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Bird SM, Strang J, Ashby D, et al. External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial. Contemp Clin Trials Commun. 2017;5:100-106doi: 10.1016/j.conctc.2017.01.006.
Bird, S. M., Strang, J., Ashby, D., Podmore, J., Robertson, J. R., Welch, S., Meade, A. M., & Parmar, M. K. B. (2017). External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial. Contemporary clinical trials communications, 5100-106. https://doi.org/10.1016/j.conctc.2017.01.006
Bird, Sheila M, et al. "External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial." Contemporary clinical trials communications vol. 5 (2017): 100-106. doi: https://doi.org/10.1016/j.conctc.2017.01.006
Bird SM, Strang J, Ashby D, Podmore J, Robertson JR, Welch S, Meade AM, Parmar MKB. External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial. Contemp Clin Trials Commun. 2017 Mar;5:100-106. doi: 10.1016/j.conctc.2017.01.006. PMID: 28424796; PMCID: PMC5389338.
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Contemp Clin Trials Commun. 2017 Mar;5:100-106. doi: 10.1016/j.conctc.2017.01.006.

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

Contemporary clinical trials communications

Sheila M Bird, John Strang, Deborah Ashby, John Podmore, J Roy Robertson, Sarah Welch, Angela M Meade, Mahesh K B Parmar

Affiliations

  1. MRC Biostatistics Unit, Cambridge CB2 0SR, UK.
  2. National Addiction Centre, King's College London, London SE5 8BB, UK.
  3. Imperial Clinical Trials Unit School of Public Health, London W12 7RH, UK.
  4. Durham University School of Applied Social Sciences, Durham DH1 3LE, UK.
  5. Edinburgh University Usher Institute of Population Health Sciences and Informatics, Edinburgh EH16 4UX, UK.
  6. Turning Point, Gloucester GL1 2HT, UK.
  7. MRC Clinical Trials Unit at University College London, London WC2B 6NH, UK.

PMID: 28424796 PMCID: PMC5389338 DOI: 10.1016/j.conctc.2017.01.006

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.

Keywords: Causality; Cessation; Data Monitoring Committee; Elicitation; External evidence; Randomized pilot trial

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