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External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial

Accepted version
Peer-reviewed

Type

Article

Change log

Authors

Bird, SM 
Strang, J 
Ashby, D 
Podmore, J 
Robertson, JR 

Abstract

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.

Description

Keywords

Causality, Cessation, Data Monitoring Committee, Elicitation, External evidence, Randomized pilot trial

Journal Title

Contemporary Clinical Trials Communications

Conference Name

Journal ISSN

2451-8654
2451-8654

Volume Title

5

Publisher

Elsevier