Objective  To analyze the current status of patient registry studies conducted in China, and to provide reference basis for improvement of patient registry studies.

Methods  Patient registry studies in China were searched in ClinicalTrials.gov, and the time limit for searching was from the establishment of the database to June 2024. The descriptive analyses was carried out to evaluate the situation, the scale, the main disease of the sponsors and funders of patient registry studies in China.

Results  As of June 2024, there were a total of 1,565 patient registry studies in China registered on ClinicalTrials.gov. The results showed that the sponsors of patient registry studies in China were mainly hospitals, universities and other institutions, of which the Peking Union Medical College Hospital had the largest number of sponsors (64, 4.09%). A total of 1,441 patient registry studies in China were funded by "other", accounting for 92.08%. Most of the patient registry studies were under the  process of recruitment (565, 36.10%). Most of the patient registry studies had 100~999 enrolled cases (713, 45.56%). The main disease area involved were cancer (186, 11.88%), stroke (81, 5.18%) and heart disease (53, 3.39%).

Conclusion  Patient registry studies in China are developing well, gradually increasing in number, covering a wide range of disease areas, with active participation of hospitals and universities. However, there are still problems and challenges such as insufficient management and transparency, limited scale of research, and single source of funding.

1.袁妮, 吕子萱, 黄祖彤, 等. 医保真实世界数据研究面临的挑战[J]. 中国医疗保险, 2024, (10): 15-23. [Yuan N, Lyu ZX, Huang ZT, et al. Challenges of real-world data research on medical insurance[J]. China Health Insurance, 2024, (10): 15-23.] DOI: 10.19546/j.issn.1674-3830.2024.10.003.

2.Inker LA, Ferrè S, Baliker M, et al. A national registry for people with all stages of kidney disease: the national kidney foundation (NKF) patient network[J]. Am J Kidney Dis, 2023, 81(2): 210-221. e1. DOI: 10.1053/j.ajkd.2022.07.016.

3.Encina G, Castillo-Laborde C, Lecaros JA, et al. Rare diseases in Chile: challenges and recommendations in universal health coverage context[J]. Orphanet J Rare Dis, 2019, 14(1): 289. DOI: 10.1186/s13023-019-1261-8.

4.Jonker CJ, Bakker E, Kurz X, et al. Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe[J]. Front Pharmacol, 2022, 13: 924648. DOI: 10.3389/fphar.2022.924648.

5.de Groot S, van der Linden N, Franken MG, et al. Balancing the optimal and the feasible: a practical guide for setting up patient registries for the collection of real-world data for health care decision making based on Dutch experiences[J]. Value Health, 2017, 20(4): 627-636. DOI: 10.1016/j.jval.2016.02.007.

6.Jonker CJ, van den Berg HM, Kwa MSG, et al. Registries supporting new drug applications[J]. Pharmacoepidemiol Drug Saf, 2017, 26(12): 1451-1457. DOI: 10.1002/pds.4332.

7.Bouvy JC, Blake K, Slattery J, et al. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013[J]. Pharmacoepidemiol Drug Saf, 2017, 26(12): 1442-1450. DOI: 10.1002/pds.4196.

8.Zhang S, Gaiser S, Kolominsky-Rabas PL. Cardiac implant registries 2006-2016: a systematic review and summary of global experiences[J]. BMJ Open, 2018, 8(4): e19039. DOI: 10.1136/bmjopen-2017-019039.

9.Resnic FS, Majithia A, Marinac-Dabic D, et al. Registry-based prospective, active surveillance of medical-device safety[J]. N Engl J Med, 2017, 376(6): 526-535. DOI: 10.1056/NEJMoa1516333.

10.裴正存, 詹思延. 病例注册登记的行动计划[J]. 药物流行病学杂志, 2016, 25(9): 583-585. [Pei ZC, Zhan SY. Initiative for patient registries[J]. Chinese Journal of Pharmacoepidemiology, 2016, 25(9): 583-585.] DOI: 10.19960/j.cnki.issn1005-0698.2016.09.012.

11.Bodilsen J, Duerlund LS, Mariager T, et al. Clinical features and prognostic factors in adults with brain abscess[J]. Brain, 2023, 146(4): 1637-1647. DOI: 10.1093/brain/awac312.

12.Gilsenan A, Harris D, Reynolds M, et al. Long-term cancer surveillance: results from the forteo patient registry surveillance study[J]. Osteoporos Int, 2021, 32(4): 645-651. DOI: 10.1007/s00198-020-05718-0.

13.Beck M, Ramaswami U, Hernberg-Ståhl E, et al. Twenty years of the fabry outcome survey (FOS): insights, achievements, and lessons learned from a global patient registry[J]. Orphanet J Rare Dis, 2022, 17(1): 238. DOI: 10.1186/s13023-022-02392-9.

14.Brooke Eileen M, World Health Organization. The current and future use of registers in health information systems[M]. Geneva: World Health Organization, 1974.

15.Zanetti R, Sacchetto L, Coebergh JW, et al. To accelerate cancer preventionin Europe: Challenges for cancer registries[J]. Eur J Cancer, 2018, 104: 151-159. DOI: 10.1016/j.ejca.2018.09.001.

16.杨星月, 刘佳, 何丽云, 等. 病例注册登记研究的应用进展 [J]. 中国循证医学杂志, 2016, 16(12): 1481-1484. [Yang  XY, Liu J, He LY, et al. Advances about application of patient registry[J]. Chinese Journal of Evidence-Based Medicine, 2016, 16(12): 1481-1484.] DOI: 10.7507/1672-2531.20160222.

17.ClinicalTrials.gov. About ClinicalTrials.gov[EB/OL]. (2024-06-07) [2024-09-11]. https://clinicaltrials.gov/about-site/about-ctg

18.Qiu HB, Cao SM, Xu RH. Cancer incidence, mortality, and burden in China: a time-trend analysis and comparison with the United States and United Kingdom based on the global epidemiological data released in 2020[J]. Cancer Commun (Lond), 2021, 41(10): 1037-1048. DOI: 10.1002/cac2.12197.

19.Feigin VL, Owolabi MO, World Stroke Organization-Lancet Neurology Commission Stroke Collaboration Group. Pragmatic solutions to reduce the global burden of stroke: a world stroke organization-lancet neurology commission[J]. Lancet Neurol, 2023, 22(12): 1160-1206. DOI: 10.1016/S1474-4422(23)00277-6.

20.Townsend N, Kazakiewicz D, Lucy Wright F, et al. Epidemiology of cardiovascular disease in Europe[J]. Nat Rev Cardiol, 2022, 19(2): 133-143. DOI: 10.1038/s41569-021-00607-3.

21.Liu J, Liu M, Chai Z, et al. Projected rapid growth in diabetes disease burden and economic burden in China: a spatio-temporal study from 2020 to 2030[J]. Lancet Reg Health West Pac, 2023, 33: 100700. DOI: 10.1016/j.lanwpc.2023.100700.