation to ethical considerations and regulatory readiness. This blog summarizes the key takeaways from that discussion, including current uses, benefits, challenges, and what’s next for AI in medical writing.

Current Use and Importance of AI in Medical Writing

AI tools can be used in many ways in medical writing, including analyzing data, generating drafts, and supporting compliance, helping writers prepare regulatory documents more efficiently. At MMS, medical writers already use a number of AI tools including Datacise® which extracts and summarizes large data sets, AI-assisted authoring tools that can draft specific document types, e.g., plain-language summaries, and Copilot, Microsoft’s AI interface that uses ChatGPT.

As well as boosting efficiency by generating time savings in the regulatory document life cycle, AI can also be used for data validation and the identification of discrepancies, missing data, or inconsistencies across complex reports and submissions. These capabilities can save medical writers’ time and improve accuracy and consistency, which are vital in today’s speed-driven clinical trials environment.

Advantages and Challenges of AI in Medical Writing

During the webinar, our speakers discussed the advantages, challenges, and barriers of using AI within medical writing. While AI tools can be used to increase efficiency when drafting specific document types, all speakers agreed that despite technology advances, the role of the medical writer would not be replaced. A human review of the AI-generated document is still very much needed to ensure the accuracy of the data reported, alignment with industry standards and guidelines, as well as the readability of the final document, and AI is not yet ready to perform the nuanced work that medical writers do. The most common concern discussed by the panel is ensuring data compliance and data security. This insight was reflected by the results of our webinar live poll with the audience of biotech, pharma, and CRO attendees– you can read the results of these here.

AI tools require access to sensitive clinical and patient data, and companies that use AI tools need to comply with complex regulatory frameworks like GDPR and HIPAA, ensuring that AI tools meet enterprise-grade security standards. Additionally, regulatory bodies are developing guidelines about AI tools which will require complete transparency concerning security and audit history. For example, recent FDA draft guidance can be found here.

AI Pilot Projects: Best Practices

In today’s fast-changing landscape, it’s essential to equip people with the training and skills needed to use emerging technologies effectively. Medical writers will need to be well versed in using a range of AI tools. This knowledge will include a clear understanding of what your tools are going to be used for, what each tool does, and how those tools integrate. At MMS, our teams are gaining experience in the use of AI through well-structured pilots. As well as helping the writer develop new capabilities, pilot projects are an instrumental tool in furthering innovation and ensuring that practical solutions are put in place which deliver productivity outcomes.

A successful pilot requires careful planning to include two key components. First, selecting the right document—with defined tags, prompts, and source materials—to generate the final document. Second, ensuring medical writers are trained on both the document type and the AI tool before the pilot begins, as they will serve as testers directly engaging with the tool. Another key element is identifying specific metrics that will be tested during the pilot, for example, time saved using the tools compared to manual effort, or the accuracy of the AI tool. Finally, a subject matter expert (SME) – independent of the testers – is needed to review the AI-generated documents to verify accuracy and alignment with industry standards.

What’s Next for AI in Medical Writing?

AI tools are now able to generate the first drafts of various documents, for example, the first draft of a clinical study report (CSR) which can significantly reduce the drafting time by about 50%. This enables medical writers to have a starting point in a CSR instead of a blank document, affording writers more time to apply their scientific judgment, regulatory expertise, and contextual understanding to refine a well-structured AI generated draft ensuring a clear message that is accurate and compliant. As Zach Weingarden, Director of AI Technology and Applications for TrialAssure, said during the webinar, ‘AI can now take on the task of generating that first draft of content for documents like clinical study reports… what used to take days or weeks can now happen in minutes. But this doesn’t eliminate the medical writer. In fact, it elevates their role.”

Additionally, AI tools can help foster a collaborative environment across distinct roles. For example, if the programming team updates a data set, these changes can automatically flow into the draft CSR, and the medical writer will not need to manually update or double check tables. More time can be spent on the interpretation of data where human expertise matters more.

Conclusion

While AI is becoming more common in the medical writing world, medical writers are still heavily involved in making final decisions about regulatory documents. This includes ensuring that the AI-generated document presents information correctly and in compliance with regulatory requirements, while ensuring that patient privacy and security are kept safe and secure. Embracing AI means empowering medical writers to focus on higher-value tasks—applying technology to drive innovation, accuracy, and efficiency across the pharma industry.

For more information on how MMS is using AI to advance innovation and efficiency in the biotech and pharma space check out the insights below:

If you missed the webinar, Shaping the Future of AI-Enabled Medical Writing, you can catch up on the replay here: https://mmsholdings.com/webinars/ai-medical-writing-webinar/