A key decision that needs to be made in clinical development of oncology drugs is the selection of the dose/schedule for the new drug or new combination before a pivotal trial is conducted. Historically, the selection of a dose for future studies has centred around using the maximum tolerated dose from an initial Phase 1 study. This approach was designed for cytotoxic chemotherapeutics and not the new agents/modalities that exist today. The FDA has proposed that this historical approach is inadequate and have setup a new initiative termed Project Optimus to highlight the importance of characterising the dose and schedule. A key goal of the initiative is to emphasize the importance of selecting a dose/doses that not only maximises the efficacy but also considers the safety i.e. design studies to explore the therapeutic window.
In this Research Topic, articles exploring views and perspectives from regulatory agencies, industry and academia/healthcare providers will discuss how they interpret and plan to address the points raised by Project Optimus. The Research Topic will also contain examples and methodology articles that are of relevance to Project Optimus highlighting how modelling and simulation techniques can be used to both design and subsequently make the right choice regarding dose/doses and even individualised dose titration strategies some of which have been used in development already.
Please note: manuscripts consisting solely of bioinformatics or computational analysis of public genomic or transcriptomic databases which are not accompanied by validation (independent cohort or biological validation in vitro or in vivo) are out of scope for this section and will not be accepted as part of this Research Topic.
A key decision that needs to be made in clinical development of oncology drugs is the selection of the dose/schedule for the new drug or new combination before a pivotal trial is conducted. Historically, the selection of a dose for future studies has centred around using the maximum tolerated dose from an initial Phase 1 study. This approach was designed for cytotoxic chemotherapeutics and not the new agents/modalities that exist today. The FDA has proposed that this historical approach is inadequate and have setup a new initiative termed Project Optimus to highlight the importance of characterising the dose and schedule. A key goal of the initiative is to emphasize the importance of selecting a dose/doses that not only maximises the efficacy but also considers the safety i.e. design studies to explore the therapeutic window.
In this Research Topic, articles exploring views and perspectives from regulatory agencies, industry and academia/healthcare providers will discuss how they interpret and plan to address the points raised by Project Optimus. The Research Topic will also contain examples and methodology articles that are of relevance to Project Optimus highlighting how modelling and simulation techniques can be used to both design and subsequently make the right choice regarding dose/doses and even individualised dose titration strategies some of which have been used in development already.
Please note: manuscripts consisting solely of bioinformatics or computational analysis of public genomic or transcriptomic databases which are not accompanied by validation (independent cohort or biological validation in vitro or in vivo) are out of scope for this section and will not be accepted as part of this Research Topic.