College of Medicine, Texas A&M Health Science Center, Bryan, Texas, USA.
Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.
Eur J Clin Invest. 2022 Nov;52(11):e13832. doi: 10.1111/eci.13832. Epub 2022 Jul 22.
In biomedicine, randomized controlled trials are regarded as the gold standard of evidence owing to their ability to minimize confounding factors that may influence results. Randomized trials that are properly designed serve as a basis for drug regulation and national guideline development. Despite the many advantages of the study design, there are several misconceptions regarding randomized trials, particularly in oncology. These misconceptions include: the difficulty of designing and conducting a trial, the length of time necessary to complete a trial, the expense, appraisal and critique, pharmaceutical industry influence, and ethical standards. Furthermore, developing regulatory and strategic frameworks has the potential to enhance the randomized trial landscape. Such initiatives will focus on relevant clinical issues that persist in oncology, reducing duplicative and unethical trials and maximizing value-based healthcare. Here, we address several misconceptions regarding randomized controlled trials and provide potential solutions to enhance their methodology and implementation.
在生物医药领域，随机对照试验因其能够最小化可能影响结果的混杂因素而被视为证据的金标准。设计合理的随机试验是药物监管和国家指南制定的基础。尽管该研究设计具有许多优点，但对于随机试验，特别是在肿瘤学领域，仍存在一些误解。这些误解包括：试验设计和实施的难度、完成试验所需的时间、费用、评估和批评、制药行业的影响以及伦理标准。此外，制定监管和战略框架有可能改善随机试验的现状。这些举措将侧重于肿瘤学中持续存在的相关临床问题，减少重复和不道德的试验，并最大限度地提高基于价值的医疗保健。在这里，我们解决了关于随机对照试验的一些误解，并提供了增强其方法和实施的潜在解决方案。
