ArticleContemporary clinical trials communications2025
Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial.
Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04459117 (Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen
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Authors and funding
9 authors.
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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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