Duilio Fuentes’s research while affiliated with National Institute of Health of Peru and other places

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.

Antecedentes: En las ciudades de Lima y Callao (Perú) se desconocen qué tipos de Medicina Alternativa y Complementaria (MAC) se aplican, así como el cómo, quiénes y dónde. Objetivo: Identificar las actividades relacionadas con la práctica y tipos de terapia de la MAC en las ciudades de Lima y Callao (Perú). Métodos: Se emplearon medios electrónicos de publicidad (Internet) y buscador comercial local, utilizando los siguientes términos: medicina alternativa y complementaria, quiropraxia, homeopatía, reiki, naturopatía, reflexología, shiatzu, fitoterapia, masoterapia, y acupuntura. Para la recolección de los datos se consideró el nombre del establecimiento, dirección, número de teléfono, distrito, terapias que aplican, procedencia (Ministerio de Salud, EsSalud, privados), documentos que respaldan su funcionamiento y el responsable del establecimiento. Resultados: Se identificaron 154 establecimientos que aplican MAC, de ellos 148 (98,6%) corresponden a Lima y 6 (1,4%) a Callao. Con respecto al tipo de terapia, se encontró que se aplica masoterapia [66], acupuntura [36], quiropraxia [35], reflexología [35], fitoterapia [23], terapia floral [23], shiatzu [23], reiki [18], homeopatía [17], mente-cuerpo [13], aromaterapia [11] y terapia neural [10]. Asimismo, de los 154 establecimientos que aplicaban MAC, 96 no señalan quién es el profesional responsable, sólo 60 lo mencionan, de los cuales el grupo mayoritario lo conforman médicos [31], seguido por los terapeutas [22]. También se encontró que de los 154 establecimientos, 107 son empresas de actividad privada y se encuentran distribuidas mayoritariamente en Miraflores, San Isidro y Surco. Conclusiones: En Lima y Callao (Perú) existen 154 establecimientos que aplican MAC, más del 90% de ellos son de naturaleza privada. En 94 (61%) de estos 154 establecimientos se desconoce quién es el responsable de aplicar la MAC; lo que podría indicar limitaciones en la eficacia, seguridad y calidad de esta práctica. Los tipos de MAC más utilizadas en los 154 establecimientos son la masoterapia, la acupuntura, la quiropraxia y la reflexoterapia.

Background: In the cities of Lima and Callao (Peru) it is unknown the type of complementary and alternative medicine (CAM) that are in use, as well as how, who and where are applied. Objectives: To identify the activities related to the practice and type of CAM in Lima and Callao (Peru). Methods: It was used electronic media advertising (Internet) and Local Business Search, using the keywords: complementary and alternative medicine, chiropractic, homeopathy, reiki, naturopathy, reflexology, shiatsu, herbal medicine, massage, and acupuncture. In the data collection it was considered the following information of every establishment: name, address, telephone number, district, therapies applied, origin (Ministry of health, EsSalud, private) documents that support its operation and the person in charge. Results: 154 establishments that apply CAM were identified, of which 148 (98.6%) correspond to Lima and 6 (1.4%) to Callao. The following are the most applied type of therapies: massage therapy [66], acupuncture [36], chiropractic [35], reflexology [35], phytotherapy [23], floral therapy [23], shiatsu [23], reiki [18], homeopathy [17], mind-body [13], aromatherapy [11] and neural therapy [10]. Additionally, from the 154 establishments that apply CAM, 96 of them did not report the person in charge, only 60 mentioned who is the responsible, of which doctors [31] constitute the largest group followed by the therapists [22]. It was also found that 107 of the 154 establishments were private sector companies and were distributed mostly in Miraflores, San Isidro and Surco. Conclusions: There are 154 establishments that apply CAM in Lima and Callao (Peru), more than 90% of them are private. In 94 (61%) of these 154 establishments it is unknown who is responsible for applying the CAM, which may indicate limitations on the efficacy, safety and quality of this practice. Massage therapy, acupuncture, chiropractic, and the reflexology are the type of CAM mostly used in the 154 establishments.

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.

This article sheds the light on historical review of the clinical trials regulatory process to the publication of the Clinical Trials Regulation in Peru, by Supreme Decree 017-2006-SA. In this context, that Regulation was amended within one year, with many critics including from the Ombudsman. It also considers the achievements as a regulatory authority that has strengthened its steering and its main objective of protecting the rights, safety and welfare of human subjects in clinical trials. Those achievements are: the internal register of clinical trials, strengthening inspections on all stakeholders that take part in research, the Notification System of Serious Adverse Events (REAS-NET), the publication of the Guideline: “Ethical, Legal and methodology in clinical trials for use of the Ethical Review Board “ which won an international award; the 1st prize in the category of fizcalization and accomplishment of the law by the Good Practice of Public Management: “Protecting the rights of human subjects in experimental studies”, the publication of the new Manual of Procedures for Clinical Trials and the implementation Plan of the National Bioethics Network in Peru.

This article sheds the light on historical review of the clinical trials regulatory process to the publication of the Clinical Trials Regulation in Peru, by Supreme Decree 017-2006-SA. In this context, that Regulation was amended within one year, with many critics including from the Ombudsman. It also considers the achievements as a regulatory authority that has strengthened its steering and its main objective of protecting the rights, safety and welfare of human subjects in clinical trials. Those achievements are: the internal register of clinical trials, strengthening inspections on all stakeholders that take part in research, the Notification System of Serious Adverse Events (REAS-NET), the publication of the Guideline: “Ethical, Legal and methodology in clinical trials for use of the Ethical Review Board “ which won an international award; the 1st prize in the category of fizcalization and accomplishment of the law by the Good Practice of Public Management: “Protecting the rights of human subjects in experimental studies”, the publication of the new Manual of Procedures for Clinical Trials and the implementation Plan of the National Bioethics Network in Peru.

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.

Se realizó una revisión de los procesos de constitución y funciones de instancias nacionales de la ética de la investigación en salud en países de Latinoamérica y Europa, que se caracterizan por su relación con la legislación y estructuras gubernamentales del ámbito de la salud, pero, sobre todo, por estar vinculados en casi la totalidad de casos con el funcionamiento de los Comités de Ética en Investigación. Sobre la base de dicha revisión se efectúa un balance primicial y perspectivas de la conformación de una Comisión Nacional de Ética de la Investigación en Salud en el Perú.

We performed a review of the constitution processes and functions of national commissions on health research ethics in Latin America and Europe countries, which are characterized by its relation with the legislation and governmental structures in health sector, but, especially, in almost totality of cases for being linked by the functioning of the Research Ethics Committees. On the basis of this review there are realized an initial balance sheet and perspectives of the conformation of a National Commission on Health Research Ethics in Peru.