[Career Path in Primary Investigators for Clinical Trials]

The final goal of clinical studies performed by physician-scientists includes the identification of novel therapeutic candidate drugs (seeds), clinical trials, and overcoming of diseases that improves patients' outcome and quality of life. To achieve this, dense intention of the development of novel treatments, and a long-term vision from the seeds to the approval of the drugs, via clinical trials, are required for primary investigators (PI). This review article explains the process from the seed development to drug approval, based on the author's experience on investigator-led clinical trials.