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.

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Aree 1 4 6 7 13 16 20 24 28 33 35 36 40 47
Adesioni 11 33 68 138 235 357 469 599 753 819 883 933 978 1004
Pazienti nei Trials 20 111 265 495 739 1615 2258 3023 3696 4294 5489 6976 8292 9277
Pazienti in MDS Registro 909 1036 1186 1293 1437 1615 1932 2415 3017 3563 4030 4376 4600 4693
Pazienti in Registro LMC GIMEMA 0 0 0 0 0 0 0 0 0 25 69 441 1115 1400

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 47 active work areas, related to 45 clinical trials (phase II and phase III studies) and 2 regional registry database (MDS Registro, Registro LMC GIMEMA). 387 hospitals operate in these areas with 1015 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
    ---
    Progetto EPICLIN
    Via Santena 7
    10126 Torino TO
    Italia

Email, phone and fax