Background Pharmacists are involved in critical steps for the performance of clinical trials (CT), such as the reception, dispensing and storage of samples.
Purpose To describe the profile and analyse the complexity level of CT.
Material and methods Descriptive and observational study. CT began in the years 2000–2018 were included. The complexity was assessed according to the classification of Calvin Lamas et al.: low complexity=6–10 points, moderate complexity=11–19 and high complexity=20–33 points. This classification is based on eight items: blinding, number of samples/CT, type of dispensation, number of pharmacy unit professionals involved, use of interactive system (IWRS/IVRS), pharmacy preparation, storage conditions and need for additional conditioning material. The complexity between the two time periods was compared (period 1=2000–2008 versus period 2=2009–2018). The following variables were also collected: name of CT, clinical units, phase, control and randomisation.
Results Two-hundred and four CT were started. There were 120 phase III (58.8%), 48 phase IV (23.5%) and 26 phase II (12.7%). One-hundred and two CT were no-blind (50%), 95 were double-blind (46.6%), five were simple-blind (2.4%) and two were triple-blind (1%). 91.2% CT were randomised and 85.1% were controlled. The median of samples/CT was 2 (0–11). 63.7% of CT had samples stored at room temperature (15°C–25°C), 21.9% refrigerated (2°C–8°C) and 14.4% both type of storage. Preparation under aseptic conditions was required for 20.6% CT. In 61.4% CT, the samples were dispensed to the investigator group and in 38.6% CT were dispensed directly to patients. Clinical units involved: oncology 16.2%, nephrology 15.7%, haematology 14.2%, pneumology 8.8%, infectious disease 7.8%, cardiology 6.9% and the rest of the units 30.4%. 12.8% of CT had high complexity, 36.8% moderate complexity and 50.5% low complexity. When comparing CT between both periods of time, 59.8% (67/112) versus 39.1% (36/92) were low complexity; 31.3% (35/112) versus 43.5% (40/92) were moderate complexity; and 8.9% (10/112) versus 17.4% (16/92) were high complexity; in periods 1 and 2, respectively.
Conclusion The most frequent CT was phase III, no-blind, randomised and controlled. Oncology, haematology and nephrology units performed almost half of the CT during the study period. Period 2 was characterised for having a higher number of high complexity CT.
References and/or acknowledgements https://core.ac.uk/download/pdf/61916246.pdf
No conflict of interest.
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