Clinical trials for medicines

Afssaps

Description

Other topics
24/04/2012

Informations

• Publié par: ansm-other-topics
• Publié le: 24 avril 2012
• Nombre de lectures: 49
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English

Extrait

27,40%
39,80%
10,00%

31,63%
37,39%
10,11%

27%
16%

28%
18%
13%
6%

28%
18%
10%
7%

69%
31%

21,80%

31,70%
35,80%
9,70%

2011

914/871

1791

Oncology and hematology
Central nervous system
Infectious diseases

Cardiovascular diseases

Clinical trials for medicines (not including cell treatment or gene therapy)
ACTIVITY STATEMENT

Afssaps- april 2012

therapy)
Applications features

2008

1050/1000

960/920

941/903

10%
8%

2009

2010

1023

1440

Phase 1 :

Number of applications for authorisation of
susbstantial amendments (SA)

Industry
Institutionnal

Number of clinical trial authorisation (CTA)
applications /Number of clinical trials

1609

Phases distribution

74%
26%

73%
27%

Phase 2 :
Phase 3 :
Phase 4 :

Sponsors distribution

Therapeutic area distribution (the 4 most
important)

27%
16%
7%
10%

27,4%
37,1%
10,0%

21,90%

20,33%

74%
26%

24,8%

66 / 83 (80%)

7

1391

51844

5,9

48742

1095

20,6

39,9

/

42,1

15,8

41,3

37

40
1624

704
0

106 (12,2%)

72 (7,2%)

88 (9,5%)

790
0
67
959

753
0
43
1232

90 (10%)

723
1
42
1362

not including recevability (days)

including recevability (days)
Mean time of SA including recevability
(days)
Safety

20,9

/

41,9

/

12

Afssaps- april 2012

51380

Suspected unexpected serious adverse
reaction (SUSAR) reports
DSUR (Development Update Safety
Reports)
VHP (Voluntary Harmonisation Procedure
)
Number of clinical trials (including cell
treatment or gene therapy) involving
France/Number of clinical trials following
VHP (%)
Number of clinical trials with France as
Leading Member State
Mean time of national CTA including
recevability post CTFG (days)

* total notifications (initial + follow up; France+ foreigner)

861

21,3

1070

48562

Afssaps assessment
Number of CTA approved
Number of refusal
Number of withdrawal of applications
Number of SA approved

Clinical trials in children

Assessment performance by Afssaps

4,1

4,3

7

19/27 (70%)

Mean time of CTA :

Afssaps- april 2012