Developing design, implementation and reporting guidelines for multi-center clinical trials is imperative_Chinese Journal of Evidence-Based Medicine

Authors：

DONG Chongya ¹ , YAN Xiaoyan ² , YAO Liang ³ ,  BIAN Zhaoxiang ³ ,  YAO Chen ^1,2

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;

Corresponding author：

BIAN Zhaoxiang, Email: bianzxiang@gmail.com; YAO Chen, Email: yaochen@hsc.pku.edu.cn

Keywords：

Multi-center clinical trial; Design; Implementation; Reporting; Guideline

DOI：

10.7507/1672-2531.201801072

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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.

Citation： DONG Chongya, YAN Xiaoyan, YAO Liang, BIAN Zhaoxiang, YAO Chen. Developing design, implementation and reporting guidelines for multi-center clinical trials is imperative. Chinese Journal of Evidence-Based Medicine, 2018, 18(7): 654-656. doi: 10.7507/1672-2531.201801072 Copy

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6. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340(7748): 698-702.

Chinese Journal of Evidence-Based Medicine

Developing design, implementation and reporting guidelines for multi-center clinical trials is imperative

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