Background:

Vaccines are potent tools to prevent outbreaks of emerging infectious diseases from becoming epidemics and need to be developed at an accelerated pace to have any impact on the course of an ongoing epidemic. The aim of this study was to describe time use in the execution of vaccine trials, to identify steps that could be accelerated to improve preparedness and planning for future emerging infectious diseases vaccine trials.

Methods:

We used a mixed-methods approach to map time use and process steps that could be accelerated during vaccine trials. Trials for vaccines against infectious diseases registered in three global trial databases reported in the period 2011–2017 were eligible to join the survey. We invited sponsors to contribute data through a predefined structured questionnaire for clinical trial process metrics. Data were stratified by trial phase, disease type (i.e. emerging infectious diseases or not emerging infectious diseases), sponsor type, and continent. Qualitative interviews were conducted with purposively selected sponsors, and thematic analysis of the interview transcripts was performed.

Results:

Based on data from 155 vaccine trials including 29,071 subjects, 52% were phase I, 23% phase II, and 25% phase III. We found that the regulatory approval, subject enrollment, study execution, and study close-out accounted for most of the cycle time of the vaccine trial process. Cycle times for the regulatory and ethical approvals, contract agreement, site initiation, and study execution were shorter in trials conducted during outbreaks. Qualitative interviews indicated that early engagement of the regulatory and independent ethical committee authorities in planning the vaccine trials was critical for saving time in trial approval. Furthermore, adapting the trial implementation to the reality of the study sites and active involvement of the local investigators during the planning of the trial and protocol writing were stated to be of paramount importance to successful completion of trials at an accelerated pace.

Conclusion:

The regulatory approval, subject recruitment, study execution, and close-out cycle times accounted for most of the vaccine trial time use and are activities that could be accelerated during a vaccine trial planning and implementation. We encourage tracking of key cycle time metrics and facilitating sharing of knowledge across industry and academia, as this may serve to reduce the time from index case detection to access of a vaccine during emerging infectious diseases epidemics.

中文翻译：

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绘制针对新兴传染病的疫苗临床试验中的时间使用

背景：

疫苗是防止新发传染病爆发成为流行病的有力工具，需要加快开发速度才能对持续流行的进程产生任何影响。本研究的目的是描述执行疫苗试验的时间使用情况，以确定可以加速的步骤，以改进未来新兴传染病疫苗试验的准备和规划。

方法：

我们使用混合方法来绘制疫苗试验期间可以加速的时间使用和流程步骤。在 2011-2017 年期间报告的三个全球试验数据库中注册的传染病疫苗试验有资格参加调查。我们邀请申办者通过预定义的结构化问卷为临床试验过程指标贡献数据。数据按试验阶段、疾病类型（即新发传染病或非新发传染病）、申办者类型和大陆分层。与有目的地选择的赞助商进行了定性访谈，并对访谈记录进行了专题分析。

结果：

根据包括 29,071 名受试者在内的 155 项疫苗试验的数据，52% 为 I 期，23% 为 II 期，25% 为 III 期。我们发现监管批准、受试者招募、研究执行和研究结束占疫苗试验过程的大部分周期时间。在爆发期间进行的试验中，监管和伦理批准、合同协议、站点启动和研究执行的周期时间更短。定性访谈表明，监管机构和独立伦理委员会当局尽早参与规划疫苗试验对于节省试验批准时间至关重要。此外，

结论：

监管批准、受试者招募、研究执行和结束周期时间占疫苗试验时间使用的大部分，并且是可以在疫苗试验计划和实施过程中加速的活动。我们鼓励跟踪关键周期时间指标并促进跨行业和学术界的知识共享，因为这可能有助于减少在新发传染病流行期间从指示病例检测到获得疫苗的时间。