European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice



    Description

Name

 

MICYRN - Maternal Infant Child and Youth Research Network

Number of peer reviewed publications in the last 5 years 2 Greenberg, R. G., McCune, S., Attar, S., Hovinga, C., Stewart, B., & Lacaze-Masmonteil, T. (2022). Pediatric clinical research networks: Role in accelerating development of therapeutics in children. Therapeutic Innovation & Regulatory Science, 56(6), 934–947. https://doi.org/10.1007/s43441-022-00453-6 Attar, S., Price, A., Hovinga, C., Stewart, B., Lacaze-Masmonteil, T., Bonifazi, F., Turner, M. A., & Fernandes, R. M. (2024). Harmonizing quality improvement metrics across global trial networks to advance paediatric clinical trials delivery. Therapeutic Innovation & Regulatory Science. https://doi.org/10.1007/s43441-024-00663-0
Number of competitive grants obtained in the last 5 years 25 contributing with partner networks and stakeholders to developing the research plan, collecting and submitting data, writing sections for each manuscripts, and coordinating the submission for the last two manuscripts
Access to expert groups Yes MICYRN maintain a database of more than 150 methodological and scientific experts who have agreed to be available for site identification, participation to DSMB, and consultation on drug development or clinical trial design.
Capacity to answer external scientific questions Yes MICYRN can help investigators and sponsors in answering scientific questions. An intake form available on the website on MICYRN and RareKids-CAN must be filled and submitted.
Site feasibility Yes MICYRN has established a Clinical Trial consortium (see website), a group made of scientific and operational leads of Clinical trial unit or clinical research unit based at each MICYRN institution member. Every CTU or CRU has developed its own SOP. MICYRN, an ARO and a Sponsor, also has its own SOP securely stored on its sharepoint server. Those SOP are not publicly available.
Participant recruitment Yes MICYRN has established a Clinical Trial consortium (see website), a group made of scientific and operational leads of Clinical trial unit or clinical research unit based at each MICYRN institution member. Every CTU or CRU has developed its own SOP. MICYRN, an ARO and a Sponsor, also has its own SOP securely stored on its sharepoint server. Those SOP are not publicly available.
Budget calculation for studies Yes MICYRN has established a Clinical Trial consortium (see website), a group made of scientific and operational leads of Clinical trial unit or clinical research unit based at each MICYRN institution member. Every CTU or CRU has developed its own SOP. MICYRN, an ARO and a Sponsor, also has its own SOP securely stored on its sharepoint server. Those SOP are not publicly available.