Characteristics, clinical benefit and reimbursement of new authorisations for oncohaematology drugs in Spain between 2017 and 2020. / Características, beneficio clínico y financiación de las nuevas autorizaciones de fármacos oncohematológicos en España entre 2017 y 2020.

OBJECTIVE: To describe the authorisations and funding resolutions for new onco-hematological drugs in Spain between 2017 and 2020, as well as the results of their main trials. METHODS: Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-hematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.A.I.T Indicator 2021 Survey. Authorisation information was obtained from the main study of the European Public Assessment Report (EPAR). Data were collected on medicines, their authorisation and main study, benefit shown, cost, and status and time to reimbursement. RESULTS: Forty-one new drugs authorised for 49 indications were identified. More than half (58.5%) were targeted therapies, and 61.2% were for the treatment of solid tumors (61.2%). Most had palliative intent (71.4%) and were indicated in relapsed or refractory disease (55.1%). Of the clinical trials, 57.1% were phase III and 63.3% were randomised. The primary endpoint was overall survival in 16.3%, increasing to 25.8% among randomised clinical trials. Regarding licensed drugs based on response rate, the median response rate was 56.4% (IQI 40.0-66.3). In those authorised on the basis of surrogate time-to-event endpoints, the median Hazard Ratio was 0.54 (IQI 0.38-0.57), and among those using overall survival was 0.71 (IQI 0.59-0.77). Globally, 22.4% had shown benefit in overall survival, with a median gain of 4 months (IQI 3.6-16.7). One third (33.3%) of the indications evaluable according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale showed substantial clinical benefit. Of the indications, 75.5% were funded, half (48.6%; 36.7% of the total) with restrictions. The median time to funding was 19.5 months (IQI 11.4-29.3). CONCLUSIONS: Most main clinical trials of new onco-haematology drugs approved in Spain used surrogate primary endpoint and, at the time of authorisation, few had shown to prolong overall survival. More than a third were uncontrolled clinical trials.

[Translated article] Current situation and evolution of the availability of drugs in the pediatric population in Spain.

OBJECTIVE: To analyze the characteristics of the new medicines approved in the pediatric population in the last 3 years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. METHODS: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorized or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. RESULTS: During the study period, 129 drugs included their indication in the pediatric population. 13.9% of them are not marketed, 46.5% are in a situation of non-financing, under study or without a request for financing, and 4.6% are financed for a specific pediatric subpopulation. 52.7% are original drugs, 4.7% are generic, 38.8% are biological, 3.8% are biosimilar, and 17.8% are orphan drugs. 57.36% of these medicines obtain the pediatric indication due to extension of the indication and 42.64% obtain it because they are new medicines that already include their studies in the pediatric population. CONCLUSIONS: Drugs with authorized indications are increasingly available in the pediatric population and the trend is to extend the indication of authorized drugs to the adult population. However, barriers in terms of financing and marketing need to be expedite and overcome to facilitate access to them.

[Translated article] Analysis of the guide to excellence in the conduct of clinical trials in hospital pharmacy.

The document "Guide to Excellence in the Conduct of Clinical Trials in Hospital Pharmacy" was drawn up by hospital pharmacists and representatives of the pharmaceutical industry. Its objective is "to unite criteria, introduce improvements in communication, harmonize and digitalize processes" in all phases of development of a clinical trial in Hospital Pharmacy Services. This special article includes the reflections of the Working Group of the Spanish Society of Hospital Pharmacy about this document. The analysis is based on its participation in the drawing of the Guide of Excellence, and includes its most relevant aspects, including those which, despite being discussed during the process of preparing the document, were finally not included, for reasons of synthesis or for further analysis and agreement. While recognizing the undoubted value of a so far unprecedented first document of consensus, the Clinical Trials Working Group also highlights the future challenges that both hospital pharmacists and pharmaceutical companies have ahead in order to improve the quality of the management of clinical trials. The Clinical Trials Working Group believes that the existence of communication routes both with the pharmaceutical industry and other agents involved in the conducting of clinical trials, as well as the improved visibility of the hospital pharmacist as an expert in the management of investigational medicines, will help achieve a better management of clinical trials in our environment and the assignment of the necessary human and material resources to reach excellence.

Analysis of the practice guideline in the conduct of clinical trials in hospital pharmacy. / Análisis de la Guía de excelencia para la realización de ensayos clínicos en farmacia hospitalaria.

The document «Guide to Excellence in the Conduct of Clinical Trials in Hospital Pharmacy¼ was drawn up by hospital pharmacists and representatives of the pharmaceutical industry. Its objective is to unite criteria, introduce improvements in communication, harmonize and digitalize processes in all phases of development of a clinical trial in hospital pharmacy services. This special article includes the reflections of the Working Group of the Spanish Society of Hospital Pharmacy about this document. The analysis is based on its participation in the drawing of the guide of excellence, and includes its most relevant aspects, including those which, despite being discussed during the process of preparing the document, were finally not included, for reasons of synthesis or for further analysis and agreement. While recognizing the undoubted value of a so far unprecedented first document of consensus, the Clinical Trials Working Group also highlights the future challenges that both hospital pharmacists and pharmaceutical companies have ahead in order to improve the quality of the management of clinical trials. The Clinical Trials Working Group believes that the existence of communication routes both with the pharmaceutical industry and other agents involved in the conducting of clinical trials, as well as the improved visibility of the hospital pharmacist as an expert in the management of investigational medicines, will help achieve a better management of clinical trials in our environment and the assignment of the necessary human and material resources to reach excellence.

Ethic Policy Forum: Inclusión de minorías étnicas latinoamericanas en los ensayos clínicos

Objetivo: Analizar los aspectos normativos y éticos relacionados a la inclusión de las minorías étnicas en los ensayos clínicos en Latinoamérica y el Caribe. Material y Métodos : Se presentan resultados del análisis ético y normativo realizado por el grupo de investigadores en bioética, del Ethic Policy Forum; foro de análisis, discusión y formulación de propuestas en políticas y normativas relacionadas con aspectos de ética en investigación en los países de Latinoamérica y el Caribe, constituido por el Instituto de Evaluación de Tecnologías en Salud e Investigación del Seguro Social de Salud del Perú, la Universidad Católica Santa María de Arequipa, Perú y la Red Internacional de Salud Colectiva y salud Intercultural de la Universidad Autónoma del Estado de México. Resultados: Se evidencia que las minorías étnicas no están adecuadamente representadas en los ensayos clínicos en Latinoamérica y el Caribe y la normativa al respecto no está estandarizada, o no existe en todos los países de la Región. Los ensayos con minorías étnicas, pueden tener beneficios, pero también potenciales riesgos y conflictos éticos, que requieren una adecuada evaluación de las vulnerabilidades, acompañamiento efectivo en el consentimiento informado y proceso de investigación, por Comités de ética de investigación capacitados salud intercultural y en ética de la investigación con pueblos indígenas y afrodescendientes. Conclusión : Los ensayos clínicos deben incluir a minorías étnicas, con potencial beneficio de los productos de investigación. La investigación debe desarrollarse bajo principios éticos y normativas que protejan a estas minorías.

Objetive: To analyze the normative and ethical aspects related to the inclusion of ethnic minorities in clinical trials in Latin America and the Caribbean. Material and Methods : The results of the ethical and normative analysis carried out by the group of researchers in bioethics of the Ethic Policy Forum are presented; forum for analysis, discussion and formulation of proposals in policies and regulations related to aspects of ethics in research in the countries of Latin America and the Caribbean, constituted by the "Instituto de Evaluación de Tecnologías en Salud e Investigación" from Peru, the Universidad Católica Santa María de Arequipa, Peru and the International Network of Collective Health and Intercultural Health of the "Universidad Autónoma del Estado de México". Results : It is evident that ethnic minorities are not adequately represented in clinical trials in Latin America and the Caribbean and the regulations in this regard are not standardized, or do not exist in all the countries of the Region. Trials with ethnic minorities can have benefits but also potential risks and ethical conflicts, which require an adequate assessment of vulnerabilities, effective support in informed consent and the research process, by Research Ethics Committees trained in intercultural health and ethics of research with indigenous peoples and Afro-descendants. Conclusion : Clinical trials should include ethnic minorities, with potential benefit from research products. Research must be developed under ethical and regulatory principles that protect these minorities.

Características de los ensayos clínicos activos desarrollados en la Seguridad Social de Salud del Perú / Characteristics of the active clinical trials developed in the Social Health Security of Peru

Objetivo: Describir las características de los ensayos clínicos activos (EC) desarrollados en la Seguridad Social de Salud del Perú. Material y métodos: Estudio observacional y descriptivo de los EC activos entre el 24 mayo al 8 julio del 2021, inscritos en el Registro Peruano de Ensayos Clínicos durante el periodo 2007-2020. Se analizó la distribución de las diferentes variables tales como N° de EC, fase, redes de EsSalud, regiones en el Perú, patrocinador, fuentes de financiamiento, especialidad, número de centros de investigación (CI) de EsSalud por EC, CIEI que aprobó los ECs por CI, y el cálculo de frecuencias relativas y absolutas. Resultados: Se identificaron 97 EC, ejecutados 144 veces en 23 diferentes CI pertenecientes a EsSalud. El 94,9% de los EC activos fue patrocinado por la industria farmacéutica y el 36% pertenecen a la especialidad de oncología. El 80,42% son de fase III y el 70,8% fue aprobado por un CIEI de EsSalud. Conclusiones: Los EC activos en EsSalud se desarrollan mayormente en Lima, son financiados por la industria farmacéutica y se aprobaron en su mayoría en los CIEIs de EsSalud.

Objetive: To describe the characteristics of active clinical trials (CTs) developed in the Social Health Security of Peru. Material and methods: Observational and descriptive study of active CTs between May 24 to July 8, 2021, registered in the Peruvian Registry of Clinical Trials during the period 2007-2020. The distribution of the different variable was analyzed, such as the number of CTs, phase, EsSalud networks, sponsor, funding sources, specialty, number of EsSalud research centers per CT, CIEI that approved CT by research center, and the calculation of relative and absolute frequencies. Results: 97 active CTs were identified, executed 144 times in 23 different research centers that belong to EsSalud. 94.9% of the active CTs were sponsored by pharmaceutical industries and 36% belong to the specialty of oncology. 80.42% are phase III and 70.8% were approved by an EsSalud CIEI. Conclusions: The active CTs in EsSalud are developed mostly in Lima, are financed by the pharmaceutical industry and are mostly approved in the CIEI of EsSalud.

Diagnóstico situacional de los Comités Institucionales de Ética en Investigación de la Seguridad Social en Perú / Situational diagnosis of the Institutional Research Ethics Committees in Social Security in Peru

Introducción: Aunque el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) ha impulsado la conformación de Comités Institucionales de Ética en Investigación (CIEI) en la Seguridad Social de Salud del Perú (EsSalud), pueden existir aspectos perfectibles. Se describen las características de los CIEI de EsSalud y sus miembros durante el 2021. Material y Métodos: Se realizó un estudio descriptivo y observacional que empleó una base de datos secundaria. Se encuestó a los miembros de los CIEI de EsSalud mediante un formulario virtual confeccionado por IETSI. Resultados: Se incluyó a 114 miembros pertenecientes a 18 redes prestacionales de EsSalud. El 52,6% de los participantes era de sexo masculino, la media de edad fue de 50,6 ± 11,9 años y el 42,1% tenía función científica. El 38,8% de los CIEI evaluó más de cinco ensayos clínicos en los últimos dos años y el 72,2% más de cinco estudios observacionales en el mismo periodo de tiempo. Los miembros refirieron limitaciones para la realización de reuniones o supervisiones virtuales, falta de tiempo para la realización de sus labores debido a la alta carga laboral y necesidad de capacitaciones sobre metodología de la investigación y bioestadística. Conclusión: Es necesario mejorar el soporte administrativo y el plan de capacitaciones a los miembros de los CIEI de EsSalud, para el logro de competencias metodológicas, éticas y regulatorias que aseguren una mejora en los procesos de evaluación y monitoreo ético de las investigaciones con seres humanos a su cargo.

Background:Although the Instituto de Evaluación de Tecnologías e Investigaciones en Salud (IETSI) has promoted the formation of Institutional Research Ethics Committees (IRECs) in the social security of Peru (EsSalud), there may be perfectible aspects. The characteristics of the IREC of EsSalud and its members during 2021 are described. : Adescriptive and observational study was Material and Methodscarried out using a secondary database. IREC members were surveyed using a virtual form created by IETSI. 114 members belonging to 18 EsSalud networks were included. Results:52.6% of the participants were male, the mean age was 50.6 ± 11.9 years, and 42.1% had a scientific role. In 38.8% of the IREC were evaluated more than five clinical trials in the last two years and 72.2% more than five observational studies in the same period. The members reported limitations for holding virtual meetings or supervisions, lack of time to carry out their tasks due to the high workload and the need for training on research methodology and biostatistics. it is Conclusion:necessary to improve the administrative support and the training plan for the members of the IREC of EsSalud, to achieve methodological, ethical, and regulatory competencies that ensure an improvement in the processes of evaluation and ethical monitoring of human research.

Protocolos de recuperación mejorada en cirugía cardiaca. Revisión sistemática con metanálisis de ensayos clínicos aleatorizados / Improved recovery protocols in cardiac surgery: Systematic review with metaanalysis of randomized clinical trails

Introducción: Múltiples son los esfuerzos realizados para incluir los protocolos de recuperación mejorada como un indicador de calidad en la atención al paciente quirúrgico, bajo la premisa de acelerar la recuperación de los enfermos, sin que esto vaya en detrimento del proceso asistencial y obtener su alta satisfacción. Para ello se hace necesario el desarrollo de la investigación avalada por la mejor evidencia científica y práctica. Objetivo: Estimar, a través de la literatura publicada, la efectividad de la aplicación de los protocolos de recuperación precoz sobre la evolución perioperatoria de pacientes a los que se les realizan procedimientos quirúrgicos cardíacos. Método: Se incluyeron ensayos clínicos controlados y aleatorizados, publicados entre enero del año 2013 y mayo de 2020. La revisión sistemática se realizó según las recomendaciones del manual 5.1.0 para revisores de la biblioteca Cochrane. Resultados: Se analizaron 6 estudios (687 pacientes/Grupo estudio=345, Grupo Control=342). La calidad metodológica de la mayoría de las investigaciones evaluadas fue buena. Se muestra una superioridad de los protocolos, ya que se acompañan de una disminución en la incidencia de complicaciones perioperatorias (RR=0,61 [0,40, 0,93]). De forma similar se encuentran relacionados con la disminución la estadía hospitalaria (diferencia de medias, efecto aleatorio, fue de -2,98 [-3,31, -2,65]. Conclusiones: A pesar de los pocos estudios incluidos, la evidencia sugiere que estos programas mejoran la evolución perioperatoria de los pacientes(AU)

Introduction: Multiple efforts are made to include improved recovery protocols as an indicator of quality in care for surgical patients, under the premise of accelerating the recovery of patients, without this being detrimental to the care process, and thus guarantee high patient satisfaction. In view of this, the development of research supported by the best scientific and practical evidence is necessary. Objective: To estimate, through the published literature, the effectiveness of the application of early recovery protocols on the perioperative evolution of patients who undergo cardiac surgical procedures. Method: Randomized controlled clinical trials, published between January 2013 and May 2020, were included. The systematic review was carried out according to the recommendations of the Cochrane Library manual 5.1.0 for reviewers. Results: Six studies were analyzed (687 patients/study group: 345, control group: 342). The methodological quality of most of the researches assessed was good. A superiority of the protocols is shown, since they are accompanied by a decrease in the incidence of perioperative complications (RR=0.61 [0.40, 0.93]). Similarly, they are related to the decrease in hospital stay (mean difference, random effect, was -2.98 [-3.31, -2.65]). Conclusions: Despite the few studies included, the evidence suggests that these programs improve the perioperative outcome of patients(AU)

Rol regulador del estado peruano en ensayos clínicos: las autorizaciones. Estudio cualitativo

Objetivos : Explicar el rol del Estado Peruano relacionado a los procesos participativos de los diversos actores que influyen en la regulación concerniente a la autorización de ensayos clínicos (EC). Metodología : Se presenta parte del estudio de caso correspondiente a una tesis de doctor llevada a cabo entre los años 2015 y 2017. Se utilizó información documental y se realizaron 14 entrevistas semiestructuradas a informantes claves. También se sistematizaron experiencias relacionadas a la autorización e inspección de ensayos clínicos, así como la verificación de centros de investigación. Se contó también con la información pública disponible del Instituto Nacional de Salud del Perú. El análisis se realizó dentro de un marco epistemológico y hermenéutico con la aprobación del Comité de Ética de la Facultad de Medicina de San Fernando. Resultados : Los temas identificados fueron los siguientes: demora en los tiempos regulatorios que autorizan los ensayos, aumento de las no autorizaciones en un determinado lapso de 3 años, suspensión de las autorizaciones para ejecutar EC en niños, lo que llevó a una progresiva reducción de las solicitudes y por consiguiente de los ensayos clínicos desde el año 2009 en adelante. Conclusiones : En el estudio realizado, la regulación del Estado Peruano en cuanto a la autorización de EC se ha debilitado al reducir el ejercicio de ciudadanía en salud de los participantes y las fortalezas de algunos actores, particularmente la generación de competencias de los investigadores para desarrollar EC.

Objectives : To explain the role of the Peruvian Government related to participation of different stakeholders influencing regulations for authorizing clinical trials (CT). Methodology : We present part of a case study corresponding to a PhD thesis performed between 2015 and 2017. We used document information and 14 semi-structured interviews with key informants were performed. We also systematized experiences related to clinical trial authorization and inspection, as well as verification of investigation sites. We also had access to publicly available information from the Peruvian National Institute of Health. The analysis was performed within epistemological and hermeneutical frameworks, and it was approved by the Ethics Committee from San Fernando Public Medicine School. Results : Issues identified were as follows: Delay in regulatory times authorized for CTs; suspension of authorizations for performing CTs in children, which led to progressive reduction in requests and consequently to a reduction in CTs from 2009 on. Conclusions : According to this study, regulations by Peruvian authorities have weakened, since participants and some stakeholders are not able to exert their rights, particularly with respect to competence generation for researchers when trying to develop CTs.

Perfil e vozes dos participantes de pesquisas clínicas no Brasil / Profiles and voices of participants in clinical research in Brazil / Perfil y voces de los participantes de investigaciones clínicas en Brasil

Resumo Este estudo de caso buscou traçar o perfil socioeconômico de participantes de ensaios clínicos em centro de pesquisa brasileiro, analisando suas decisões, motivações e experiências, seu conhecimento sobre riscos, benefícios e cuidados dispensados e o processo de consentimento. Dados de 327 participantes foram coletados, realizando-se entrevistas semiestruturadas com 19 deles. Nas pesquisas executadas no centro estudado houve maior participação de homens, de pessoas com poucos anos de estudo formal e de baixa renda. A maioria é aposentada, não tem assistência privada à saúde e tende a não perceber os efeitos da investigação ou superestimar os benefícios médicos diretos. A busca pelo tratamento médico foi o principal fator que influenciou suas decisões/participação, e a assinatura do termo de consentimento livre e esclarecido não garantiu a expressão da autonomia. Conclui-se que o perfil e o conteúdo dos discursos dos participantes são sensíveis indicadores de vulnerabilidade e desigualdade social.

Abstract This case study aimed to trace the socioeconomic profile of participants in clinical research at a Brazilian research center, analyzing their decisions, motivations, experiences, knowledge of risks, benefits and health care provided, and the consent process. The data of 327 participants were collected, and semi-structured interviews conducted with 19 of them. In the research carried out at the center studied there was a greater participation of men and of people with few years of formal education and low income. Most are retired and have no private health plan, tend not to notice the effects of the investigation, or to overestimate its direct medical benefits. The search for medical treatment was the main factor influencing their decisions/participation, and signing the informed consent form did not guarantee the expression of autonomy. We concluded that the participants' profile and speeches content are sensitive indicators of vulnerability and social inequality.

Resumen Este estudio de caso trató de esbozar el perfil socioeconómico de participantes de ensayos clínicos en un centro de investigación brasileño, analizando sus decisiones, motivaciones y experiencias, su conocimiento sobre los riesgos, beneficios y cuidados prestados y el proceso de consentimiento. Se recopilaron datos de 327 participantes y se realizaron entrevistas semiestructuradas con 19 de ellos. En las investigaciones realizadas en el centro estudiado hubo una mayor participación de hombres, de personas con pocos años de educación formal y con bajos ingresos. La mayoría es jubilada y no tiene asistencia sanitaria privada, tiende a no percibir los efectos de la investigación o a sobrestimar los beneficios médicos directos. La búsqueda de tratamiento médico fue el factor principal que influyó en sus decisiones/participación, y la firma del término de consentimiento libre e informado no garantizó la expresión de la autonomía. Se concluye que el perfil y el contenido de los discursos de los participantes son sensibles indicadores de vulnerabilidad y desigualdad social.

[Participant-funded clinical trials on rare diseases]. / Ensayos clínicos en enfermedades raras financiados por los participantes.

The development of medicines for certain rare diseases can be frustrated by lack of funding. In certain cases the patients themselves, or their relatives, occasionally fund the clinical trial in which they will be treated with the investigational medicine. There are 3models of self-funded research: 2of them, "pay to try" and "pay to participate", have already been put into practice. The third, the "plutocratic" proposal, which has been recently put forward is still a theoretical model. In this work the scientific, social and ethical benefits and risks of the 2clinical research models, "pay to participate" and the "plutocratic" proposal, are reviewed. Patient-funded clinical trials are frequently performed through crowdfunding. The most controversial aspects of this funding modality are also addressed in this article from several perspectives. Finally, a future scenario that would allow the launching of self-funded clinical trials in Spain by the "plutocratic" proposal is proposed.

How to start and develop a multicenter, prospective, randomized, controlled trial. / Cómo poner en marcha y desarrollar un estudio multicéntrico prospectivo, controlado y aleatorizado.

Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial. The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years. In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended. When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines. Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately. And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1-3 months keeps participants engaged in the study.

Participant-funded clinical trials on rare diseases.

The development of medicines for certain rare diseases can be cut short by lack of funding. In certain cases the patients themselves, or their relatives, occasionally fund the clinical trial in which they will be treated with the investigational medicine. There are three models of self-funded clinical research: two of them, 'pay to try' and 'pay to participate', have already been put into practice. The third, the 'plutocratic' proposal, which has been recently put forward is still a theoretical model. In this work the scientific, social and ethical benefits and risks of the two clinical research models, 'pay to participate and the 'plutocratic' proposal, are reviewed. Patient-funded clinical trials are frequently performed through crowdfunding. The most controversial aspects of this funding modality are also addressed in this article from several perspectives. Finally, a future scenario that would allow the launching of self-funded clinical trials in Spain by the 'plutocratic' proposal is proposed.

Comparison of effectiveness between a conventional catheter and a manual commercial catheter: randomized trial of simulation of intraosseous access in a biological model / Comparación de la eficacia entre un catéter convencional y un catéter comercial manual: ensayo aleatorizado de simulación de acceso intraóseo en modelo biológico

Abstract Introduction: In the emergency services an action of paramount importance in critically ill patients is to obtain an early vascular access. When vascular access is not established, an intraosseous route should be obtained; otherwise, the mortality of these critically ill patients is almost 100%. In Colombia, the intraosseous access is not used because of the high costs of the devices and the lack of training of the healthcare staff to conduct the procedure. Objective: To determine the efficacy of a low-cost device to establish intraosseous access. Materials and methods: Quantitative approach, experimental design in a simulated environment with chicken tarsus and metatarsus. An analysis was conducted using frequency tables and central tendency measurements. Likewise, further analyses were done using Fisher's exact test, Chi2, and Mann-Whitney test. Results: A total of 99% of the procedures were successful with both catheters. The average time for intraosseous access was 6.6 seconds with Insyte 14 catheter and 4.7 seconds with Din 1515x Illinois Desch device (P = 0.001). There were no significant differences in the number of attempts to secure a successful intra-osseous access using any of the 2 devices (P = 0.56). Conclusion: There was no significant difference between the Ci 14 and the Si 14 catheter to establish a successful intraosseous access in the chicken tarsus and metatarsus in a simulated environment.

Resumen Introducción: En los servicios de urgencias una acción de primordial importancia en pacientes críticamente enfermos es obtener un acceso vascular temprano. En los casos en que no se logre obtener un acceso venoso, se debe obtener una vía intraósea, o de lo contrario la mortalidad de estos pacientes críticamente enfermos asciende casi al 100%. En Colombia no se realiza el uso del acceso intraóseo por los altos costos de los dispositivos requeridos y la falta de entrenamiento del personal de salud para dicho procedimiento. Objetivo: Determinar la eficacia de un dispositivo de bajo costo para el acceso intraóseo. Materiales y métodos: Enfoque cuantitativo, diseño experimental en ambiente simulado con tarso-metatarso de pollo. Se realizó un análisis mediante tablas de frecuencia y medidas de tendencia central. Así mismo, se realizaron análisis mediante el test exacto de Fisher, ji cuadrado y test de Mann Whitney. Resultados: El 99% de los procedimientos fueron exitosos con los dos catéteres. La mediana del tiempo para el acceso intraóseo fue de 6.6 segundos con el catéter Insyte 14® y de 4.7 segundos con el dispositivo Din 1515x Illinois Desch® (p=0.001). No se encontraron diferencias significativas en el número de intentos para lograr un acceso intraóseo exitoso con ambos dispositivos (p = 0.56). Conclusiones: No existe diferencia significativa entre el catéter Ci 14 y el Di 15 para lograr un acceso intraóseo exitoso en el tarso metatarso del pollo en un ambiente simulado.

Participantes de ensaios clínicos em oncologia: perfil e aspectos envolvidos nas suas decisões / Participants of oncologic clinical trials: profile and aspects involved in their decisions / Participantes de ensayos clínicos en oncología: perfil y aspectos implicados en sus decisiones

Resumo Estudo sobre os participantes de ensaios clínicos na área de oncologia, discutindo o paradoxo entre progresso científico e iniquidade social. Buscou-se conhecer quem são essas pessoas e analisar aspectos envolvidos nas suas decisões, com base em entrevistas e documentos. Houve maior participação feminina. Os participantes tendem a ter poucos anos de estudo formal e baixa renda. A maioria é aposentada e do lar e não tem assistência à saúde privada. Suas decisões giraram em torno da busca pela cura ou melhora, e pela garantia de acesso regular a cuidados integrais de saúde e medicamentos. A assinatura do termo de consentimento livre e esclarecido não garantiu a expressão da autonomia, pois informações essenciais como os objetivos, riscos e cuidados pós-estudo são praticamente desconhecidas. Os participantes da pesquisa tendem a não compreender os objetivos da investigação, ou superestimam os benefícios médicos diretos de sua participação, sem consciência dos riscos envolvidos e do que significa uma pesquisa. Os resultados deveriam incitar ao exercício e ao diálogo mais críticos entre os diferentes atores e instituições envolvidos na área da pesquisa com seres humanos, objetivando promover uma ciência consciente e responsável, que impeça que pessoas sejam colocadas em situação de desigualdade, vulnerabilidade e sofrimento moral.

Abstract This is a study about the participants of clinical trials in the field of oncology that discusses the paradox between scientific advances and social inequality. We sought to get to know these people and to analyze the aspects involved in their decisions based on interviews and documents. Female participation was more expressive. The participants tend to have low schooling and low income. Most of them are retirees and housewives, and do not get assistance from the private health system. Their decisions revolved around the search for cure or recovery, as well as for the assurance of regular access to comprehensive health care and medicines. Signing the free and informed consent form did not guarantee the expression of autonomy, because crucial information, such as the goals, risks and post-study care are virtually unknown. The research participants tend to not understand the goals of the investigation, or they overestimate the direct medical benefits of their participation, and they tend to be unaware of the risks involved and of what does a research mean. The results should stimulate more critical practices and dialogues among the different players and institutions involved in the field of the research with human subjects, with the goal of promoting a science that is conscious and responsible, and that prevents people from being put in situations of inequality, vulnerability and moral suffering.

Resumen Estudio sobre los participantes de ensayos clínicos en el área de oncología, discutiendo la paradoja entre avance científico y desigualdad social. Se buscó conocer quiénes son esas personas y analizar los aspectos involucrados en sus decisiones, con base en entrevistas y documentos. Hubo mayor participación femenina. La tendencia es que los participantes tienen pocos años de estudio formal y bajos ingresos. La mayoría es jubilada y ama de casa, y no tiene asistencia médica privada. Sus decisiones giraron en torno a la búsqueda de la cura o una mejora, y el acceso regular garantizado a la atención médica integral y a los medicamentos. La firma del formulario de consentimiento voluntario e informado no constituyó una expresión de autonomía, ya que información esencial como objetivos, riesgos y cuidados posteriores al estudio es prácticamente desconocida. Los participantes de la investigación tienden a no comprender los objetivos de la investigación, o sobreestiman los beneficios médicos directos de su participación, sin ser conscientes de los riesgos implicados y lo que significa una investigación. Los resultados deberían incitar al ejercicio y al diálogo más críticos entre los diferentes actores e instituciones involucrados en el área de la investigación con seres humanos, a fin de promover un entendimiento consciente y responsable, que impida que las personas sean colocadas en situación de desigualdad, vulnerabilidad y sufrimiento moral.

Assessment of the methodological and ethical quality of clinical trials published in family medicine journals / Valoración de la calidad metodológica y ética de los ensayos clínicos publicados en revistas de medicina de familia (2010-2013)

Objective: To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals. Methods: Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded. Results: CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average κ was 0.96 (95% CI: 0.93-0.99). Conclusions: We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013).

Objetivo: Evaluar algunas variables sobre la calidad metodológica y ética de los ensayos clínicos publicados en 10 revistas de medicina de familia. Métodos: Estudio descriptivo de calidad sobre 10 revistas de medicina de familia incluyendo ensayos clínicos en humanos publicados entre 2010 y 2013. Obtuvimos 141 ensayos clínicos y fueron excluidos 2447. Resultados: Ensayos clínicos controlados paralelos en el 92,9% (intervalo de confianza del 95% [IC 95%]: 92.0-93.9). Aleatorización enmascarada en el 72.3% (IC 95%: 71.7-73.1), descentralizada en el 51.8% (IC 95%: 51.4-52…4) y utilizando como control un tratamiento activo el 82.2% (IC 95%: 81.5-83.1). Consentimiento informado escrito en el 48.9% (IC 95%: 48.5-49.5) y no fue retirado en el 56.0% (IC 95%: 55.5-56.7). En 134 ensayos clínicos se contó con la aprobación por un comité ético de investigación clínica (CEIC), y en 117 no hubo conflicto de intereses. Se obtuvo un κ medio de 0,96 (IC 95%: 0.93-0.99). Conclusiones: Observamos, tras considerar las normas CONSORT, un aumento en algunas variables de calidad, como la aleatorización enmascarada (19.6%) y la aprobación por un CEIC (75%), en los ensayos clínicos publicados en 10 revistas de medicina de familia (2010-2013).

Archibald Cochrane: evidencia, efectividad y toma de decisiones en salud / Archibald Cochrane: evidence, effectiveness and decision-making in health

Resumen: Actualmente, la Medicina Basada en Evidencia tiene un papel fundamental en la toma de decisiones médicas, ya que intenta, a través de los métodos de la ciencia, justificar las diferentes alternativas que se le pueden ofrecer a un paciente. Para entender la evolución histórica de esta forma de practicar la medicina, es necesario revisar la contribución de uno de los principales participantes en este movimiento cultural: Archibald Leman Cochrane, quien ayudó a definir el marco teórico que ha permitido incorporar la ciencia a la práctica de la medicina. Su papel, al insistir en la necesidad de integrar la evidencia científica y conjuntarla con la experiencia clínica, constituyó un elemento fundamental y decisivo en el desarrollo de una nueva disciplina, la Medicina Basada en Evidencia.

Abstract: Nowadays, Evidence-Based Medicine plays a fundamental role while making medical decisions, considering that through the methods of science, it attempts to justify the variety of alternatives that may be offered to patients. In order to understand the historical evolution of this way of practicing medicine, it is necessary to review the contribution of one of the main participants in this cultural movement: Archibald Leman Cochrane, who helped to define the theoretical framework that has allowed the integration of science into the practice of medicine. Since he insisted in the need of integrating scientific evidence into clinical experience, his role became a fundamental and decisive element in the development of a new discipline: Evidence-Based Medicine.

[Archibald Cochrane: evidence, effectiveness and decision-making in health]. / Archibald Cochrane: evidencia, efectividad y toma de decisiones en salud.

Nowadays, Evidence-Based Medicine plays a fundamental role while making medical decisions, considering that through the methods of science, it attempts to justify the variety of alternatives that may be offered to patients. In order to understand the historical evolution of this way of practicing medicine, it is necessary to review the contribution of one of the main participants in this cultural movement: Archibald Leman Cochrane, who helped to define the theoretical framework that has allowed the integration of science into the practice of medicine. Since he insisted in the need of integrating scientific evidence into clinical experience, his role became a fundamental and decisive element in the development of a new discipline: Evidence-Based Medicine.

Drug Cost Avoidance in Prostate Cancer Clinical Trials.

OBJECTIVES: Economic impact of prostate cancer is increasing in relation to its increased incidence and increased patient survival. Clinical trials are essential to evaluate the efficacy and safety of new treatments but may also result in economic benefits by avoiding the cost of the drug. Our objective is to determine the avoided cost in investigational drugs in clinical trials of prostate cancer conducted in a period of 18 years in a tertiary center. MATERIAL AND METHODS: We carried out an observational of prevalence study with retrospective collected data of clinical trials involving currently marketed drugs and cost avoidance during the study period (1996-2013) was calculated. RESULTS: We include in this review five clinical trials on prostate cancer that met selection criteria of 18 performed. All of them were phase III, multicenter, international and with current marketed drugs. 136 patients were included. Total cost avoidance of 696,002€ and an average cost avoidance by clinical trial of 139,200€ were obtained. Average cost avoidance per patient was 5,118€. CONCLUSION: Cost avoidance in investigational drugs is a tangible benefit of clinical trials, whose realization is a source of economic benefits for the hospital, not only by directly generated by each trial. Clinical trials are an exceptional framework for progress in clinical research and real savings for the health system.

Biosimilars in Dermatology: Current Situation (Part II).

The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this second part of the review, we will look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. We will also review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system.