(Form 1-2) R&D Proposal English part (Research purpose, plan and methods) Project Promoting Clinical Trials for Development of New Drugs Research purpose Background Research regarding the creation of protocols for clinical trials/investigator-initiated 1 clinical trials aimed at drug development (Step 1) Research regarding the conduct Specified clinical trials of clinical Investigator-initiated clinical trials clinical trials aimed at [Drugs with new active ingredients] 2 drug development according to Investigator-initiated clinical trials already created protocols (or with new indications etc.] Title of grant program protocol synopsis) (Step 2) Research regarding the creation of protocol Research aimed at practical concept for clinical trials/investigator-initiated application of drugs using the clinical trials using the patient registry (Step 1) 3 disease registration system Research regarding the conduct of clinical (patient registry) trials/investigator-initiated clinical trials using the patient registry (Step 2) Title of proposed R&D project Name of R&D Principal Investigator Affiliated institution and position of R&D Principal Investigator R&D period (planned) / (for years) R&D costs FY2019: Yen FY2020: Yen FY2021: Yen FY2022: Yen
(Form 1-2) R&D Proposal English part (Research purpose, plan and methods) Project Promoting Clinical Trials for Development of New Drugs Title of grant program 1 Research regarding the creation of protocols for clinical trials/investigator-initiated clinical trials aimed at drug development (Step 1) 2 Research regarding the conduct of clinical clinical trials aimed at drug development according to already created protocols (or protocol synopsis) (Step 2) Specified clinical trials Investigator-initiated clinical trials [Drugs with new active ingredients] Investigator-initiated clinical trials with new indications etc.] 3 Research aimed at practical application of drugs using the disease registration system (patient registry) Research regarding the creation of protocol concept for clinical trials/investigator-initiated clinical trials using the patient registry (Step 1) Research regarding the conduct of clinical trials/investigator-initiated clinical trials using the patient registry (Step 2) Title of proposed R&D project Name of R&D Principal Investigator Affiliated institution and position of R&D Principal Investigator R&D period (planned) / (for years) R&D costs FY2019: Yen FY2020: Yen FY2021: Yen FY2022: Yen Research purpose Background