Current situation and challenge of registry in China

Abstract

Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and irregularity of registries limit their applicability. This article aims to describe the status of registries in China and the related challenges. Patient registries for observational studies were retrieved from the International Clinical Trials Registry to quantitatively evaluate the number of comparatively high-quality registries in China. A literature search was also performed to provide support and updates. A total of 64 patient registries were retrieved from ClinicalTrials.gov using disease, product, and health service as criteria. The sample sizes ranged from 15 to 30 400, with only 12 registries marked as completed. This article describes and compares the detailed information in many aspects. The efficient use of registries has already made considerable progress in China; however, registries still require standardization, high-quality transition, and coordinated development.

Keywords

Chinese / registry study / patient registries / observational study

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Acknowledgements

We are grateful to all the authors whose hard work made this study possible. Special thanks to Ms. Xiaoxiao Li, who helped us classify the drugs and the devices.

Compliance with ethic guidelines

Yang Zhang, Yuji Feng, Zhi Qu, Yali Qi, and Siyan Zhan declare that they have no conflict of interest. This manuscript is a review article and does not involve a research protocol requiring approval from relevant institutional review boards or ethics committees.

RIGHTS & PERMISSIONS

2014 Higher Education Press and Springer-Verlag Berlin Heidelberg