The Use of AI/ChatGPT in the Preparation of Aggregate Safety Reports & Signal Management Activities

In the highly regulated environment of PV, the implementation of artificial intelligence (AI) in safety writing is not just an idea for the future-it is a reality that is inevitably going to transform the field. Associate Director of UBC Global Safety Writing, Laurent Vidal and UBC Safety Scientist, Christopher Henry recently explored the current AI landscape, aiming to encapsulate the fundamental shifts driving this PV work transformation.

It is first important to understand the capabilities of AI, a technology that simulates human intelligence, offering solutions to complex problems. The use of AI in safety writing takes on two distinct forms: analytical, which delves into the vast sea of literature and safety data to extract pertinent information and safety trends, and generative, which crafts narratives and figures to populate reports and to support safety analyses.

The true power of AI shines when it simplifies the intricate web of standard operating procedures (SOPs) and internal processes. It is like having a digital companion who ensures that every step we take in our daily work is in line with the highest standards of compliance. Functioning like a skilled detective piecing together a puzzle to reveal a clearer picture of safety procedures, our digital companion can walk us through the overlaps, conflicts, and gaps of our SOPs.

However, AI's role does not stop there. It dives deeper into safety data, analyzing safety trends with a lens that considers demographics such as gender, age, and ethnicity. This is not just about numbers; it is about understanding the human element behind the data, ensuring that the central focus of the analysis remains the safety of patients.

The real-world applications of AI in safety writing are as diverse as they are impressive. From scraping websites for safety-relevant information to comparing document versions to highlight updates, AI assists in real-time, ensuring that safety reports are as current as they are accurate. Our digital companion is always on the lookout for the latest information that could impact patient safety.

Yet, some limitations must be considered. The concerns surrounding data confidentiality and the consistency of analysis methods are not taken lightly. It is critical that AI users receive adequate training to manage and preserve data confidentiality while maintaining consistent data analysis when using an AI tool. Human accountability is crucial. AI may support human judgment, but it cannot replace the critical eye of safety scientists who make the final call on safety recommendations. The collaboration between AI and human expertise is not just beneficial-it is essential. Together, they create a synergy that elevates safety writing to new heights, ensuring that patient safety remains the cornerstone of PV.

At UBC, we share a vision where AI and safety writing come together to forge a safer path toward a more informed future. It is a narrative that is not just about technology, but about the promise it holds for enhancing the lives of patients around the world.

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ABOUT UBC: United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Our combined scientific expertise in pharmacovigilance, risk management, and signal detection and assessment, underpinned by innovative technologies, offer our customers flexible solutions generating the relevant insights necessary to make informed decisions earlier, meet stakeholder requirements, and ensure the safety of products.

ABOUT THE AUTHORS:

Laurent Vidal, PhD, Associate Director, Global Safety Writing, Pharmacovigilance

Dr. Vidal joined UBC in 2010 as a member of the Global Safety Writing team. Dr. Vidal oversees and coordinates the preparation of aggregate periodic safety reports, such as PBRERs, DSURs and PADERS, as well as the conduct of safety signal management activities for pharmaceutical products that are already on the market and/or still under clinical development.

Christopher Henry, PhD, Safety Scientist, Global Safety Writing, Pharmacovigilance

Dr. Henry joined UBC in 2022 as a member of the Global Safety Writing team. Dr. Henry authors periodic safety reports such as DSURs, PBRERs, PADERs, and signal detection activities for both products on the market and/or still under clinical development. His IT skills allowed him to lead the automation and artificial intelligence development within the UBC pharmacovigilance department.

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