The European and American Use of Exploratory Approaches for First-in-Human Studies

Exploratory approaches for first‐in‐human clinical studies have evolved over the last few years and have stimulated the issuance of national regulatory guidances in some European countries as well as the United States. With the increasing implementation of these approaches and the recent preparation...

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Published inClinical and translational science Vol. 3; no. 1; pp. 38 - 41
Main Authors Silva-Lima, Beatriz, Carlson, David, Jones, David R., Laurie, David, Stahl, Elke, Maria, Vasco, Janssens, Walter, Robinson, William T.
Format Journal Article
LanguageEnglish
Published Malden, USA Blackwell Publishing Inc 01.02.2010
John Wiley & Sons, Inc
Subjects
Biological products
Biological Products - therapeutic use
Clinical trials
Clinical Trials as Topic - ethics
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - trends
Design
Drug dosages
Drug Industry
Drugs, Investigational
eIND
Ethics, Medical
Europe
expCTA
expIND
exploratory clinical trial
fi rst-in-human studies
Good Manufacturing Practice
Humans
ICH M3
International Cooperation
Studies
Toxicology
Treatment Outcome
United States
United States
Europe
United Kingdom > UK
Belgium
France
Portugal
Germany
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Summary:Exploratory approaches for first‐in‐human clinical studies have evolved over the last few years and have stimulated the issuance of national regulatory guidances in some European countries as well as the United States. With the increasing implementation of these approaches and the recent preparation of a multiregional regulatory guidance (ICH M3 rev2), an exchange of experiences on the opportunities and challenges of exploratory clinical trials was desirable; thus, a workshop focusing on the use of this clinical approach was planned and conducted in Lisbon, Portugal, March 18–19, 2009 sponsored by the Portuguese Health Authority (INFARMED) and DIA. The structure of the workshop focused in three main areas. Regulatory representatives from Portugal, Belgium, Germany, the United Kingdom and the United States formally reviewed their experiences. This was followed by a discussion on issues from an ethics review perspective as well as an insight to the opportunities in the area of biologics. The industry perspective was presented by representatives from Merck, Pfizer, J&J, Novartis, Speedel, AstraZeneca, GSK, and Roche. Finally, through break out sessions, issues were identified to be addressed moving forward. It is the purpose of this paper to report on the outcome of this workshop. Clin Trans Sci 2010; Volume #: 1–4
Bibliography:Report of the DIA/INFARMED Sponsored Workshop "Exploratory Phase I Clinical Trials (expCTAs)-Practical Experiences from the Industry and Regulatory Perspective," March 18-19, 2009 Lisbon, Portugal.
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ArticleID:CTS174
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Report of the DIA/INFARMED Sponsored Workshop “Exploratory Phase I Clinical Trials (expCTAs)—Practical Experiences from the Industry and Regulatory Perspective,” March 18–19, 2009 Lisbon, Portugal.
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1752-8054
1752-8062
DOI:10.1111/j.1752-8062.2010.00174.x