ReviewSeminars in oncology2016
Pharmacodynamic endpoints as clinical trial objectives to answer important questions in oncology drug development.
Review in Seminars in oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed.
- Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations.Cancer chemotherapy and pharmacology · 2022Trial
- Efficacy assessment in phase I clinical trials: endpoints and challenges.Annals of oncology : official journal of the European Society for Medical Oncology · 2025Review
- Exploration of Imaging Biomarkers for Metabolically-Targeted Osteosarcoma Therapy in a Murine Xenograft Model.Cancer biotherapy & radiopharmaceuticals · 2023Article
- Article
- Comparative Oncology Assessment of a Novel Inhibitor of Valosin-Containing Protein in Tumor-Bearing Dogs.Molecular cancer therapeutics · 2022Article
- Preserving the Phosphoproteome of Clinical Biopsies Using a Quick-Freeze Collection Device.Biopreservation and biobanking · 2022Article
- Early drug development in solid tumours: analysis of National Cancer Institute-sponsored phase 1 trials.Lancet (London, England) · 2022Article
- PDI inhibitor LTI6426 enhances panobinostat efficacy in preclinical models of multiple myeloma.Cancer chemotherapy and pharmacology · 2022Article
- Real-world assessment of attenuated dosing anti-PD1 therapy as an alternative dosing strategy in a high-income country (as defined by World Bank).Frontiers in oncology · 2022Article
- Prognostic/predictive markers in systemic therapy resistance and metastasis in breast cancer.Therapeutic advances in medical oncology · 2022Review
- Clinical trial challenges, design considerations, and outcome measures in rare CNS tumors.Neuro-oncology · 2021Article
- Review
- Low-dose pembrolizumab in the treatment of advanced non-small cell lung cancer.International journal of cancer · 2021Observational
- Phase 0 and window of opportunity clinical trial design in neuro-oncology: a RANO review.Neuro-oncology · 2020Article
- A Phase I Study of Ganetespib and Ziv-Aflibercept in Patients with Advanced Carcinomas and Sarcomas.The oncologist · 2018Article
- Molecular Pharmacodynamics-Guided Scheduling of Biologically Effective Doses: A Drug Development Paradigm Applied to MET Tyrosine Kinase Inhibitors.Molecular cancer therapeutics · 2018Article
- On the Design of Combination Cancer Therapy.Cell · 2017Article
- Review
- From the Broad Phase II Trial to Precision Oncology: A Perspective on the Origins of Basket and Umbrella Clinical Trial Designs in Cancer Drug Development.Cancer journal (Sudbury, Mass.)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
Analyzing the molecular interplay between malignancies and therapeutic agents is rarely a straightforward process, but we hope that this special issue of Seminars has highlighted the clinical value of such endeavors as well as the relevant theoretical and practical considerations. Here, we conclude with both an overview of the various high-value applications of clinical pharmacodynamics (PD) in developmental therapeutics and an outline of the framework for incorporating PD analyses into the design of clinical trials. Given the increasingly recognized importance of determining and administering the biologically effective dose (BED) and schedule of targeted agents, we explain how clinical PD biomarkers specific to the agent mechanism of action (MOA) can be used for the development of pharmacodynamics-guided biologically effective dosage regimens (PD-BEDR) to maximize the efficacy and minimize the toxicity of targeted therapies. In addition, we discuss how MOA-based PD biomarker analyses can be used both as patient selection diagnostic tools and for designing novel drug combinations targeting the specific mutational signature of a given malignancy. We also describe the role of PD analyses in clinical trials, including for MOA confirmation and dosage regimen optimization during phase 0 trials as well as for correlating molecular changes with clinical efficacy when establishing proof-of-concept in phase I/II trials. Finally, we outline the critical technological developments that are needed to enhance the quality and quantity of future clinical PD data collection, broaden the types of molecular questions that can be answered in the clinic, and, ultimately, improve patient outcomes.
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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.