gms | German Medical Science

Background: In routine, the evaluation and presentation of results from systematic searches in literature and study registries for inclusion in value dossiers requires many individual steps at the pharmaceutical company. Some of them are performed manually and across teams. Citavi^®, a reference management system, is used to manage the results of the information retrieval in our company. Until recently, only basic information of study registry entries was presented by the system import filter and detailed information had to be found through additional research on study registry websites. Additionally, Citavi^® is not available for all groups, so that, especially in cooperation with agencies, screening with inclusion/exclusion assessment was performed in Excel^®. After finalizing screening and selection, results from Excel^® were manually merged with the matching references from Citavi^® into tables for the value dossier. In the process, formatting had to be done manually and several control steps were necessary to ensure the correct mapping.

All these steps were time-consuming and error-prone due to the manual process.

Therefore, there was a need to simplify these process steps and make them more secure.

Methods / Results: In collaboration with the Citavi^® vendor and the pharmaceutical company elements were defined and created to simplify and automate these processes.
a. Improved import filters for study registry information: Additional information on the indication, study type and availability of study results is imported, matched to the respective study registry. This simplifies screening and updates.
b. Add-on for importing screening results from Excel^® back into Citavi^®: The add-on enables the import of entries from Excel^® back to the original reference. This allows, especially in collaboration with external partners, a secure and rapid assignment of screening results.
c. Citation styles for tabular presentation in appendix 4C/4D of value dossier module 4: The references are automatically converted into citations in the style required by the official template (Anlage II.6 Modul 4). Manual assignment of the screening results is therefore no longer necessary. Consequently, the tables can be created with just a few clicks.

Conclusions: These elements were successfully implemented in Citavi^® and led to a more efficient and, due to a higher degree of automation, secure processing of literature and study registry searches for value dossiers in the pharmaceutical company.

Keywords: value dossier, screening, reference management, module 4 - appendices, cooperation