Phase 0 trials

Phase 0 clinical trials are a novel process involved in drug development. These trials conducted before phase I are the first phase in which humans receive a minimal amount of an agent allowing researchers to study the pharmacokinetics of a drug in humans. Phase 0 trials do not provide therapeutic effects to participants raising a controversial issue. Despite so, phase 0 trials have posed benefits as they allow for the elimination of potential drugs that have limited therapeutic efficiency. Although phase 0 trials are more expensive than preclinical trials, they help optimize the selection of drugs to advance into further human trials. Learning about phase 0 clinical trials including study design, practical considerations, benefits and challenges, standard research team, and budgetary considerations is important because it allows researchers to learn more about how they can implement phase 0 into their clinical trials to improve the drug development process.