Ethical and Practical Issues in Phase 1 Trials in Healthy Volunteers

Stephen Senn

doi:10.1002/9781118763070.ch4

Ethical and Practical Issues in Phase 1 Trials in Healthy Volunteers

Stephen Senn^*

^*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

2 Citations (Scopus)

Abstract

On 13 March 2006 eight healthy male volunteers entered the first phase of a 'first-in-man' study, TGN1412-HV, designed to test the safety of TGN1412, a monoclonal antibody produced by the company TeGenero. This chapter focuses on the TGN1412-HV trial, which is a useful one to use to make many points of relevance to first-in-man studies generally. The chapter highlights that careful planning is necessary for first-in-man studies and that planning is not possible without calculation. In TGN1412-HV subjects were not dosed simultaneously but at intervals of 10 minutes according to the schedule. The chapter discusses the issues that could be addressed in constructing a design and also in making statements about eventual analysis. The general message of the chapter is that careful planning is necessary for first-in-man studies and that planning is not possible without calculation.

Original language	English
Title of host publication	Statistical Methods for Evaluating Safety in Medical Product Development
Publisher	Wiley-Blackwell
Pages	84-98
Number of pages	15
ISBN (Electronic)	9781118763070
ISBN (Print)	9781119979661
DOIs	https://doi.org/10.1002/9781118763070.ch4
Publication status	Published - 23 Feb 2015

Keywords

First-in-man trials
Healthy volunteers
TGN1412-HV
Trial design

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10.1002/9781118763070.ch4

Cite this

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Ethical and Practical Issues in Phase 1 Trials in Healthy Volunteers

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Keywords

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