Dose optimisation is a critical aspect of phase 3 studies in oncology, as it helps to ensure that patients receive the most effective dose of a new drug while minimising side effects. In oncology, the goal of dose optimisation is to achieve the maximum therapeutic benefit while maintaining patient safety.

Here are some strategies for dose optimisation in phase 3 studies in oncology:
1. Dose-finding studies: Dose-finding studies are typically conducted in earlier stages of drug development, but they can also be used to determine the optimal dose for phase 3 studies. These studies typically involve testing different doses of a drug in a small group of patients to determine the optimal dose for further testing.
2. Population pharmacokinetic modeling: Population pharmacokinetic modeling involves analysing data from phase 1 and 2 trials to estimate the optimal dose for phase 3 studies. This approach takes into account the variability in drug exposure among patients and can be used to identify patient subgroups that may require different dosing regimens.
3. Biomarker-based dosing: Biomarkers can be used to predict drug response and guide dosing in phase 3 studies. For example, some cancer drugs are only effective in patients with specific genetic mutations or expression patterns. Biomarker-based dosing can help to maximise the therapeutic benefit of a drug while minimising toxicity.
4. Adaptive dosing: Adaptive dosing involves adjusting the dose of a drug based on patient response or toxicity. This approach allows for the optimisation of dosing in real-time and can help to maximise the therapeutic benefit while minimising side effects.
5. Comparative dosing: Comparative dosing involves comparing the efficacy and safety of different doses of a drug in a head-to-head trial. This approach can help to determine the optimal dose for phase 3 studies while also providing valuable information about the safety and efficacy of different doses.

What is changing with project OPTIMUS
Project OPTIMUS (Opportunities to Promote Optimization and Targeted Investigations of Medical Products) is a new initiative launched by the U.S. Food and Drug Administration (FDA) in 2020. The goal of Project OPTIMUS is to improve the efficiency of clinical trials by optimizing dosing strategies for investigational drugs in early-phase clinical trials.
The FDA recognizes that identifying the optimal dose of an investigational drug is a critical step in drug development, but current methods for dose selection can be time-consuming and inefficient. Project OPTIMUS aims to address this issue by using innovative trial designs, advanced modeling and simulation techniques, and other tools to more efficiently determine the optimal dose of an investigational drug.
Through Project OPTIMUS, the FDA hopes to encourage sponsors to use more innovative trial designs, such as adaptive designs, and to incorporate modeling and simulation techniques into their dose optimization strategies. The initiative also aims to promote the use of biomarkers and other predictive tools to help inform dose selection and optimization.
Overall, Project OPTIMUS represents a shift in the way the FDA approaches dose optimization in early-phase clinical trials. By encouraging sponsors to use more innovative and efficient approaches to dose selection, the FDA hopes to improve the efficiency of clinical trials and accelerate the development of new therapies for patients.