The role of evidence-based medicine in guiding clinical research and practice: opinion based on studies on antiviral drugs for the treatment of COVID-19_Chinese Journal of Evidence-Based Medicine

Authors：

ZHOU Qi ^1,2 , DONG Chongya ^3,4 , WANG Yeming ⁵ , ZHANG Boheng ⁶ ,  CHEN Yaolong ² , YAO Chen ^3,4

1. Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
2. Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences (2021RU017), School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
3. Department of Biostatistics, Peking University First Hospital, Beijing 100034, P. R. China;
4. Peking University Clinical Research Institute, Beijing 100191, P. R. China;
5. Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing 100020, P. R. China;
6. Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen 361015, P. R. China;

Corresponding?author：

CHEN Yaolong, Email: yaochen@hsc.pku.edu.cn

Keywords：

Evidence-based medicine; Evidence ecosystem; 3E model; COVID-19

DOI：

10.7507/1672-2531.202112143

Video：

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Abstract Full text Figures/Tables Video References Cited by

This paper analyzed clinical studies, systematic reviews and clinical practice guidelines on the treatment of COVID-19 with antiviral drugs. It elaborated on the evidence ecosystems in these studies following the "efficacy, evidence-based practice, effectiveness" (3E) model that considered five elements: research hypothesis, research evidence, big data from healthcare facilities, real-world data, and real-world evidence. Finally, this paper summarized the experience in the production, transformation and application of evidence. This paper could help clinicians conduct high-quality clinical research and provide good clinical practice based on the best currently available evidence.

Citation： ZHOU Qi, DONG Chongya, WANG Yeming, ZHANG Boheng, CHEN Yaolong, YAO Chen. The role of evidence-based medicine in guiding clinical research and practice: opinion based on studies on antiviral drugs for the treatment of COVID-19. Chinese Journal of Evidence-Based Medicine, 2022, 22(4): 373-379. doi: 10.7507/1672-2531.202112143 Copy

1.	Guyatt GH. Evidence-based medicine. Ann Inter Med, 1991, 114: A16.
2.	楊克虎, 陳耀龍. 寫在循證醫學誕生20周年. 中國循證兒科雜志, 2011, 6(3): 161-164.
3.	Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on. Lancet, 2017, 390(10092): 415-423.
4.	Holshue ML, DeBolt C, Lindquist S, et al. First case of 2019 Novel Coronavirus in the United States. N Engl J Med, 2020, 382(10): 929-936.
5.	Cytel Inc. Global coronavirus COVID-19 clinical trial tracker. Available at: https://www.covid-trials.org/.
6.	Epistemonikos. Living overview of evidence (LOVE) COVID-19 evidence platform. Available at: https://app.iloveevidence.com/loves/5e6fdb9669c00e4ac072701d?population=5e7fce7e3d05156b5f5e032a&intervention_variable=603b9fe03d05151f35cf13dc&classification=systematic-review.
7.	Stamm TA, Andrews MR, Mosor E, et al. The methodological quality is insufficient in clinical practice guidelines in the context of COVID-19: systematic review. J Clin Epidemiol, 2021, 135: 125-135.
8.	Pearson H. How COVID broke the evidence pipeline. Nature, 2021, 593(7858): 182-185.
9.	姚晨, 趙文樂. 新型冠狀病毒肺炎(COVID-19)臨床研究的啟示與國家臨床試驗網絡構想. 中國循證醫學雜志, 2020, 20(5): 497-503.
10.	Jung RG, Di Santo P, Clifford C, et al. Methodological quality of COVID-19 clinical research. Nat Commun, 2021, 12(1): 943.
11.	Li Y, Cao L, Zhang Z, et al. Reporting and methodological quality of COVID-19 systematic reviews needs to be improved: an evidence mapping. J Clin Epidemiol, 2021, 135: 17-28.
12.	Dagens A, Sigfrid L, Cai E, et al. Scope, quality, and inclusivity of clinical guidelines produced early in the covid-19 pandemic: rapid review. BMJ, 2020, 369: m1936.
13.	Zhao S, Lu S, Wu S, et al. Analysis of COVID-19 guideline quality and change of recommendations: a systematic review. Health Data Science, 2021, 2021: 1-22.
14.	朱政, 胡雁, 周英鳳, 等. 構建數據化和可信的證據生態系統: 首屆全球循證高峰論壇報道. 中國循證醫學雜志, 2017, 17(12): 1378-1380.
15.	Boutron I, Créquit P, Williams H, et al. Future of evidence ecosystem series: 1. introduction evidence synthesis ecosystem needs dramatic change. J Clin Epidemiol, 2020, 123: 135-142.
16.	Créquit P, Boutron I, Meerpohl J, et al. Future of evidence ecosystem series: 2. current opportunities and need for better tools and methods. J Clin Epidemiol, 2020, 123: 143-152.
17.	Ravaud P, Créquit P, Williams HC, et al. Future of evidence ecosystem series: 3. from an evidence synthesis ecosystem to an evidence ecosystem. J Clin Epidemiol, 2020, 123: 153-161.
18.	Akl EA, Haddaway NR, Rada G, et al. Future of evidence ecosystem series: evidence synthesis 20: when systematic, scoping, rapid, living, and overviews of reviews come together. J Clin Epidemiol, 2020, 123: 162-165.
19.	Wang Y, Zhou Q, Xu M, et al. Characteristics of clinical trials relating to COVID-19 registered at ClinicalTrials. gov. J Clin Pharm Ther, 2020, 45(6): 1357-1362.
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22.	McMahon JH, Udy A, Peleg AY. Remdesivir for the treatment of Covid-19 - preliminary report. N Engl J Med, 2020, 383(10): 992-993.
23.	Goldman JD, Lye DCB, Hui DS, et al. Remdesivir for 5 or 10 days in patients with severe Covid-19. N Engl J Med, 2020, 383(19): 1827-1837.
24.	Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. JAMA, 2020, 324(11): 1048-1057.
25.	Pan H, Peto R, et al. Repurposed antiviral drugs for Covid-19 - interim WHO solidarity trial results. N Engl J Med, 2021, 384(6): 497-511.
26.	Ader F, Bouscambert-Duchamp M, Hites M, et al. Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial. Lancet Infect Dis, 2022, 22(2): 209-221.
27.	Alhazzani W, Evans L, Alshamsi F, et al. Surviving sepsis campaign guidelines on the management of adults with coronavirus disease 2019 (COVID-19) in the ICU: first update. Crit Care Med, 2021, 49(3): e219-e234.
28.	Australian National COVID-19 Clinical Evidence Taskforce. Australian guidelines for the clinical care of people with COVID-19. Available at: http://www.covid19evidence.net.au/.
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30.	COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. Available at: https://www.covid19treatmentguidelines.nih.gov/.
31.	Agarwal A, Rochwerg B, Lamontagne F, et al. A living WHO guideline on drugs for covid-19. BMJ, 2020, 370: m3379.
32.	Qaseem A, Yost J, Etxeandia-Ikobaltzeta I, et al. Should remdesivir be used for the treatment of patients with COVID-19. Rapid, living practice points from the American college of physicians (Version 2). Ann Intern Med, 2021, 174(5): 673-679.
33.	The National Institute for Health and Care Excellence (NICE). COVID-19 rapid guideline: managing COVID-19. Available at: https://www.nice.org.uk/guidance/ng191.
34.	Chalmers JD, Crichton ML, Goeminne PC, et al. Management of hospitalised adults with coronavirus disease 2019 (COVID-19): a European Respiratory Society living guideline. Eur Respir J, 2021, 57(4): 2100048.
35.	Collins R, Bowman L, Landray M, et al. The magic of randomization versus the myth of real-world evidence. N Engl J Med, 2020, 382(7): 674-678.
36.	汪旻暉, 趙楊, 鄧亞中, 等. 真實世界數據/真實世界證據應用的政策法規及指導原則的比較研究. 中國臨床藥理學與治療學, 2020, 25(8): 878-889.
37.	黃亞芳, 閻小妍, 李雪迎, 等. 真實世界證據在醫療器械臨床研究中的應用. 中國循證醫學雜志, 2017, 17(12): 1373-1377.
38.	晉菲斐, 姚晨, 馬軍, 等. 高效可行的臨床真實世界數據采集模式探索—海南博鰲樂城國際醫療旅游先行區的實踐. 中國食品藥品監管, 2020, (11): 21-31.
39.	晉菲斐, 姚晨, 閻小妍, 等. 基于中國醫院的真實世界數據應用于臨床研究的鴻溝: 一項定性研究. 英國醫學雜志中文版, 2021, 24(4): 202-207.
40.	肖婷婷, 楊凱, 黃晨, 等. 可能用于新型冠狀病毒肺炎治療的抗病毒藥物. 中華臨床感染病雜志, 2020, 13(2): E012.
41.	Warren TK, Jordan R, Lo MK, et al. Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys. Nature, 2016, 531(7594): 381-385.
42.	Sheahan TP, Sims AC, Leist SR, et al. Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV. Nat Commun, 2020, 11(1): 222.
43.	Sheahan TP, Sims AC, Graham RL, et al. Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses. Sci Transl Med, 2017, 9(396): eaal3653.
44.	World Health Organization. WHO R&D Blueprint-Ad-hoc expert consultation on clinical trials for Ebola therapeutics. Available at: https://www.who.int/ebola/drc-2018/summary-deliberations-ebola-therapeutics.pdf?ua=1.
45.	Mulangu S, Dodd LE, Davey RT, et al. A randomized, controlled trial of Ebola virus disease therapeutics. N Engl J Med, 2019, 381(24): 2293-2303.
46.	伯納德, Bernard, 傅愫如, 等. 實驗醫學研究導論. 北京: 知識出版社, 1985.
47.	Institute of Medicine (US) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical practice guidelines we can trust. Washington (DC): National Academies Press (US), 2011.
48.	Hughes LD, McMurdo ME, Guthrie B. Guidelines for people not for diseases: the challenges of applying UK clinical guidelines to people with multimorbidity. Age Ageing, 2013, 42(1): 62-69.
49.	Gurevitch J, Koricheva J, Nakagawa S, et al. Meta-analysis and the science of research synthesis. Nature, 2018, 555(7695): 175-182.
50.	Ponce OJ, Alvarez-Villalobos N, Shah R, et al. What does expert opinion in guidelines mean. A meta-epidemiological study. Evid Based Med, 2017, 22(5): 164-169.
51.	孫鑫, 譚婧, 唐立, 等. 重新認識真實世界研究. 中國循證醫學雜志, 2017, 17(2): 126-130.
52.	閻小妍, 董沖亞, 姚晨. 大數據時代的循證醫學研究. 中國循證醫學雜志, 2017, 17(3): 249-254.
53.	劉爽, 馮時, 郭昊, 等. 醫療大數據應用于真實世界研究現狀及展望. 醫學信息學雜志, 2020, 41(3): 14-18.
54.	張冬, 張俊華, 孫鳳, 等. 真實世界研究與中醫藥大數據. 世界中醫藥, 2019, 14(12): 3119-3122.
55.	李敏, 時景璞, 于慧會. 真實世界研究與隨機對照試驗, 單病例隨機對照試驗在臨床治療性研究中的關系比較. 中華流行病學雜志, 2012, 33(3): 342-345.
56.	Rubin D, Chan-Tack K, Farley J, et al. FDA approval of remdesivir - a step in the right direction. N Engl J Med, 2020, 383(27): 2598-2600.
57.	Mozaffari E, Chandak A, Zhang Z, et al. Remdesivir treatment is associated with improved survival in hospitalized patients with COVID-19. The World Microbe Forum, 2021. Available at: https://www.abstractsonline.com/pp8/#!/9286/presentation/11269.
58.	Chokkalingam AP, Li H, Asubonteng J, et al. Comparative effectiveness of remdesivir treatment in patients hospitalized with covid-19. The World Microbe Forum, 2021. Available at: https://www.abstractsonline.com/pp8/#!/9286/presentation/10403.
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1. Guyatt GH. Evidence-based medicine. Ann Inter Med, 1991, 114: A16.
2. 楊克虎, 陳耀龍. 寫在循證醫學誕生20周年. 中國循證兒科雜志, 2011, 6(3): 161-164.
3. Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on. Lancet, 2017, 390(10092): 415-423.
4. Holshue ML, DeBolt C, Lindquist S, et al. First case of 2019 Novel Coronavirus in the United States. N Engl J Med, 2020, 382(10): 929-936.
5. Cytel Inc. Global coronavirus COVID-19 clinical trial tracker. Available at: https://www.covid-trials.org/.
6. Epistemonikos. Living overview of evidence (LOVE) COVID-19 evidence platform. Available at: https://app.iloveevidence.com/loves/5e6fdb9669c00e4ac072701d?population=5e7fce7e3d05156b5f5e032a&intervention_variable=603b9fe03d05151f35cf13dc&classification=systematic-review.
7. Stamm TA, Andrews MR, Mosor E, et al. The methodological quality is insufficient in clinical practice guidelines in the context of COVID-19: systematic review. J Clin Epidemiol, 2021, 135: 125-135.
8. Pearson H. How COVID broke the evidence pipeline. Nature, 2021, 593(7858): 182-185.
9. 姚晨, 趙文樂. 新型冠狀病毒肺炎(COVID-19)臨床研究的啟示與國家臨床試驗網絡構想. 中國循證醫學雜志, 2020, 20(5): 497-503.
10. Jung RG, Di Santo P, Clifford C, et al. Methodological quality of COVID-19 clinical research. Nat Commun, 2021, 12(1): 943.
11. Li Y, Cao L, Zhang Z, et al. Reporting and methodological quality of COVID-19 systematic reviews needs to be improved: an evidence mapping. J Clin Epidemiol, 2021, 135: 17-28.
12. Dagens A, Sigfrid L, Cai E, et al. Scope, quality, and inclusivity of clinical guidelines produced early in the covid-19 pandemic: rapid review. BMJ, 2020, 369: m1936.
13. Zhao S, Lu S, Wu S, et al. Analysis of COVID-19 guideline quality and change of recommendations: a systematic review. Health Data Science, 2021, 2021: 1-22.
14. 朱政, 胡雁, 周英鳳, 等. 構建數據化和可信的證據生態系統: 首屆全球循證高峰論壇報道. 中國循證醫學雜志, 2017, 17(12): 1378-1380.
15. Boutron I, Créquit P, Williams H, et al. Future of evidence ecosystem series: 1. introduction evidence synthesis ecosystem needs dramatic change. J Clin Epidemiol, 2020, 123: 135-142.
16. Créquit P, Boutron I, Meerpohl J, et al. Future of evidence ecosystem series: 2. current opportunities and need for better tools and methods. J Clin Epidemiol, 2020, 123: 143-152.
17. Ravaud P, Créquit P, Williams HC, et al. Future of evidence ecosystem series: 3. from an evidence synthesis ecosystem to an evidence ecosystem. J Clin Epidemiol, 2020, 123: 153-161.
18. Akl EA, Haddaway NR, Rada G, et al. Future of evidence ecosystem series: evidence synthesis 20: when systematic, scoping, rapid, living, and overviews of reviews come together. J Clin Epidemiol, 2020, 123: 162-165.
19. Wang Y, Zhou Q, Xu M, et al. Characteristics of clinical trials relating to COVID-19 registered at ClinicalTrials. gov. J Clin Pharm Ther, 2020, 45(6): 1357-1362.
20. Mehta HB, Ehrhardt S, Moore TJ, et al. Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis. BMJ Open, 2020, 10(6): e039978.
21. Wang Y, Zhang D, Du G, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet, 2020, 395(10236): 1569-1578.
22. McMahon JH, Udy A, Peleg AY. Remdesivir for the treatment of Covid-19 - preliminary report. N Engl J Med, 2020, 383(10): 992-993.
23. Goldman JD, Lye DCB, Hui DS, et al. Remdesivir for 5 or 10 days in patients with severe Covid-19. N Engl J Med, 2020, 383(19): 1827-1837.
24. Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. JAMA, 2020, 324(11): 1048-1057.
25. Pan H, Peto R, et al. Repurposed antiviral drugs for Covid-19 - interim WHO solidarity trial results. N Engl J Med, 2021, 384(6): 497-511.
26. Ader F, Bouscambert-Duchamp M, Hites M, et al. Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial. Lancet Infect Dis, 2022, 22(2): 209-221.
27. Alhazzani W, Evans L, Alshamsi F, et al. Surviving sepsis campaign guidelines on the management of adults with coronavirus disease 2019 (COVID-19) in the ICU: first update. Crit Care Med, 2021, 49(3): e219-e234.
28. Australian National COVID-19 Clinical Evidence Taskforce. Australian guidelines for the clinical care of people with COVID-19. Available at: http://www.covid19evidence.net.au/.
29. Infectious Diseases Society of America. Infectious Diseases Society of America Guidelines on the treatment and management of patients with COVID-19. Infectious diseases society of America 2021 (Version 5.5. 3). Available at: https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/.
30. COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. Available at: https://www.covid19treatmentguidelines.nih.gov/.
31. Agarwal A, Rochwerg B, Lamontagne F, et al. A living WHO guideline on drugs for covid-19. BMJ, 2020, 370: m3379.
32. Qaseem A, Yost J, Etxeandia-Ikobaltzeta I, et al. Should remdesivir be used for the treatment of patients with COVID-19. Rapid, living practice points from the American college of physicians (Version 2). Ann Intern Med, 2021, 174(5): 673-679.
33. The National Institute for Health and Care Excellence (NICE). COVID-19 rapid guideline: managing COVID-19. Available at: https://www.nice.org.uk/guidance/ng191.
34. Chalmers JD, Crichton ML, Goeminne PC, et al. Management of hospitalised adults with coronavirus disease 2019 (COVID-19): a European Respiratory Society living guideline. Eur Respir J, 2021, 57(4): 2100048.
35. Collins R, Bowman L, Landray M, et al. The magic of randomization versus the myth of real-world evidence. N Engl J Med, 2020, 382(7): 674-678.
36. 汪旻暉, 趙楊, 鄧亞中, 等. 真實世界數據/真實世界證據應用的政策法規及指導原則的比較研究. 中國臨床藥理學與治療學, 2020, 25(8): 878-889.
37. 黃亞芳, 閻小妍, 李雪迎, 等. 真實世界證據在醫療器械臨床研究中的應用. 中國循證醫學雜志, 2017, 17(12): 1373-1377.
38. 晉菲斐, 姚晨, 馬軍, 等. 高效可行的臨床真實世界數據采集模式探索—海南博鰲樂城國際醫療旅游先行區的實踐. 中國食品藥品監管, 2020, (11): 21-31.
39. 晉菲斐, 姚晨, 閻小妍, 等. 基于中國醫院的真實世界數據應用于臨床研究的鴻溝: 一項定性研究. 英國醫學雜志中文版, 2021, 24(4): 202-207.
40. 肖婷婷, 楊凱, 黃晨, 等. 可能用于新型冠狀病毒肺炎治療的抗病毒藥物. 中華臨床感染病雜志, 2020, 13(2): E012.
41. Warren TK, Jordan R, Lo MK, et al. Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys. Nature, 2016, 531(7594): 381-385.
42. Sheahan TP, Sims AC, Leist SR, et al. Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV. Nat Commun, 2020, 11(1): 222.
43. Sheahan TP, Sims AC, Graham RL, et al. Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses. Sci Transl Med, 2017, 9(396): eaal3653.
44. World Health Organization. WHO R&D Blueprint-Ad-hoc expert consultation on clinical trials for Ebola therapeutics. Available at: https://www.who.int/ebola/drc-2018/summary-deliberations-ebola-therapeutics.pdf?ua=1.
45. Mulangu S, Dodd LE, Davey RT, et al. A randomized, controlled trial of Ebola virus disease therapeutics. N Engl J Med, 2019, 381(24): 2293-2303.
46. 伯納德, Bernard, 傅愫如, 等. 實驗醫學研究導論. 北京: 知識出版社, 1985.
47. Institute of Medicine (US) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical practice guidelines we can trust. Washington (DC): National Academies Press (US), 2011.
48. Hughes LD, McMurdo ME, Guthrie B. Guidelines for people not for diseases: the challenges of applying UK clinical guidelines to people with multimorbidity. Age Ageing, 2013, 42(1): 62-69.
49. Gurevitch J, Koricheva J, Nakagawa S, et al. Meta-analysis and the science of research synthesis. Nature, 2018, 555(7695): 175-182.
50. Ponce OJ, Alvarez-Villalobos N, Shah R, et al. What does expert opinion in guidelines mean. A meta-epidemiological study. Evid Based Med, 2017, 22(5): 164-169.
51. 孫鑫, 譚婧, 唐立, 等. 重新認識真實世界研究. 中國循證醫學雜志, 2017, 17(2): 126-130.
52. 閻小妍, 董沖亞, 姚晨. 大數據時代的循證醫學研究. 中國循證醫學雜志, 2017, 17(3): 249-254.
53. 劉爽, 馮時, 郭昊, 等. 醫療大數據應用于真實世界研究現狀及展望. 醫學信息學雜志, 2020, 41(3): 14-18.
54. 張冬, 張俊華, 孫鳳, 等. 真實世界研究與中醫藥大數據. 世界中醫藥, 2019, 14(12): 3119-3122.
55. 李敏, 時景璞, 于慧會. 真實世界研究與隨機對照試驗, 單病例隨機對照試驗在臨床治療性研究中的關系比較. 中華流行病學雜志, 2012, 33(3): 342-345.
56. Rubin D, Chan-Tack K, Farley J, et al. FDA approval of remdesivir - a step in the right direction. N Engl J Med, 2020, 383(27): 2598-2600.
57. Mozaffari E, Chandak A, Zhang Z, et al. Remdesivir treatment is associated with improved survival in hospitalized patients with COVID-19. The World Microbe Forum, 2021. Available at: https://www.abstractsonline.com/pp8/#!/9286/presentation/11269.
58. Chokkalingam AP, Li H, Asubonteng J, et al. Comparative effectiveness of remdesivir treatment in patients hospitalized with covid-19. The World Microbe Forum, 2021. Available at: https://www.abstractsonline.com/pp8/#!/9286/presentation/10403.
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