ReviewClinical cancer research : an official journal of the American Association for Cancer Research2025
FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.
Review in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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
4 citing papers in PubMed.
- A modular framework for antibody-drug conjugate biomarkers.Nature reviews. Clinical oncology · 2026Review
- Population Pharmacokinetics and Model-Informed Dose Optimization of Teicoplanin in Adults with Hematological Malignancies.Pharmaceutics · 2026Article
- Late-phase strategies to overcome limitations of PD-1/PD-L1 therapy: a clinical development trajectory through 2030.Frontiers in oncology · 2026Review
- FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early-Phase Trials Using Innovative Trial Designs and Biomarkers.Clinical cancer research : an official journal of the American Association for Cancer Research · 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
9 authors.
Funding
Abstract
The MTD has historically been the recommended phase II dose, and this dosage has typically been evaluated in registrational clinical trials for oncology drugs. With the emergence of targeted therapies, this approach may lead to the investigation of unnecessarily high dosages that elicit additional toxicity without added benefit. The utilization of innovative trial designs and model-informed approaches during clinical development can potentially lead to more informed dosage selection. Exposure-response analyses, clinical utility index, and other model-informed approaches have been successfully applied to understand preliminary activity and safety data for various classes of modern oncology drugs, providing insights to support the proposed dosage(s) for the registrational trial. Seamless trial designs have also played an important role in dosage selection by leveraging preplanned flexibilities and statistical procedures to increase efficiency during the conduct of trials. Critically, both approaches can be fit for purpose, allowing for adaptation and the usage of the totality of relevant clinical and nonclinical data. Despite this, the evaluation of MTD remains prevalent in registrational trials. This article, the third in a series of three describing best-practice approaches to dosage optimization in oncology drug development, highlights successful applications of and relevant considerations for innovative trial designs and model-based approaches to aid the selection of better optimized dosages for evaluation in registrational clinical trials.
Indexed as
Identifiers
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.