Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC / Clinical Trials Data Management System XAVIA SIDEC

El ensayo clínico constituye el método empleado para evaluar un producto, sustancia, medicamento, técnica diagnóstica o terapéutica. La industria biotecnológica emplea sistemas de gestión de ensayos clínicos para lograr un manejo eficiente de los datos recopilados durante el proceso. El Centro de Inmunología Molecular (CIM) emplea el Sistema de Gestión de Ensayos Clínicos XAVIA Clínicas desarrollado por la UCI, para soportar el 100 por ciento de los ensayos clínicos desde el 2012. XAVIA Clínicas posee limitantes en sus funcionalidades; además, a partir de la experiencia obtenida por su uso, se identificaron mejoras y nuevas funcionalidades que constituyen el incentivo para desarrollar un nuevo sistema. El objetivo del presente artículo es presentar el Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC y su generalización en las instituciones de BioCubaFarma. Se estudió la bibliografía referente al manejo de datos de ensayos clínicos y cuadernos de recogida de datos electrónicos y se analizaron sistemas homólogos disponibles en el mercado internacional. La metodología de desarrollo empleada fue AUP-UCI. Se utilizó Eclipse como entorno integrado de desarrollo, Java como lenguaje de programación, JBoss como servidor de aplicaciones y PostgreSQL como sistema de gestión de bases de datos. El Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC facilita y flexibiliza el diseño y aprobación de los Cuadernos de recogida de información (CRD), estandariza la información manejada, valida los datos recopilados a través de reglas, mejora el flujo de información entre las entidades que conducen el ensayo y optimiza el proceso de monitoreo(AU)

Clinical trial is the method used to evaluate a product, substance, medicine, diagnostic or therapeutic technique. The biotechnology industry employs clinical trial management systems to achieve efficient management of data collected during clinical trials. CIM (Centro de Inmunología Molecular) uses the Clinical Trials Management System XAVIA Clínicas developed by UCI, to support 100 percent of clinical trials since 2012. This system has limitations in its functionalities; furthermore, based on the experience obtained, improvements and new functionalities were identified, so it was decided to develop a new version of the system. The objective of this article is to present the Clinical Trials Data Management System XAVIA SIDEC and its generalization in BioCubaFarma institutions. The bibliography referring to the clinical trial data management and electronic data collection notebooks was studied and homologous systems available in the international market were analyzed. The development methodology used was AUP-UCI. Eclipse was used as an integrated development environment, Java as a programming language, JBoss as an application server and PostgreSQL as a database management system. The Clinical Trials Data Management System XAVIA SIDEC facilitates and makes the Case Report Forms (CRF) design and approval more flexible, standardizes the information handled, validates the data collected through rules, improves the flow of information between the entities conducting the trial and optimizes the monitoring process(AU)

Discussion on Design of Clinical Trial Protocol of Laser Medical Devices / 中国医疗器械杂志

Guidance and reference are provided for protocol designer. The classification of laser medical devices are introduced. The key points such as the selection of control group, evaluation indicators and method, criteria of inclusion and exclusion, and application of blinded, etc. are discussed, and the importance of management of defects in medical device is emphasized.

Analysis on clinical study protocols of traditional Chinese medicine for coronavirus disease 2019 / 中国中药杂志

To analyze the registered clinical trial protocols of traditional Chinese medicine(TCM) for the prevention and treatment of coronavirus disease 2019(COVID-19), in order to provide information for improving the quality of research design. The website of the Chinese Clinical Trial Registry(www.chictr.org.cn) and the American Clinical Trial Registry(clinicaltrials.gov) were searched to collect protocols of TCM for COVID-19. Documents were screened following the inclusion criteria, and data were extracted in regard to registration date, study objective, type of design, sponsor, patient, sample size, intervention, and evaluation index. Descriptive analysis was conducted. A total of 49 clinical trial protocols of TCM for COVID-19 were included. Primary sponsors were mainly hospitals or universities in places like Hubei, Beijing, Zhejiang and other regions. The implementation units are mainly in Hubei, Guangdong, Zhejiang, Henan and other regional hospitals. The types of study design were mainly experimental studies(40), including 30 randomized parallel controlled trials, 7 non-randomized controlled trials, 2 single arm trials and 1 consecutively recruited trial; besides, there were also 6 observational studies, 2 health service studies and 1 preventive study. The sample size reached a total of 30 562 cases, with a maximum of 20 000 for a single study and a minimum of 30. The 49 trials subjects included healthy people(3), isolation and observation cases(1), suspected cases(10),confirmed COVID-19 patients(31) and COVID-19 recovery patients(4). Of the 31 trials planned to include confirmed COVID-19 patients, 16 protocols no definite disease classification, 3 with a clear exclusion of severe subjects, 4 with common subjects, 2 with light, common or severe subjects, 1 with light and common subjects, 1 with common or severe subjects, 3 with severe subjects, and 1 with severe or critical subjects. The experimental interventions included Chinese patent medicine(Lianhua Qingwen Capsules/Granules, Huoxiang Zhengqi Dropping Pills/Oral Liquid, Babao Dan, Gubiao Jiedu Ling, Jinhao Jiere Granules, Compound Yu-xingcao Mixture, Jinye Baidu Granules, Shufeng Jiedu Capsuless, Shuanghuanglian Oral Liquid, Tanreqing Injection, Xuebijing Injection, Reduning Injection, Xiyanping Injection), Chinese medicinal decoction and taichi. The primary evaluation outcomes mainly included antipyretic time, clinical symptom relief, novel coronavirus nucleic acid turning to negative, conversion rate of severe cases and chest CT. There was a quick response of clinical research on the prevention and treatment of COVID-19 with TCM, with the current registered protocols covers the whole process of disease prevention, treatment and rehabilitation. However, issues need to be concerned, including unclear definition of patient's condition, unclear research objectives, unclear intervention process and inappropriate outcomes, etc. In addition, researchers should consider the actual difficulties and workload of doctors in epidemic response environment, and make effort to optimize the process and improve the operability of research protocols under the principle of medical ethics.

Progress in trial registration in Latin America and the Caribbean, 2007-2013 / Registro de ensayos clínicos en América Latina y el Caribe / Registro de ensaios clínicos na América Latina e no Caribe

ABSTRACT This descriptive study identifies trends in clinical trial registration in the World Health Organization International Clinical Trial Registry Platform (ICTRP) for Latin America and the Caribbean (LAC), from 2007-2013, and provides adjusted estimates for registration rates by population and publications (2007-2011). Trends and data are presented by subregion and language in interactive graphs, including annual registration rates by population (2007-2011) and publications (LILACS and MEDLINE) listed in SCIENTI Network (Science and Technology Indicators). Of the 11 945 clinical trials involving LAC countries, 8 282 were in South America, with Brazil leading at 4 070 (49%); 2 421 in North and Central America, with Mexico leading at 1 886 (78%); and 1 242 in the Caribbean, with Puerto Rico leading at 857 (69%). After adjusting by population and publication rates Chile, Panama, Argentina, and Peru led registration rates per 1 million inhabitants. Variations in the number of trials per year are quite substantial. Clinical trial registration increased in a steady yet inconsistent way. The implementation of the Policy on Research for Health has been followed by an increase in countries that require registration and have established clinical trial registries. However, there is room for improvement in adherence throughout LAC. Trial registration is offered gratis by Brazilian, Cuban, Peruvian, and United States registries, among others.

RESUMEN En este estudio descriptivo se establecen las tendencias en cuanto al registro de ensayos clínicos en la Plataforma de Registros Internacionales de Ensayos Clínicos (ICTRP) de la Organización Mundial de la Salud (OMS) en América Latina y el Caribe en el período 2007-2013, y se incluyen cálculos ajustados de las tasas de registro por población y por publicaciones (2007-2011). Las tendencias y los datos se presentan por subregiones e idiomas en gráficos interactivos, y además se incluyen las tasas anuales de registro por población (2007-2011) y publicaciones (LILACS y MEDLINE) que figuran en la Red ScienTi (indicadores de ciencia y tecnología). De los 11 945 ensayos clínicos realizados en países de América Latina y el Caribe, 8 282 tuvieron lugar en América del Sur, en donde Brasil lleva la delantera con 4 070 (49 %); 2 421 se realizaron en América del Norte y Centroamérica, donde México se ubica en primer lugar con 1 886 (78 %), y 1 242 se realizaron en el Caribe, donde la mayoría de los ensayos fueron en Puerto Rico, con un número de 857 (69 %). Después de ajustar las tasas por población y publicaciones, Chile, Panamá, Argentina y Perú tuvieron las tasas más altas de registro por 1 millón de habitantes. Hubo amplias variaciones en el número de ensayos clínicos por año. El registro de ensayos clínicos aumentó de manera constante, aunque no uniforme. La ejecución de la Política de investigación para la salud de la Organización Panamericana de la Salud (OPS) llevó a un aumento del número de países que han establecido registros de ensayos clínicos y que requieren que se realice este registro. Sin embargo, podría mejorarse la observancia de esa política en América Latina y el Caribe en su totalidad. El registro de ensayos es gratuito en Brasil, Cuba, Estados Unidos y Perú.

RESUMO Estudo descritivo que identifica as tendências no registro de ensaios clínicos na Plataforma Internacional de Registro de Ensaios Clínicos (ICTRP) da Organização Mundial da Saúde (OMS) para América Latina e Caribe de 2007 a 2013, e apresenta estimativas ajustadas dos índices de registro por população e publicação (2007-2011). As tendências e os dados são apresentados por sub-região e idioma em gráficos interativos, incluindo os índices anuais de registro por população (2007-2011) e publicação (LILACS e MEDLINE) listada na SCIENTI Network (Science and Technology Indicators). Dos 11.945 ensaios clínicos realizados nos países da América Latina e Caribe, 8.282 foram conduzidos na América do Sul, na sua maioria (4.070) no Brasil (49%), 2.421 nas Américas Central e do Norte, na maior parte (1.886) no México (78%), e 1.242 no Caribe, em maior número (857) em Porto Rico (69%). Após o ajuste por população e publicação, Chile, Panamá, Argentina e Peru apresentaram os maiores índices de registro por 1 milhão de habitantes. A variação no número anual de estudos é bastante considerável. Verificou-se um crescimento estável, porém inconsistente, no registro de ensaios clínicos. Com a implementação da Política para pesquisa em saúde, aumentou o número de países em que o registro de ensaios clínicos é exigido e que implantaram registros próprios. No entanto, é possível melhorar ainda mais a adesão na América Latina e Caribe visto que este registro é gratuito no Brasil, Cuba, Peru e nos Estados Unidos, entre outros.