Digital Applications in Clinical Trials

EffPha’s President and CEO, Dr. Frank Shen was invited by Taiwan Research-based Biopharmaceutical Manufacturers Association (TRPMA) to give another speech on Apr 10, 2023 with the topic of Digital Applications in Clinical Trials, which continued Dr. Frank Shen’s previous two speeches discussing the topics of Digital Applications in Clinical Trials and Decentralized Clinical Trial (DCT) at TRPMA.

This speech has attracted many TFDA drug reviewers, and the experts who are concerned about the development of new drugs, clinical trials, and the regulations of the development of digital clinical trials to join and discuss.

The COVID-19 pandemic has brought changes, including the innovation of digital technologies, which is driving digital transformation in Life Sciences and Health Care, and shaping a new era for clinical trials. TFDA published the “Draft Guidance on Use of Decentralized Measures in Clinical Trial of Drugs” in January, 2023. The Prescription Drug User Fee Act VII (PDUFA VII) has recently requested US FDA to establish a framework for the use of digital health technologies in drug development in order to accelerate drug development and new drug launch.

With the support of the adoption of decentralized clinical trial by industry and the relevant regulations proactively developed by health authorities, the applications of technologies relating to decentralized clinical trial is increasing. Patient-centric clinical trials not only offer the trial subjects convenience but also reduce the costs and time spent on trials for pharmaceutical industry. Therefore, decentralized clinical trials have become the future trend.

In order to let the audience know the applications of digital technologies in various aspects of clinical trials, Dr. Frank Shen illustrated the points from clinical trial design to clinical platform for data collection and development of remote monitoring with data acquisition devices. In addition, Dr. Frank Shen shared how to apply digital technologies to find opportunities for speeding up clinical trials process in drug development as well as the potential applications of predictive analytics and real-world data in clinical trials. Dr. Frank Shen emphasized the functions of digitization lie in an increase in efficiency and data quality in this speech. While offering the trial subjects convenience, the safety of subjects shall also be considered to hopefully reach the goal of a win-win for patient centricity and success in clinical trials.