AutoMW: Model-based Automated Medical Writing

Medical Writing is an art of writing scientific documents which includes regulatory and research-related content. To obtain approval for marketing new medicines, pharmaceutical companies are obligated to provide drug authorities with a huge volume of documents related to clinical trials. Creating these clinical trial documents is a time, effort, and skill-intensive process as the required information exists in fragmented form distributed across various information sources. To overcome these challenges in medical writing, we propose Automated Medical Writing tool (AutoMW). AutoMW enables the digitalization of information from different sources of information using a meta-model-based approach and leverages these models for the automated generation of clinical trial documents as per the regulatory authority document templates. This paper describes the approach and illustrates its utility and efficacy in real-world clinical trial application of two use cases - breast cancer, and diabetes.