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Características de los ensayos clínicos autorizados en el Perú, 1995-2012
Abstract
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.
... Sin embargo, en las últimas décadas la investigación clínica se ha extendido a otras regiones emergentes como Asia, África y Latinoamérica, debido a condiciones más favorables para el reclutamiento de sujetos y la reducción de costos 6 . Específicamente en Latinoamérica han aumentado progresivamente el número de estudios en países como Chile, Argentina, Perú y Colombia [7][8][9][10] . ...
... Al indagar las características del diseño metodológico de los ensayos clínicos, es posible evidenciar que en Colombia predominan ampliamente los protocolos de fase III aleatorizados, de dos grupos paralelos, doble ciego y controlados con placebo, lo cual es propio de los estudios pivotales que sustentan las solicitudes de autorización de nuevos medicamentos ante agencias regulatorias. Esto coincide con los hallazgos previos en Colombia y otros países latinoamericanos, donde dicho perfil era el más común para los estudios [7][8][9][10] . Así mismo, el número global de sujetos a enrolar en dichos protocolos es alto, lo que da cuenta que principalmente se radican estudios de confirmación terapéutica por encima de aquellos de fases exploratorias o de prueba de concepto que implican un menor tamaño de muestra. ...
... y Argentina[7][8][9] . Sin embargo, es notable la baja proporción de trastornos endocrinos, respiratorios y cardíacos observada en la muestra de protocolos, lo cual podría indicar una disminución de propensión hacia estas categorías frente a los resultados de Carreño y de Molina et al., en los cuales dichas áreas terapéuticas eran preponderantes en los ensayos clínicos en Colombia13,14 .Por otra parte, el estudio brinda un acercamiento a las características farmacéuticas de los productos involucrados en los ensayos clínicos. ...
Los ensayos clínicos son esenciales para la evaluación de la seguridad y eficacia de productos farmacéuticos. Regiones emergentes como Latinoamérica han tenido un aumento en la ejecución de este tipo de estudios, tradicionalmente concentrados en países desarrollados. El propósito de este trabajo fue identificar las principales características con relevancia metodológica y bioética de los protocolos de ensayos clínicos de medicamentos presentados en Colombia ante la agencia regulatoria nacional. Se realizó un estudio observacional descriptivo, con base en el consolidado de los protocolos radicados al INVIMA y la información de EudraCT. Se incluyeron 597 protocolos, en los que se destaca el diseño aleatorizado (83,1%) doble ciego (66,7%), controlados por placebo (57,1%) y grupos paralelos (64,5%). Las enfermedades en investigación más frecuentes fueron neoplasias (22,8%). Se observó una baja representación de poblaciones vulnerables específicas como mujeres embarazadas (0,7%) o sujetos en situación de emergencia (2,4%) y escasas formulaciones especiales para población pediátrica (3,0%). La caracterización evidencia similitudes respecto al contexto regional y sugiere factores relevantes para evaluar y planificar protocolos en centros de investigación clínica. Palabras clave: Características del estudio; Desarrollo de medicamentos; Investigación farmacéutica; Ensayos clínicos como tema; Protocolos de ensayos clínicos como tema.
... De acuerdo a la información de la OGITT del INS (34) , desde el año 1995 a la fecha se han presentado 1475 protocolos de ensayos clínicos para autorización, de ellos, obtuvieron autorización 1255 (85,1%); 78 (5,3%) no fueron autorizados; 96 (6,5%) no completaron trámites por diferentes motivos (desistimiento, abandono, suspensión, etc.), con un número importante (476) de ensayos activos y en ejecución hasta agosto del 2012. Pese a tener un número importante de ensayos aprobados y en curso, y a la complejidad administrativa o limitaciones existentes en otros países para el desarrollo de ensayos, en los últimos años existe una tendencia a disminuir el número de ensayos presentados para evaluación y posterior ejecución. ...
The regulation of clinical trials by the Government is a process of continuous change and adaptation, current challenge is to ensure the safety of participants and get balance of administrative procedures. Development and regulation of clinical trials in different countries vary according to the situation, context national or international execution, determining the insufficiency of national regulation requiring review of international regulation. The aim of this publication is to present a comprehensive overview of the role of Government in the regulation of clinical trials in different realities. It includes a review of the regulation in The European Union, The United States and some Latin American countries and finally the regulation in Peru. Contemporary trends in the regulation of clinical trials, are characterized by increasing standards of quality, ensuring the safety of the participants, promote transparency, lower bureaucratic processes and strengthening ethics IRB committees in the framework of open democratic processes, involving all stakeholders in dynamic processes based on current knowledge and changing tendencies. The challenge is to promote the development of clinical trials from the government institutions (universities, research centers, institutes, hospitals, etc.) priorizing local needs including orphan drugs, prevalent and neglected diseases, and therapeutic use of active components of local native plants.
This paper is a reflexive essay on public health research in Latin America, which is a result of the market's intervention in the manner in which research is conducted. In this regard, global conflicts of interest -caused by pharmaceutical, agroindustrial and extraction companies- influence the homogenization of the research conducted in the field of health. This is how medical education, scientific papers and marketing are useful for inserting and standardizing research formats. Likewise, free trade agreements appear as one of the strategies of the global ideology influencing the object of research, the reasons behind it and how it is conducted. These strategies tend to nullify critical thinking, which is necessary for discussing aspects that are absent from most studies on public health. An example of this would be the influence of environmental pollution on human health, one of the most concerning issues for the Latin American population.
The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide.
Shifts in clinical trial application rates over time indicate if the attractiveness of a country or region for the conduct of clinical trials is growing or decreasing. The purpose of this observational study was to track changes in drug trial application patterns across several EU countries in order to analyze the medium-term impact of the EU Clinical Trials Directive 2001/20/EC on the conduct of drug trials.
Rates of Clinical Trial Applications (CTA) for studies with medicinal products in those six countries in the EU, which authorize on average more than 500 trials per year, were analyzed. Publicly available figures on the number of annually submitted CTA, the distribution of trials per phase and the type of sponsorship were tracked; missing data were provided by national drug agencies.
Since 2001, the number of CTA in Italy and Spain increased significantly (5.0 and 2.5% average annual growth). For Italy, the gain was driven by a strong increase of applications from academic trial sponsors; Spain's growth was due to a rise in trials run by commercial sponsors. The Netherlands, Germany, France and the UK saw a decline (1.9, 2.3, 3.0 and 5.3% average annual diminution; significant (P < 0.05) except for Germany) in clinical drug trials. The decrease in the UK was caused by a sharp fall in academic trial activities. Across the six analyzed countries, no EU-wide trial-phase-specific patterns or trends were observed.
The EU Clinical Trials Directive 2001/20/EC did not achieve the harmonization of clinical trial requirements across Europe. Rather, it resulted in the leveling of clinical trial activities caused by a continuing decrease in CTA rates in the Netherlands, Germany, France and the UK. Southern European countries, Italy and Spain, benefited to some extent from policy changes introduced by the Directive. In Italy's case, national funding measures helped to considerably promote the conduct of non-commercial trials. On the other hand, the EU Directive-driven transition from liberal policy environments, based on non-explicit trial approval through notifications, towards red-taped processes of trial authorization, contributed to the decreases in trial numbers in Germany and the UK. In the latter case, national research governance concerns had a share in the country's marked decline. However, different EU member states successfully developed best practices, which a new European legislation should take into consideration to resume Europe's attractiveness and international competitiveness for the conduct of clinical trials.
To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil.
Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features.
A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil.
No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.
In a trend that has received surprisingly little attention, contract research organizations (CROs) have gradually taken over much of academia's traditional role in drug development over the past decade. Dr. Miriam Shuchman reports.
Clinical practice is changing rapidly. New cardiovascular drugs, antiinflammatory drugs, cancer chemotherapy, and other pharmacologic weapons are being added to physicians' therapeutic armamentarium virtually daily. Most clinical studies that bring new drugs from bench to bedside are financed by pharmaceutical companies. Many of these drug trials are rigorously designed, employing the skills of outstanding clinical researchers at leading academic institutions. But academic medical centers are no longer the sole citadels of clinical research. The past 10 years have seen the spectacular growth of a new research model. Commercially oriented networks of contract-research organizations (CROs) and site-management organizations (SMOs) have altered . . .
One of the critical issues to be discussed at the next World Health Assembly (Geneva May 22–26) will be a resolution about a global framework on essential health research and development. Over past years the crisis in research and development in the worldwide pharmaceutical industry and in particular the absence of research and development for new medicines targeting diseases that mainly affect people in developing countries (neglected diseases) has become a global concern. This worrying situation is clearly shown by the number of drugs targeting neglected tropical diseases. From 1975 to 1999 only 13 drugs from 1393 new chemical entities (NCE) marketed were indicated for a neglected disease. The 13 drugs included four for malaria and nine for the most neglected diseases. Three more drugs could be added if tuberculosis is included in the analysis (table). (excerpt)
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