EPICLIN project
COMPUTERIZATION OF DATA COLLECTION FOR EXPERIMENTAL STUDIES IN ONCOLOGY
Center of clinical epidemiology for the experimental study in oncology of the CPO Piemonte
Intro
The Centre of Clinical Epidemiology for experimental oncological studies
sets its goal in supplying methodological support to research groups, through collaboration in setting,conducting and analysing clinical studies, prioritizing on spontaneous studies rather than commercial ones.
With this aim in mind, thanks to the help and funding of Compagnia di San Paolo, in 2003 the design of the website
EPICLIN
(acronim for "EPIdemiologic CLINic") has been started in order to supply IT instruments useful for managing and collecting data (case report forms, CRFs) of trials.
Objectives
Realising a
web application
in order to facilitate
data-collection for experimental studies
(in substitution of traditional paper files), clinical monitoring and statistic analysis.
The Epiclin website has been created to favour the managing of multicentric studies in the oncological and oncoematological sphere on a national and international scale. Those studies are promoted especially by the Oncological Network of Piedmont and Valle d'Aosta, by the Italian Foundation for Lymphomas and by the Italian Foundation for Myelodysplastic Syndromes.
| 2014 | 2024 | |
|---|---|---|
| Aree | 2 | 19 |
| Adesioni | 64 | 337 |
| Pazienti nei Trials | 6019 | 14527 |
| Pazienti in MDS Registro | 4106 | 5980 |
| Pazienti in Registro LMC GIMEMA | 113 | 2887 |
Each area corresponds to a clinical study enrollment phase, follow-up or analysis.
The active centers, through specific subscriptions, can participate in multiple areas.
The MDS register has been acquired since 2008.
Methods
The web site has been developed within the Organisation by a team of computer scientists, a team coordinated by epidemiologists and experimenters of trials. Through a modular structure that guarantees the flexibility of the data-entry system, many different areas of access have been implemented, which are reserved only for authorised users and respecting all measures of security and privacy.( D.Lgs. 196/2003)
Guaranteed features:
- Continuous maintenance of the application and operativity of the host
- Admin server and assistance towards the web site users
- Security of informations implemented through a frequent data backup
In all areas there are:
- Procedures of enrollment of patients and assignment of identification codes
- Automation and control of randomising operations
- Management centralisation of medical reports on behalf of medical laboratories
- Real time registration of negative events and toxicity during therapy
- Website interface also developed in English
Outcomes
The EPICLIN website, online since May 2004, allows to collect data through the web in association with or replacing the traditional paper cards. To day there are
52
active work areas, related to
50
clinical trials (phase II and phase III studies) and
2
regional registry database
(MDS Registro, Registro LMC GIMEMA).
439
hospitals operate in these areas with
1166
subscriptions.
The uninterrupted, real-time data collection allows to evaluate the activity carried out by each centre, with a focus on completeness and formal correctness of collected data.
Conclusions
The data collection via web represents an organisational support appreciated by clinicians, with an increasement of collaborations with the Centre of Clinical Epidemiology through the years. Furthermore, the development of Epiclin carried out by human resources within the Centre allows experimenters a high flexibility in usage and a constant collaboration towards the development of different areas.
Contacts
Regular mail
-
SC Epidemiologia dei Tumori - CPO U
AOU Città della Salute e della Scienza di Torino - PO Molinette
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Progetto EPICLIN
Via Santena 7
10126 Torino TO
Italia
Email, phone and fax
- Email: info@epiclin.it
- Phone: +39 011 6336854
- Fax: +39 011 6706692