Dunn, DT;
Glidden, DV;
(2019)
The Connection between the Averted Infections Ratio and the Rate Ratio in Active-control Trials of Pre-exposure Prophylaxis Agents.
Statistical Communications in Infectious Diseases
, 11
(1)
, Article 20190006. 10.1515/scid-2019-0006.
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[Statistical Communications in Infectious Diseases] The Connection between the Averted Infections Ratio and the Rate Ratio in Active-control Trials of Pre-exposure Prophylaxis Agents.pdf - Published Version Download (1MB) | Preview |
Abstract
The design and analysis of active-control trials to evaluate experimental HIV pre-exposure prophylaxis (PrEP) agents pose serious statistical challenges. We recently proposed a new outcome measure, the averted infections ratio (AIR) – the proportion of infections that would be averted by using the experimental agent rather than the control agent (compared to no intervention). The main aim of the current paper is to examine the mathematical connection between AIR and the HIV incidence rate ratio, the standard outcome measure. We also consider the sample size implications of the choice of primary outcome measure and explore the connection between effectiveness and efficacy under a simplified model of adherence.
| Type: | Article |
|---|---|
| Title: | The Connection between the Averted Infections Ratio and the Rate Ratio in Active-control Trials of Pre-exposure Prophylaxis Agents |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1515/scid-2019-0006 |
| Publisher version: | https://doi.org/10.1515/scid-2019-0006 |
| Language: | English |
| Additional information: | his work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License. https://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Keywords: | hiv, non-inferiority, active-control trials |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10079834 |
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