Overview of the 100-year History of Clinical Trials_Chinese Journal of Evidence-Based Medicine

Authors：

 LIU Ya-li ^1,2 , XIE Qi ³ ,  LIU Bao-yan ⁴ , FANG Ze-ping ⁵ , ZHANG Li-li ⁶ , LUO Jing-yi ⁷ , FENG Yu-chen ⁶ , ZHANG Xiao-kang ⁶

1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
2. Evidence-Based Medicine Center of Lanzhou University, Lanzhou 730000, China;
3. TCM Date Center, China Academy of Chinese Medical Sciences, Beijing 100700, China;
4. Department of Clinical Research Center, China Academy of Chinese Medical Sciences, Beijing 100700, China;
5. The School of Public Health, Xi'an Jiaotong University, Xi'an 710061, China;
6. The Second Clinical Medical College of Lanzhou University, Lanzhou 730000, China;
7. The First Clinical Medical College of Lanzhou University, Lanzhou 730000, China;

Corresponding author：

LIU Bao-yan, Email: liuby@mail.cintcm.ac.cn

Keywords：

Clinical trial; Memorabilia; History

DOI：

10.7507/1672-2531.20160189

Video：

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In this essay, classical events and related characters in the developments of clinical trial methodology were searched and summarized. The 'first' and major methodological progresses in the milestone events of clinical trials were therefore presented. This study is purposed to delineate the historically vicissitudinous progress of the clinical trial with typical figures and events, study and analyze the profound background of the renovation of clinical research methods, and provide references for clinical and scientific researchers, health policy makers and medical students to comprehensively review the history of clinical trial.

Citation： LIU Ya-li, XIE Qi, LIU Bao-yan, FANG Ze-ping, ZHANG Li-li, LUO Jing-yi, FENG Yu-chen, ZHANG Xiao-kang. Overview of the 100-year History of Clinical Trials. Chinese Journal of Evidence-Based Medicine, 2016, 16(11): 1241-1249. doi: 10.7507/1672-2531.20160189 Copy

1.	The James Lind Library. Available at:http://www.jameslindlibrary.org/.
2.	刘保延, 谢琪, 刘雅莉.临床试验溯源.北京:科学技术出版社, 2016.
3.	Lind J. A treatise of the scurvy. Available at:http://www.jameslindlibrary.org/lind-j-1753/.
4.	Haygarth J. Available at:http://www.jameslindlibrary.org/haygarth-j-1800/.
5.	Chave SP. Henry Whitehead and cholera in Broad Street. Med Hist, 1958, 2(2):92-108.
6.	Fibiger J. On treatment of diptheria with serum. Hospitalstidende, 1898, 6309-6325.
7.	Box JF. RA Fisher and the design of experiments, 1922-1926. Am Stat, 1980, 34(1):1-7.
8.	Lane-Claypon J. A further report on cancer of the breast. London:Ministry of Healt, 1926.
9.	Frost WH. Risk of Persons in Familial Contact with Pulmonary Tuberculosis. Am J Public Health Nations Health, 1933, 23(5):426-432.
10.	Medical Research Council, Patulin Clinical Trials Committee. Clinical trial of patulin in the common cold. Lancet, 1944(2):373-375.
11.	Marshall G, Blacklock J, Cameron C, et al. Streptomycin treatment of pulmonary tuberculosis:a medical research council investigation. BMJ, 1948, 2(4582):769-782.
12.	Chalmers I, Enkin M, Keirse M, et al. Effective care in pregnancy and childbirth. Oxford, UK:Oxford University Press, 1989.
13.	Paul JR. Clinical epidemiology. J Clin Invest, 1938, 17(5):539-541.
14.	Guyatt GH. Evidence-based medicine. ACP J Club, 1991, 114(S2):A16.
15.	Guyatt G, Cairns J, Churchill D, et al. Evidence-Based Medicine:A New Approach to Teaching the Practice of Medicine. JAMA, 1992, 268(17):2420-2425.
16.	田玲, 张宏梁, 马凌飞.国内外转化医学发展现状与展望.医学研究杂志, 2011, 40(1):17-20.
17.	Cochrane. Available at:http//www.chchrane.org.
18.	Andrew E, Anis A, Chalmers T, et al. A Proposal for Structured Reporting of Randomized Controlled Trials. JAMA, 1994, 272(24):1926-1931.
19.	Begg C, Cho M, Eastwood S, et al. Importing the quality of reporting of randomized controlled trials, The CONSORT statement. JAMA, 1996, 276(8):637-639.
20.	Grade working group. Available at:http://www.gradeworkinggroup.org.
21.	International Clinical Trials Registry Platform (ICTRP). Available at:http://www.who.int/ictrp/en/.
22.	刘保延.真实世界的中医临床研究范式.中医杂志, 2013, 54(6):451-455.
23.	WHO Statement on Public Disclosure of Clinical Trial Results.[2016-7]. Available at:http://www.who.int/ictrp/results/Draft_WHO_Statement_results_reporting_clinical_trials.pdf?ua=1.
24.	Taichman DB, Backus J, Baethge C, et al. Sharing Clinical Trial Data:A Proposal from the International Committee of Medical Journal Editors. PLoS Med, 2016, 13(1):e1001950.
25.	History, Policies, and Laws. Available at:https://clinicaltrials.gov/ct2/about-site/history.
26.	Extensions of the CONSORT Statement. Available at:http://www.consort-statement.org/extensions.
27.	Elma EV, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement:guidelines for reporting observational studies. J Clin Epidemiol, 2008, 61(4):344-349.
28.	Jarlais DD, Lyles C, Crepaz N, et al. Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions:The TREND Statement. Am J Public Health, 2004, 94(3):361-366.
29.	Bossuyt PM, Reitsma JB, Bruns DE, et al. Toward Complete and Accurate Reporting of Studies of Diagnostic Accuracy The STARD Initiative. Am J Clin Pathol, 2003, 119:18-22.
30.	Gagnier JJ, Kienle G, Altman DG, et al. The CARE guidelines:consensus-based clinical case reporting guideline development. J Clin Epidemiol, 2014, 67(1):46-51.
31.	好的临床研究应该什么样?[2016-10].

1. The James Lind Library. Available at:http://www.jameslindlibrary.org/.
2. 刘保延, 谢琪, 刘雅莉.临床试验溯源.北京:科学技术出版社, 2016.
3. Lind J. A treatise of the scurvy. Available at:http://www.jameslindlibrary.org/lind-j-1753/.
4. Haygarth J. Available at:http://www.jameslindlibrary.org/haygarth-j-1800/.
5. Chave SP. Henry Whitehead and cholera in Broad Street. Med Hist, 1958, 2(2):92-108.
6. Fibiger J. On treatment of diptheria with serum. Hospitalstidende, 1898, 6309-6325.
7. Box JF. RA Fisher and the design of experiments, 1922-1926. Am Stat, 1980, 34(1):1-7.
8. Lane-Claypon J. A further report on cancer of the breast. London:Ministry of Healt, 1926.
9. Frost WH. Risk of Persons in Familial Contact with Pulmonary Tuberculosis. Am J Public Health Nations Health, 1933, 23(5):426-432.
10. Medical Research Council, Patulin Clinical Trials Committee. Clinical trial of patulin in the common cold. Lancet, 1944(2):373-375.
11. Marshall G, Blacklock J, Cameron C, et al. Streptomycin treatment of pulmonary tuberculosis:a medical research council investigation. BMJ, 1948, 2(4582):769-782.
12. Chalmers I, Enkin M, Keirse M, et al. Effective care in pregnancy and childbirth. Oxford, UK:Oxford University Press, 1989.
13. Paul JR. Clinical epidemiology. J Clin Invest, 1938, 17(5):539-541.
14. Guyatt GH. Evidence-based medicine. ACP J Club, 1991, 114(S2):A16.
15. Guyatt G, Cairns J, Churchill D, et al. Evidence-Based Medicine:A New Approach to Teaching the Practice of Medicine. JAMA, 1992, 268(17):2420-2425.
16. 田玲, 张宏梁, 马凌飞.国内外转化医学发展现状与展望.医学研究杂志, 2011, 40(1):17-20.
17. Cochrane. Available at:http//www.chchrane.org.
18. Andrew E, Anis A, Chalmers T, et al. A Proposal for Structured Reporting of Randomized Controlled Trials. JAMA, 1994, 272(24):1926-1931.
19. Begg C, Cho M, Eastwood S, et al. Importing the quality of reporting of randomized controlled trials, The CONSORT statement. JAMA, 1996, 276(8):637-639.
20. Grade working group. Available at:http://www.gradeworkinggroup.org.
21. International Clinical Trials Registry Platform (ICTRP). Available at:http://www.who.int/ictrp/en/.
22. 刘保延.真实世界的中医临床研究范式.中医杂志, 2013, 54(6):451-455.
23. WHO Statement on Public Disclosure of Clinical Trial Results.[2016-7]. Available at:http://www.who.int/ictrp/results/Draft_WHO_Statement_results_reporting_clinical_trials.pdf?ua=1.
24. Taichman DB, Backus J, Baethge C, et al. Sharing Clinical Trial Data:A Proposal from the International Committee of Medical Journal Editors. PLoS Med, 2016, 13(1):e1001950.
25. History, Policies, and Laws. Available at:https://clinicaltrials.gov/ct2/about-site/history.
26. Extensions of the CONSORT Statement. Available at:http://www.consort-statement.org/extensions.
27. Elma EV, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement:guidelines for reporting observational studies. J Clin Epidemiol, 2008, 61(4):344-349.
28. Jarlais DD, Lyles C, Crepaz N, et al. Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions:The TREND Statement. Am J Public Health, 2004, 94(3):361-366.
29. Bossuyt PM, Reitsma JB, Bruns DE, et al. Toward Complete and Accurate Reporting of Studies of Diagnostic Accuracy The STARD Initiative. Am J Clin Pathol, 2003, 119:18-22.
30. Gagnier JJ, Kienle G, Altman DG, et al. The CARE guidelines:consensus-based clinical case reporting guideline development. J Clin Epidemiol, 2014, 67(1):46-51.
31. 好的临床研究应该什么样?[2016-10].

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