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Background: Phase I clinical trials (PICT) are the first stage a new drug is tested in humans. The effects of investigational medicinal products (IMP) in humans are therefore unknown. Hospital pharmacists have been involved in clinical trials for many years. The management of PICT by hospital pharmacists has not been described yet. Objective: The aim of the study was to analyze the management of PICT in a hospital pharmacy and to compare practices between 4 hospitals and 2 clinical research units (CRU) in France and Belgium in order to identify potential difficulties related to the management of PICT by pharmacists and to elaborate some recommendations. Methods: It was a descriptive observational study. First in a Belgian teaching hospital, we identified and characterized the management of PICT at the pharmacy. Data on PICT prescriptions with preparation were collected. Secondly, in 3 other hospital pharmacies and in 2 pharmacy services CRU we analyzed the management of PICT. A pharmacist of each pharmacy was interviewed. Results: In hospitals the majority of PICT is commercial studies conducted in oncology. At the first hospital we received 84 prescriptions for PICT with a preparation during the collect from 11 protocols. In the 2 clinical research units PICT involve healthy volunteers. In hospital pharmacies no major differences between the management of PICT and phases II and III clinical trials was observed except for the transport from pharmacy to patient. Some difficulties related to commercial bags were explained by interviewed pharmacists. Conclusions: This study highlights for the first time the management of PICT in hospital pharmacies. This is comparable to the management of phase II and III trials. Some difficulties were highlighted regarding preparations of PICT IMP: complexity, timing and non-exact volume with commercial bags. A planning with patients in PICT could be organized for pharmacies. The study could be repeated in other hospitals to confirm these results.

Clinical Trials, Phase I as Topic --- Pharmacy Service, Hospital --- Hospitals, University