Evaluación ética de la memoria económica de los contratos de ensayos clínicos con medicamentos en españa

Zusammenfassung

Objectives: To analyze the homogeneity of the economic report of the contracts of Spanish medical centers participating in clinical trials for detecting points of potential conflict of interest in clinical research. Material and methods: We analyzed, through a self-autoquestionnaire, the financial report of the contracts of 40 public and private healthcare facilities randomly selected. All Spanish regions are represented, including nine who have only a model contract. Results: The investigator team is the recipient majority (97.5% of cases) the economic remuneration for participating in a clinical trial. The percentage differs according to the center considered, being greater in the public setting (p=0.021) but no specified in 50% of the contracts. In all public centers and in 60% of those belonging to the private sector a price list of tests (p=0.013) is not provided. In 57.5% of the patients are paid by the promoter. In 17.5% failed to mention that the comparative drug to be supplied free of charge. And, 77.5% did not specify whether the costs of meetings relating to the clinical trial or not to include in the expenses of the promoter. Conclusions: There is a high heterogeneity in the content of the budgetary information. The implementation of a single contract model would reduce the inequalities between schools, conflict of interest and increase transparency and quality of the clinical trial.