Creation of Scientific Response Documents for Addressing Product Medical Information Inquiries: Mixed Method Approach...

Pharmaceutical manufacturers address health care professionals' information needs through scientific response documents (SRDs), offering evidence-based answers to medication and disease state questions. Medical information departments, staffed by medical experts, develop SRDs that provide concise summaries consisting of relevant background information, search strategies, clinical data, and balanced references. With an escalating demand for SRDs and the increasing complexity of therapies, medical information departments are exploring advanced technologies and artificial intelligence (AI) tools like large language models (LLMs) to streamline content development. While AI and LLMs show promise in generating draft responses, a synergistic approach combining an LLM with traditional machine learning classifiers in a series of human-supervised and -curated steps could help address limitations, including hallucinations. This will ensure accuracy, context, traceability, and accountability in the development of the concise clinical data summaries of an SRD.

This study aims to quantify the challenges of SRD development and develop a framework exploring the feasibility and value addition of integrating AI capabilities in the process of creating concise summaries for an SRD.

To measure the challenges in SRD development, a survey was conducted by phactMI, a nonprofit consortium of medical information leaders in the pharmaceutical industry, assessing aspects of SRD creation among its member companies. The survey collected data on the time and tediousness of various activities related to SRD development. Another working group, consisting of medical information professionals and data scientists, used AI to aid SRD authoring, focusing on data extraction and abstraction. They used logistic regression on semantic embedding features to train classification models and transformer-based summarization pipelines to generate concise summaries.

Of the 33 companies surveyed, 64% (21/33) opened the survey, and 76% (16/21) of those responded. On average, medical information departments generate 614 new documents and update 1352 documents each year. Respondents considered paraphrasing scientific articles to be the most tedious and time-intensive task. In the project's second phase, sentence classification models showed the ability to accurately distinguish target categories with receiver operating characteristic scores ranging from 0.67 to 0.85 (all P<.001), allowing for accurate data extraction. For data abstraction, the comparison of the bilingual evaluation understudy (BLEU) score and semantic similarity in the paraphrased texts yielded different results among reviewers, with each preferring different trade-offs between these metrics.

This study establishes a framework for integrating LLM and machine learning into SRD development, supported by a pharmaceutical company survey emphasizing the challenges of paraphrasing content. While machine learning models show potential for section identification and content usability assessment in data extraction and abstraction, further optimization and research are essential before full-scale industry implementation. The working group's insights guide an AI-driven content analysis; address limitations; and advance efficient, precise, and responsive frameworks to assist with pharmaceutical SRD development.