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：

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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, J?nne 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.	姜輝, 呂肖芳, 張麗, 等. 代謝組學在中醫藥現代化研究中的應用. 中華中醫藥雜志, 2013, 28(3): 588-590.
17.	趙晨, 張曉雨, 胡嘉元, 等. 中醫同證候系疾病臨床研究母方案設計方法. 中醫雜志, 2018, 59(2): 111-115.
18.	中國心血管病報告編寫組. 《中國心血管病報告 2016》概要. 中國循環雜志, 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.	鄧伏雪, 王小娟, 胡云鳳, 等. 急性心肌梗死并發首次心力衰竭患者在院死亡率及臨床預后分析. 西安交通大學學報(醫學版), 2015, 36(1): 135-140.
21.	楊利. 鄧鐵濤教授" 冠心三論”. 湖南中醫藥導報, 2004, 10(6): 8-10.
22.	王東海, 董波. 冠心病心絞痛證型分布的回顧性分析. 世界中西醫結合雜志, 2015, 10(3): 387-389.
23.	張敏州, 王磊. 鄧鐵濤教授論治冠心病介入術后病證的學術思想探析. 中醫藥管理雜志, 2006, 14(1): 32-33.
24.	霍根紅, 李娟. 中醫藥防治 PCI 術后支架內血栓研究述評. 中醫學報, 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, J?nne 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. 姜輝, 呂肖芳, 張麗, 等. 代謝組學在中醫藥現代化研究中的應用. 中華中醫藥雜志, 2013, 28(3): 588-590.
17. 趙晨, 張曉雨, 胡嘉元, 等. 中醫同證候系疾病臨床研究母方案設計方法. 中醫雜志, 2018, 59(2): 111-115.
18. 中國心血管病報告編寫組. 《中國心血管病報告 2016》概要. 中國循環雜志, 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. 鄧伏雪, 王小娟, 胡云鳳, 等. 急性心肌梗死并發首次心力衰竭患者在院死亡率及臨床預后分析. 西安交通大學學報(醫學版), 2015, 36(1): 135-140.
21. 楊利. 鄧鐵濤教授" 冠心三論”. 湖南中醫藥導報, 2004, 10(6): 8-10.
22. 王東海, 董波. 冠心病心絞痛證型分布的回顧性分析. 世界中西醫結合雜志, 2015, 10(3): 387-389.
23. 張敏州, 王磊. 鄧鐵濤教授論治冠心病介入術后病證的學術思想探析. 中醫藥管理雜志, 2006, 14(1): 32-33.
24. 霍根紅, 李娟. 中醫藥防治 PCI 術后支架內血栓研究述評. 中醫學報, 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.

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