征稿特刊

为研究不足的患者群体推进治疗

Advancing Therapeutics for Understudied Patient Groups

特刊简介：

儿童、孕产妇、老年人等研究不足人群在药物研发全周期的代表性严重不足，导致其获益 - 风险评估困难，给药方案多依赖外推，证据支撑薄弱。这类人群的生理、代谢及病理特征异于普通群体，会显著改变药物暴露量、疗效与安全性，给医患双方带来用药不确定性。填补证据缺口需整合临床前研究、临床试验方法学、模型引导药物研发及真实世界证据。

本专题旨在汇集相关研究与观点，增进对研究不足人群用药及治疗优化的理解，欢迎有助于弥合证据缺口、指导监管决策、改善该类人群个体化药物治疗的投稿。

本期特刊议题包括但不限于：

• 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.

📌本期特刊截稿日期：

June 30, 2026

复制链接查阅特刊更多信息：

https://www.ascpt.org/Resources/ASCPT-News/View/ArticleId/28743/CPT-Call-for-Papers-Understudied-Populations

期刊简介

Clinical Pharmacology & Therapeutics (CPT）是美国临床药理学与治疗学学会（ASCPT）的旗舰期刊，是实验和临床医学领域的权威跨学科期刊，致力于发表治疗学的性质、作用、疗效和评估方面的进展。

Citation Impact

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