European Medicines Agency - Regulatory - Regulation of medicines

1 - Research experience and ability



  Description

Name

FP-MCRN - Family Pediatricians Medicines for Children Research Network)

Number of completed trials 1
Number of ongoing trials 1
Total number of participants actually recruited each year 4200
Proportion of eligible participants actually recruited each year 3400
Describe way of screening and participant recruitment The FP-MCRN can survey more than 6.000.000 Italian children.The merit of FP is their close elective involvement with children and their families. In Italy, a FP generally establishes a very strong and close “pediatrician-parents” and “pediatrician-child” relationship. For this reason it become easier the capacity to assess and involve outpatients in clinical trials. Practical reasons:1) Numbers of patients;2)FP as a member of the family;3) Direct relationship with the children;4) Presence of territorial pathologies;5) Frequency of the contacts out-patient both in ambulatory and domiciliary : Importance of the family communication. 1)Explain in simple way, easily comprehensible and with sincerity; 2)Reassurance on:importance of the benefits,risks minimisation; experience of the pediatricians; the policy privacy;the protection of the data;3)Correct information and family consent ;4) Correct Information and Children Assent
Total number of collaborating centres 3
Academic investigator initiated studies
Number of ongoing and completed clinical trials. Absolute number 0
Number of ongoing and completed clinical trials. Proportion of all studies 100%
Number of paediatric specialties covered by paediatric trials] 3
Number of paediatric conditions covered by paediatric trials] 3
Number of other ongoing research studies programs] 1
Proportion of academic initiated studies 100% of the budget derived from governmental programs (AIFA PhVG Call 2008-2009 and AIFA PHVG Call 2010-2011) AIFA
Proportion of budget The budget handled for complete and ongoing trials is derived from FP-MCRN Onlus funding sources (AIFA Pharmacovigilance Call 2008-2009 and 2010-2011)
Number of registered study participants.
All studies
1
Number of ongoing and completed trials 2
Number of paediatric specialties covered by paediatric trials 3
Number of paediatric conditions covered by paediatric trialss 3
Number of registered study participants all studies 1