Author: [AUTHOR] Published on 12/10/2025 10:27:00 AM
CALL FOR PAPERS
Clinical Pharmacology and Therapeutics (CPT) is seeking submissions for its upcoming special themed issue on "Advancing Therapeutics for Understudied Patient Groups," scheduled for publication in December 2026.
Understudied populations such as paediatrics, pregnant and breastfeeding women, elderly, critically ill, individuals with multimorbidity or obesity, racial minorities, and those with advanced degrees of organ dysfunction remain underrepresented across the drug development lifecycle – from early phase trials to post-marketing research. Consequently, the benefit-risk assessment in these understudied populations remains challenging, and dosing recommendations often rely on extrapolation, or the doses prescribed are often suboptimal or inadequately supported by evidence. The physiological, metabolic, and pathophysiological differences in these populations can significantly alter drug exposure, response, and safety, creating uncertainty for clinicians and patients alike. Addressing these evidence gaps requires an integrated approach spanning preclinical research, clinical trial methodology, model-informed drug development, and real-world evidence. This themed issue aims to bring together studies, perspectives, and evaluations that enhance understanding of drug use and therapeutic optimization in understudied populations across both drug development and clinical practice. We welcome submissions that help bridge persistent evidence gaps, inform regulatory and policy decisions, and ultimately improve individualised pharmacotherapy for understudied populations traditionally excluded from research; this includes the following topics, but not limited to:
- Characterising pharmacokinetics and pharmacodynamics, and optimising dosing strategies (model-informed drug development, population PK/PD modelling, physiologically based pharmacokinetic modelling) for understudied populations
- Use of AI, digital twins, machine learning, and simulation tools to inform dose selection and trial design in understudied populations
- Innovative trial designs (e.g., adaptive, pragmatic, opportunistic sampling) to enhance the inclusion of understudied populations
- Justification and evaluation of clinical trial eligibility criteria, including discussions of unnecessary exclusions
- Evaluations of regulatory guidelines and frameworks (e.g., ICH E5, E7, E21 draft, FDA MIDD initiative) including risk mitigation strategies enabling participation of women of childbearing potential, pregnant women, children, or those with organ impairment
- Barriers and facilitators to trial participation from the perspectives of sponsors, clinicians, patients, and communities
- Clinician prescribing practices, including maternal and child health contexts
- Clinician perspectives on MIDD, modelling, and evidence generation for challenging populations
- Community-level factors affecting access, trust, and participation in research
- Digital health technologies supporting drug development or clinical decision-making in understudied populations. Regulatory and ethical considerations when including paediatrics, pregnant women, and critically ill patients in clinical trials
- Improving racial diversity in clinical trials through improving access to clinical trials, increasing patient engagement, and using digital health technology.
Submissions of original research are particularly encouraged, but reviews, position/white papers, or shorter 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.
To be considered for publication in this high-profile themed issue, manuscripts should be submitted via the online submission and tracking system by June 30, 2026.
If you would like to make a pre-submission inquiry, please contact the CPT editorial office at cpteditor@ascpt.org.
