Chugai Pharmaceutical Co., Ltd. and NTT DATA Corporation have conducted a demonstration test of a solution for improving the efficiency of clinical trial-related document preparation using AI technology from January to June, 2020.
Clinical trial operations require the creation of a variety of documents and procedures from planning to implementation and application for drug approval. NTT DATA has been developing a solution based on the concept of improving the process efficiency of documentation, for example, by automatically creating clinical trial-related documents from a clinical trial protocol1). In this demonstration, Chugai and NTT DATA are collaborating by conducting concept verification, evaluating the usefulness of this solution and identifying future system issues.
Based on the results of this demonstration, NTT DATA aims to provide commercial services of this solution in FY2021. Furthermore, based on the cooperative relationship between the two companies obtained through this demonstration, we will collaborate and accelerate our efforts toward digital transformation of clinical development operations
New drug development is a process that involves research, collection and analysis of clinical data in clinical trials, and evaluation of efficacy and safety. It usually takes about 9 to 17 years on average to launch a new drug2). Both pharmaceutical companies and medical institutions participating in clinical studies have expended so much effort to ensure the quality of clinical trial activities and data. In addition, efficient development of high-quality clinical trial-related documents is a common challenge among pharmaceutical companies.
NTT DATA is developing a cross-pharmaceutical company/clinical site total solution platform for clinical trials to connect a wide range of clinical trial processes through the most advanced IT technology to help accelerate new drug development.
Under the goal of optimization of all value chains, one of the basic strategies of CHUGAI DIGITAL VISION 20303), Chugai aims at further acceleration of clinical trial processes. Chugai supports NTT DATA’s initiative and conducted the demonstration test jointly with NTT DATA to develop a new solution using AI technology, leveraging Chugai’s extensive experience.
The solution, as one of total solution platforms for clinical trials, allow sequential and comprehensive generation of various clinical trial-related documents (such as informed consent form for patients, statistical analysis plan, case report form to enter patients’ clinical trial data, and clinical study report summarizing the clinical trial results), using data from the protocol as input information, through AI technology, as well as technology components such as ontology4) and semantics5).