ABSTRACT
Antecedentes y objetivo Los datos disponibles avalan las diferencias por género en el liderazgo de las investigaciones clínicas (IC). Este estudio analiza en qué medida las mujeres lideran estas investigaciones. Materiales y métodos Estudio observacional retrospectivo en un hospital universitario terciario asociado a uno de los institutos de investigación sanitaria más importantes de España. Analizamos los investigadores principales (IP) por género (2001-2020). Variable principal: proporción de IC lideradas por mujeres durante el período de estudio. Variables secundarias: diferencias de IP por género según el tipo de estudio: ensayos clínicos (EC) o estudios de no-intervención (ENI) y según la financiación. Fuentes de datos: registros del Comité de Ética en Investigación con medicamentos (CEIm) y del Departamento de Recursos Humanos. Resultados Durante el estudio, el CEIm aprobó 8.466 protocolos; el 52% (4.408/8.466) fueron EC y el resto, ENI. Las mujeres lideraron un 39,7% (3.360/8.466) del total. La brecha de género se observó principalmente en EC: las mujeres fueron IP de un 31,5% de ellos (1.391/4.408) y de un 48,5% (1.969/4.058) de los ENI. Ello a pesar de la tendencia creciente del número de facultativas. Los estudios de financiación privada fueron más comúnmente liderados por hombres. Conclusiones Nuestros resultados demuestran que existe una infrarrepresentación de las mujeres en puestos de liderazgo en la investigación, principalmente en aquellos con financiación privada. Este estudio refuerza la idea de que todavía queda un largo camino por recorrer en este campo. Se necesitan más estudios para la identificación de diferencias existentes que permitan implantar cambios a nivel institucional y cultural que promuevan la igualdad de género en el ámbito de la investigación clínica (AU)
Background and objective Available data support differences by gender in the leadership of clinical investigations (CI). This study analyzes to what extent women lead these investigations. Materials and method Observational-retrospective study in a tertiary university hospital associated with one of the most important health research institutes in Spain. We analyzed the principal investigators (PI) by gender from 2001 to 2020. Main outcome: proportion of CI led by female doctors (FD) during the study period. Secondary outcomes: differences in PI by gender according to the type of study: clinical trials (CT) or non-interventional-researches (NIR) and according to type of funding. Data sources: Research Ethics Committee (REC) and Human Resources Department registries. Result During the study, the REC approved 8,466 protocols, 52% (4,408/8,466) were EC, the rest were NIR. Women led 39.7% (3,360/8,466) of the total. The gender gap was observed mainly in EC: FD were IP of 31.5% of them (1,391/4,408) and 48.5% (1,969/4,058) of NIR. This despite the increasing trend in the number of FD staff. By type of funding, when the studies were supported by private sector there was a wider gap markedly unfavorable for women. Conclusions Our results show that there is underrepresentation of women in research leadership, mainly those with private financing. This study reinforces the idea that there is still a long way to go in this field. More studies are necessary to identify the existing differences that allow the implementation of actions at the institutional and cultural level that promote gender equality in the field of clinical research (AU)
Subject(s)
Humans , Female , Biomedical Research/statistics & numerical data , Women , Leadership , Retrospective Studies , SpainABSTRACT
BACKGROUND AND OBJECTIVE: Available data support differences by gender in the leadership of clinical investigations (CI). This study analyzes to what extent women lead these investigations. MATERIALS AND METHODS: Observational-retrospective study in a tertiary university hospital associated with one of the most important health research institutes in Spain. We analyzed the principal investigators (PI) by gender from 2001 to 2020. MAIN OUTCOME: proportion of CI led by female doctors (FD) during the study period. SECONDARY OUTCOMES: differences in PI by gender according to the type of study: clinical trials (CT) or non-interventional-researches (NIR) and according to type of funding. DATA SOURCES: Research Ethics Committee (REC) and Human Resources Department registries. RESULTS: During the study, the REC approved 8466 protocols, 52% (4408/8466) were EC, the rest were NIR. Women led 39.7% (3360/8466) of the total. The gender gap was observed mainly in EC: FD were IP of 31.5% of them (1391/4408) and 48.5% (1969/4058) of NIR. This despite the increasing trend in the number of FD staff. By type of funding, when the studies were supported by private sector there was a wider gap markedly unfavorable for women. CONCLUSIONS: Our results show that there is underrepresentation of women in research leadership, mainly those with private financing. This study reinforces the idea that there is still a long way to go in this field. More studies are necessary to identify the existing differences that allow the implementation of actions at the institutional and cultural level that promote gender equality in the field of clinical research.
Subject(s)
Leadership , Physicians , Humans , Female , Spain , Retrospective Studies , WorkforceABSTRACT
No disponible
Subject(s)
Humans , Multicenter Studies as Topic/statistics & numerical data , Multicenter Studies as Topic/standards , Process Assessment, Health Care , SpainABSTRACT
Clinical research plays an increasingly strong role in the development of respiratory medicine. Familiarity with issues that affect research on human subjects is therefore essential, particularly so with regard to the conduct of clinical trials of medical with medications. This paper begins with a brief introduction to the ethics of clinical research. We highlight the importance of directives on ethics and the need to understand and comply with them when any type of experiment is conducted on humans. Following is a brief description of historical codes of bioethics and an account of their underlying principles, origins, and consequences. Finally, we discuss Spanish Royal Decree 23/2004 of February 6, 2004 which came into force on May 1 that year; we outline its general principles and analyze 2 types of problem that have emerged: those that result from the article requiring a single central opinion and those of investigators who act independently of the pharmaceuticals industry. The situation of clinical research in respiratory medicine at our hospital is then described. Finally, the 7 requirements of ethical research listed by Emanuel and colleagues are proposed as a tool that pneumologists can use to analyze and assess whether or not a specific trial meets minimum ethical requirements.
Subject(s)
Biomedical Research/ethics , Pulmonary Medicine/ethics , Biomedical Research/legislation & jurisprudence , Humans , Pulmonary Medicine/legislation & jurisprudence , SpainABSTRACT
La investigación clínica en neumología desempeña un papel cada vez más relevante en el desarrollo de la especialidad. Por ello se hace necesario el conocimiento de los aspectos éticos en investigación con seres humanos y, en concreto, en ensayos clínicos con medicamentos. Se comienza la revisión con una breve introducción a los aspectos éticos en investigación clínica resaltando su importancia y obligado conocimiento y cumplimiento a la hora de llevar a cabo cualquier tipo de experimentación en seres humanos. Posteriormente, se realiza una breve descripción de los códigos éticos históricos y de los principios de la bioética mencionando su origen, así como las consecuencias que de ellos se derivan. Nos detenemos en el reciente Real Decreto 223/2004, de 6 de febrero, que entró en vigor en España el pasado 1 de mayo de 2004, para destacar sus principios generales y analizar los principales problemas que de él se derivan, fundamentalmente 2: los que son consecuencia de la exigencia del "dictamen único", y los relativos a los investigadores cuando actúan como promotores independientes de la industria farmacéutica. Se describe el papel de la neumología dentro de la investigación clínica con medicamentos en nuestro hospital, para posteriormente proponer los 7 requisitos del grupo de Emanuel como guía práctica para ayudar a los investigadores en neumología a analizar y valorar si un determinado ensayo cumple las mínimas exigencias de la ética clínica
Clinical research plays an increasingly strong role in the development of respiratory medicine. Familiarity with issues that affect research on human subjects is therefore essential, particularly so with regard to the conduct of clinical trials of medical with medications. This paper begins with a brief introduction to the ethics of clinical research. We highlight the importance of directives on ethics and the need to understand and comply with them when any type of experiment is conducted on humans. Following is a brief description of historical codes of bioethics and an account of their underlying principles, origins, and consequences. Finally, we discuss Spanish Royal Decree 23/2004 of February 6, 2004 which came into force on May 1 that year; we outline its general principles and analyze 2 types of problem that have emerged: those that result from the article requiring a single central opinion and those of investigators who act independently of the pharmaceuticals industry. The situation of clinical research in respiratory medicine at our hospital is then described. Finally, the 7 requirements of ethical research listed by Emanuel and colleagues are proposed as a tool that pneumologists can use to analyze and assess whether or not a specific trial meets minimum ethical requirements
Subject(s)
Humans , Pulmonary Medicine/ethics , Biomedical Research/ethics , Pulmonary Medicine/legislation & jurisprudence , Biomedical Research/legislation & jurisprudence , SpainABSTRACT
Correct functioning of the Ethics Committee (EC) guarantees respect to the rights of the subjects participating in clinical research. The European transposition of the clinical trial guidelines by the Royal Decree (RD) 223/2004 February 6 speeds up and simplifies the administrative procedures for the authorization of clinical trials. However, it is clear that it has meant a considerable effort on the work and administrative load of the ECs. An account is made on the adaptation procedures of the EC of the Hospital La Paz to apply the new Royal Decree and a short reflection is made on the most immediate consequences and repercussions in the EC activity.
Subject(s)
Clinical Trials as Topic/legislation & jurisprudence , Drug Therapy/ethics , Ethics Committees, Clinical , SpainABSTRACT
El correcto funcionamiento de los Comités Éticos de Investigación Clínica (CEIC) garantiza el respeto a los derechos de los sujetos participantes en investigación clínica. La transposición europea de la normativa de ensayos clínicos con el Real Decreto (RD) 223/2004, de 6 de febrero, viene a agilizar y simplificar los trámites administrativos para la autorización de los ensayos clínicos, pero es evidente que ha supuesto un considerable esfuerzo sobre el trabajo y la carga administrativa de los CEIC. Se hace una exposición sobre los procedimientos de adecuación del CEIC del Hospital La Paz para la aplicación del nuevo RD y una breve reflexión de las repercusiones y consecuencias más inmediatas en la actividad de los CEIC
Correct functioning of the Ethics Committee (EC) guarantees respect to the rights of the subjects participating in clinical research. The european transposition of the clinical trial guidelines by the Royal Decree (RD) 223/2004 February 6 speeds up and simplifies the administrative procedures for the authorization of clinical trials. However, it is clear that it has meant a considerable effort on the work and administrative load of the ECs. An account is made on the adaptation procedures of the EC of the Hospital La Paz to apply the new Royal Decree and a short reflection is made on the most immediate consequences and repercussions in the EC activityCorrect functioning of the Ethics Committee (EC) guarantees respect to the rights of the subjects participating in clinical research. The european transposition of the clinical trial guidelines by the Royal Decree (RD) 223/2004 February 6 speeds up and simplifies the administrative procedures for the authorization of clinical trials. However, it is clear that it has meant a considerable effort on the work and administrative load of the ECs. An account is made on the adaptation procedures of the EC of the Hospital La Paz to apply the new Royal Decree and a short reflection is made on the most immediate consequences and repercussions in the EC activity
