4CPS-249\u2005Implementation of an integrated software for clinical trials management and automated preparation of investigational drugs in a hospital pharmacy

Abstract

Background In conducting clinical trials (CT), the hospital pharmacy is responsible for receiving, handling and dispensing investigational drugs while ensuring a high level of quality. All CT-related data are to be documented and reported in compliance with the CT protocol and good clinical practice, thereby encouraging the implementation of an information technology system to support and improve standard operating procedures management. Purpose The aim of this pilot study was to evaluate a software, specifically designed for managing investigational and non-investigational medicinal products (IMPs/NIMPs), fully integrated into the robotic compounding platform of injectable drugs. Material and methods The software was installed in the pharmacy-based Clinical Trials Unit in July 2018. IMPs/NIMPs, individual patient data, sponsor and investigator data were entered into the software database according to the ongoing CT protocols. Detailed reports were recorded, including the delivery to the CT site, the inventory at the CT site, the use by each patient, the accountability, and the return to the sponsor or alternative disposition of unused investigational drugs. Any changes to the CT protocols were traced. In addition, through the integration with the robotic compounding platform, individually prescribed doses for parenteral administration were prepared by using the supporting device for manual preparation which verifies dosing accuracy by gravimetric control and ensures identity by photographic recognition. Results Two months after the installation, about 20% of the 60 ongoing cancer CT were managed through the software, involving, overall, 25 patients. In total, 10 investigational medicinal products were entered, of which four for oral administration and six injectable drugs. Overall, 39 individually prescribed doses were manually prepared by using a workflow system for compounding. Before implementation, the dose errors were not recorded. After implementation, the mean absolute dose error amounted to ±1.56% ranging from ±0.13%\u2009to±4.29%. The automated data handling and record-keeping were ensured, thus improving quality in the preparation process and reports’ traceability. The centralised management of all documents reduced time for data entry by the pharmacy staff and minimised human errors. Conclusion The software for managing cancer CT in the hospital pharmacy, currently under validation, was successfully implemented, thereby encouraging the insertion of further CT protocols. References and/or acknowledgements No conflict of interest.