Harnessing Gen AI for Clinical Protocol Authoring

By dev | April 8, 2025

Learn how Faro Health is leveraging the company’s industry-leading Study Designer and the latest in generative AI technology to accelerate the process of writing clinical protocol documents. 

The challenge with clinical drug trial development: Eroom’s Law

Over the past 60 or more years, the pace of innovation in technology has tended to continually increase – computers get faster and chips get smaller, roughly adhering to the well-known concept of Moore’s Law. But despite significant advances in technology, in the biopharma industry, the cost and time to develop new drugs has only increased with time. This observation led to the creation of the term “Eroom’s Law” (Moore’s Law, spelled backwards), coined by Dr. Jack Scannell and colleagues in 2012 in Nature Reviews Drug Discovery, which estimates that the inflation-adjusted cost of developing a new drug roughly doubles every nine years. A study conducted in 2020 to estimate the true cost of drug development found that the median R&D spend required to bring a new drug to market between 2009-2018 was $1.1B. 

The AI revolution

So, what can be done to change this trend? While the factors that contribute to these skyrocketing costs are numerous, many in the industry believe that the significant advances in AI technology in the last few years offer a real opportunity to finally increase efficiency in the drug development process. One potential application of AI to clinical development is the use of large language models (LLMs) to speed up the often-laborious process of medical writing. 

While a lot of the excitement around AI recently could be described as “hype”, as we have crested the peak of the hype cycle and begun applying AI technology to real scenarios, we are starting to better understand both the value and limitations of currently available LLMs. At Faro Health, our team has put a substantial amount of work into understanding and mitigating the common pitfalls of LLMs today. This has resulted in a remarkably powerful AI based authoring system that can significantly shorten the time to author the first draft of clinical protocols designed and structured in Faro’s Study Designer. 

Faro’s Approach to Generative AI for Protocol Writing 

As anyone who has been paying attention to or using LLMs like ChatGPT knows, they’re great at generating a large amount of text in a very short period of time, but are prone to issues like “hallucination” when it doesn’t know an answer – making up answers that sound real, but are not. LLMs can also be biased in how they respond, due to inherent biases present in their training data, and no matter how good they are, they aren’t a substitute for an actual clinical professional. Given these considerations, Faro has developed a unique approach to generating clinical documentation that enables users to get all of the upsides of LLMs, while reducing or eliminating the downsides.

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