The evolutionary logic of the U.S. clinical trial registration system and its implications for China_Chinese Journal of Evidence-Based Medicine

Authors：

LI Xiaotian ,  WANG Yang

School of Philosophy and Social Development, Huaqiao University, Xiamen 361000, P. R. China;

Corresponding author：

WANG Yang, Email: hquwangyang@hqu.edu.cn

Keywords：

U.S. clinical trial registration system; International cancer database; Major disease registration system; Publication bias

DOI：

10.7507/1672-2531.202506176

Video：

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By dividing the evolution of the U.S. clinical trial registration system into three phases—emergence, inception, and maturity—this study systematically traces its half-century development and reveals the underlying tensions and institutional logic. The U.S. clinical trial registration system is not merely a technical instrument, but a comprehensive institutional platform reconciling the conflicts among scientific rationality, commercial interests, and the public’s right to know. The emergence phase (1971—1985) originated from the establishment and public disclosure of the International Cancer Database to meet cancer research needs and safeguard patients’ survival rights. The inception phase (1986—2004) unfolded against the backdrop of the FDA’s drug approval crisis, with the construction of major disease registration systems breaking the regulatory deadlock and achieving an “incremental revolution”. The maturity phase (2004—2016) centered on controlling publication bias and advancing institutionalization and legalization. The 2004 paroxetine incident galvanized global consensus on trial registration, and the 2007 U.S. Congressional mandate marked the pivotal turning point toward a fully mature system. Today, China still faces low registration rates and insufficient legal constraints. Drawing on the U.S. experience, China should prioritize institutional publicness, legal enforceability, and the containment of publication bias to strategically upgrade its clinical trial registration system.

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1. James S, Rao SV, Granger CB. Registry-based randomized clinical trials--a new clinical trial paradigm. Nat Rev Cardiol, 2015, 12(5): 312-316.
2. Lasker M. Need for a commission on the conquest of cancer as a national goal by 1976.
3. Citizens Committee for the Conquest of Cancer. Mr. Nixon: you can cure cancer. 1969.
4. Congress of the United States of America. The national cancer act of 1971. 1971.
5. Schneider JH. Information services of the International Cancer Research Data Bank (ICRDB) program in cancer chemotheraphy and pharmacology. Adv Pharmacol Chemother, 1980, 17: 25-35.
6. Masys DR, Hubbard SM. Technical information programs of the National Cancer Institute. J Am Soc Inf Sci, 1987, 38(1): 60-64.
7. Congress of the United States of America. Health research extension act of 1985. 1985.
8. Merrill RA. Modernizing the FDA: an incremental revolution. Health Aff (Millwood), 1999, 18(2): 96-111.
9. 宋华琳, 刘炫. 同情用药法律制度的发展与改革: 以美国经验为参照探讨同情用药制度的完善. 中国医药报, 2020.
10. McCray AT. Better access to information about clinical trials. Ann Intern Med, 2000, 133(8): 609-614.
11. Congress of the United States of America. Food and Drug Administration Modernization Act of 1997 (FDAMA). 1997.
12. National Center for Biotechnology Information. MeSH: publication bias.
13. Begg CB, Berlin JA. Publication bias: a problem in interpreting medical data. J R Stat Soc A, 1988, 151(3): 419-463.
14. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol, 1986, 4(10): 1529-1541.
15. Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA, 1990, 263(10): 1385-1389.
16. Dickersin K. Report from the panel on the Case for Registers of Clinical Trials at the Eighth Annual Meeting of the Society for Clinical Trials. Control Clin Trials, 1988, 9(1): 76-81.
17. Tiner R. Medical editors' trial amnesty. Lancet, 1997, 350(9087): 1329.
18. Dickersin K. Why register clinical trials. -Revisited. Control Clin Trials, 1992, 13(2): 170-177.
19. Dickersin K, Rennie D. Registering clinical trials. JAMA, 2003, 290(4): 516-523.
20. Maxwell C. Clinical trials, reviews, and the Journal of Negative Results. Br J Clin Pharmacol, 1981, 11(1): 15-18.
21. Roberts I, Po AL, Chalmers I. Intellectual property, drug licensing, freedom of information, and public health. Lancet, 1998, 352(9129): 726-729.
22. Lancet. Is GSK guilty of fraud. Lancet, 2004, 363(9425): 1919.
23. Krleza-Jerić K. Clinical trial registration: the differing views of industry, the WHO, and the Ottawa Group. PLoS Med, 2005, 2(11): e378.
24. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA, 2004, 292(11): 1363-1364.
25. World Health Organization. New York Statement General Consensus of Stakeholders.
26. World Health Organization. Ministerial summit on health research. Mexico statement on health research.
27. Rockhold F. The Society for Clinical Trials supports United States legislation mandating trials registration. Clin Trials, 2005, 2(2): 193.
28. Moore TJ. Deadly medicine: why tens of thousands of heart patients died in America’s worst drug disaster. New York: Simon & Schuster, 1995.
29. Congress of the United States of America. Food and Drug Administration amendments act of 2007 (FDAAA). 2007.
30. Department of Health and Human Services. Final rule for clinical trials registration and results information submission. 2016.
31. U. S. National Library of Medicine. ClinicalTrials. gov history, policies, and laws.
32. Charles C. The adequacy of FDA to assure the nation’s drug supply. Hearing before the Committee on Energy and Commerce, House of Representatives, 110th Congress. Washington (DC): U. S. Government Printing Office, 2007.
33. Institute of Medicine of The National Academies. Developing a national registry of pharmacologic and biologic clinical trials. Washington (DC): National Academies Press (US), 2006.
34. 关于《赫尔辛基宣言》2008年修正版. 药物评价研究. 2009, 32(1): 70-74.
35. 中国政府网. 中国和印度加入世卫组织国际临床试验注册平台. 2007.
36. 陈冯富珍. 世界卫生组织总干事陈冯富珍贺信. 中国骨伤, 2007, 20(10): 658.
37. 吴泰相, 米娜瓦尔·阿不都, 郝园, 等. 中国临床试验注册10年: 现状与问题. 中国循证医学杂志, 2018, 18(6): 521-525.
38. World Health Organization. Global action plan for clinical trial ecosystem strengthening.

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