Marrero TR, Garcés GO, Arbolaez EM, Rodríguez RM, Méndez TR

Language: Spanish
References: 0
Page: 199-208
PDF size: 392.08 Kb.

ABSTRACT

Introduction: clinical trials are almost a unique opportunity to establish the efficacy of a certain product, as well as, the frequency and intensity in which adverse events occur.
Objective: an observational, cross-sectional descriptive study in health systems and services was carried out, as well as, the structure and process of the system were analyzed in order to characterize adverse event detection, management and reporting in clinical trials and to elaborate a strategy.
Methods: the study was carried out at “Dr. Celestino Hernández Robau” University Hospital from Santa Clara between March, 2014 and June, 2015, and the strategic plan was used as a methodological guide. Clinical researchers and trials monitored by the National Coordinating Center of Clinical Trials were taken as sample.
Results: characterization showed a moderately adequate structure since documentation and human resources were partially available, material resources were partially sufficient and more than the 64 % of professionals refer high learning needs; process was considered partially adequate since quality of medical evolutions was not considered adequate, nurse evolutions were adequate and quality of reporting moderately adequate. To solve this problem and taking into account the results obtained, an interventional strategy was elaborated to promote adverse event detection, management and reporting in clinical trials, which was evaluated by experts as appropriate.