Developing design, implementation and reporting guidelines for multi-center clinical trials is imperative
1. The First Hospital, Peking University, Beijing, 100034, P.R.China
2. Clinical Research Institute, Peking University, Beijing, 100191, P.R.China
3. Gansu Provincial Clinical and Evidence-based Medicine Research Institute, Lanzhou, 730000, P.R.China
4. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, 999077, P.R.China
With the encouragement of the 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 now than before. However, we need to recognize that there are still some shortcomings in current multi-center trials. In this article, we summarized the problems and challenges and provided corresponding solutions with the aim to reduce heterogeneity between study centers and avoid excessive center effect 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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