Cancer therapy can be divided into four stages:
Tumor stage drug treatment (1) I clinical trial is a preliminary clinical pharmacology and human safety evaluation tests. Including human tolerance test and pharmacokinetic trials, provide the basis for the administration of the program. I clinical trial of a typical human body pharmacology test.
Tumor stage drug treatment (2) clinical trial of efficacy and safety of new drugs the initial evaluation, and Phase II clinical trials for the recommended clinical dose. Typical phase clinical trial is to explore the test.
Tumor stage drug treatment (3) clinical trial is to further evaluate the efficacy and safety of new drugs, is to expand the multi-center clinical trial. Typical clinical trials is to verify that test. Phase clinical trials in the analysis based on data obtained, clinical trials should be verified on the target indication and the population of drug is safe, effective, and risk assessment for the benefit and drug approved for marketing to provide sufficient basis for drug use while writing provide a complete description of the information. Phase III clinical trials for this study can be related to dose. Effect relationship, a wider range of people, different stages of the disease, or combination therapy, long-term drug use research.
Tumor stage drug treatment (4) clinical trial of post-marketing surveillance of new drugs, is widely used in clinical test under the conditions of efficacy and adverse reactions, special attention should be found in the rare adverse reactions. clinical trials are usually for the rationalization of drug use has a positive effect. clinical trial may include safety studies, drug interaction studies, epidemiological studies. Should be noted that Au should be allowed clinical trials to market within the permitted indications.
The staging for the drug treatment trial stage under the premise of protecting the safety of new drug research and development step by step is very important. However, the clinical stage of drug treatment in clinical research process in different types of research purposes and sometimes may not necessarily be limited to "corresponding" sequence of time stages of clinical trials such as the pharmacokinetics of the test, sometimes in order to test the depth of the answer as raised new issues, need to , trial at the same time or even continue. As background to apply for registration of drugs, different levels of maturity, a drug for which application for listing of required clinical trials, should be implemented in accordance with the provisions of the relevant regulations.