Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines

Table 1

Main objectives of each stage of testing in human subjects in the process of evaluating new drugs, surgical procedures, or diagnostic methods of Western medicine.

	Phase I	Phase II	Phase III	Phase IV
Drugs	(1) Assessment of acute side effects; (2) Investigation on metabolic and pharmacological profiles	Pilot efficacy evaluation	Confirmation of efficacy	Surveillance on rare chronic harms and effectiveness in practical settings
Surgical procedures	(1) Safety assessment (mainly operational complications); (2) Feasibility assessment	Pilot efficacy evaluation	Confirmation of efficacy	Surveillance on chronic safety and long term effectiveness in practical settings
Diagnostic methods	Determination of normal range and initial diagnostic cutoff point	Evaluation of specificity and sensitivity	Evaluation of clinical consequences after introducing the test	Surveillance on long term clinical consequences in practical settings