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.

[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.

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

El documento «Guía de excelencia para la realización de ensayos clínicos en farmacia hospitalaria» ha sido elaborado por farmacéuticos de hospital y representantes de la industria farmacéutica. Su objetivo es aunar criterios, introducir mejoras en la comunicación, armonizar y digitalizar procesos en todas las fases de desarrollo de un ensayo clínico en los servicios de farmacia hospitalaria.El presente artículo especial recoge las reflexiones del Grupo de Trabajo de Ensayos Clínicos de la Sociedad Española de Farmacia Hospitalaria acerca del documento. El análisis se basa en su participación en la elaboración de la guía de excelencia, y recoge los aspectos más relevantes de la misma, haciendo referencia también a algunos puntos que, pese a ser motivo de discusión durante el proceso de elaboración del documento, finalmente no se incluyeron, por motivos de síntesis o para un posterior desarrollo y acuerdo.Reconociendo el indudable valor de un primer documento de consenso, inédito hasta el momento, desde el Grupo de Trabajo de Ensayos Clínicos se ponen de manifiesto también algunos retos a futuro en la gestión de los ensayos clínicos que se presentan para ambos colectivos, farmacia hospitalaria e industria farmacéutica.En opinión del grupo de trabajo, la apertura de vías de comunicación, tanto con la industria farmacéutica como con otros agentes implicados en la realización de ensayos clínicos, y el consecuente aumento de la visibilidad del farmacéutico de hospital como experto en el manejo del medicamento en investigación, ayudará a mejorar la calidad de la gestión de la medicación de ensayos clínicos en nuestro entorno, así como la asignación de los recursos humanos y los materiales necesarios para alcanzar la excelencia. (AU)

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. (AU)