Publication details

Metodika pro sběr dat a vyhodnocení léčby vysoce inovativními léčivými přípravky

Title in English Methodology of data collection and evaluation of treatment with highly innovative drugs
Authors

DUŠEK Ladislav SCHWARZ Daniel BURGER Michal BLAHA Milan KOŽENÝ Pavel NĚMEČEK Karel BRABEC Petr KLIMEŠ Daniel MÁJEK Ondřej PAVLÍK Tomáš

Year of publication 2013
MU Faculty or unit

Faculty of Medicine

Description The methodology of data collection and evaluation of treatment with highly innovative drugs was developed for purposes of unified data collection and evaluation. The methodology defines range and means of collection of data on innovative drugs, as well as the process of collection and evaluation of data from clinical practice. The methododology design is in accordance with the § 39d of the Law 48/1997 Coll. and § 42 a § 43 of the Regulation 376/2011 Coll. Main objective is collection of data on innovative drugs and processing of background information necessary for the cost-effectiveness analysis and other analyses using a guaranteed, controlled, representative central database.

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