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
Externally published	Yes

Keywords

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

Access to Document

10.1002/9781118763070.ch4

Cite this

@inbook{f677df8a340f44d7adf07f53ba312ae0,

title = "Ethical and Practical Issues in Phase 1 Trials in Healthy Volunteers",

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.",

keywords = "First-in-man trials, Healthy volunteers, TGN1412-HV, Trial design",

author = "Stephen Senn",

year = "2015",

month = feb,

day = "23",

doi = "10.1002/9781118763070.ch4",

language = "English",

isbn = "9781119979661",

pages = "84--98",

booktitle = "Statistical Methods for Evaluating Safety in Medical Product Development",

publisher = "Wiley-Blackwell",

address = "United States",

}

TY - CHAP

T1 - Ethical and Practical Issues in Phase 1 Trials in Healthy Volunteers

AU - Senn, Stephen

PY - 2015/2/23

Y1 - 2015/2/23

N2 - 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.

AB - 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.

KW - First-in-man trials

KW - Healthy volunteers

KW - TGN1412-HV

KW - Trial design

UR - http://www.scopus.com/inward/record.url?scp=84947710890&partnerID=8YFLogxK

U2 - 10.1002/9781118763070.ch4

DO - 10.1002/9781118763070.ch4

M3 - Chapter

AN - SCOPUS:84947710890

SN - 9781119979661

SP - 84

EP - 98

BT - Statistical Methods for Evaluating Safety in Medical Product Development

PB - Wiley-Blackwell

ER -

Ethical and Practical Issues in Phase 1 Trials in Healthy Volunteers

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this