ArticleFrontiers in oncology2023
Project Optimus, an FDA initiative: Considerations for cancer drug development internationally, from an academic perspective.
Article in Frontiers in oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 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
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Reporting on patient's body mass index (BMI) in recent clinical trials for patients with breast cancer: a systematic review.Breast cancer research : BCR · 2024Pooled it
- Review
- Leveraging Healthy Volunteers for Anticancer Drug Clinical Pharmacology Studies: A Review Article Featuring Futibatinib as an Example.Clinical and translational science · 2026Review
- The value of target-site physiologically-based pharmacokinetics for high-affinity small molecules: a mechanistic foundation for precision dosing in oncology and hematology.Cancer chemotherapy and pharmacology · 2026Article
- Single-cell spatial pharmacobiology identifies conserved stromal barriers to therapeutic antibody delivery in human solid tumors.Nature biotechnology · 2026Article
- Regulatory challenges and current policy for cardiotoxicity detection in oncology drug development.Journal of thrombosis and thrombolysis · 2026Article
- Comparing clinical practice guidelines on the prevention and management of chemotherapy-induced hand-foot syndrome.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Review
- Intravenous Lipopolysaccharide Challenge in Healthy Participants Reveals Pharmacodynamic Markers in Blood and Bone Marrow for Early-Phase Oncology Drug Development.Clinical pharmacology and therapeutics · 2026Article
- Pioneering pharmacometrics practice in Korea: an eight-year retrospective analysis of 192 projects from the first dedicated service organization (2016-2024).Translational and clinical pharmacology · 2026Review
- Real-world outcomes of reduced-dose versus standard-dose antibody drug conjugates in metastatic breast cancer: a retrospective cohort study.Breast cancer research and treatment · 2026Article
- Model-Informed Drug Development (MIDD) for Analgesics: Review of Applications, Regulatory Integration, and Emerging Directions.Journal of pain research · 2026Review
- Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments.Clinical pharmacology and therapeutics · 2025Article
- Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials.Clinical trials (London, England) · 2025Review
- Exploring the Association Between Intra-Patient Variability in Trough Concentration of Pazopanib and Clinical Outcomes in Renal Cell Carcinoma and Soft Tissue Sarcoma Patients.Clinical pharmacology and therapeutics · 2025Article
- Window-of-opportunity trials to screen effective agents and optimize dose in breast cancer prevention.NPJ breast cancer · 2025Review
- Review
- EXCALIBER-RRMM: a phase III trial of iberdomide, daratumumab, and dexamethasone in relapsed/refractory multiple myeloma.Future oncology (London, England) · 2025Article
- Using Pharmacokinetic and Pharmacodynamic Analysis to Optimize the Dosing Regimens of Fanastomig (EMB-02) in Patients With Advanced Solid Tumors.CPT: pharmacometrics & systems pharmacology · 2025Article
- TODO: A Triple-Outcome Double-Criterion Optimal Design for Dose Monitoring-and-Optimization in Multi-Dose Randomized Trials.Statistics in medicine · 2025Article
- Opportunities for Precision Dosing of Cytotoxic Drugs in Non-Small Cell Lung Cancer: Bridging the Gap in Precision Medicine.Clinical pharmacokinetics · 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
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Modern cancer therapeutics are increasingly targeted, bringing the promise of new and improved activity, alongside better tolerability. However, while many are indeed resulting in dramatic improvements in disease control and patient survival, short- and long-term tolerability has not always accompanied it. The choice of dose and schedule is often in the upper range of the therapeutic window, driven by the maximum tolerated dose (MTD) model of previous cytotoxic agents. There is increasing recognition that this needs to change, by taking a more holistic approach to determine the optimal dose for desired biological effects and tolerability early in clinical development. In the US, the FDA's Oncology Centre of Excellence is addressing this
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What OpenQuestion holds
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.