TORONTO, ON—(Marketwired – November 03, 2017) – 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.[1] Most recently in 2017, the European Medicines Agency (EMA) has revised its guidance on first–in–human trials to include additional strategies to mitigate and manage 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.[2]

Also, in recent years, first–in–human studies have become more complex, focusing on multiple parts such as single–dose ascension, multiple–dose ascension, food interactions, different age groups or gender and relative bioavailability of different formulations. While most first–in–human studies are conducted in healthy volunteers, patient populations may also need to be considered. As such, data generated during the course of these trials should be carefully reviewed and used to inform the decision to initiate a subsequent study part or to evaluate dosage selection.

Learning Objectives:

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.

  • Learn about the updated EMA guidelines on first–in–human studies and how they may impact your clinical trials
  • Discover strategies to optimize data review for safe dose escalation
  • Understand best practices in dose selection and risk mitigation

Join speakers from INC Research/inVentiv Health on Thursday, November 9, 2017 at 11am EST (4pm GMT). For more information about this complimentary event please visit: First–In–Human Studies – An Examination of the Evolving Regulatory and Clinical Practices.


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[1] French Company Bungled Clinical Trial that Led to a Death and Illness, Report Says

Science Magazine,–company–bungled–clinical–trial–led–death–and–illness–report–says

[2] Revised Guideline on First–in–Human Clinical Trials, European Medicines Agency,

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