Responsabile: Daniela Luzi
One of the principal methods to verify the results on clinical research is to investigate new drugs, therapies or medical devices under normal conditions of use. This is mainly done developing a clinical investigation plan described in detail in the clinical trial protocol that is then carried out in specific structures of the healthcare system. This process is known under the name of clinical trial. It is a complex process that involves several actors and is divided into different phases, each one regulated by national laws and international directives aiming to safeguard citizens and public health. For this reason each clinical investigation plan is carefully evaluated by Ethical Committees and Competent Authorities (in Italy the Ministry of Health and the Italian Medicines Agency) that have the task of authorizing the start-up of clinical investigations and monitoring their execution. Moreover, another crucial point is the dissemination of research results, which often do not find adequate channels of publication.
The main objectives of this research activity is to provide methods and tools that enhance the entire lifecycle of clinical trials in order to reduce both times and costs of investigations as well as facilitating the transfer of its results in daily clinical practices.
- Conceptual models that describe clinical protocols aiming at facilitating both the protocol authoring and the retrieval of information contained in these documents;
- Modelling of clinical investigation lifecycle focused in particular on information flow and document exchange in order to identify and design information systems supporting different phases of the investigation process;
- Analysis of the standards used to represent clinical data as well as their application in the context of clinical investigations in order to facilitate information exchange and system interoperability;
- Analysis of the national and European regulations adopted in investigations of both pharmaceutical products and medical devices considering also Good Medical Practice issued by international organisations.
- Methods for the analysis of information and management systems focused in particular on information and documentation flows;
- Process modelling languages,
- Standards for clinical data representation.
|Daniela Luzi||Cristiana Crescimbene||Fabrizio Ricci (ITB-CNR)|
|Fabrizio Pecoraro||Gregorio Mercurio (ITB-CNR)|