Simpson Joe Leigh
College of Medicine, Florida International University, Building HLS II, Room 672, Miami, FL 33315, USA.
Hum Reprod. 2008 Oct;23(10):2179-81. doi: 10.1093/humrep/den250. Epub 2008 Jul 9.
The randomized clinical trial (RCT) is a powerful experimental design that when properly executed produces generalizable results. Conducting a RCT becomes complex when technical skills are required. Without requisite skills, a RCT may yield misleading results, an elegant RCT unwittingly generating spurious results due to technical inexperience. This pitfall is applicable to procedures used to evaluate assisted reproductive technologies. RCTs assessing the value of preimplantation genetic screening, also called preimplantation genetic diagnosis for aneuploidy testing--require three general prerequisites--proper study design, skilled operators (embryo biopsy), and skilled laboratory cytogeneticists (diagnosis). Lacking either of the latter two, even an elegantly designed RCT is not necessarily valid.
随机临床试验（RCT）是一种强大的实验设计，若执行得当，可产生具有广泛适用性的结果。当需要技术技能时，进行随机临床试验就会变得复杂。若缺乏必要技能，随机临床试验可能会产生误导性结果，一项精心设计的随机临床试验可能会因技术经验不足而无意中产生虚假结果。这一缺陷适用于评估辅助生殖技术的程序。评估植入前基因筛查价值的随机临床试验，也称为用于非整倍体检测的植入前基因诊断，需要三个一般前提条件——恰当的研究设计、熟练的操作人员（胚胎活检）和熟练的实验室细胞遗传学家（诊断）。缺少后两者中的任何一个，即使是设计精巧的随机临床试验也不一定有效。
