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Margarida Menezes Ferreira
ClinicalClinical TrialsTrials inin Portugal.Portugal.WellcomeWellcome !!
Margarida Menezes FerreiraMargarida Menezes FerreiraR&D CoordinationR&D Coordination
PT delegate at BWP/CHMP, CPWP/CHMP and alternate member of CAT PT delegate at BWP/CHMP, CPWP/CHMP and alternate member of CAT -- EMEAEMEA(([email protected]@infarmed.pt))
CMC Strategy Forum Europe 2009
Margarida Menezes Ferreira
ClinicalClinical TrialsTrials inin PortugalPortugal
1994 – 95 – 96 – 97 – 98 – 99 – 00 – 01 – 02 – 03 – 04 – 05 – 06 – 07 – 08 - 09 - …
Legal: DL n.º 97/95, May 10 hospital ethical committees
Legal series:National ethical committee - CEIC
DL 97/94, April 9 Lei 46/04, Aug 19
Systematic Data collection – national
databasetransition
Inicial PT regulation of CT
Increase subjects protection / scientific credibility of the results
PT adoption of EU CT Regulation
Directive 2001/20/EC
(Transposed in Lei 46/04, Aug 19 )
Directive 2003/94/EC
(Transposed in DL n.º 176/06, Aug 30 )
Directive n.º 2005/28/EC)(Transp. in DL 102/07, Abr 2)
CE ← GCP
IMP ← GMP
GCP & GMP
Progressive
regulation →
harmonization EU
Margarida Menezes Ferreira
• Subjects Protection– Information and Consent, – Recrutment procedures– Compensation / liability
• Trial– Scientific relevance– Benefit / risk Assessment
• Protocol– Objectives and means– Investigators Qualification– Human and structural resources /
research hospital facilities
• IMP Quality and Safety– Pharmaceutical quality data– Preclinical / toxicological data– Clinical data / previous human exposure
• Safety of subjects– Trial information– Protocol (population, intervention, time of
exposure, etc)
CTCT’’S ASSESSMENTS ASSESSMENT
CEIC Ethical Committee
INFARMED, I.P.Competent Authority
Margarida Menezes Ferreira
Margarida Menezes Ferreira
Consulted in April 20, 2009
EU MS nº trials population trials/100,000DK 1746 5.510.000 32BE 2113 10.660.000 20AU 1344 8.200.000 16FI 864 5.330.000 16SE 1390 9.000.000 15ND 2362 16.500.000 14FR 4024 65.070.000 6IR 362 5.980.000 6UK 3552 58.790.000 6DE 4726 82.060.000 6LUX 26 480.000 5PT 513 10.620.000 5IT 2677 59.500.000 4
Margarida Menezes Ferreira
Consulted in April 20, 2009
Margarida Menezes Ferreira
PHASE I PT = 7
• 3 cancer
• 2 ophthalmology
• 2 neurology
Consulted in April 20, 2009
Margarida Menezes Ferreira
TotalApplications completed
Applications completedon time
conclusion days(mean)
estimate performed estimate performed
27 43
2646
42
31
34
60
estimate performed
Clinical trial(legal <60 days)
35 27
variation(<35 days)
63 51
APPLICATION TYPE
CLINICAL TRIALS INFARMED2009 T1
Margarida Menezes Ferreira
COD ATC 2008 T1 ∑ ANO 2009 T1 2009 T3 2009 T4
L
N
J
B
C
S
A
R
H
M
G
D
V
Antineoplasic andImunomodulators 12 4 4
Central Nerve System 5 8 8
Anti-Infeccious diseases 3 1 1
Blood e Haematopoiesis 3 3 3
Cardiovascular System 2 2 2
Sensory Organs 2 2 2
Gastro, intestinal metabolic 5 3 3
Respiratory System 1 1 1
Skeletal Muscle 3 1 1
Genito. Urinary. Sexual 0 2 2
0
Outros 0 0 0
2
0
2
2009 T2
Endocrine System 0
Dermathologics 0
CLINICAL TRIALS INFARMED2009 T1
Margarida Menezes Ferreira
IMP IMP TypeType inin CT: Portugal vs EUCT: Portugal vs EU
Portugal UE
Origem Biológica
RadioFarm
Químicos
Origem Biológica
RadioFarm
Terapia CelularOGMsHerbal
Terapia Génica
Homeopáticos
Bio.OGMs ; Bio.D .-Plas m a;Terap ia C elu lar; Terap ia Génica; OGMs ; MBPantas H om eopáticos
= 0
Químicos
(fonte: (fonte: EudraCTEudraCT))
56%44%
56%42%
2%
Margarida Menezes Ferreira
PhasePhase andand SponsorshipSponsorship TypeType: PT : PT vsvs EUEU
0%10%20%30%40%50%60%70%80%90%
100% EU PT
Fist in man, 4%
21%
4%
19%
65%
13%
40%
12%
27%
IVIIIIII
TrialTrial PhasePhase
(fonte: (fonte: EudraCTEudraCT))
Académicos
Comerciais
Académicos
Comerciais
UE
PT
AndAnd Sponsor Sponsor typetype
80%
20%
95%
5%
Pharma
Industry
Pharma
Industry
Academy
Academy
Margarida Menezes Ferreira
One Clinical trial on its way through the approval procedure in the EU
+
++
+
-
++
+
+
+ -
Time Competent Authorities Ethics Committees
Results
0
30
60
90
120
From comunication of Dr. Hartmut Kraft, "the Importance of clinical trials shared assessment" in Conference "Intervention Strategy of Health Product Agencies: Streghtening of Cooperation and Information on Work Sharing" 12 December 2008, Paris
Margarida Menezes Ferreira
Voluntary Harmonisation Procedure(VHP)
• Supported by Heads of Medicines Agencies
• Volunteer sponsor + volunteer NCAs
• Pilot phase to start in Feb. 2009start in Feb. 2009
• Pre submission to CTFG and common assessment by participating NCAs, then the national step (formal CTA to NCA)
• Tools : • Common objectives : subjects’ safety ; IMP quality + safety; best
time frames,• A common CTA core data set, a single repository, an electronic
submission,From comunication of Dr. Hartmut Kraft, "the Importance of clinical trials shared assessment" in Conference "Intervention Strategy of Health Product Agencies: Streghtening of Cooperation and Information on Work Sharing" 12 December 2008, Paris
Margarida Menezes Ferreira
Criteria for application/selection for VHPCriteria for application/selection for VHP•• pilot phasepilot phase - only MN-CTs without MA in the EUwithout MA in the EU with the following criteria
would undergo the VHP:
– FIH MN-CTs and particularly with investigational medicinal products with known or anticipated risk factors as described in EMEA/CHMP/SWP/294648/2007.
– MN-CTs with “Critical” investigational medicinal products (limited community expertise e.g. IMP with novel modes of action, novel manufacturing process, novel administration and storage requirements, links to a class of medicinal product with recognised safety concerns, unresolved pre-clinical abnormal findings, for instance monoclonal antibodies, advanced therapies) or “Critical” MN-CTs (e.g. for limited trial populations e.g. orphan diseases, less common types of cancer, paediatrics diseases with small numbers, adult diseases with small numbers or unmet medical needs), based on NCA’s judgement, endorsed by the CTFG
– MN-CTs with very large population and where the sponsor indicates a need for harmonisation (e.g. large phase III CTs and many MS concerned)
• CTA decisions in VHP- Phase III remain on a national level.
From comunication of Dr. Hartmut Kraft, "the Importance of clinical trials shared assessment" in Conference "Intervention Strategy of Health Product Agencies: Streghtening of Cooperation and Information on Work Sharing" 12 December 2008, Paris
Margarida Menezes Ferreira
Margarida Menezes Ferreira
