ReviewCPT: pharmacometrics & systems pharmacology2024
Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development.
Review in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Prognostic Model-Guided Randomization Improves Efficiency in Early-Phase Trials: Evidence From Surveys and Simulations.Clinical and translational science · 2026Pooled it
- From Phase Ib/II to Seamless Phase II/III: A Simulation-Based Discussion of Design Strategies for Dose Optimization and Confirmatory Phase.Clinical pharmacology and therapeutics · 2026Article
- A review of seamless phase I/II trial designs towards oncology dose optimization with examples of clinical pharmacology considerations in early drug development.European journal of clinical pharmacology · 2026Review
- Elevating the Patient Voice in Early Phase Oncology Drug Development: The Value of Patient-Reported Outcomes in Dosage Optimization Leveraging Clinical Pharmacology Principles.Clinical pharmacology and therapeutics · 2026Article
- Review
- Information borrowing in phase II randomized dose-ranging clinical trials in oncology.BMC medical research methodology · 2026Article
- The interplay between autophagy and immunogenic cell death: nanomaterial-based strategies for cancer immunotherapy.Journal of nanobiotechnology · 2026Review
- International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Review
- Optimal Dosage Justification for Datopotamab Deruxtecan in HR-Positive/HER2-Negative Breast Cancer Through Model-Informed Drug Development Approaches.Clinical and translational science · 2026Article
- Delaying cancer progression by integrating toxicity constraints in a model of adaptive therapy.NPJ systems biology and applications · 2026Article
- Oleanolic acid and its derivatives in breast cancer therapy: mechanistic insights, structural modifications, and novel delivery strategies.Frontiers in pharmacology · 2026Review
- Late-phase strategies to overcome limitations of PD-1/PD-L1 therapy: a clinical development trajectory through 2030.Frontiers in oncology · 2026Review
- Physiologically-Based Pharmacokinetic Modeling of the PARP Inhibitor Niraparib.CPT: pharmacometrics & systems pharmacology · 2026Article
- Practical Pharmacokinetic-Pharmacodynamic Models in Oncology.Pharmaceutics · 2025Review
- National Cancer Institute Cancer Treatment Tolerability Consortium: Current status and future directions.Cancer · 2025Article
- Indication-Specific Dosing and Dose-Evaluation Strategies in New Indications for Non-Oncology Monoclonal Antibodies.Journal of clinical pharmacology · 2025Review
- Oncology Dose Optimization: Tailored Approaches to Different Molecular Classes.Clinical pharmacology and therapeutics · 2025Review
- QSP modeling of loncastuximab tesirine with T-cell-dependent bispecific antibodies guides dose-regimen strategy.NPJ systems biology and applications · 2025Article
- Window-of-opportunity trials to screen effective agents and optimize dose in breast cancer prevention.NPJ breast cancer · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Project Optimus is a US Food and Drug Administration Oncology Center of Excellence initiative aimed at reforming the dose selection and optimization paradigm in oncology drug development. This project seeks to bring together pharmaceutical companies, international regulatory agencies, academic institutions, patient advocates, and other stakeholders. Although there is much promise in this initiative, there are several challenges that need to be addressed, including multidimensionality of the dose optimization problem in oncology, the heterogeneity of cancer and patients, importance of evaluating long-term tolerability beyond dose-limiting toxicities, and the lack of reliable biomarkers for long-term efficacy. Through the lens of Totality of Evidence and with the mindset of model-informed drug development, we offer insights into dose optimization by building a quantitative knowledge base integrating diverse sources of data and leveraging quantitative modeling tools to build evidence for drug dosage considering exposure, disease biology, efficacy, toxicity, and patient factors. We believe that rational dose optimization can be achieved in oncology drug development, improving patient outcomes by maximizing therapeutic benefit while minimizing toxicity.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.