Monday, March 24, 2008

Phase 0 clinical trial

Traditionally, we have been talking about the phase I to phase IV clinical trials in drug development. We start from the small trials in healthy volunteers (phase I) to dose finding or proof of concept (POC) trials (phase II) to pivotal trials (Phase III), the post-marketing trial (Phase IV). Or we start from trials for MTD (maximal tolerable dose) - Phase I to trials for MED (minimal effective dose) - Phase II. Now there comes a new phase of clinical trial - Phase 0.
According to wikipedia, "Phase 0 is a recent designation for exploratory, first-in-human trials conducted in accordance with the U.S. Food and Drug Administration’s (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies.[7] Phase 0 trials are also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was anticipated from preclinical studies. Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body).
A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best PK parameters in humans to take forward into further development. They enable base go/no go decisions to be based on relevant human models instead of relying on animal data, which can be unpredictive and vary between species."

While the term 'phase 0' is fancy and novice, the usefulness of phase 0 trials needs to be proved in the future. At this point, I guess it is just a concept from governmental agencies such NCI (national cancer institute). I doubt that the industry will really be interested in this Phase 0 trial.

1 comment:

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