Quality control of large scale clinical trials / 中国临床药理学与治疗学

ABSTRACT

In the recent 2 decades,the clinical medical mode has been changed greatly.The experience-based medical mode is gradually replaced by evidence-based mode,ie,evidence-based medicine.Large scale clinical trials provide robust evidence for clinical practice and quality control is critical for the success of one trial.We discuss six facets on this subject,including protocol design,staff training,manual formulating,organization,data management and monitoring.The objective of quality control is to ensure the study conducted according to the protocol,the results are reliable and protect the human rights of participants.