Current problems and improvement suggestions in blinding of drug clinical trials
Blinding is an important segment of drug clinical trials,which can directly affect the quality of clinical trial.The current problems of blinding are as follows:Responsibilities clearly of all participants but lack of supervision;due to lack of training,there is a significant difference in the abilities and experiences of the participants.There is a high risk of blinding failure cause of the quality of placebo preparation varies.The on-site operation of blinding is not standardized,which seriously affects the quality and efficiency of work.Based on the above issues,suggestions include:Clarifying regulatory authorities and increasing regulatory efforts,strengthening the sense of responsibility and attaching importance to the attribution of responsibility,clarifing personnel division of labor and strengthening standardized training,improving standard operating procedures(SOP)continuously in order to adapt working needs.The standardization process of the blinding requires peer communication.Supervision and responsibility are important guarantees for the high-quality blinding implementation in clinical trials.
clinical drug trialsblinding implementationblinding workstandard operating procedurestandardized training
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