Clinical trial Investigation in Portugal – 5 year report (2007-2011)

January 2, 2013 | By Márcio Barra

This is a long post, so please bear with me.

When I created this blog, I thought that it would be interesting to share, besides recent news that I find interesting (which sadly, are too many and come out so fast for me to write about), some academic work that I’ve written over the last months.  I still don’t know if this will be a common feature, but the appeal of sharing some original articles, with information that someone might find useful instead of just letting them sit on my computer, is great. If any of this information is helpful to you, please let me know in the comments section!

Please enjoy this article on Clinical trials applications conducted in Portugal.

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The following article concerns Clinical Trial Investigation conducted in Portugal, and presents data collected from five years worth of data, 2007 to 2011. It details:

  •  The number of PAECs – Pedidos de Autorização de Ensaio Clinicos (Portuguese for Clinical Trial Authorization Requests) – submitted to Infarmed, including the number of authorized and non authorized trials and observed tendencies
  • Information on those PAECS, like clinical trial phase and divided by Anatomical Therapeutic Chemical Classification System (ATC)
  • Sponsors of Clinical trials

The information on this document was obtained from data collected by Infarmed, more specifically by their Clinical Trials Unit – Unidade de Ensaios Clinicos Infarmed. Information from the yearly activity reports were also collected (1).

Number of clinical trials by phase and sponsors of the trials

2007

Phase Number of PAECS %
Phase I 7 5%
Phase II 30 23%
Phase III 74 56%
Phase IV 21 16%
Total 132
  • Pharmaceutical industry sponsors: 127
  • Academic sponsors: 5

Of the 132 trials, one was deemed either non valid or canceled.

2008

Phase Number of PAECS %
Phase I 3 2%
Phase II 31 21%
Phase III 100 68%
Phase IV 12 8%
Total 146
  • Pharmaceutical industry sponsors: 139
  • Academic sponsors: 7

2009

Phase Number of PAECS %
Phase I 6 5%
Phase II 27 23%
Phase III 73 64%
Phase IV 9 8%
115

 

  • Pharmaceutical industry sponsors: 103
  • Academic sponsors: 12

2010

Phase Number of PAECS %
Phase I 2 2%
Phase II 17 16%
Phase III 79 73%
Phase IV 9 8%
 Total 107
  • Pharmaceutical industry sponsors: 101
  • Academic sponsors: 6

2011

Phase Number of PAECS %
Phase I 6 7%
Phase II 19 21%
Phase III 58 66%
Phase IV 5 6%
Total 107
  • Pharmaceutical industry sponsors: 82
  • Academic sponsors: 6

2007 – 2011

Phase Total number of PAECS %
Phase I 24 4%
Phase II 124 21%
Phase III 384 65%
Phase IV 56 10%
588

Data Analysis

Analyzing the numbers, there’s a clear reduction on the total number of clinical trials submitted for authorization in Portugal over the last 5 years. From 2007 to 2011, the total number of CT submissions went down from 136 to 88, which corresponds to an approximate 35% reduction on total submissions. In 2008, however, there was a slight growth, with 10 more submissions than in 2007.

The average decision time by Infarmed went through a more positive evolution thought the years. Starting with 45 days in 2007, it went down to 43 days in 2008 and to 42 days in 2009. The average decision time remained the same in 2010 and only in 2011 did it go further down, to 41 days.

The bulk of the PAECS in Portugal were for Phase III trials, a total of 384 trials and about 65% of the total number of PAECS during 2007-2011. Phase II come in second, with a total of 124 PAECS in the 5 year period. As for phase IV and Phase I trials PAECS, phase IV PAECS stayed always in third place save for one year, 2011. Phase I trials PAECS come at last place.

PAECS by ATC Classification of the experimental medicines

2007

Code

ATC Classification

Number of PAECS

L

Antineoplastic and immunomodulators

36

J

Antiinfectives for systemic use

14

N

Nervous system

14

C

Cardiovascular system

10

B

Blood and blood forming organs

9

H

Systemic hormonal preparations

7

G

Genito-urinary system and sex hormones

6

S

Sensory organs

4

R

Respiratory system

4

A

Alimentary tract and metabolism

3

M

Musculo-skeletal system

3

D

Dermatologicals

2

V

Various

1

113

There were 132 validated and registred trials in 2007, with 131 total trials approved and one trial either canceled or deemed non-valid. The data above lacks ATC classification on 18 PAECS in 2007, information not available on the Infarmed Database.

2008

Code

ATC Classification

Number of PAECS

L

Antineoplastic and immunomodulators

43

N

Nervous system

25

J

Antiinfectives for systemic use

19

A

Alimentary tract and metabolism

13

B

Blood and blood forming organs

12

S

Sensory organs

10

C

Cardiovascular system

9

G

Genito-urinary system and sex hormones

6

M

Musculo-skeletal system

4

R

Respiratory system

3

H

Systemic hormonal preparations

1

V

Various

1

D

Dermatologicals

0

146

2009

Code

ATC Classification

Number of PAECS

L

Antineoplastic and immunomodulators

36

N

Nervous system

24

C

Cardiovascular system

12

J

Antiinfectives for systemic use

7

S

Sensory organs

7

B

Blood and blood forming organs

6

A

Alimentary tract and metabolism

5

G

Genito-urinary system and sex hormones

5

M

Musculo-skeletal system

5

H

Systemic hormonal preparations

3

D

Dermatologicals

3

R

Respiratory system

2

V

Various

0

115

2010

Code

ATC Classification

Number of PAECS

L

Antineoplastic and immunomodulators

41

N

Nervous system

11

C

Cardiovascular system

11

J

Antiinfectives for systemic use

10

A

Alimentary tract and metabolism

8

H

Systemic hormonal preparations

6

R

Respiratory system

5

S

Sensory organs

5

B

Blood and blood forming organs

4

G

Genito-urinary system and sex hormones

4

M

Musculo-skeletal system

2

D

Dermatologicals

0

V

Various

0

107

2011 

Code

ATC Classification

Number of PAECS 

L

Antineoplastic and immunomodulators

36

J

Antiinfectives for systemic use

17

N

Nervous system

11

S

Sensory organs

8

B

Blood and blood forming organs

6

G

Genito-urinary system and sex hormones

2

A

Alimentary tract and metabolism

2

M

Musculo-skeletal system

2

C

Cardiovascular system

1

H

Systemic hormonal preparations

1

R

Respiratory system

1

V

Various

1

D

Dermatologicals

0

88

2007-2011

Code

ATC Classification

Total number of Clinical Trials in the 2007-2011 time frame

L

Antineoplastic and immunomodulators

192

N

Nervous system

85

J

Antiinfectives for systemic use

67

C

Cardiovascular system

43

B

Blood and blood forming organs

37

S

Sensory organs

34

A

Alimentary tract and metabolism

31

G

Genito-urinary system and sex hormones

23

H

Systemic hormonal preparations

18

M

Musculo-skeletal system

16

R

Respiratory system

16

D

Dermatologicals

5

V

Various

3

570 (*)

(*) Data from 18 PAECS from 2007 is missing

Data Analysis

Through the last 5 years, Antineoplastic and immunomodulators drugs had the most PAECS submitted in Portugal. In 2008 and 2010 there was a rise in the number of PAECS submitted to Infarmed, while 2007, 2009 and 2011 had an equal number of PAECS for Antineoplastic and immunomodulators drug trials.
Antiinfectives drugs were one of the two classes which had more PAECS submitted in 2011 than in 2007. The highest peak was in 2008, with 2011 a few PAECS behind. They secured the 2nd place in 2011.

Drugs for the Cardiovascular system suffered the steepest decrease in the number of PAECS submitted, going from 10 in 2007 to only 1 in 2011.
As mentioned, data on 18 PAECS from 2007 is unavailable. The lacking data impact on the established ranking is thus unknown.

In the future, I will update this post with information from 2012 (when it becomes available). I will also try and contextualize the numbers with the current state of clinical trials in Portugal and the overall industry mindset at the moment.

Sources

1. Infarmed. Estatísticas de Avaliação de Ensaios Clínicos pelo Infarmed. 2011; Available from: http://www.infarmed.pt/portal/page/portal/INFARMED/MEDICAMENTOS_USO_HUMANO/ENSAIOS_CLINICOS/ESTATISTICAS/Tab/Gr%E1ficos_2006_2011.pdf.
2. Infarmed. Relatório de Actividades. 2007; Available from: http://www.infarmed.pt/portal/page/portal/SOBRE_O_INFARMED/DOCUMENTOS_INSTITUCIONAIS/relatorio%20actividades%202007-site.pdf.
3. Infarmed. Relatório de Actividades. 2008; Available from: http://www.infarmed.pt/portal/page/portal/SOBRE_O_INFARMED/DOCUMENTOS_INSTITUCIONAIS/relatorio_actividades2008.pdf.
4. Infarmed. Relatório de Actividades. 2009; Available from: http://www.infarmed.pt/portal/page/portal/SOBRE_O_INFARMED/DOCUMENTOS_INSTITUCIONAIS/Relatorio%20de%20actividades%202009.PDF.
5. Infarmed. Relatório de Actividades. 2010; Available from: http://www.infarmed.pt/portal/page/portal/SOBRE_O_INFARMED/DOCUMENTOS_INSTITUCIONAIS/Relat2010_11_04_11v3.pdf.

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