Quality control of large scale clinical trials

Abstract

Abstract: In the recent 2 decades, the clinical medical mode has been changed greatly.The experience-based medical mode is gradually replaced by evidence-based modeie evidencebased medicine.Large scale clinical trials provide robust evidence for clinical practice and quality control is critical for the success of one trial.We discuss six facets on this subject, including protocol design, staff training, manual formulating, organization, data management and monitoring.The objective of quality control is to ensure the study conducted according to the protocol, the results are reliable and protect the human rights of participants.

Key words: Large scale clinical trial, Quality control, Evidence-based medicine, Monitoring

CLC Number:

R969

MA Li-yuan, WANG Wen. Quality control of large scale clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2010, 15(1): 106-109.

References

[1] The ALLHAT Officer s and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hyper tensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker v s diuretic: The Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT) [J]. JAMA, 2002, 288: 2981-2997.
[2] Sever PS, Poulter N R, Dahlof B, et al. Antihy pertensive therapy and the benefits of atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial: lipid-lowering arm ex tension [J]. J Hyper tens, 2009, 27(5): 947-954.
[3] Lisheng L, Yuqing Z, Guozhang L, et al. The Felodipine Event Reduction(FEVER) study: Arandomized long-term placebo controlled trial in
4 Chine se hy pe rtensive pa tients[J]. Chine se hy pe rtensive pa tients[J]. J Hyper tens, 2005, 23(12): 2157-2172.
[4] Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hyper tensive patients at high cardio vascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial[J]. Lancet, 2004, 363(9426): 2022-2031.
[5] Weber MA, Bakris GL, Dahlöf B, et al. Baseline characteristics in the Avoiding Cardiovascular events through Combination the rapy in Patients Living with Systolic Hyper tension (ACCOMPLIS H) trial:a hypertensive population at high cardiovascular risk[J]. Blood Pressure, 2007, 16(1): 13-19.
[6] 卓宏. 临床试验方案设计中主要疗效指标及试验时间的考虑要素[J]. 中国临床药理学杂志, 2008, 24(3): 270-272.
[7] 王文, 马丽媛, 邹效漫. 国际多中心临床试验的监查[J]. 中国临床药理学与治疗学, 2004, 9(7): 835-837.
[8] 国家食品药品监督管理局令(第3 号). 药物临床试验质量管理规范[S]. 2003 年8 月6 号.
[9] 邹建东, 熊宁宁, 汪秀琴, 等. 临床试验的数据和安全监察[J]. 中国临床药理学与治疗学, 2004, 9(5): 598-600.
[10] 赵超. 临床适应性设计与药物评价的考虑[J]. 中国临床药理学与治疗学, 2008, 13(1): 1-5.

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