Come standardizzare gli studi clinici con SAS Clinical Data Integration Massimo Bursi (DEDAGROUP LIFE SCIENCE MANAGER) & Alberto Romanelli (SAS DOMAIN EXPERT COMMERCIAL)

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Perché CDISC?

Perche’ tanta attenzione?

Perche’ tanta attenzione? CDISC Business Case 2006… le promesse! Communication & transfer of data among project teams and partners is easier A greater level of accuracy and less training with a constant process Decision making is simplified Scientists can do the science rather than being concerned with the data Opens up a wider choice of tools/technology (as long as they are standards compliant)

Perche’ tanta attenzione? CDISC standards from the beginning of a research study Researchers can save 70-90% of time and resources during the Study Start Up stage (time to first patient enrolled), and ~ 75% of non- patient participation time during Study Conduct and Analysis. Regulatory eSubmissions, using updated baseline numbers for the time and cost of getting a drug to market, it can be saved per submission: 18% of the total cost.

Perche’ tanta attenzione? An average of two years can be saved off of an average 12-year clinical development program lifecycle – just by standardizing data. Regulators have stated they will begin requiring CDISC standards for eSubmissions in the U.S. (FDA) and in Japan (PMDA) because standards enable them to use sophisticated review tools and conduct higher quality reviews Regulators do not plan to require CDISC standards for data collection; however, they are encouraging the use of standards from the start because this helps in maintaining traceability and improves data quality at the end of the study (therefore in the eSubmission).

Perche’ tanta attenzione? It is now possible to use sophisticated tools to analyze and aggregate data across studies for specific disease areas, and potentially enable the creation of databases that can serve as a repository for cross-consortia data. This type of shared data leads to opportunities for disease modeling and biomarker qualification that was previously impossible with non-standardized data. In the case of safety reporting, it was found that the time to complete an Adverse Drug Experience report was reduced from 35 minutes to less than 1 minute, on average.

Perche’ tanta attenzione? CDISC adoption encourages re-use across disease areas that require common information. CDISC allows the ability to capture patterns of data, match controlled terminologies, and reuse research concepts across different therapeutic areas.

CDISC COME OPPortunità CDISC non è solamente uno Standard Regolatorio… CDISC è oramai uno Standard Industriale! (impariamo da altri mercati!) CDISC non è un obbligo… CDISC è un’opportunità : per introdurre processi efficienti ed efficaci lungo tutta la filiera dei dati (preclinici e clinici) per utilizzare i dati al meglio i dati presenti al fine di evitare di effettuare nuovi studi (preclinica e clinica) CDISC è la metodologia che va unita ad un approccio tecnologico end-to-end

LA REALTA’ CDISC E’ ORA! Vision: Medical Innovation

Un approccio end-to-end

analytics platform for life science Un approccio end-to-end ai Life science data SAS Analytics Platform for Life Science Analisti SAS

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GRAZIE! Subtitle