Early public research funding response to COVID-19 pandemic in Brazil

Abstract INTRODUCTION: This study investigated the role of early public research funding regarding the COVID-19 pandemic in Brazil. METHODS: We examined the budget for research projects relating to the number of cases and deaths and the relationship between each federal unit, gross domestic product (GDP) per capita, and the national GDP per capita. RESULTS: Using data from the websites of official funding agencies and the Brazilian government, we found that, in the first four months since the first case in Wuhan, China (December 31, 2019), around US$ 38.3 million were directed to public funding for scientific investigations against the COVID-19 pandemic. However, only 11 out of 27 federal units provided funding during the initial stages of the outbreak, and those that did provide financing were not necessarily the units having the most inhabitants, highest GDP, or the greatest number of cases. The areas of research interest were also identified in the funding documents; the most common topic was "diagnosis" and the least common was "equipment for treatment." CONCLUSIONS: Brazilian researchers had access to funding opportunities for projects against COVID-19. However, strategies to minimize the economic impacts of COVID-19 are crucial in mitigating or avoiding substantial financial and social shortcomings, particularly in terms of an emerging market such as Brazil.

Importancia de la investigación clínica independiente en la medicina: dificultades y recomendaciones / Importance of independent clinical research in medicine: difficulties and recommendations

Resumen La investigación clínica es la herramienta de mayor importancia para la identificación de estrategias diagnósticas y terapéuticas que deriven en mayor eficacia y seguridad. A pesar de su trascendencia, la implementación exitosa de la investigación clínica presenta numerosas dificultades; entre las más relevantes se encuentra la poca disponibilidad de recursos para realizar ensayos clínicos independientes. Por lo general, la industria farmacéutica absorbe los costos asociados con la mayoría de los ensayos clínicos, sin embargo, esto puede generar una disociación entre los temas de interés y las prioridades en salud, al existir interés económico como principal motivación de estos protocolos. Además del papel relevante de la industria farmacéutica, es importante que las instancias gubernamentales favorezcan las condiciones, tanto económicas como regulatorias, para la implementación de investigación clínica independiente, que aborde temas de interés médico y terapéutico, aunque no genere beneficios económicos empresariales.

Abstract Clinical research is the most important tool for the identification of diagnostic and therapeutic strategies that derive in higher efficacy and safety. Despite its significance, successful implementation of clinical research faces numerous difficulties, with one the most relevant being limited availability of resources for the performance of independent clinical trials. Generally, the pharmaceutical industry absorbs the costs associated with most clinical trials; however, this can generate dissociation between subjects of interest and health priorities when economic interest is the main driver of these protocols. In addition to the relevant role played by the pharmaceutical industry, it is important that government agencies favor adequate conditions, both in economic and regulatory aspects, for the implementation of independent clinical research that addresses subjects of medical and therapeutic interest, even if it does not generate corporate economic benefits.

Diabetes research in Mexico: a map of 13 years of public funding / La investigación en diabetes en México: un mapa de 13 años de financiamiento público / Pesquisa em diabetes no México: um mapa de 13 anos de financiamento público

Abstract: In Mexico, diabetes represents a serious public health problem and a high-cost disease for the health system. Health research is essential for generating new knowledge to combat such a serious issue, however, there is not enough information on how to generate and use it. This paper examines the public funding of 303 diabetes research projects, granted by the National Council of Science and Technology in Mexico between 2002 and 2014. The projects were systematized and classified according to their type of research, discipline or subject, and aim of knowledge. Considering these information, an econometric model that links the funding with the characteristics of the projects was prepared. The results show that the funding is focused on the basic and biomedical areas, particularly on genetic research, and also that diabetes research resources have increased over time, not steadily, but rather cyclically. In diabetes research projects there is a high level of concentration at several dimensions: research areas, topics, objects, institutions conducting research, and regions. The analysis of the resource allocation suggests that Mexico needs a stronger and oriented diabetes research agenda, including in its bases discussions about balance between basic and applied research, and about oriented research towards practical implementations. The importance of promoting health systems research to improve diabetes care is also discussed, as well as implementing mechanisms to assess the impact of diabetes research in short, medium and long term, as part of Mexico's science and technology policy.

Resumen: En México la diabetes es un grave problema de salud pública y es una enfermedad de alto costo para el sistema de salud. La investigación en salud es esencial para generar nuevo conocimiento para combatir este problema, pero existe escasa información sobre su generación y uso. Este trabajo examina el financiamiento público de 303 proyectos de investigación sobre diabetes, otorgados por el Consejo Nacional de Ciencia y Tecnología en México, entre 2002 y 2014. Los proyectos fueron sistematizados y clasificados de acuerdo con el tipo de investigación, disciplina o temática, y objetivo de generación de conocimiento. Con estos datos, se elaboró un modelo econométrico que relacional el financiamiento con las características de los proyectos. Los resultados muestran que el financiamiento está centrado en áreas básica y biomédica, particularmente en investigación genética, y que los recursos destinados a la investigación en diabetes se han incrementado en el tiempo pero no de manera constante, sino coyuntural. En los proyectos de investigación sobre diabetes hay un alto nivel de concentración en varias dimensiones: áreas de investigación, temáticas, objeto de estudio, instituciones que realizan la investigación, y regiones. El análisis de la asignación de recursos sugiere que México necesita una agenda de investigación en diabetes más fuerte y orientada, con fundamento en discusiones sobre el equilibrio entre investigación básica y aplicada, y sobre investigación orientada hacia implementaciones de tipo práctico. SE discute también la importancia de promover investigación sobre el sistema de salud para mejorar el cuidado a los pacientes con diabetes, así como la de implementar mecanismos para evaluar el impacto de la investigación en diabetes a corto, mediano y largo plazo, como parte de la política de ciencia y tecnología en México.

Resumo: No México, o diabetes representa um grave problema de saúde pública e uma doença de custo elevado para o sistema de saúde. A pesquisa em saúde é essencial para gerar novos conhecimentos para combater o problema, mas não há informação suficiente para gerar e utilizá-los. O artigo examina o financiamento público de 303 projetos de pesquisa em diabetes, através do Conselho Nacional de Ciência e Tecnologia do México entre 2002 e 2014. Os projetos foram sistematizados e classificados de acordo com o tipo de pesquisa, disciplina ou assunto e o objetivo do conhecimento. Com base nessa informação, foi preparado um modelo econométrico que associa o financiamento às características dos projetos. Os resultados mostram que o financiamento está concentrado nas áreas de pesquisa básica e biomédica, principalmente em pesquisa genética, e que os recursos para pesquisa em diabetes aumentaram ao longo do tempo, não continuamente, mas ciclicamente. Os projetos de pesquisa em diabetes mostram uma forte concentração em diversas dimensões: área de pesquisa, tema, objeto, instituição que realiza a pesquisa e região do país. A análise da alocação de recursos sugere que o México precisa de uma agenda de pesquisa mais forte e orientada, com bases que incluam discussões sobre o equilíbrio entre pesquisa básica e aplicada, e para pesquisa voltada para implementações práticas. O artigo também discute a importância de promover pesquisas em sistemas de saúde para melhorar os cuidados em diabetes, além de implementar mecanismos para avaliar o impacto da pesquisa em diabetes no curto, médio e longo prazo como parte da política de ciência e tecnologia do país.

Impact of regulatory assessment on clinical studies in Brazil / Impacto da avaliação regulatória em estudos clínicos no Brasil

SUMMARY Introduction: Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. Objective: This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process. Method: The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process. Results: 46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses. Conclusion: Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country’s scientific development.

RESUMO Introdução: apesar da recente expansão de estudos clínicos alocados para o Brasil, a demora dos prazos regulatórios locais impacta diretamente em sua realização. Objetivo: este artigo analisa o processo de alocação de estudos clínicos para o Brasil em comparação a outros países, bem como o impacto financeiro dos estudos não realizados em decorrência da interrupção pela demora no processo regulatório. Método: foram comparados os processos de alocação de estudos em nove países com estágios semelhantes de desenvolvimento econômico e países da América Latina através dos siteshttp://data.worldbank.org/data-catalog/GDP-ranking-table, http://worldpopulationreview.com e clinicaltrials.gov, que engloba 185 países. Os 46 estudos patrocinados pela indústria farmacêutica tiveram o processo de avaliação regulatória analisado. Resultados: foram analisados 46 estudos patrocinados pela indústria submetidos no país entre junho de 2007 e junho de 2013; 18 (39%) foram descontinuados pelo atraso na obtenção das aprovações necessárias. Para os estudos aprovados, o recrutamento de pacientes começou, em média, aos 11 meses após os demais países. Estima-se que 530 pacientes brasileiros não tiveram a oportunidade de participar desses estudos. As perdas financeiras foram da ordem de 14,6 milhões de dólares para o país, incluindo custos com paciente, medicação, suprimentos e despesas administrativas. Conclusão: o Brasil tem um enorme potencial para a realização de estudos clínicos. Investigadores, associações de deficientes e pacientes portadores de doenças crônicas, patrocinadores e autoridades devem trabalhar juntos para desenvolver um processo de aprovação eficiente, previsível e antes de tudo transparente. O atual ambiente regulatório deve e pode ser melhorado e aperfeiçoado, caso contrário não resultará em benefícios tangíveis para o paciente, para a sociedade e a evolução médico-científica do país.

Eventos adversos en la terapia farmacológica de la enfermedad inflamatoria intestinal / Adverse events associated with the treatment of inflammatory bowel disease

Background: The purpose of inflammatory bowel disease (IBD) treatment is to achieve resolution of symptoms and remission of disease with a minimum of adverse events (AE). Aim: To report AE of different prescriptions used for the treatment of IBD. Material and Methods: Analysis of a registry of patients with IBD held at a private clinic from 1976 to 2013. All used medications, the occurrence and severity of AE were recorded. Results: The records of 346 patients aged 16 to 86 years, 74% with ulcerative colitis, were analyzed. The most commonly type of medications prescribed were 5-aminosalicylates (5-ASAs) in 329 patients (92%), followed by adrenal steroids in 218 (61%). Forty nine AE were recorded in the same number of patents (14%). These were more common in patients with Crohn disease (n = 19, 21%). An univariate analysis, demonstrated that extra-intestinal manifestations, hospitalizations secondary to IBD crisis, requirement of surgery and treatment with steroids, immunosuppressants or biologic agents were significantly associated with the presence of AE. AEs were more common with immunosuppressants, followed by 5-ASAs and steroids. Discontinuation of therapy was required in 79, 100 and 43% of patients taking these medications, respectively. Twenty percent of AEs were severe. Leukopenia and pancytopenia along with alopecia were the most common AEs attributable to azathioprine. Conclusions: The occurrence of AEs in patients with IBD is uncommon. Even inmunosuppressants or biologic agents have a low rate of AE and most of them mild.

A snapshot of cancer in Chile: analytical frameworks for developing a cancer policy

INTRODUCTION: The South American country Chile now boasts a life expectancy of over 80 years. As a consequence, Chile now faces the increasing social and economic burden of cancer and must implement political policy to deliver equitable cancer care. Hindering the development of a national cancer policy is the lack of comprehensive analysis of cancer infrastructure and economic impact. OBJECTIVES: Evaluate existing cancer policy, the extent of national investigation and the socio-economic impact of cancer to deliver guidelines for the framing of an equitable national cancer policy. METHODS: Burden, research and care-policy systems were assessed by triangulating objective system metrics -epidemiological, economic, etc. - with political and policy analysis. Analysis of the literature and governmental databases was performed. The oncology community was interviewed and surveyed. RESULTS: Chile utilizes 1% of its gross domestic product on cancer care and treatment. We estimate that the economic impact as measured in Disability Adjusted Life Years to be US$ 3.5 billion. Persistent inequalities still occur in cancer distribution and treatment. A high quality cancer research community is expanding, however, insufficient funding is directed towards disproportionally prevalent stomach, lung and gallbladder cancers. CONCLUSIONS: Chile has a rapidly ageing population wherein 40% smoke, 67% are overweight and 18% abuse alcohol, and thus the corresponding burden of cancer will have a negative impact on an affordable health care system. We conclude that the Chilean government must develop a national cancer strategy, which the authors outline herein and believe is essential to permit equitable cancer care for the country.

La investigación en salud y la evaluación de tecnologías sanitarias en Chile / Health research and Health Technology Assessment in Chile

Health research is considered an essential element for the improvement of population health and it has been recommended that a share of the national health budget should be allocated to develop this field. Chile has undertaken efforts in the last decades in order to improve the governmental structure created to promote the development of health research, which has increased human resources and funding opportunities. On the other hand, the sustained economic growth of Chile in the last decades suggests that the health expenditure will maintain its increasing trend in the following years. This additional funding could be used to improve coverage of current activities performed in the health system, but also to address the incorporation of new strategies. More recently, health technology assessment (HTA) has been proposed as a process to support decisions about allocation of resources based on scientific evidence. This paper examines the relationship between the development of health research and the HTA process. First, it presents a brief diagnosis of the situation of health research in Chile. Second, it reviews the conceptual basis and the methods that account for the relationship between a HTA process and the development of health research. In particular, it emphasizes the relevance of identifying information gaps where funding additional research can be considered a good use of public resources. Finally, it discusses the challenges and possible courses of action that Chile could take in order to guarantee the continuous improvement of an articulated structure for health research and HTA.

Application of the enterprise management tools Lean Six Sigma and PMBOK in developing a program of research management / Aplicação das ferramentas de gestão empresarial Lean Seis Sigma e PMBOK no desenvolvimento de um programa de gestão da pesquisa científica

OBJECTIVE: Introduce a program for the management of scientific research in a General Hospital employing the business management tools Lean Six Sigma and PMBOK for project management in this area. METHODS: The Lean Six Sigma methodology was used to improve the management of the institution's scientific research through a specific tool (DMAIC) for identification, implementation and posterior analysis based on PMBOK practices of the solutions found. RESULTS: We present our solutions for the management of institutional research projects at the Sociedade Beneficente Israelita Brasileira Albert Einstein. The solutions were classified into four headings: people, processes, systems and organizational culture. A preliminary analysis of these solutions showed them to be completely or partially compliant to the processes described in the PMBOK Guide. CONCLUSION: In this post facto study, we verified that the solutions drawn from a project using Lean Six Sigma methodology and based on PMBOK enabled the improvement of our processes dealing with the management of scientific research carried out in the institution and constitutes a model to contribute to the search of innovative science management solutions by other institutions dealing with scientific research in Brazil.

OBJETIVO: Implementar um programa de gestão da pesquisa científica em um hospital geral aplicando as ferramentas de gestão empresarial Lean Seis Sigma e PMBOK no gerenciamento de projetos nessa área. MÉTODOS: Foi utilizada a metodologia Lean Seis Sigma para melhoria do processo de gestão da pesquisa científica institucional por meio de ferramenta específica (DMAIC) para identificação, implementação e posterior análise das soluções encontradas, tendo como base as boas práticas descritas no PMBOK. RESULTADOS: São apresentadas as soluções implementadas na Sociedade Beneficente Israelita Brasileira Albert Einstein para o gerenciamento dos projetos de pesquisa institucionais. As soluções foram categorizadas em quatro instâncias: pessoas, processos, sistema e cultura organizacional. Uma análise preliminar das soluções implementadas mostra que essas são, total ou parcialmente, aderentes às preconizadas no Guia PMBOK. CONCLUSÃO: Neste estudo de caso post facto, verificou-se que as soluções implementadas a partir do projeto Lean Seis Sigma e baseadas no PMBOK permitiram a melhoria de processo da gestão da pesquisa científica institucional, constituindo um modelo que pretende contribuir com a busca de soluções inovadoras na gestão da pesquisa pelas diferentes instituições com atividade científica no Brasil.

Principales características de la investigación biomédica actual, en Chile / Main characteristics of current biomedical research, in Chile

Background: Biomedical research is a fundamental tool for the development of a country, requiring human and financial resources. Aim: To define some current characteristics of biomedical research, in Chile. Methods: Data on entities funding bio-medical research, participant institutions, and the number of active investigators for the period 2007-2009 were obtained from institutional sources; publications indexed in PubMedfor2008-2009 were analysed. Results: Mostfinancial resources invested in biomedical research projects (approximately US$ 19 million per year) came from the "Comisión Nacional de Investigación Científica y Tecnológica" (CONICYT), a state institution with 3 independent Funds administering competitive grant applications open annually to institutional or independent investigators in Chile. Other sources and universities raised the total amount to US$ 26 million. Since 2007 to 2009, 408 investigators participated in projects funded by CONICYT. The main participant institutions were Universidad de Chile and Pontificia Universidad Católica de Chile, both adding up to 84% of all funded projects. Independently, in 2009,160 research projects -mainly multi centric clinical trials- received approximately US$ 24 million from foreign pharmaceutical companies. Publications listed in PubMed were classified as "clinical research" (n = 879, including public health) or "basic biomedical research" (n = 312). Conclusions: Biomedical research in Chile is mainly supported by state funds and university resources, but clinical trials also obtained an almost equivalent amount from foreign resources. Investigators are predominantly located in two universities. A small number of MD-PhD programs are aimed to train and incorporate new scientists. Only a few new Medical Schools participate in biomedical research. A National Registry of biomedical research projects, including the clinical trials, is required among other initiatives to stimulate research in biomedical sciences in Chile.

Investigación clínica: aproximación a sus tipos y sus formas de financiamiento / Clinical research: an approximation to its types and sponsoring

La investigación se realiza con el propósito de generar nuevos conocimientos o la aplicación de estos. La investigación clínica es una forma especial de investigación médica. La industria farmacéutica es una de las más importantes formas de financiamiento de la investigación clínica. Los médicos que participan solo en la recolección de datos, en estudios de investigación clínica, son considerados como investigadores y tienen la misión de elegir adecuadas formas de financiamiento que mantengan los estándares éticos y de calidad en investigación.

Investigation is conducted with the purpose of the generation of new data or its application. Clinical investigation is a special form of medical investigation. Pharmaceutical industry is one of the most important forms of sponsorship of clinical investigation. Doctors who participate only in data collection are considered as investigators and have the mission to select adequate sponsors, in order to maintain the ethical and quality issues that investigation requires.