External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial.
External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial.
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DOI：
10.1016/j.conctc.2017.01.006
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发表时间：
2017-03
影响因子：
1.5
通讯作者：
Parmar MKB
中科院分区：
文献类型：
--
作者：
Bird SM;Strang J;Ashby D;Podmore J;Robertson JR;Welch S;Meade AM;Parmar MKB
如果我们有理由相信N-ALIVE先导试验不会进入主试验，则基于监狱的N-ALIVE先导试验已承诺通知研究伦理委员会和参与者。在本文中，我们描述了如何从苏格兰的国家纳洛酮计划，一个相关的公共卫生政策，评估前/后的第三年的外部数据，预计通过事先征求意见的苏格兰结果在一个月前，他们发布的官方统计数据。我们总结了N-ALIVE试验指导数据监测委员会（TS-DMC）对N-ALIVE自己的中期数据以及来自苏格兰的纳洛酮释放（NOR）的审议如何导致决定在N-ALIVE试点试验中停止随机化，并建议当地主要研究者向尚未释放的已随机化囚犯提供NOR。
The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-Data Monitoring Committee (TS-DMC) on N-ALIVE's own interim data, together with those on naloxone-on-release (NOR) from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released.