[1] 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. [2] United States of America Congress. 21st century cures act[EB/OL]. (2016-12-13)[2021-03-05]. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf. [3] Food and Drug Administration. Framework for FDA’s real-world evidence program[EB/OL]. (2018-12-01)[2021-03-05]. https://www.fda.gov/media/120060/download. [4] Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: draft guidance for industry and Food and Drug Administration staff[EB/OL]. (2017-08-31)[2021-03-05]. https://www.fda.gov/media/99447/download. [5] Food and Drug Administration. Use of electronic health records in clinical investigations[EB/OL]. (2018-07-01)[2021-03-05]. https://www.fda.gov/media/97567/download. [6] Food and Drug Administration. Submitting documents utilizing real-world data and real-world evidence to FDA for drugs and biologics[EB/OL]. (2019-05-01)[2021-03-05]. https://www.fda.gov/media/124795/download. [7] National Medical Products Administration. Guiding principles of real-world evidence supporting drug development and evaluation (trial implementation)[EB/OL]. (2020-01-03)[2021-03-05]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20200107151901190.html. [8] Center for Drug Evaluation of National Medical Products Admini-stration. Technical guiding principles of real-world study supporting the development and evaluation of children's drugs (trial implementation)[EB/OL]. (2020-08-27)[2021-03-05]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200901104448101.html. [9] Vinogradova Y, Coupland C, Hill T, et al.Risks and benefits of direct oral anticoagulants versus warfarin in a real world setting: cohort study in primary care[J]. British Medical Journal, 2018, 362: k2505. [10] Wang SC, Liu BY, Xiong NN, et al.Discussion on solutions to ethical issues of clinical researches in a real world[J]. Chinese Journal of Integrated Traditional and Western Medicine(中国中西医结合杂志), 2013, 33(04): 437-442. [11] Zhang NN, Shi HX, Zhou HW, et al.Characterisrics of TCM real-world research[J]. Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology(世界科学技术·中医现代化), 2018, 20(9): 1496-1500. [12] Platt R, Brown JS, Robb M, et al.The FDA Sentinel Initiative - an evolving national resource[J]. N Engl J Med, 2018, 379(22):2091-2093. [13] Taylor LG, Panucci G, Mosholder AD, et al.Antipsychotic use and stroke: a retrospective comparative study in a non-elderly population[J]. J Clin Psychiatry, 2019, 80(4): m12636. [14] Eworuke E, Welch EC, Tobenkin A, et al.Use of FDA's Sentinel System to quantify seizure risk immediately following new ranolazine exposure[J]. Drug Saf, 2019, 42(7): 897-906. [15] Li J, Panucci G, Moeny D, et al.Association of risk for venous thromboembolism with use of low-dose extended and continuous-cycle combined oral contraceptives: a safety study using the Sentinel Distributed Database[J]. JAMA Intern Med, 2018, 178(11): 1482-1488. [16] Mack CD, Dreyer NA, Bosco J, et al.Using real-world evidence to inform decision making[J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2014, 23(1): 17-28. [17] Xuan JW, Cheng J, Xue XF, et al.Real world medical database construction and its applications on hospital management, clinical diagnosis and treatment, rational medicine use, and meticulous management of medical insurance[J]. China Journal of Pharmaceutical Economics(中国药物经济学), 2019, 14(5): 10-17. [18] Zhao H, Wei L, Li H, et al. Appropriateness of antibiotic prescriptions in ambulatory care in China: a nationwide descriptive database study[J]. Lancet Infect Dis, 2021, 3099(20): 30596-X. [19] Luo JM, Wu J, Chen SN, et al.Impact analysis on disease management cost of nilotinib as first-line treatment for chronic myeloid leukemia in China[J]. Chin Heal Insur(中国医疗保险), 2018(4): 59-65. [20] Adisasmito W, Chan PK, Lee N, et al.Effectiveness of antiviral treatment in human influenza A (H5N1) infections: analysis of a global patient registry[J]. J Infect Dis, 2010, 202(8): 1154-1160. [21] Chan PK, Lee N, Zaman M, et al.Determinants of antiviral effectiveness in influenza virus a subtype H5N1[J]. J Infect Dis, 2012, 206(9): 1359-1366. [22] Oner AF, Dogan N, Gasimov V, et al.H5N1 avian influenza in children[J]. Clin Infect Dis, 2012, 55(1): 26-32. [23] Adisasmito W, Aisyah DN, Aditama TY, et al.Human influenza A H5N1 in Indonesia: health care service-associated delays in treatment initiation[J]. BMC Public Health, 2013, 13: 571. [24] Chen SB, Yu F.Suggestions on the development of real world study on the rare diseases and orphan drugs[J]. Journal of International Pharmaceutical Research(国际药学研究杂志), 2019, 46(9): 699-704. [25] Guan J.The value and potential risk of real world evidence with ethical considerations[J]. Med Phil(医学与哲学), 2017, 38(10) : 27-30. |