Evidence from non-randomized and partially randomized studies (N: Non-randomized)

来自非随机和部分随机研究的证据（N：非随机）

• 批准号: 5423125
• 负责人: Dr. Claudia Schmoor, Ph.D.
• 金额: --
• 依托单位: Zentrum Klinische Studien
• 依托单位国家: 德国
• 项目类别: Research Units
• 财政年份: 2004
• 资助国家: 德国
• 起止时间: 2003-12-31 至 2010-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/5423125?language=en
• 关键词: Evidence; non; randomized; partially; studies

Randomized controlled trials (RCTs) are regarded to be the gold standard for the comparison of treatments in clinical trials. Nevertheless, the discussion about evidence from observational or partially randomized studies is still a current topic for various reasons. In some situations a randomization is not possible, feasible, or not enforceable. Another argument concerns the external validity. While a random assignment to treatment ensures internal validity of the comparison of the treatments, an assessment of external validity can best be achieved by comparing the randomized study sample to the population of patients who did not consent to randomization but met all other eligibility criteria. These considerations have led to the foundation of the 'Non-randomized Studies Methods Group' of the Cochrane Collaboration whose main task is the production of guidance on the inclusion of non-randomized studies in systematic reviews. This shows that research in this area is indicated. In the absence of evidence from RCTs it is natural to seek evidence from non-randomized or partially randomized studies. In this project, we focus on the one hand on the assessment of approaches introduced to gain for evidence from such studies and on the other hand on the development of innovative statistical methods with special emphasis on their practical applicability.

随机对照试验(RCT)被认为是临床试验中比较治疗的金标准。然而，由于各种原因，关于来自观察性或部分随机研究的证据的讨论仍然是一个当前的话题。在某些情况下，随机化是不可能的、可行的或不可强制执行的。另一个论点与外部有效性有关。虽然随机分配治疗确保了治疗比较的内部有效性，但通过将随机研究样本与不同意随机分配但符合所有其他资格标准的患者群体进行比较，可以最好地实现外部有效性评估。这些考虑导致了Cochrane协作的“非随机化研究方法小组”的成立，该小组的主要任务是为将非随机研究纳入系统评价提供指导。这表明在这一领域的研究是有意义的。在缺乏随机对照试验证据的情况下，从非随机或部分随机研究中寻找证据是很自然的。在这个项目中，我们一方面侧重于评估为从这类研究中获取证据而采用的方法，另一方面侧重于发展创新的统计方法，特别强调其实际适用性。