External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial
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Published version
Author(s)
Type
Journal Article
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.
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.
Date Issued
2017-01-18
Date Acceptance
2017-01-14
Citation
Contemporary Clinical Trials Communications, 2017, 5, pp.100-106
ISSN
2451-8654
Publisher
Elsevier
Start Page
100
End Page
106
Journal / Book Title
Contemporary Clinical Trials Communications
Volume
5
Copyright Statement
© 2017 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/)
(http://creativecommons.org/licenses/by/4.0/)
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000399161700014&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Data Monitoring Committee
Randomized pilot trial
External evidence
Elicitation
Causality
Cessation
RANDOMIZED CLINICAL-TRIALS
HOME EMERGENCY NALOXONE
HEROIN OVERDOSE
DEATHS
RELEASE
PROGRAM
PRISON
SCOTLAND
ENGLAND
WALES
Publication Status
Published