Tudur Smith Catrin, Hickey Helen, Clarke Mike, Blazeby Jane, Williamson Paula
North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.
Trials. 2014 Jan 23;15:32. doi: 10.1186/1745-6215-15-32.
Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust.
An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group's average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods.
Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were 'Research into methods to boost recruitment in trials' (considered the highest priority), 'Methods to minimise attrition' and 'Choosing appropriate outcomes to measure'. Fifty other topics were included in the list of priorities and consensus was reached that two topics, 'Radiotherapy study designs' and 'Low carbon trials', were not priorities.
This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with a focus on topics that will have most impact and relevance.
对临床试验的设计、实施、分析和报告所采用的方法进行研究至关重要，以确保有有效的方法可用，并且基于试验结果做出的临床决策是基于最佳可得证据，即可靠且有力的证据。
对英国临床研究协作组织注册的48个临床试验单位（CTU）进行了在线德尔菲调查。在第一轮中，要求CTU主任确定需要进行方法学研究的重要主题。在第二轮中，记录他们对每个主题重要性水平的看法，在第三轮中，要求他们审查小组的平均意见，并在适当时修改他们之前的意见。发送直接提醒以最大限度地提高每一轮的回复数量。结果采用描述性方法进行总结。
41名（85%）CTU主任至少回复了一轮德尔菲过程：25名（52%）在第一轮回复，32名（67%）在第二轮回复，24名（50%）在第三轮回复。只有12名（25%）回复了所有三轮，18名（38%）回复了第二轮和第三轮。CTU主任们达成共识，试验方法学研究的前三大优先事项是“提高试验招募率的方法研究”（被认为是最高优先事项）、“减少损耗的方法”和“选择合适的测量结果”。另外50个主题也被列入优先事项清单，并且达成共识，“放射治疗研究设计”和“低碳试验”这两个主题不是优先事项。
本次优先级设定活动确定了英国临床研究协作组织注册的CTU主任这一关键利益相关者群体认为最重要的研究主题。使用稳健的方法来确定这些优先事项将有助于确保这项工作为试验方法学研究议程提供信息，重点关注最具影响力和相关性的主题。
