| Autor: |
Song YY; Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China., Tang L; Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China., Xia L; Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China., Hao RM; Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China., Yang ZM; Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China. |
| Abstrakt: |
The prolongation of patient's overall survival is the accepted as gold standard to prove clinical values of anti-cancer drugs. However, if overall survival is taken as the primary endpoint in clinical trials for cancer types with a relatively good prognosis in the process of new anti-cancer drug research and development, the time to market the drugs will be prolonged due to the long follow-up time. In addition, overall survival is often interfered by confounding factors such as follow-up treatment. Therefore, regulatory agencies have established an accelerated review model using surrogate endpoints for the approval of new anti-cancer drugs, but there are still some problems in the use of surrogate endpoints in cancer clinical trials. From the perspective of new drug review, the authors expounds the key points of confirming and rationally using surrogate endpoints in clinical trials of anti-cancer drugs, which will improve the level of clinical trials of new anti-cancer drugs and accelerate the development of anti-tumor drugs. |
