Gilberto Denucci - IPD-Farma

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Additional benefits of Phase 0 • The results of Phase 0 trials can improve the efficiency and chance of success of subsequent trials. • Phase 0 trials could help to evaluate the effects of an agent at the molecular level, select the lead agent from a group of compounds, and assist in optimizing the selection of the starting dose for subsequent studies. In addition, these studies can aid in developing reasonable dose escalation schedules, whereby doses of a drug are slowly increased over time in order to find the highest dose with an acceptable level of adverse side effects in the patient.
Phase 0 for which drugs? Phase 0 trials are useful for testing targeted therapeutic drugs with wide therapeutic indexes (i.e., have a desired effect on the target without significant side effects at certain doses), as well as drugs which require development of biomarkers which may be useful for future studies. Most conventional chemotherapy drugs currently on the market have a narrow range of efficacy, or therapeutic index (i.e., doses that are effective are close to the level of doses that cause side effects). Phase 0 trials are not appropriate for drugs that have very narrow therapeutic indexes.
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Gilberto Denucci - IPD-Farma

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