European Medicines Agency - Regulatory - Regulation of medicines

1 - Research experience and ability



  Description

Name

I-BFM-SG - International BFM Study Group

Number of completed trials 6
Number of ongoing trials 8
Total number of participants actually recruited each year
Proportion of eligible participants actually recruited each year The partecipation to the study is based on the decision of the National Study Group. According to that the proportion of eligible patients is >90%
Describe way of screening and participant recruitment ALL completed trials - IDH (1991-1995): SR ALL (355)* - Pulses (1995-2000): MR ALL (2618)* - HSCT in VHR ALL (1995-2000): VHR ALL (357)* - AIEOP-BFM ALL (2000-2006): ALL (4827)* - Interfant-99 (1999-2006): ALL below the age of one year (ALL<1y) (482)* - EsPhALL* (2004-2009): ALL positive for the t(9;22) translocation (181)* *in parentheses the number of recruited patients in each trial ALL ongoing studies - ALLIC (2002- )ALL clinical protocol for countries with limited resources - Interfant-06**( 2007- )ALL<1y - HSCT** in VHR ALL ( 2003-) - AIEOP-BFM ALL 2009 ( 2009-) - EsPhALL"bridge"study ( 2010-) **web-based trials AML ongoing studies - Relapsed AML 2001/01 (2001-) - ICC APL Study 01 (2008-) - Down Syndrome ML 2006 (2006-)
Total number of collaborating centres
Academic investigator initiated studies
Number of ongoing and completed clinical trials. Absolute number 14
Number of ongoing and completed clinical trials. Proportion of all studies
Number of paediatric specialties covered by paediatric trials] 1
Number of paediatric conditions covered by paediatric trials] 3
Number of other ongoing research studies programs]
Proportion of academic initiated studies > 90%
Proportion of budget >90% derived from governmental programs and support by charities and private foundations (differences in the proportion depend by countries)
Number of registered study participants.
All studies
8820
Number of ongoing and completed trials
Number of paediatric specialties covered by paediatric trials 1
Number of paediatric conditions covered by paediatric trialss 4
Number of registered study participants all studies