Development of clinical trials at “Dr. Juan Bruno Zayas Alfonso General Hospital”
Keywords:
clinical trial, Good Clinical Practices, Cuba.Abstract
Introduction: In 1998 "Dr. Juan Bruno Zayas Alfonso" General Hospital in Santiago de Cuba was inserted in the National Clinical Trials network. The Good Clinical Practices Certificate since 2011 has contributed to the sanitary registration of new products and their subsequent commercialization.
Objective: To describe the experience acquired and the development achieved by the General Hospital "Dr. Juan Bruno Zayas Alfonso" in the execution of multicenter clinical trial protocols.
Methods: A descriptive study was conducted on the execution of clinical trials carried out at the "Dr. Juan Bruno Zayas Alfonso" General Hospital from 2005 to December 2020. The following variables were analyzed: promoting center, product evaluated, phase of the clinical trial, medical specialties, main indications, patients included and investigators.
Results: Thirty-nine clinical trials were carried out, mainly phase II, III and IV drug development trials, mostly from Center for Molecular Immunology and the Center for Genetic Engineering and Biotechnology. In oncological diseases, 23 (58.9 %) and 16 (41 %) investigations in various non-oncological indications were performed. The most used research products were CIMAvaxEGF, nimotuzumab, streptokinase (proctokinase) suppositories and erythropoietin. The specialties of oncology and pneumology stood out with the execution of 10 (25.6 %) and 5 (12.8 %) trials, respectively. A total of 474 patients were included and 109 investigators participated.
Conclusions: The General Hospital "Dr. Juan Bruno Zayas Alfonso", has maintained a systematic work in the execution of multicenter clinical trials and contributed to the sanitary registration of several pharmaceutical products.Downloads
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