Five Key Considerations For Writing First-In-Human Protocols Under EMA Guidelines

As pharmaceuticals move from animal to first-in-human (FIH) clinical trials, establishing appropriate strategies to minimise risk in early phase clinical trials is necessary and should be a priority for the safety and wellness of clinical trial participants, whether patients or healthy volunteers. The goal of FIH clinical trials is to study the human pharmacology, tolerability and safety of pharmaceuticals to compare how effects seen in non-clinical studies translate into humans. To further improve strategies to identify and mitigate risks for trial participants, the European Medicines Agency implemented an updated guidance in February 2018. The Guidance on Strategies to Identify and Mitigate Risks for First in Human and Early Clinical Trials with Investigational Medicinal Products addresses the important issues needing consideration during the study design process.