Current situation and challenge of registry in China

doi:10.1007/s11684-014-0355-x

Front. Med.

2014, Vol. 8

Issue (3) : 294-299 https://doi.org/10.1007/s11684-014-0355-x

REVIEW

Current situation and challenge of registry in China

Yang Zhang¹, Yuji Feng², Zhi Qu¹, Yali Qi³, Siyan Zhan¹(

)

¹. Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing 100191, China
². Pfizer Investment Co., Ltd., Beijing 100010, China
³. Department of Epidemiology, School of Public Health, Beihua University, Jilin 132001, China

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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

Corresponding Author(s): Siyan Zhan

Online First Date: 02 September 2014 Issue Date: 09 October 2014

Cite this article:

Yang Zhang,Yuji Feng,Zhi Qu, et al. Current situation and challenge of registry in China[J]. Front. Med., 2014, 8(3): 294-299.

URL:

https://academic.hep.com.cn/fmd/EN/10.1007/s11684-014-0355-x
https://academic.hep.com.cn/fmd/EN/Y2014/V8/I3/294

Fig.1 The variation in the number of registries in China from January 2009 to April 2014.

NCT number	Title	Study design	Estimated enrollment	Start date	Completion date	Population	Sponsor
NCT01779310	Clinical pathway for Alzheimer’s disease in China	Case only	1024	Nov. 2012	Apr. 2013	Outpatients with clinically significant cognitive impairment per judgment of the participating physicians	Peking University
NCT02093156	A predictive score identifies patients with inadequate bowel preparation for colonoscopy	Prospective	605	Sep. 2013	Dec. 2013	Patients with digestive diseases from the Endoscopy Center	Fourth Military Medical University
NCT01939613	Colloid improves organs function in resuscitation of extensive burn patients	Case control	47	Jul. 2010	Jul. 2013	Extensive burn patients admitted within four hours after injury	Tang-Du Hospital
NCT02109120	MMP-9 monitoring particulate cerebral embolization	Cohort	48	Feb. 2012	Nov. 2013	Patients under CEA in the Peking Union Medical College Hospital (PUMCH)	PUMCH
NCT02105025	A novel clinically usable point score to prejudge the complexity of colonoscopy	Prospective	612	Oct. 2013	Jan. 2014	Patients with digestive diseases from the Endoscopy Center	Fourth Military Medical University
NCT01838629	The effect of universal salt iodization on thyroid diseases	Ecological or community	12 438	Jul. 2009	Jun. 2012	Patients with thyroid disease in Hangzhou	Weimin Xu
NCT01755351	Comparative study about the influence of diabetes distress and depression on treatment adherence in Chinese type 2 diabetes patients	Cohort	200	Dec. 2011	Dec. 2012	Patients with type 2 diabetes who visited two local hospitals between December 2011 and April 2012	Shandong Provincial Hospital
NCT01752452	Effect of ulnar styloid fracture on the outcome of distal radial fractures treated with external fixation	Case control	106	Jan. 2009	Oct. 2012	Unstable distal radial fracture patients: (1) the initial dorsal angulation>20°, (2) with dorsal or volar commination of the metaphysis, (3) shortening of radius>5 mm, and (4) with an associated ulnar fracture	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT01867853	Volume responsiveness before spontaneous breath trial predicts the outcome of mechanical ventilation weaning in critically ill patients	Case only	82	Oct. 2012	Mar. 2013	Patients mechanically ventilated and ready to undergo spontaneous breathing trial with a T-piece	Southeast University, China
NCT01984970	Evaluation McGrath series 5 videolaryngoscope for double-lumen tube intubation	Prospective	43	Nov. 2013	Jan. 2014	Adult patients scheduled for thoracic surgery requiring double-lumen tube insertion for one-lung ventilation	Huazhong University of Science and Technology
NCT02011776	A randomized, parallel-group comparison study of topical corticosteroids in dry eye patients with Sjögren syndrome	Case control	35	Mar. 2013	Nov. 2013	People who suffered from dry eye disease caused by the Sjögren syndrome	Santen Pharmaceutical (China) Co., Ltd.
NCT02102581	Evaluation of short-term effects of tourniquet use in different ways during total knee arthroplasty (TKA)	Case control	60	Feb. 2011	Dec. 2011	Consecutive patients who underwent routine TKA	Peking Union Medical College Hospital

Tab.1 Characteristics of the 12 completed registries in China

Tab.2 Registries in China stratified by disease, drug, device, and cases

Tab.3 Number of registries according to disease

Tab.4 Characteristics of QUEST, CNSR, TIT, and CABG registries

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