Complejidad de los ensayos clínicos desde la perspectiva del Servicio de Farmacia

  1. Marta Calvín Lamas
  2. María Teresa Rabuñal Álvarez
  3. Fernando Busto Fernández
  4. Elena Fernández Gabriel
  5. Begoña Feal Cortizas
Atención Farmacéutica

ISSN: 1139-7357

Ano de publicación: 2012

Volume: 14

Número: 6

Páxinas: 416-423

Tipo: Artigo

Outras publicacións en: Atención Farmacéutica


Objective: To establish a method for evaluating the complexity of clinical trials (CT) from the perspective of the pharmacy department (PD), and determine the level of complexity of these CT performed at our center. Method: Retrospective, descriptive, observational study about CT started between 2008 and 2010. The study was developed in five phases: analysis of involved issues, scoring/activity allocation, CT identification, scores/CT determination and assessment of the complexity. It was determined the mean complexity: global, by medical specialty, pathology, phase and starting year. Results: 145 CT were studied. The overall average complexity was moderate (13.6 ±4.7). 33.8% of CT presented low complexity, 52.4% had moderate and 13.8% had high. The greater complexity corresponds to the oncology CTs. Conclusions: The CT complexity from the PD perspective is a measure that depends on the consumed resources and should be considered in order to secure the economic contribution received by the PD for its participation.