European Medicines Agency - Regulatory - Regulation of medicines

1 - Research experience and ability



  Description

Name

PEDSTART - French national paediatric research network

Number of completed trials 0
Number of ongoing trials 2
Total number of participants actually recruited each year 206
Proportion of eligible participants actually recruited each year 156
Describe way of screening and participant recruitment Within the TREOCAPA trial: the Investigators usually inform the parents before the baby is actually born but also after birth. After obtaining parental consent, the baby is included in the study. All inclusion and non-inclusion criteria are evaluated and if suitable, the child will be randomized. Several investigational team support were developed for this study: a training course was developed in collaboration with EFCNI on approaching parents for recruitment of their child into the TREOCAPA study and a Patient information sheet summary was developed to help the parents to better understand the study and facilitate the inclusions.
Total number of collaborating centres 28
Academic investigator initiated studies
Number of ongoing and completed clinical trials. Absolute number 2
Number of ongoing and completed clinical trials. Proportion of all studies 100%
Number of paediatric specialties covered by paediatric trials] 2
Number of paediatric conditions covered by paediatric trials] 2
Number of other ongoing research studies programs] 0
Proportion of academic initiated studies 56%
Proportion of budget
Number of registered study participants.
All studies
192
Number of ongoing and completed trials 2
Number of paediatric specialties covered by paediatric trials 2
Number of paediatric conditions covered by paediatric trialss 2
Number of registered study participants all studies 1