Master protocol applied to the prevention and treatment of Traditional Chinese Medicine for coronary heart disease: ideas and methods of evidence-based optimization_Chinese Journal of Evidence-Based Medicine

Authors：

HU Jiayuan ¹ , ZHANG Xiaoyu ¹ , ZHAO Chen ² , SUN Yang ¹ , CHEN Shiqi ¹ , LI Chengyu ¹ , LIU Shuo ¹ , QIU Ruijin ¹ ,  TIAN Guihua ¹ ,  SHANG Hongcai ¹

1. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;
2. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, 999077, P.R.China;

Corresponding author：

TIAN Guihua, Email: rosetgh@163.com; SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Master Protocol; Clinical research; Coronary heart disease; Traditional Chinese Medicine; Diseases with same syndrome pattern series

DOI：

10.7507/1672-2531.201804099

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a highly efficient new model of clinical trials which could obtain more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials on angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol on diseases with similary syndrome pattern series of Traditional Chinese Medicine.

Citation： HU Jiayuan, ZHANG Xiaoyu, ZHAO Chen, SUN Yang, CHEN Shiqi, LI Chengyu, LIU Shuo, QIU Ruijin, TIAN Guihua, SHANG Hongcai. Master protocol applied to the prevention and treatment of Traditional Chinese Medicine for coronary heart disease: ideas and methods of evidence-based optimization. Chinese Journal of Evidence-Based Medicine, 2019, 19(1): 102-106. doi: 10.7507/1672-2531.201804099 Copy

1.	Redman MW, Allegra CJ. The master protocol concept. Semin Oncol, 2015, 42(5): 724-730.
2.	Woodcock J, LaVange LM. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med, 2017, 377(1): 62-70.
3.	Herbst R, Rubin E, LaVange L, et al. Issue brief: conference on clinical cancer research. Available at: http://www.focr.org/sites/default/files/.CCCR12 Master Protocol.pdf.
4.	Conley BA, Doroshow JH. Molecular analysis for therapy choice: NCI MATCH. Semin Oncol, 2014, 41(3): 297-299.
5.	Kummar S, Williams PM, Lih CJ, et al. Application of molecular profiling in clinical trials for advanced metastatic cancers. J Natl Cancer Inst, 2015, 107(4): djv003.
6.	Barker AD, Sigman CC, Kelloff GJ, et al. I-SPY2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharm Ther, 2009, 86(1): 97-100.
7.	Kaplan R, Maughan T, Crook A, et al. Evaluating many treatments and biomarkers in oncology: a new design. J Clin Oncol, 2013, 31(36): 4562-4568.
8.	Kim ES, Herbst RS, Wistuba II, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov, 2011, 1(1): 44-53.
9.	Sleijfer S, Bogaerts J, Siu LL. Designing transformative clinical trials in the cancer genome era. J Clin Oncol, 2013, 31(15): 1834-1841.
10.	Herbst R, Rubin E, LaVange L, et al. Design of a disease-specific master protocol. Presented at the friends of cancer research/brookings conference on clinical cancer research, Washington, DC, November14, 2012.
11.	Herbst RS, Gandara DR, Hirsch FR, et al. Lung master protocol (Lung-MAP)-a biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400. Clin Cancer Res, 2015, 21(7): 1514-1524.
12.	Steuer CE, Papadimitrakopoulou V, Herbst RS, et al. Innovative clinical trials: the LUNG-MAP study. Clin Pharmacol Ther, 2015, 97(5): 488-491.
13.	Clinical trial designs for studying targeted therapies. Available at: https://am.asco.org/clinical-trial-designs-studying-targeted- therapies.
14.	Berry DA. The brave new world of clinical cancer research: adaptive biomarker-driven trials integrating clinical practice with clinical research. Mol Oncol, 2015, 9(5): 951-959.
15.	Redig AJ, Jänne PA. Basket trials and the evolution of clinical trial design in an era of genomic medicine. J Clin Oncol, 2015, 33(9): 975-977.
16.	姜辉, 吕肖芳, 张丽, 等. 代谢组学在中医药现代化研究中的应用. 中华中医药杂志, 2013, 28(3): 588-590.
17.	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.
18.	中国心血管病报告编写组. 《中国心血管病报告 2016》概要. 中国循环杂志, 2017, 32(6): 521-530.
19.	Thygesen K, Alpert JS, White HD. Universal definition of myocardial infarction. Eur Heart J, 2007, 28(20): 2525-2538.
20.	邓伏雪, 王小娟, 胡云凤, 等. 急性心肌梗死并发首次心力衰竭患者在院死亡率及临床预后分析. 西安交通大学学报(医学版), 2015, 36(1): 135-140.
21.	杨利. 邓铁涛教授" 冠心三论”. 湖南中医药导报, 2004, 10(6): 8-10.
22.	王东海, 董波. 冠心病心绞痛证型分布的回顾性分析. 世界中西医结合杂志, 2015, 10(3): 387-389.
23.	张敏州, 王磊. 邓铁涛教授论治冠心病介入术后病证的学术思想探析. 中医药管理杂志, 2006, 14(1): 32-33.
24.	霍根红, 李娟. 中医药防治 PCI 术后支架内血栓研究述评. 中医学报, 2016, 31(3): 426-429.
25.	Fox JL. Master protocol for squamous cell lung cancer readies for launch. J Nat Biotechnol, 2014, 32(2): 116-118.

1. Redman MW, Allegra CJ. The master protocol concept. Semin Oncol, 2015, 42(5): 724-730.
2. Woodcock J, LaVange LM. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med, 2017, 377(1): 62-70.
3. Herbst R, Rubin E, LaVange L, et al. Issue brief: conference on clinical cancer research. Available at: http://www.focr.org/sites/default/files/.CCCR12 Master Protocol.pdf.
4. Conley BA, Doroshow JH. Molecular analysis for therapy choice: NCI MATCH. Semin Oncol, 2014, 41(3): 297-299.
5. Kummar S, Williams PM, Lih CJ, et al. Application of molecular profiling in clinical trials for advanced metastatic cancers. J Natl Cancer Inst, 2015, 107(4): djv003.
6. Barker AD, Sigman CC, Kelloff GJ, et al. I-SPY2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharm Ther, 2009, 86(1): 97-100.
7. Kaplan R, Maughan T, Crook A, et al. Evaluating many treatments and biomarkers in oncology: a new design. J Clin Oncol, 2013, 31(36): 4562-4568.
8. Kim ES, Herbst RS, Wistuba II, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov, 2011, 1(1): 44-53.
9. Sleijfer S, Bogaerts J, Siu LL. Designing transformative clinical trials in the cancer genome era. J Clin Oncol, 2013, 31(15): 1834-1841.
10. Herbst R, Rubin E, LaVange L, et al. Design of a disease-specific master protocol. Presented at the friends of cancer research/brookings conference on clinical cancer research, Washington, DC, November14, 2012.
11. Herbst RS, Gandara DR, Hirsch FR, et al. Lung master protocol (Lung-MAP)-a biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400. Clin Cancer Res, 2015, 21(7): 1514-1524.
12. Steuer CE, Papadimitrakopoulou V, Herbst RS, et al. Innovative clinical trials: the LUNG-MAP study. Clin Pharmacol Ther, 2015, 97(5): 488-491.
13. Clinical trial designs for studying targeted therapies. Available at: https://am.asco.org/clinical-trial-designs-studying-targeted- therapies.
14. Berry DA. The brave new world of clinical cancer research: adaptive biomarker-driven trials integrating clinical practice with clinical research. Mol Oncol, 2015, 9(5): 951-959.
15. Redig AJ, Jänne PA. Basket trials and the evolution of clinical trial design in an era of genomic medicine. J Clin Oncol, 2015, 33(9): 975-977.
16. 姜辉, 吕肖芳, 张丽, 等. 代谢组学在中医药现代化研究中的应用. 中华中医药杂志, 2013, 28(3): 588-590.
17. 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.
18. 中国心血管病报告编写组. 《中国心血管病报告 2016》概要. 中国循环杂志, 2017, 32(6): 521-530.
19. Thygesen K, Alpert JS, White HD. Universal definition of myocardial infarction. Eur Heart J, 2007, 28(20): 2525-2538.
20. 邓伏雪, 王小娟, 胡云凤, 等. 急性心肌梗死并发首次心力衰竭患者在院死亡率及临床预后分析. 西安交通大学学报(医学版), 2015, 36(1): 135-140.
21. 杨利. 邓铁涛教授" 冠心三论”. 湖南中医药导报, 2004, 10(6): 8-10.
22. 王东海, 董波. 冠心病心绞痛证型分布的回顾性分析. 世界中西医结合杂志, 2015, 10(3): 387-389.
23. 张敏州, 王磊. 邓铁涛教授论治冠心病介入术后病证的学术思想探析. 中医药管理杂志, 2006, 14(1): 32-33.
24. 霍根红, 李娟. 中医药防治 PCI 术后支架内血栓研究述评. 中医学报, 2016, 31(3): 426-429.
25. Fox JL. Master protocol for squamous cell lung cancer readies for launch. J Nat Biotechnol, 2014, 32(2): 116-118.

Next Article
Editorial

Chinese Journal of Evidence-Based Medicine

Master protocol applied to the prevention and treatment of Traditional Chinese Medicine for coronary heart disease: ideas and methods of evidence-based optimization

Abstract Full text Figures/Tables Video References Cited by

Next Article

Format

Content