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Therapeutic Research
Abstract
Objectives: In April 2020, a clinical trial of a novel Covid–19 vaccine candidate developed by Sichuan University started in Japan. The aim of this paper is to present our experiences in launching the clinical trial as an academic research organization( ARO). Methods: Various issues occurred in launching the clinical trial. We retrospectively extracted the critical and rate–limiting issues, and summarized countermeasures taken for each issue and the results. Results: Four issues were extracted as follows; 1) language barrier, 2) regulatory requirements, 3) required standards for the study protocol and the investigator’s brochure, and export process for investigational products, and 4) business practices. The language barrier and the difference in business practices were resolved owing to cooperation with local partners who were fluent in Japanese through close and timely communication. China has been a position to participate in global drug–regulation since joining the ICH(The International Council for Harmonisation) in 2017. However, the consensus of interpretation and application of technical guidelines between Japan and China was not sufficient. Therefore, we first presented difference of requirements between Japan and China GxPs(Good x Practice) to PMDA, and subsequently explained the scientific validity of individual study data created in China based on the China GxPs in detail. Conclusions: We successfully contributed to the launching of the clinical trial of the Covid–19 vaccine candidate developed by a foreign academic institute. Accumulated knowledge and professional experience in medical and regulatory science, product manufacturing, and project management in our ARO may be a key factor for overcoming various hurdles in the global pharmaceutical development.
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