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Coordination and planning of clinical research on a national and global level
Fertility and Sterility ( IF 6.6 ) Pub Date : 2020-06-01 , DOI: 10.1016/j.fertnstert.2020.04.032
Adam J Devall 1 , Henk Jan Out 2 , Ben Willem J Mol 3 , James M N Duffy 4 , Barbara Collura 5 , Silke Dyer 6
Affiliation  

In reproductive medicine, the needs and desires of infertility patients drive future research, with the most important outcome being live birth of a baby. Large, multicenter, randomized clinical trials are considered the best research tool to evaluate the effectiveness of medical interventions, but they can often take a long time to find definitive answers. Advances in individual participant data (IPD) and network meta-analysis have enabled research questions to be answered more quickly, but better planning could streamline this process further. To harmonize research findings that are taking place globally in this way, it is crucial that the same outcomes are collected in clinical trials conducted in reproductive medicine. Furthermore, the conduct of clinical trials often requires collaboration on an international scale; however, individual countries have their own processes for research prioritization and delivery. We describe the perspective of high- and low-resourced settings and industry as well as the mechanisms of prioritization and coordination that are in place in different settings. In addition, we discuss the importance of the patient perspective, which can help shape the research question, clinical trial design, and the logistical operations of trial delivery. The need for increased global collaboration and coalitions within and between stakeholders is evident for the research community to accelerate advances and maximize benefits in reproductive medicine.

中文翻译:

在国家和全球层面协调和规划临床研究

在生殖医学中,不孕症患者的需求和愿望推动着未来的研究,最重要的结果是活产婴儿。大型、多中心、随机临床试验被认为是评估医疗干预有效性的最佳研究工具,但它们通常需要很长时间才能找到明确的答案。个体参与者数据 (IPD) 和网络元分析的进步使研究问题能够得到更快的回答,但更好的规划可以进一步简化这一过程。为了以这种方式协调全球正在发生的研究结果,至关重要的是在生殖医学的临床试验中收集相同的结果。此外,临床试验的进行往往需要国际范围的合作;然而,各个国家都有自己的研究优先排序和交付流程。我们描述了高资源和低资源环境和行业的观点,以及不同环境中的优先级和协调机制。此外,我们讨论了患者视角的重要性,这有助于形成研究问题、临床试验设计和试验交付的后勤操作。研究界显然需要加强利益相关者内部和之间的全球合作和联盟,以加快生殖医学的进步和最大化收益。我们描述了高资源和低资源环境和行业的观点,以及不同环境中的优先级和协调机制。此外,我们讨论了患者视角的重要性,这有助于形成研究问题、临床试验设计和试验交付的后勤操作。研究界显然需要加强利益相关者内部和之间的全球合作和联盟,以加快生殖医学的进步和最大化收益。我们描述了高资源和低资源环境和行业的观点,以及不同环境中的优先级和协调机制。此外,我们讨论了患者视角的重要性,这有助于形成研究问题、临床试验设计和试验交付的后勤操作。研究界显然需要加强利益相关者内部和之间的全球合作和联盟,以加快生殖医学的进步和最大化收益。
更新日期:2020-06-01
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