In Japan, it is quite rare for an investigator to submit an investigational new drug application to initiate a clinical trial and obtain approval of a drug on the basis of clinical trial results. This means that development of new therapies is currently driven almost entirely by pharmaceutical companies as opposed to independent investigators. Here, we provide our perspective on the reasons for this situation and advocate investigator-initiated cancer drug development as a means of increasing access to better therapies for Japanese cancer patients.
- Chiyo K. Imamura
- Naoko Takebe
- Naoto T. Ueno
