[The design, implementation, supervision and reporting of multi-centered acupunctural clinical trial].
In order to ensure and enhance the level and quality of acupunctural clinical trial, the design, implementation, supervision and reporting of multi-centered acupunctural clinical trial, its concrete methods and main significance, were introduced in this paper by taking the Major State Basic Research Development Program of China("973 Program") and "11th Five-Year Plan Period" National Key Technology Research and Development Program of China supported items for illustration. Besides that attention should be paid to randomization, controlling and blinded methods, the power and the sample size calculation as well as the medical ethics are also important in design. The registration of clinical trials, formulation of the standard operation procedures and training of researchers are the key points in the implementing process. And the emphases in supervision are the establishment and execution of a supervising system, which are the important links for ensuring the quality of research. In addition, the reporting of acupunctural clinical trials should follow the CONSORT (Consolidated Standards for Reporting Trials) statement and the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) recommendations.
College of Acupuncture and Manipulation, Chengdu University of Traditional Chinese Medicine, Chengdu.
Ying
Y
Li
Fan-Rong
FR
Liang
Ling
L
Zhao
D015670:Acupuncture Therapy / Q000379:methods / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*; D012107:Research Design