Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-06-30 DOI:10.1016/j.conctc.2025.101517

Mandy Wan , Mark A. Turner , Gilles Cambonie , Ruth Kemper , Naouel Bouafia , Lea Levoyer , Alpha Diallo , Mikko Hallman , Jean-Christophe Rozé

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引用次数: 0

Abstract

The management of investigational product (IP) supply is a complex endeavour when designing and delivering clinical trials. In contrast to industry-sponsored trials where IP supplies are coordinated by teams of specialists working together throughout the entire supply chain, investigator initiated clinical trials often face IP-related challenges that can result in substantial trial delays, higher costs, and even early termination of the trial. Despite the challenges faced by investigators, there has been relatively few discussions on this topic in the literature. In this short communication, we describe our experiences and the lessons learned in managing IP supply during the design and execution of a multinational paediatric investigator initiated clinical trial. These experiences are shared to provide researchers with tools and strategies to improve the future implementation of investigator-initiated clinical trials.

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在设计和交付儿科研究者发起的临床试验中与研究产品供应有关的经验和教训

在设计和提供临床试验时，研究产品（IP）供应的管理是一项复杂的工作。与由行业赞助的试验相比，知识产权供应由整个供应链中的专家团队共同协调，研究者发起的临床试验经常面临与知识产权相关的挑战，这些挑战可能导致大量的试验延迟，更高的成本，甚至提前终止试验。尽管研究人员面临着挑战，但文献中关于这一主题的讨论相对较少。在这篇简短的交流中，我们描述了我们在设计和执行一项多国儿科研究者发起的临床试验期间管理知识产权供应的经验和教训。分享这些经验，为研究人员提供工具和策略，以改进未来研究者发起的临床试验的实施。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.