Developing design, implementation and reporting guidelines for multi-center clinical trials is imperative
1. Peking University First Hospital, Beijing, 100034, P.R.China
2. Peking University Clinical Research Institute, Beijing, 100191, P.R.China
3. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, 999077, P.R.China
With the encouragement of national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common at present than before. However, it should be recognized there still exists shortcomings in current multi-center trials. In this paper, we summarize the problems and challenges and provide corresponding resolutions with the aim to reduce heterogeneity between study centers and avoid excessive center effects in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.
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