探索性试验 Exploratory Trial


  探索性研究:和所有临床试验一样应有清晰和明确的目的,但与确证性试验相比,它们的目的并不总是对预先定义的假设进行简单检验。此外,探索性试验可能有时需要采用更灵活的方法进行设计,以便根据积累的结果更改设计。它们的分析可能仅限于数据探索,也可能进行假设检验,但假设的拟定可能依赖于数据。尽管这类试验可能对整体的相关证据有贡献,但不能作为证明有效性的正式依据。1)

  Like all clinical trials, an exploratory study should has clear and precise objectives. However, in contrast to confirmatory trials, their objectives may not always lead to simple tests of pre-defined hypotheses. In addition, exploratory trials may sometimes require a more flexible approach to design so that changes can be made in response to accumulating results. Their analysis may entail data exploration; tests of hypothesis may be carried out, but the choice of hypothesis may be data dependent. Such trials cannot be the basis of the formal proof of efficacy, although they may contribute to the total body of relevant evidence. 2)



  • 概念/探索性试验.txt
  • 最后更改: 2年前
  • 老T