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J Clin Exp Tox 2017 Volume 1 | Issue 2
Toxicology and Pharmacology
November 01-02, 2017 | Toronto, Canada
International Conference on
First-in-human studies are a key milestone in drug
development. In such studies, a drug already tested in a
preclinical setting (in vitro, animals) is tested in humans for the
first time. Study participants, who are often healthy volunteers,
face an element of risk as the ability to predict the effects
in humans is limited. In recent history, albeit in rare cases,
study subjects have experienced serious harm in such trials.
Regulatory guidelines have evolved following such events to
ensure the safety and well-being of study subjects, and most
recently in 2017 the European Medicines Agency (EMA) has
revised its guidance on first-in-human trials. The revised
guidance includes additional strategies to mitigate and mange
risks for study subjects, including guidance for the calculation
of the starting dose, rules for subsequent dose escalation and
the criteria for establishing the maximum dose. The guidance
also provides criteria to stop a study, review emerging data and
handling of adverse events in relation to the study stopping
rules. Over recent years, first-in-human studies have become
increasingly complex and include multiple parts such as single-
dose ascension, multiple-dose ascension, food interactions,
different age groups or gender, proof of concept, or relative
bioavailability of different formulations. As such data generated
during the course of the trial should be carefully reviewed and
used to inform the decision to initiate a subsequent study part
or to inform the selection of the doses to be evaluated. This
session will discuss the evolving requirements for conducting
first-in-human studies and will focus on the key regulatory and
clinical considerations in ensuring subject safety.
Speaker Biography
Beatrice Setnik has been working in the area of CNS research, clinical drug development
and abuse potential assessment for over 16 years and is an expert in the area of abuse
liability evaluation. She is currently the Vice President of Scientific and Medical Affairs
at INC Early Phase and an Adjunct Professor with the Department of Pharmacology
and Toxicology at the University of Toronto. She earned her Doctorate degree in
Pharmacology and the Collaborative Program in Neuroscience from the University of
Toronto in 2005.
e:
Beatrice Setnik
INC Research, Canada
First-in-human studies – An examination of the evolving regulatory and clinical
practices to ensure subject safety