1.Introduction Phase Ⅱ trials are typically designed to identify promising treatment therapies that warrant further investigation in subsequent phase Ⅲ con-firmatory trials,playing a vital role in evidence generatio...1.Introduction Phase Ⅱ trials are typically designed to identify promising treatment therapies that warrant further investigation in subsequent phase Ⅲ con-firmatory trials,playing a vital role in evidence generation of drug de-velopment.The basic design features of phase II trials include interim go/no-go decisions to prevent exposing too many patients to poten-tially ineffective treatments.Appropriate go/no-go decisions and effi-cient trial designs can shorten the research duration and increase trial success rates.展开更多
基金funded by Beijing Nova Program(grant number:20230484277)National Natural Science Foundation of China(grant number:82303955).
文摘1.Introduction Phase Ⅱ trials are typically designed to identify promising treatment therapies that warrant further investigation in subsequent phase Ⅲ con-firmatory trials,playing a vital role in evidence generation of drug de-velopment.The basic design features of phase II trials include interim go/no-go decisions to prevent exposing too many patients to poten-tially ineffective treatments.Appropriate go/no-go decisions and effi-cient trial designs can shorten the research duration and increase trial success rates.
