Department of Medicine, Faculty of Medicine, Memorial University of Newfoundland, St. John, NL, Canada.
Methods Mol Biol. 2021;2249:193-211. doi: 10.1007/978-1-0716-1138-8_11.
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 control trial include emphasis on the principal research question, randomization, blinding; definitions of outcome measures, of inclusion and exclusion criteria, and of co-morbid and confounding factors; enrolling an adequate sample size; planning data management and analysis; preventing challenges to trial integrity such as drop-out, drop-in, and bias. The application of pre-trial 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.
今天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、盲法；定义结局测量、纳入和排除标准，以及合并症和混杂因素；招募足够的样本量；计划数据管理和分析；防止试验完整性受到挑战，如脱落、混入和偏倚。强调了试验前规划的应用，以确保适当应用流行病学原则，从而使临床研究具有可行性和可推广性。此外，还讨论了资金策略和试验团队组成。
