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 proceedingChapterpeer-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 languageEnglish
Title of host publicationStatistical Methods for Evaluating Safety in Medical Product Development
PublisherWiley-Blackwell
Pages84-98
Number of pages15
ISBN (Electronic)9781118763070
ISBN (Print)9781119979661
DOIs
Publication statusPublished - 23 Feb 2015
Externally publishedYes

Keywords

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

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