1. |
Yuan B. Towards a clinical efficacy evaluation system adapted for personalized medicine. Pharmgenomics Pers Med, 2021, 14: 487-496.
|
2. |
吴家睿. 精确医学5年历程的回顾与思考(上). 医学与哲学, 2021, 42(20): 1-4,10.
|
3. |
Food and Drug Administration. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-efficient-clinical-trial-design-strategies-expedite-development-oncology-drugs-and.
|
4. |
于亚南, 杜培艳, 刘骏, 等. 精准医学创新性临床试验设计“主方案”研究的概念, 设计与案例. 中国新药杂志, 2020, 29(23): 2712-2717.
|
5. |
高珺, 苏丽文, 袁鹰, 等. 抗肿瘤药物主方案试验设计进展及统计考量. 中国卫生统计, 2021, 38(6): 950-955.
|
6. |
Woodcock J, LaVange LM. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med, 2017, 377(1): 62-70.
|
7. |
Ornes S. Core concept: basket trial approach capitalizes on the molecular mechanisms of tumors. Proc Natl Acad Sci USA, 2016, 113(26): 7007-7008.
|
8. |
Park JJH, Hsu G, Siden EG, et al. An overview of precision oncology basket and umbrella trials for clinicians. CA Cancer J Clin, 2020, 70(2): 125-137.
|
9. |
Hyman DM, Puzanov I, Subbiah V, et al. Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. N Engl J Med, 2015, 373(8): 726-736.
|
10. |
Volovat SR, Ciuleanu TE, Koralewski P, et al. A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer. Oncotarget, 2020, 11(33): 3105-3117.
|
11. |
Hyman DM, Piha-Paul SA, Won H, et al. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature, 2018, 554(7691): 189-194.
|
12. |
Simon R, Geyer S, Subramanian J, et al. The Bayesian basket design for genomic variant-driven phase II trials. Semin Oncol, 2016, 43(1): 13-18.
|
13. |
Berry SM, Broglio KR, Groshen S, et al. Bayesian hierarchical modeling of patient subpopulations: efficient designs of Phase II oncology clinical trials. Clin Trials, 2013, 10(5): 720-734.
|
14. |
Chu Y, Yuan Y. A Bayesian basket trial design using a calibrated Bayesian hierarchical model. Clin Trials, 2018, 15(2): 149-158.
|
15. |
Hobbs BP, Landin R. Bayesian basket trial design with exchangeability monitoring. Stat Med, 2018, 37(25): 3557-3572.
|
16. |
郭晓慧, 黄仟, 谢雁鸣, 等. 伞式设计与篮式设计在中医药循证评价中的应用. 中国中药杂志, 2021, 46(8): 2010-2015.
|
17. |
胡嘉元, 张晓雨, 赵晨, 等. 母方案设计用于冠心病中医药防治方案循证优化的思路和实施方法. 中国循证医学杂志, 2019, 19(1): 102-106.
|
18. |
Hyman DM, Solit DB, Arcila ME, et al. Precision medicine at Memorial Sloan Kettering Cancer Center: clinical next-generation sequencing enabling next-generation targeted therapy trials. Drug Discov Today, 2015, 20(12): 1422-1428.
|
19. |
李涵, 孙杨, 张晓雨, 等. 以证统病—中医临床思维的回归与创新. 世界中医药, 2019, 14(10): 2552-2556, 2562.
|
20. |
赵晨, 张晓雨, 胡嘉元, 等. 中医同证候系疾病临床研究母方案设计方法. 中医杂志, 2018, 59(2): 111-115.
|
21. |
李建生. 基于病证结合模式重视以证统病的诊疗形式. 中医杂志, 2011, 52(7): 558-561.
|
22. |
黄晓珊. 抗敏镇咳颗粒治疗风咳证异病同治的临床研究. 南京: 南京中医药大学, 2020.
|
23. |
Liu W, Zhou L, Feng L, et al. BuqiTongluo granule for ischemic stroke, stable angina pectoris, diabetic peripheral neuropathy with Qi deficiency and blood stasis syndrome: rationale and novel basket design. Front Pharmacol, 2021, 12: 764669.
|
24. |
Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence-what is it and what can it tell us. N Engl J Med, 2016, 375(23): 2293-2297.
|
25. |
杨娜, 赵京红. 基于中医理论指导下异病同治(痰瘀互阻证)的临床研究. 中国实用医药, 2014, (26): 245-245, 246.
|
26. |
蒋雪峰, 徐雯, 周腊梅. 益肾蠲痹丸治疗腰痛的临床效果观察. 黑龙江医药, 2019, 32(6): 1369-1370.
|
27. |
黎凤仪, 叶婷慧. 止渴降糖方对糖尿病肾病和哮喘的异病同治的临床疗效. 大众科技, 2021, 23(9): 47-50.
|
28. |
关之玥, 刘岩, 张晶晶, 等. 母方案平台试验设计方法及其在相关领域中的应用. 中国循证医学杂志, 2021, 21(8): 986-992.
|
29. |
陈凯先. 精准医学和中医药创新发展. 世界科学技术-中医药现代化, 2017, 19(1): 7-18.
|