Clinical Trial Report


(1) Categories of illnesses subject to test; total number of cases; gender, age and analysis by grouping of patients; establishment of a control group (when necessary);
(2) Clinical trial methods;
(3) Statistical method and evaluation method in use;
(4) Clinical evaluation standards;
(5) Clinical trial results;
(6) Clinical trial conclusion;
(7) Adverse event and side effect during the clinical trials and treatment measures
(8) Analysis of clinical trials effects.
(9) Indications, scope of application, contradictions and precautions.
(10) Existing problems and suggestions for improvement.

A medical device applicant should pay attention to the following aspects related to a clinical trial report.
1) The gap between the completion date of the type test and the starting date for the clinical trials should not be larger
than that stipulated by the SFDA - half of a year when the clinical trial is needed and one year when the clinical trial is unnecessary.
2) Usually a contrasting group is mandatory in clinical trials unless there are recognized clinical indicators.
3) The number of patients recruited in the clinical trials must be based on certain documents, for example, the data on the efficacy of a trial.
4) Experienced experts should be invited to confirm the indicators of safety and efficacy of the product in the trial.
5) It is better to not use complicated statistical methods, and simple methods which can also be used repeatedly are encouraged.