Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial
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 c...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-08-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000912 |
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| author | Mandy Wan Mark A. Turner Gilles Cambonie Ruth Kemper Naouel Bouafia Lea Levoyer Alpha Diallo Mikko Hallman Jean-Christophe Rozé |
| author_facet | Mandy Wan Mark A. Turner Gilles Cambonie Ruth Kemper Naouel Bouafia Lea Levoyer Alpha Diallo Mikko Hallman Jean-Christophe Rozé |
| author_sort | Mandy Wan |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-054e793f90fc4fa88c5c9a201fe2628a |
| institution | DOAJ |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-054e793f90fc4fa88c5c9a201fe2628a2025-08-20T02:46:43ZengElsevierContemporary Clinical Trials Communications2451-86542025-08-014610151710.1016/j.conctc.2025.101517Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trialMandy Wan0Mark A. Turner1Gilles Cambonie2Ruth Kemper3Naouel Bouafia4Lea Levoyer5Alpha Diallo6Mikko Hallman7Jean-Christophe Rozé8Guy's and St Thomas' NHS Foundation Trust, Evelina London Children's Hospital, Pharmacy Department, London, UK; Institute of Pharmaceutical Science, King's College London, London, UK; Corresponding author. Guy's and St Thomas' NHS Foundation Trust, Evelina London Children's Hospital, Evelina Pharmacy Department, Westminster Bridge Road, London, SE1 7EH, UK.Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK; Conect4children Stichting, Utrecht, NetherlandsDepartment of Neonatal Medicine and Pediatric Intensive Care, Arnaud de Villeneuve Hospital, Montpellier University Hospital, Montpellier, France; Pathogenesis and Control of Chronic Infection, INSERM, University of Montpellier, Montpellier, FranceEuropean Foundation for the Care of Newborn Infants, EFCNI, Munich, GermanyClinical Trial Safety and Public Health, ANRS|Emerging Infectious Diseases, Paris, France; Clinical Research Safety Department, INSERM, Paris, FranceClinical Trial Safety and Public Health, ANRS|Emerging Infectious Diseases, Paris, France; Clinical Research Safety Department, INSERM, Paris, FranceClinical Trial Safety and Public Health, ANRS|Emerging Infectious Diseases, Paris, France; Clinical Research Safety Department, INSERM, Paris, FranceDepartment of Pediatrics and Adolescent Medicine, Oulu University Hospital, and Research Unit of Clinical Medicine and MRC Oulu, University of Oulu, Oulu, FinlandDepartment of Neonatalogy, Nantes University Hospital, Nantes, France; Centre d'Investigation Clinique CIC1413, INSERM-Nantes University Hospital, Nantes, FranceThe 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.http://www.sciencedirect.com/science/article/pii/S2451865425000912Investigational drugsInvestigator initiated clinical trials |
| spellingShingle | Mandy Wan Mark A. Turner Gilles Cambonie Ruth Kemper Naouel Bouafia Lea Levoyer Alpha Diallo Mikko Hallman Jean-Christophe Rozé Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial Contemporary Clinical Trials Communications Investigational drugs Investigator initiated clinical trials |
| title | Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial |
| title_full | Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial |
| title_fullStr | Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial |
| title_full_unstemmed | Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial |
| title_short | Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial |
| title_sort | experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator initiated clinical trial |
| topic | Investigational drugs Investigator initiated clinical trials |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000912 |
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