Considerations to develop agile and flexible clinical trial capabilities in Japan
In Japan, a typical drug approval filing strategy can result in a significant time lag between the initial approval of the new drug outside of Japan and the subsequent approval of the drug inside Japan.
Recently, companies have looked to strategies to include Japan directly in initial global clinical trials. These allows Japan earlier drug approval and may reduce the required number of patients to gain approval in Japan. However, Japan faces several cultural and economic challenges that make it difficult to manage a fixed workforce against a variable portfolio of clinical research.
This paper presents a unique approach to evolve the traditional local clinical development model in Japan, while lowering costs, improving productivity, and potentially accelerating drug approval timelines. Get insights on: