Registers as Central Real World Data Source: The Experience of the Italian Multiple Sclerosis and Related Disorders Register

Registers collecting data from clinical practice (real world data) have gained increasing interest in recent years in the sci­entific, administrative, and regulatory fields. The value of lon­gitudinal data collection in deepening knowledge about a spe­cific pathology and its healthcare complexity is increasingly recognized. This article describes the development, organ­izational structure, and technical characteristics of the Ital­ian Multiple Sclerosis and Related Disorders Register (RISM). This multicentre and prospective study gathers demograph­ic, clinical, and epidemiological data from the Italian popula­tion with multiple sclerosis and related diseases. The study, officially launched in 2015, but containing data collected since the 1990’s, currently involves the active participation of 136 specialized clinical centres and more than 80,000 enrolled pa­tients. The analysis of data in RISM allows for a detailed de­scription of the characteristics of multiple sclerosis and re­lated diseases, providing new insights useful for healthcare planning, cost evaluation, treatment efficacy and safety as­sessment, and scientific research studies. The main demo­graphic and clinical data of enrolled patients are reported, with a focus on specific study cohorts. In a continuous effort to im­prove data quality, RISM has implemented specific quality in­dicators. Starting from the RISM experience, crucial aspects such as the institutional recognition of the disease register, the contribution that register can provide in pharmacovigilance studies, the organizational and management challenges, and privacy issues are discussed.