| [1] |
国家药品监督管理局. 真实世界证据支持药物研发与审评的指导原则（试行）[EB/OL]. (2020-01-07)[2020-03-29].
URL
|
| [2] |
US Food and Drug Administration. Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics guidance for industry[EB/OL]. (2019-05-08)[2020-03-30].
URL
|
| [3] |
Yasunaga H, Yamana H, Sanchez MR, et al. Data Governance Arrangements for Real-World Evidence in Japan[R]. OHE Consulting Report, London: Office of Health Economics, 2019.
|
| [4] |
Cave A, Kurz X, Arlett P. Real-world data for regulatory decision making: challenges and possible solutions for Europe[J]. Clin Pharmacol Ther, 2019, 106(1): 36-39.
|
| [5] |
Lee EK, Park JA, Cole A, et al. Data Governance Arrangements for Real-World Evidence in South Korea[R]. OHE Consulting Report, London: Office of Health Economics, 2019.
|
| [6] |
U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Use of real-world evidence to support regulatory decision-making for medical devices. Guidance for industry and Food and Drug Administration staff[EB/OL]. (2017-08-31)[2020-03-20].
URL
|
| [7] |
ISPOR Connection. Real-life data: A growing need[EB/OL]. (2017-01-23)[2020-03-30].
URL
|
| [8] |
Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence - what is it and what can it tell us?[J]. N Engl J Med, 2016, 375(23): 2293-2297.
|
| [9] |
Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and real-world data for evaluating drug safety and effectiveness[J]. JAMA, 2018, 320(9): 867-868.
|
| [10] |
蔡兆伦, 尹源, 张波. 胃肠间质瘤领域的真实世界临床研究[J]. 中华胃肠外科杂志, 2019, 22(9): 826-830.
|
| [11] |
Franklin JM, Schneeweiss S. When and how can real world data analyses substitute for randomized controlled trials?[J]. Clin Pharmacol Ther, 2017, 102(6): 924-933.
|
| [12] |
Franklin JM, Glynn RJ, Martin D, et al. Evaluating the use of nonrandomized real-world data analyses for regulatory decision making[J]. Clin Pharmacol Ther, 2019, 105(4): 867-877.
|
| [13] |
田磊, 岳彩宾, 管欣, 等. 真实世界研究与随机对照试验在临床实践及卫生决策中应用的比较[J]. 中国医院药学杂志, 2019, 39(3): 274-277.
|
| [14] |
孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究[J]. 中国循证医学杂志, 2017, 17(2): 126-130.
|
| [15] |
Wang X, Zhang R, Du N, et al. An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202)[J]. Ther Adv Med Oncol, 2020, 12: 1758835920905424.
|
| [16] |
中国临床医学真实世界研究施行规范专家委员会. 中国临床医学真实世界研究施行规范[J]. 解放军医学杂志, 2018, 43(1): 1-6.
|
| [17] |
Mangat PK, Halabi S, Bruinooge SS, et al. Rationale and design of the targeted agent and profiling utilization registry (TAPUR) study[J]. JCO Precis Oncol, 2018: 1-14.
|
| [18] |
Haukoos JS, Lewis RJ. The propensity score[J]. JAMA, 2015, 314(15): 1637-1638.
|
| [19] |
Kurth T, Walker AM, Glynn RJ, et al. Results of multivariable logistic regression, propensity matching, propensity adjustment, and propensity-based weighting under conditions of nonuniform effect[J]. Am J Epidemiol, 2006, 163(3): 262-270.
|
| [20] |
Li Q, Zou J, Jia M, et al. Palliative Gastrectomy and survival in patients with metastatic gastric cancer: A propensity score-matched analysis of a large population-based study[J]. Clin Transl Gastroenterol, 2019, 10(5): e00048.
|
| [21] |
Coronado GD, Vollmer WM, Petrik A, et al. Strategies and opportunities to STOP colon cancer in priority populations: design of a cluster-randomized pragmatic trial[J]. Contemp Clin Trials, 2014, 38(2): 344-349.
|
| [22] |
Coronado GD, Petrik AF, Vollmer WM, et al. Effectiveness of a mailed colorectal cancer screening outreach program in community health clinics[J]. JAMA Intern Med, 2018, 178(9): 1174-1181.
|
| [23] |
Nielson CM, Petrik AF, Jacob L, et al. Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial[J]. Cancer Med, 2018, 7(9): 4781-4790.
|
| [24] |
Kang YK, Boku N, Satoh T, et al. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): A randomised, double-blind, placebo-controlled, phase 3 trial[J]. Lancet (London, England), 2017, 390(10111): 2461-2471.
|
| [25] |
Ott P, Calvo E, Sharma P, et al. O-007 nivolumab monotherapy in patients with advanced gastric or gastroesophageal junction (GEJ) cancer and 2 or more prior treatment regimens: sub-analysis of the CheckMate 032 study[J]. Ann of Oncol, 2017, 28(3): iii139.
|
| [26] |
Chau I, Le DT, Ott PA, et al. Developing real-world comparators for clinical trials in chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer[J]. Gastric Cancer, 2020, 23(1): 133-141.
|
| [27] |
Mokadem I, Dijksterhuis W, van Putten M, et al. Recurrence after preoperative chemotherapy and surgery for gastric adenocarcinoma: A multicenter study[J]. Gastric Cancer, 2019, 22(6): 1263-1273.
|
| [28] |
Liu Q, Luo D, Cai S, et al. Real-world implications of nonbiological factors with staging, prognosis and clinical management in colon cancer[J]. Cancers(Basel), 2018, 10(8): 263.
|
| [29] |
EORTC. Imatinib mesylate with or without surgery in treating patients with metastatic gastrointestinal stromal tumor that is responding to imatinib mesylate[EB/OL]. (2012-09-24)[2020-03-30].
URL
|
| [30] |
Kim JH, Ryu MH, Yoo C, et al. Long-term survival outcome with tyrosine kinase inhibitors and surgical intervention in patients with metastatic or recurrent gastrointestinal stromal tumors: A 14-year, single-center experience[J]. Cancer Med, 2019, 8(3): 1034-1043.
|
| [31] |
刘雪丽, 韩晟, 官海静, 等. 基于真实世界数据开展药物经济学评价[J]. 中国研究型医院, 2017, 4(3): 24-27.
|
| [32] |
蒯丽萍, 张钧. 药物经济学的成本-效果分析[J]. 药学实践杂志, 2005, 23(4): 251-255.
|
| [33] |
Mar J, Anton-Ladislao A, Ibarrondo O, et al. Stage- and age-adjusted cost-effectiveness analysis of laparoscopic surgery in rectal cancer[J]. Surg Endosc, 2020, 34(3): 1167-1176.
|