JMIR Publications

ABSTRACT

Background:

The regulatory affairs division in a pharmaceutical establishment is the point of contact between regulatory authorities and pharmaceutical companies. They are delegated to the crucial and strenuous task of extracting and summarizing relevant information in the most meticulous manner from various search systems. An AI-based intelligent search system that can significantly bring down the manual efforts in existing processes of the regulatory affairs department while maintaining/ improving the quality of final outcomes is desirable. We proposed a frequently asked questions (FAQ) component and its utility in an AI-based intelligent search system in this paper. The scenario is furthermore complicated by the lack of publicly available relevant datasets in the regulatory affairs domain to train the machine learning models that can facilitate cognitive search systems for regulatory authorities.

Objective:

This paper aims to use AI-based intelligent computational models to automatically detect similar questions in the regulatory affairs domain and evaluate the RQE system.

Methods:

We used the transfer learning techniques and experimented with transformer-based models pre-trained on corpora collected from different resources, like BERT, Clinical BERT, and BlueBERT. We used a manually labeled dataset that contained 150 question pairs in the pharmaceutical regulatory domain to evaluate our model’s performance.

Results:

The clinical BERT model performs better than other pre-trained BERT-based models in identifying question similarity from the regulatory affairs domain. The BERT model reaches superior performance when fine-tuned with enough clinical domain question pairs. The best model achieves an accuracy of 90.66% on the test set.

Conclusions:

This work demonstrates the possibility of using pre-trained language models to recognize question similarity in the pharmaceutical regulatory domain. Transformer-based models pre-trained on clinical notes give a cut above performance than models pre-trained on biomedical text in recognizing question’s semantic similarity in this domain. We also discuss the challenges of using data augmentation techniques to tackle the issue of lack of relevant data in this domain. Our work is the foundation of further studies that apply state-of-the-art linguistic models to regulatory documents in the pharmaceutical industry.