Current Edition

Ensuring Appropriate and Reliable Data is Collected for Conclusive First-in-human/Phase I Trials

The purpose of clinical trials is to find answers to a research question by generating data to prove or disprove a hypothesis. By their very nature, first-in-human (FIH) and most Phase I trials are exploratory, and are conducted without a statistical hypothesis; and so their aim is to obtain reliable information on the safety, tolerability, pharmacokinetics and mechanism of action of a drug. Nariné Baririan at SGS explores how there are four main steps in clinical data processing, including data management and data analysis.