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How First-Time-in-Human Studies Are Being Performed: A Survey of Phase I Dose-Escalation Trials in Healthy Volunteers Published Between 1995 and 2004

From the Department of Pharmacology, the Danish University of Pharmaceutical Sciences, Copenhagen, Denmark (Ms Buoen, Dr Bjerrum); and Prosidion Ltd, Oxford, United Kingdom (Dr Thomsen).

First-time-in-human studies are small, time-lagged dose-escalation studies including volunteer subjects evaluating safety and tolerability. There is little consensus in the design of a first-time-in-human study, and it is difficult to get an overview of studies performed. One hundred five studies comprising 3323 healthy volunteers published in the 5 major clinical pharmacology journals since 1995 were analyzed. The average trial was placebo controlled, double blind including 32 subjects at 5 dose levels but with great variation in cohort size and dose-escalation method. The parallel single-dose design was the most common design, with the crossover designs being more frequent in the early publications. Despite discussions on the optimization of phase I trials, little seems to be happening. The development of study designs and evaluation methods for cancer trials is extensive, but formal statistically based methods and more scientific study designs are unusual in phase I dose-escalation trials in healthy volunteers.

Key Words: Phase 1 • first-time-in-man • healthy volunteers • dose escalation • new safe medicines faster

Address for reprints: Camilla Buoen, MSc, Danish University of Pharmaceutical Sciences, Department of Pharmacology, Universitetsparken 2, Copenhagen 2100, Denmark.

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