European Medicines Agency - Regulatory - Regulation of medicines

1 - Research experience and ability



  Description

Name

PRINTO - Pediatric Rheumatology International Trials Organisation

Number of completed trials 13
Number of ongoing trials 10
Total number of participants actually recruited each year 292
Proportion of eligible participants actually recruited each year 90%
Describe way of screening and participant recruitment The number above refers to the average of the total number of patients recruited for the trials from 2006 to 2016 (industry sponsored)=2923. PRINTO performs a feasibility survey asking PRINTO centres to indicate the potential number of patients that might be eligible based on the inclusion/exclusion criteria. Once the trial is implemented a log of patients eligible and patient recruited is kept by PRINTO (for academic studies) or by the pharmaceutical industry.
Total number of collaborating centres 408
Academic investigator initiated studies
Number of ongoing and completed clinical trials. Absolute number 5
Number of ongoing and completed clinical trials. Proportion of all studies 40% (2/5)
Number of paediatric specialties covered by paediatric trials] 2
Number of paediatric conditions covered by paediatric trials] 5
Number of other ongoing research studies programs] 7
Proportion of academic initiated studies 50%
Proportion of budget 100%
Number of registered study participants.
All studies
408
Number of ongoing and completed trials 20
Number of paediatric specialties covered by paediatric trials 2
Number of paediatric conditions covered by paediatric trialss 5
Number of registered study participants all studies 244