Registry AntiMycotics (RAM)

The aim of this project is to develop a fungal disease registry which will be used for the routine collection of data from patients undergoing treatment for candidemia, aspergillosis or other invasive fungal infections. The primary focus of this registry is to collect information needed for post-approval cost-effectiveness research of new and expensive anti-fungal agents. The registry, however, will be designed for use by clinicians, infectious disease specialists, researchers, microbiologists and hospital pharmacists with the aim of providing insights into the utilization of these pharmaceuticals for the treatment of invasive fungal infections within their own organization and in the Netherlands as a whole.

Setting up a de novo patient registry, and its maintenance, is costly and time consuming. Therefore, the proposed registry uses the existing data logistics and legal frameworks of the PHARMO Institute. The development costs therefore are reduced and it is expected that setting up the registry will take three years. For representativeness, the data collection will be expanded to academic hospitals and microbiological laboratories. Furthermore, FDA part 11 certified web-modules will be employed to collect additional information of patients and medical specialists. Attention will be paid to validation and quality aspects of the data in the proposed registry. The use of the registry will be supervised by the “Stichting Werkgroep Antibiotica Beleid” (SWAB), is limited to scientific and statistical research by professional groups and must fulfill Dutch privacy laws. Through the connection with the PHARMO database, comparative research is possible with patients that use non-expensive antifungals or do not use antifungals at all allowing research into e.g., side effects of these medicines.

Website Registry AntiMycotics

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