Author: [AUTHOR] Published on 7/30/2026 12:00:00 AM
CALL FOR PAPERS
Clinical Pharmacology & Therapeutics (CPT) is seeking submissions for an upcoming themed issue on “Quantitative Clinical Pharmacology for Next-Generation Drug Development: Turning Data, Models, and Mechanisms Into Decisions.”
In this issue, we aim to highlight the latest and most innovative advancements in the use of quantitative clinical pharmacology to support drug development and therapeutic decision-making. Specifically, the issue will focus on approaches that (i) translate diverse sources of evidence into practical decisions, including dose selection, population selection, exposure-response interpretation, extrapolation, uncertainty quantification, and benefit-risk assessment; (ii) advance the application of model-informed drug development, new approach methodologies, innovative trial designs, Bayesian statistics, real-world evidence, artificial intelligence and machine learning, digital health technologies, multi-omics, and advanced therapeutics such as cell and gene therapies; and (iii) strengthen transparent, reproducible, fit-for-purpose evidence generation for regulatory, clinical, and patient-centered decision-making. Inter-disciplinary contributions illustrative of collaborative and integrated pursuit of evidence generation at the intersection of quantitative clinical pharmacology, precision medicine, biostatistics, real-world evidence and/ or pharmacoeconomic research are particularly welcome.
This themed issue will explore advances that are enabling impactful application of quantitative sciences in decision-making and evidence generation in clinical pharmacology and therapeutics. It will feature methods, models, data sources, and case studies that inform therapeutic development, regulatory evaluation, clinical practice, and implementation in patient care.
We welcome submissions on a variety of topics, including but not limited to:
- Perspectives on the intersection of statistical, clinical, and pharmacological principles in evidence generation, drug development, and regulatory decision-making
- Case studies illustrating practical implementation of the ICH M15 guideline across contexts of use (e.g., dose selection, population selection, pivotal trial design, labeling) leveraging diverse modeling methodologies (e.g., PBPK, QSP, Exposure-Response, Disease Progression Modeling, AI/ML)
- Probability of success from statistical, pharmacological, and drug development perspectives
- Causal inference methods for regulatory use of real-world evidence, including design, diagnostics, and sensitivity analyses, and HTA methods such as indirect treatment comparison (network meta-analysis, simulated treatment comparison)
- Adaptive, model-based designs for cell & gene therapies and other “one-and-done” modalities
- Case studies illustrating integration of NAMs and Model-Informed Drug Development (MIDD), Plausible Mechanism Pathway in clinical pharmacology and regulatory decision-making
- Drug repurposing as an alternative to de novo drug development
- Standards for reproducibility, reporting, and open data/code for model-informed drug development
- Federated learning and privacy-aware methods for integrating diverse sources of pharmacologic and and real-world data
- Methods for digital health technologies and continuous monitoring (wearables), including handling measurement error or missing data
- Integrated multi-omics, quantitative systems pharmacology, and statistical frameworks for precision dosing and predictive enrichment
- Uncertainty quantification, calibration, and regulatory-acceptable validation for artificial intelligence, machine learning, and hybrid mechanistic/data-driven models in drug development
Submissions of original research are particularly encouraged, but reviews, position/white papers, or perspectives are also welcome. Educational, tutorial-style papers will also be considered. In the cover letter of your submission, please state that you are responding to this Call for Papers. Please contact cpteditor@ascpt.org for details about manuscript types and format requirements, or review our Author Guidelines here.
The submission deadline for this issue is TBD. Please inquire with the editorial office.
If you would like to make a pre-submission inquiry, please contact the CPT editorial office at cpteditor@ascpt.org.
