[en] Objectives: to determine the characteristics of clinical trials (CT) developed in the Complejo Hospitalario Universitario A Coruña, to establish a scale of complexity from the perspective of pharmacy service, evaluate the complexity and to quantify the cost avoidance in investigational drugs. Material and methods: Prevalence study. Period of study: characteristics 2008- 2014 (n=422), complexity 2008-2013 (n=340), cost avoidance 2001-2012 (rheumatology CT), 2009-2014 (congenital coagulopathies CT) and 1996-2013 (prostate cancer CT). A scale of complexity was developed, its internal consistence was determinate by Cronbach´s alpha. Cost avoidance was calculated by CT, by patient and total in the period of study. Results: CT studied were phase III 60,2%, double-blind 51,0%, randomized 76,3%, international multicenter 81,8%, sponsored by pharmaceutical companies 85,1% and CT in adults 96,9%. Oncology and rheumatology carried out 56,2% of CT. Cronbach´s α of the scale of complexity was 0,738. 12,1% of CT were situated at high level and 55,0% at medium level. Total cost avoidance in rheumatology CT (n=44) was 2.813.589€, in congenital coagulopathies CT (n=11) 2.689.494€ and 696.002€ in prostate cancer CT (n=5). Conclusions: Clinical trials show an increasing trend. In commercial CT predominate phase III, double-blind and international multicenter whereas in noncommercial CT predominate phase II, open label and national multicenter. The scale of complexity developed showed internal consistence, more than 50% of CTs are located at medium level. Estimated cost avoidance in investigational drugs in CT allows to know the impact of clinical trials in the pharmaceutical expenditure.

[gl] Obxectivos: Determinar as características dos ensaios clínicos (EC) con medicamentos desenvolvidos no Complexo Hospitalario Universitario A Coruña, establecer unha escala de complexidade dende a perspectiva do servizo de farmacia, valorar a complexidade e cuantificar o custo evitado en medicamentos. Material e métodos: Estudo de prevalencia. Período de estudo: características 2008-2014 (n=422), complexidade 2008-2013 (n=340), custo evitado 2001-2012 (EC reumatoloxía), 2009-2014 (EC coagulopatías conxénitas) y 1996-2013 (EC cancro de próstata). Desenvolveuse unha escala de complexidade, determinando a consistencia interna mediante o alfa de Cronbach. Foi cuantificado o custo evitado por EC, por paciente e total no período de estudo. Resultados: Os EC estudados eran fase III 60,2%, dobre cego 51,0%, aleatorizados 76,3%, internacionais 81,8%, comerciais 85,1% e en adultos 96,9%. Oncoloxía e reumatoloxía realizaron o 56,2%. O alfa de Cronbach da escala de complexidade foi 0,738. O 12,1% dos EC tiveron complexidade alta e o 55,0% complexidade media. O custo evitado total en EC de reumatoloxía (n=44) foi 2.813.589€, en EC en coagulopatías conxénitas (n=11) 2.689.494€ e en EC en cancro de próstata (n=5) 696.002€. Conclusións: Obsérvase unha tendencia crecente nos EC realizados. Nos EC comerciais predominan fase III, dobre cego e internacionais mentres que nos non comerciais predominan fase II, abertos e multicéntricos nacionais. A escala de complexidade presenta consistencia interna e máis da metade dos EC sitúanse en nivel medio. O custo evitado estimado en medicamentos en EC permite coñecer o impacto dos EC no gasto farmacéutico.