Author: [AUTHOR] Published on 12/16/2024 12:00:00 AM

CALL FOR PAPERS

Clinical Pharmacology & Therapeutics: Pharmacometrics and Systems Pharmacology (PSP), an official journal of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), is inviting submissions for a special mini-themed issue on Applications and Innovations in Model-Based Meta-Analysis (MBMA) scheduled for publication in December 2025.

Meta-analysis constitutes the highest level of evidence generation, by using quantitative methods to aggregate and summarize results from multiple trials. MBMA expands on the traditional notions from pairwise meta-analysis and leverages key elements such as longitudinal disease and/or treatment effect trends or pharmacologic concepts. In this regard, additional and more comprehensive information can be integrated into a meta-analytic model, allowing the use of the model for simulation and prediction purposes. MBMA can be applied throughout the drug development continuum from aiding early development to informing trial design (e.g., dose or patient selection) and critical portfolio decisions extending to market access and health economics.

With the increasing incorporation of big data and artificial intelligence/machine learning (AI/ML) in drug development, the implementation of MBMA will also likely evolve, to include the various advantages that advanced analytics can provide. MBMA is fast becoming an integrated component of the model-informed drug development (MIDD) toolbox.

It is therefore essential to underscore the utilization of MBMA in general, as publications of MBMA are relatively scarce compared to, e.g., traditional pairwise meta-analysis or comparative network meta-analysis.

This proposal calls for use cases of MBMA and exploration into future directions of MBMA from the broader clinical pharmacology community. Areas of interest will include but are not limited to:

• Innovative MBMA methodologies and/or applications
• MBMA integrated into high-impact decision making
  • E.g., study design, dose selection, go/no-go based on probability of success, …
• Application of MBMA at multiple stages of drug development in a single program, or for multiple indications/molecules within a therapeutic area
• Integration of MBMA with other modeling and simulation approaches, e.g. quantitative systems pharmacology (QSP)
• Incorporation of MBMA to support regulatory engagement and interactions with health authorities
• Broad, cross-functional collaborations for MBMA model development, in particular any biostatistical or pharmacoeconomic considerations
• MBMA as an external/synthetic control arm
• Use of novel data sources for MBMA, such as real-world data (RWD)
• Utilization of AI/ML as part of the MBMA process, such as natural language processing for abstract screening
• Combination of individual- and aggregate-level data into the same MBMA

Original research articles are encouraged. Submissions may also include reviews/mini-reviews, tutorials, position/white papers, PSP case reports, and perspectives from regulatory agencies, academia, societies, and industry. Please contact alethea@ascpt.org for details about manuscript types and format requirements.

To be considered for publication in this themed issue, manuscripts should be submitted via the online submission and tracking system by June 15, 2025.