Curtis Bryan M, Barrett Brendan J, Parfrey Patrick S
Department of Medicine, Memorial University of Newfoundland, St. John's, Canada.
Methods Mol Biol. 2009;473:95-111. doi: 10.1007/978-1-59745-385-1_5.
Today's clinical practice relies on the application of well-designed clinical research, the gold standard test of an intervention being the randomized controlled trial. Principles of the randomized controlled trial include emphasis on the principal research question, randomization, and blinding; definitions of outcome measures, inclusion and exclusion criteria, and comorbid and confounding factors; enrolling an adequate sample size; planning data management and analysis; preventing challenges to trial integrity, such as dropout, drop-in, and bias. The application of pretrial planning is stressed to ensure the proper application of epidemiological principles, resulting in clinical studies that are feasible and generalizable. In addition, funding strategies and trial team composition are discussed.
当今的临床实践依赖于精心设计的临床研究的应用，干预措施的金标准测试是随机对照试验。随机对照试验的原则包括强调主要研究问题、随机化和盲法；结局指标、纳入和排除标准以及共病和混杂因素的定义；招募足够的样本量；规划数据管理和分析；防止对试验完整性的挑战，如退出、加入和偏倚。强调预审规划的应用，以确保流行病学原则的正确应用，从而产生可行且可推广的临床研究。此外，还讨论了资金策略和试验团队的组成。
