Embracing Technology Innovation Strategies for Large Language Models in Medical Writing

Discover the value of technology to ensure accuracy, compliance and quality document creation and delivery.

Clinical trials need to move faster. Sponsors need more efficiency. In a world where acceleration is imperative, are artificial intelligence (AI) models like large language models (LLMs) the answer?

PPD™ Functional Service Partnership (FSP) Medical Writing solutions experts explored the potential benefits of LLM tools in clinical and regulatory documentation. Drawing on extensive experience testing, using and advising on various sponsor technologies in our roles as embedded team members, these insights offer valuable perspectives on the role of LLMs in enhancing medical writing processes.

How LLMs can be used effectively to support medical writing

An LLM is a sophisticated machine learning or deep learning model that is used within software applications to recognize and generate text. LLMs are trained on large datasets, and there are several ways medical writers can take advantage of LLMs right now to add efficiency to their work:

• LLMs can help make complex technical text easier for patients to understand. Medical writing can be full of technical text that is not very patient-friendly. LLMs excel at producing clear and accessible prose suitable for a broad audience. This is useful for assisting with patient-centric documentation, such as informed consent forms and lay summaries. Medical writers still need to thoroughly check the output of LLMs to ensure the simplification of the content is accurate.
• LLMs summarize complex documents to help aid with learning. LLMs can help users get up to speed quickly. For example, LLMs can efficiently summarize the content of clinical protocols or Investigator’s Brochures facilitating a more efficient writing process.
• LLMs assist with information extraction. LLMs are a useful tool for extracting dense information contained in white papers or info-rich tables, such as a schedule of assessments. This allows the writer to gain quick context for drafting with speed. However, the medical writer must check that no errors or omissions have occurred.
• LLMs support simple administrative tasks. There are many everyday tasks that LLMs help with, such as preparing meeting minutes. This can free up valuable time for other more critical work.

Challenges and opportunities of LLMs

It is important to note that while LLMs have great value in the writing process, they should not be viewed as standalone tools. LLMs should be used as a starting point and then augmented by the skills of medical writers trained to ensure the documents stand up to regulatory scrutiny.

LLMs are trained using already established content, but clinical research will always consist of new drugs and therapies with a lack of pre-existing written information. With that in mind, there will always be a need for an expert who is up to date on regulations to apply their knowledge to the output and ensure the accuracy of content provided.

In the future we can expect to routinely use specialized LLM agents that are engineered specifically to perform tasks like querying a study protocol, simplifying the schedule of assessments or converting study results into report-ready descriptions. Increasing user adoption will require clear and effective LLM training. Medical writers need to be proficient in using LLMs to perform writing tasks. The quality of the output is directly related to the quality of the interaction with the LLM.

Embracing technology as part of the process in accelerating delivery

With growing pressure to improve efficiency, how can a company choose the right technology among myriad providers? And what does a medical writing team need to look like in the future?

Choose wisely, balancing curiosity with objectivity, to see the holistic value. New technologies continue to emerge, requiring rigorous vetting and careful planning to ensure seamless integration within your technology solution. For example, can your AI choice integrate within structured content authoring tools to further enhance their capabilities?

You should focus on where there is the most value for all your users (content developers and reviewers), and what technology will work best within your processes. No technology exists in a silo; it must seamlessly flow across functions to be effective. You must look at technology as part of a holistic solution to understand where it can add acceleration and efficiency. PPD FSP Medical Writing solutions experts anticipate future writers’ toolkits will integrate technologies like LLMs and structured content authoring, enabling AI-driven insights from structured data. This approach will accelerate document creation, enhance document development efficiency and leverage on cross-document synergies.

Critical skill development. Hire, train and develop your team to have a future-focused mindset, driven by curiosity and enthusiasm for fully utilizing technology. Highly skilled medical writing talent is needed to drive document delivery from inception to completion. Effective project management skills are also vital, focusing on accountability and mitigation of risk, to sustain the momentum gained from technologies like LLMs.

Innovative technology, like LLMs, will continue to evolve. But no matter where the future goes, expert medical writers will be needed to get the most value from such technology to ensure accuracy, compliance and ultimately quality of document delivery and content.

PPD FSP Medical Writing solutions help biopharmaceutical, biotech and medical device organizations translate complex scientific data into clear and compliant scientific statements, delivered through the flexibility of an FSP model. For sponsors who are developing and investing in their own technology, PPD FSP Medical Writing solutions provide expert writers who know how to work with and consult on AI technologies.