Decentralized Clinical Trial with Integration in Mind (CDE)

EffPha’s President and CEO, Dr. Frank Shen was invited by Division of New Drugs in Center for Drug Evaluation (CDE) to give a speech at the Clinical Trials Center Collaborative Platform Meeting on Aug 1, 2023 with the topic of Decentralized Clinical Trial (DCT) with Integration in Mind, in order to promote decentralized clinical trials.

This speech has attracted many officials of Taiwan Ministry of Health and Welfare (MOHW), investigators and study staff of clinical trial centers across Taiwan to join and discuss.

Following the development in the post-pandemic era, the operation of decentralized clinical trials for pharmaceuticals continues to grow worldwide. To align with the global trends in clinical trial development and improve the environment for running clinical trials in Taiwan, while ensuring the rights, safety, and well-being of trial participants, as well as the credibility and confidentiality of clinical trial data, TFDA announced the "Draft Guidance on Implementation of Decentralized Clinical Trials for Pharmaceuticals" in January, 2023. This action aims to enable clinical trials in Taiwan to gradually adapt to this new global trend, and accelerate innovation in drug development.

Dr. Frank Shen led the audience to learn the development of decentralized clinical trials, illustrating the points of implementation for decentralized clinical trials, and how to use digital technologies and remote monitoring devices in a clear and concise way. This patient-centric clinical trial model allows trial participants to engage in trials in the environments of their daily lives, reducing the needs for physical visits to trial centers. It enhances the convenience of trials, providing trial participants with greater opportunities to take part. Dr. Frank Shen emphasized in this speech that it is essential to ensure the effectiveness and reliability of the trial when conducting decentralized clinical trials. That is, the implementation could be decentralized, but it could not compromise the accuracy and credibility of the trial results.

Dr. Frank Shen mentioned the roles and functions of trial centers will undergo transformation to adapt to this new trial model in decentralized clinical trials. The audience also engaged in discussions to share their clinical practice experiences in the aspect of the application and impact of this emerging trend in clinical trials.