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Agenzia Italiana del Farmaco - Italian Medicines Agency
Rome, ITALY
The Italian Monitoring Centre for Clinical Trials:
an effective tool and source of information
http://oss-sper-clin.agenziafarmaco.it/
INTRODUCTION
MATERIALS AND METHODS
What is OsSC
Goals
• A public information tool for Italian clinical trials on medicines
• A link with EudraCT and Eudravigilance
• An important window for Italian clinical research
• Creating a real network among health professionals
• Modernizing the Italian system of applied research in the health field
• Encouraging investments in clinical research in Italy
• Promoting phase I and II trials
• Giving unquestionable references to those who work in the clinical
research branch
What does it contain
List of Italian clinical trials / Ethics Committees / certified private sites
Whom does it inform
Information collected for each study
Ethics Committees / Sponsors / CROs / clinical researchers /
Local Health Units / competent authorities / people
• General information, i.e.:
- Protocol title, code and file
- Sponsor and participating institutions
- Study design (phase, randomization, etc.)
- International Code Disease, MedDRA
- Drug(s) information (name, dosage, route, etc.)
- Eligibility (inclusion and exclusion criteria)
- Study population (age, gender) and duration of the study
• Administrative information, i.e.:
- Study evaluation (date, approval/rejection, etc.)
- Opening of the study for subjects’ enrolment
- Study status (open/ongoing/closed) and patients’ accrual
- Conclusion of the study and results
Control activities
• Avoiding identical research projects
• Fostering uniformity and harmonization of local authorization procedures
• Defending citizens and patients, improving transparency, credibility and
access to clinical research
Support activities
• Supplying clinical trial sites physicians, paramedical and administrative
personnel with training and information
• Fostering administrative simplification
• Speeding up authorization procedures
Guideline activities
• Bringing up to date rules in order to promote standardization and quality of
processes
• Determining priority sectors in the field of health care in which furthering
and assisting clinical research
Official publications
• “Annual Report” on clinical trials in Italy
• “Bulletin” on clinical trials in Italy (periodical updating)
(also available on-line on the OsSC’s web site)
RESULTS
Clinical trials per year
Year
2000
2001
2002
2003
2004
2005
I sem. 2006
Total
80%
CT
555
605
558
566
606
621
328
3,839
Therapeutic branch
%
72.7
27.3
443
11.5
Immunology and infectious diseases
363
9.5
Neurology
311
8.1
Gastroenterology
272
7.1
Endocrinology
224
5.8
Respiratory system diseases
163
4.2
Nephrology/Urology
129
3.4
Hematology
128
3.3
Psychiatry/Psychology
108
2.8
Musculo-skeletal system diseases
105
2.7
Ophthalmology
98
2.6
Dermatology/Plastic surgery
85
2.2
Rheumatology
82
2.1
Gynecology and obstetrics
70
1.8
Genito-urinary system
66
1.7
Anesthesiology
55
1.4
Pharmacology/Toxicology
32
0.8
Pediatrics/Neonatology
23
0.6
Otolaryngology
14
0.4
National
50%
40%
30%
20%
2000
189
2001
2002
2003
2004
2005
I sem.
2006
Phase II and III CTs in Italy
80%
Phase III
Phase II
Total
60%
50%
(Local health units,
Hospitals, Public/Private
Institutes of Research
and Care, Scientific
associations,
Universities, Research
organizations,
Foundations,
Governmental bodies)
40%
3,839
100.0
494
27.5
Cardiology/Vascular diseases
(pharmaceutical
companies)
1,048
1,055
60%
70%
No profit
%
Oncology
International
Sponsors
305
CT
70%
Clinical trials per Sponsor
type: profit / no profit
Sponsor type
CT
Profit
2,791
Clinical trials per therapeutic branch
Multi-centre CTs typology in Italy
30%
Traumatology and emergency medicine
7
0.2
20%
Odontology and maxillofacial surgery
6
0.2
3,839
100.0
2000
2001
2002
2003
2004
2005
I sem.
2006
Total
CONCLUSIONS
OsSC is a snapshot of Italian clinical research and a leading instrument capable of identifying less investigated therapeutic areas and promoting specific projects
in order to meet patients’ demands.
Could OsSC be something more?
• A place for scientific discussions
• A network facilitating information interchange and fast communications among all the trials’ participants (ECs, Sponsors, Competent Authorities)
• On-going update for professional users
• On-line Journal
Clinical Trial Unit - [email protected]
Tomino Carlo, Aita Paola, Barchetti Maria Federica, Caciolli Sergio, Coppari Roberta, de Gregori Simona, De Nigro Luca,
Galluccio Antonio, Guglielmi Fulvia, Marchetti Marisa, Misticoni Consorti Adele, Raimondo Simonetta, Russo Maria Elena