ABSTRACT
Abstract The present manuscript discussed some relevant aspects related to private sponsored clinical trials in dentistry. For decades, the academy has been the major responsible for research in Brazil. Distant from the trade sector, academic research has not always provided clear benefits to society. A key aspect of making benefits clearer is the process of scientific knowledge transference to decision-makers, which is, in fact, the ground of evidence-based dentistry. Although private sponsoring of clinical research seems to be part of the research progress of the business rates, investment in Brazil is lower than those observed in other countries. It is particularly important to understand that instead of creating its own rules, dentistry imported the high-quality standards originally designed for pharmaceutical studies. Therefore, it is critical to understand the original rules and how dental items are classified by regulatory agencies. In fact, knowledge about international and local regulation is a basic assumption in industry-sponsored research. Despite globalization, the identification of industry-sponsored studies through open access databases is still very hard and time-demanding. A common concern when conducting industry-sponsored trials is study biases. Fortunately, many relevant organizations, academic and industry groups, have been working seriously against that. Finally, for less experienced researchers, many aspects related to industry-sponsored studies - such as confidentiality, authorship, budget - are deeply discussed until a final version of the trial agreement can be written and signed, protecting all sides. In short, the scenario should be improved, but it already represents a nice opportunity for dental research.
Subject(s)
Clinical Trials as Topic , Brazil , IndustryABSTRACT
Objetivos. Describir las principales características de los ensayos clínicos (EC) autorizados en el Perú desde 1995 a agosto de 2012. Materiales y métodos. Se realizó un estudio transversal, en el que se revisaron todos los expedientes de protocolos de EC presentados para su evaluación y posible aprobación al INS, cuyos datos forman parte del Registro Peruano de EC. Se realizó el análisis descriptivo de los estados de aprobación de los EC, fase de estudio, especialidad, y otras características afines a ellos. Resultados. Se encontraron 1475 EC, de los cuales 1255 (85,1%) fueron autorizados. De un EC registrado el año 1995 se incrementó a 176 ensayos presentados en el 2008, disminuyendo en el 2011 a 128 ensayos. Entre los EC aprobados, el 64,1% corresponden a EC en fase III. Oncología (22,4%), Infectología (15,5%) y Endocrinología (12,7%) fueron las especialidades más estudiadas y solo el 1.19%, corresponde a enfermedades tropicales desatendidas. Los hipoglicemiantes orales, antivirales de uso sistémico y antineoplásico fueron los medicamentos más estudiados. La industria farmacéutica transnacional fue el principal patrocinador (87,1%) y ejecutor de ensayos clínicos (62,3%) los cuales se realizan mayormente en Lima. Conclusiones. Los ensayos clínicos que se realizan en el país son principalmente en enfermedades no transmisibles y son estudios en fase III. La industria farmacéutica constituye el principal patrocinador. Solo el 1.2%, corresponde a enfermedades tropicales desatendidas, lo cual muestra la poca atención a los problemas de salud de poblaciones en situaciones de vulnerabilidad.
Objective. To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012. Material and methods. Cross-sectional study, which reviewed all records of CT submitted for review and possible approval by INS, whose data are part of the Peruvian Registry of Clinical Trials. We performed a descriptive analysis of the states of the CT approval and other characteristics. Results. 1475 clinical trials were assessed, of which 1255 (85.1%) were authorized. From 1 clinical trial officially registered in 1995, its quantity increased to 176 trials submitted in 2008, and then, declined to 128 in 2011. Among the approved CT, 64.1% was in Phase III. Oncology (22.4%), infectious diseases (15.5%) and endocrinology (12.7%) were the most studied specialties and a only 1.2% were for neglected tropical diseases. The oral hypoglycemic drugs, systemic antiviral and antineoplastic agents were the most studied investigational products. The transnational pharmaceutical industry was the main sponsor (87.1%) and executors (62.3%) of clinical trials were mostly in Lima. Conclusions. Clinical trials in Peru mainly focus on noncommunicable diseases and phase III studies. The pharmaceutical industry is the main sponsor. A very small number of authorized clinical trials in Peru were for neglected tropical diseases that shows little attention to the health problems in vulnerable populations.