Clinical Development and Utilization of Real-World Data | Use of Digital Technology

Clinical development is an important research process for verifying the safety and efficacy of new drugs. This process confirms that the drugs are indeed effective and safe for patients. Clinical development is usually divided into the following stages.

Phase I Trial : The safety of the drug is confirmed in a small number of healthy volunteers

Phase II Trial : The efficacy and safety of the drug are confirmed in a small number of patients

Phase III Trial : The efficacy and safety of the drug are confirmed in a large number of patients, and final data is collected

Phase IV Trial : Even after the drug is on the market, insights into its long-term efficacy and safety are obtained

In recent years, there is increased attention on designing clinical studies utilizing medical data known as real-world data. Real-world data includes anonymized treatment histories, prescription histories, and clinical test data from patients at medical institutions. Analyzing these data allows researchers to identify what treatments patients are currently on and provides hints as to which treatments can alleviate patients’ concerns.

Example of Real-World Data Analysis

Real-world data contains records of actual treatments stored as a database. To utilize this information in clinical studies, data visualization by using data science technology is essential for better comprehension. For instance, a flowchart of hepatocellular carcinoma treatment, as shown below, allows the information to be more easily understood. Eisai aims to develop high-quality clinical study designs by combining the results of real-world data analysis with the knowledge and experience of medical professionals.

Sankey diagram showing the treatment flow of hepatocellular carcinoma patients (a diagram that visualizes the flow of processes and data between). The colors represent the types of treatments, and the width of the flows highlights the proportion of patients. TACE: Transarterial Chemoembolization, TAE: Transarterial Embolization, RFA: Radiofrequency Ablation, PEI: Percutaneous Ethanol Injection, HAIC: Hepatic Arterial Infusion Chemotherapy

References

1) Akada et al. Database analysis of patients with hepatocellular carcinoma and treatment flow in early and advanced stages. Pharmacol Res Perspectives. (2019)