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1.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(3): 250-255, 2020 Mar 06.
Artículo en Chino | MEDLINE | ID: mdl-32187931

RESUMEN

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation. Based on the review practice of vaccine registration clinical trials in recent years, we summarized the common problems in safety analysis and report and accordingly puts forward a series of thoughts and suggestions, including discussing the role of statistics in safety analysis, putting forward the framework of safety analysis and report involved analysis content, analysis index and analysis dimension, in which attention is paid to the severity analysis; emphasizing the initiative analysis on risk signal and encouraging the evidence-based initiative safety evaluation. At the same time, this paper discusses the basic principles of the presentation of safety data in the package inserts, as well as the comprehensive consideration of the safety data of each phase of the trial and different subjects. It can be used for reference by sponsor to promote vaccine clinical research and evaluation in China.


Asunto(s)
Investigación Biomédica , Ensayos Clínicos como Asunto , Vacunas , China , Análisis de Datos
3.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(3): 235-238, 2020 Mar 06.
Artículo en Chino | MEDLINE | ID: mdl-32187929

RESUMEN

The outbreak of pneumonia caused by the novel coronavirus (2019-nCoV) in Wuhan, Hubei province of China, at the end of 2019 shaped tremendous challenges to China's public health and clinical treatment. The virus belongs to the ß genus Coronavirus in the family Corornaviridae, and is closely related to SARS-CoV and MERS-CoV, causing severe symptoms of pneumonia. The virus is transmitted through droplets, close contact, and other means, and patients in the incubation period could potentially transmit the virus to other persons. According to current observations, 2019-nCoV is weaker than SARS in pathogenesis, but has stronger transmission competence; it's mechanism of cross-species spread might be related with angiotensin-converting enzyme Ⅱ (ACE2), which is consistent with the receptor SARS-CoV. After the outbreak of this disease, Chinese scientists invested a lot of energy to carry out research by developing rapid diagnostic reagents, identifying the characters of the pathogen, screening out clinical drugs that may inhibit the virus, and are rapidly developing vaccines. The emergence of 2019-nCoV reminds us once again of the importance of establishing a systematic coronavirus surveillance network. It also poses new challenges to prevention and control of the emerging epidemic and rapidly responses on scientific research.


Asunto(s)
Betacoronavirus/patogenicidad , Infecciones por Coronavirus/epidemiología , Brotes de Enfermedades , Pandemias , Neumonía Viral/epidemiología , Betacoronavirus/aislamiento & purificación , Investigación Biomédica , China , Infecciones por Coronavirus/prevención & control , Humanos , Neumonía Viral/prevención & control , Vigilancia de la Población
5.
Nature ; 579(7799): 320, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32188957
7.
J Frailty Aging ; 9(1): 14-22, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32150209

RESUMEN

With aging populations around the world, frailty is becoming more prevalent increasing the need for health systems and social systems to deliver optimal evidence based care. However, in spite of the growing number of frailty publications, high-quality evidence for decision making is often lacking. Inadequate descriptions of the populations enrolled including frailty severity and frailty conceptualization, lack of use of validated frailty assessment tools, utilization of different frailty instruments between studies, and variation in reported outcomes impairs the ability to interpret, generalize and implement the research findings. The utilization of common data elements (CDEs) and core outcome measures (COMs) in clinical trials is increasingly being adopted to address such concerns. To catalyze the development and use of CDEs and COMs for future frailty studies, the Canadian Frailty Network (www.cfn-nce.ca; CFN), a not-for-profit pan-Canadian nationally-funded research network, convened an international group of experts to examine the issue and plan the path forward. The meeting was structured to allow for an examination of current frailty evidence, ability to learn from other COMs and CDEs initiatives, discussions about specific considerations for frailty COMs and CDEs and finally the identification of the necessary steps for a COMs and CDEs consensus initiative going forward. It was agreed at the onset of the meeting that a statement based on the meeting would be published and herein we report the statement.


Asunto(s)
Investigación Biomédica/organización & administración , Fragilidad , Canadá , Elementos de Datos Comunes , Consenso , Humanos
8.
Orthop Clin North Am ; 51(2): 177-188, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32138856

RESUMEN

There exists an unmet need for locally relevant and sustainable orthopedic research in low- and middle-income countries. Partnerships between high-income countries and low- and middle-income countries can bridge gaps in resources, knowledge, infrastructure, and skill. This article presents a select list of models for high-income countries/low- and middle-income countries research partnerships including academic partnerships, international research consortia, professional society-associated working groups, and nongovernmental organization partnerships. Models that produce research with lasting legacy are those that promote mutually beneficial partnerships over individual gains.


Asunto(s)
Academias e Institutos/organización & administración , Investigación Biomédica/organización & administración , Países en Desarrollo , Ortopedia/organización & administración , Investigación Biomédica/economía , Países en Desarrollo/economía , Salud Global , Relaciones Interinstitucionales , América del Norte , Organizaciones/economía , Organizaciones/organización & administración , Ortopedia/economía , Pobreza
9.
J Assoc Physicians India ; 68(3): 72-74, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32138489

RESUMEN

The fourth industrial revolution refers to a fusion of technologies which blend the physical, digital and biological worlds. It can mitigate miseries of the teeming masses. However, India faces the unique challenge. It is both the creator of enormous amount of data required for this revolution as well as largest potential market for those innovations in the coming future. This article traces the challenges and draws parallels with the past experiences. The first transformation is expected to hit healthcare sector much sooner than projected earlier. It outlines the call to action required of our thought leaders today.


Asunto(s)
Inteligencia Artificial , Investigación Biomédica , Prestación de Atención de Salud , Predicción , India
18.
Zhonghua Wei Chang Wai Ke Za Zhi ; 23(2): 123-128, 2020 Feb 25.
Artículo en Chino | MEDLINE | ID: mdl-32074790

RESUMEN

Many breakthroughs in the field of surgical clinical researches have been achieved in China, but the overall quality is relatively limited, largely because of the insufficiency in standardization, rationality and scientificity of methodology. In consideration of the nature of surgical procedures and equipments, it is necessary to establish a set of methodological system, suitable for the high-quality clinical research in the surgical field. IDEAL collaboration has put forward a systematic methodological framework for innovation in surgical procedure and equipment. For the clinical research on surgical innovation, the IDEAL framework can be divided into five sequential stages, namely, Idea, Development, Exploration, Assessment and Long-term follow-up. In different stages, the difficulties to be faced, the problems to be solved, and the research design to be adopted are diverse and progressive. Although the IDEAL framework is not perfect, it is currently the best framework for surgical clinical research. While performing surgical clinical research, we should continue to think about how to improve the surgical clinical research methodology.


Asunto(s)
Investigación Biomédica/normas , Cirugía General , Proyectos de Investigación , China
19.
Zhonghua Wei Chang Wai Ke Za Zhi ; 23(2): 129-133, 2020 Feb 25.
Artículo en Chino | MEDLINE | ID: mdl-32074791

RESUMEN

Clinical research is a form of scientific study, whose subjects focus on patients. Its main contents include the etiology, diagnosis, treatment and prognosis related to their disease. Its working place is mainly in medical service and institutes. It is organized and conducted jointly by clinical doctors, epidemiologists, statisticians and multidisciplinary experts. Surgical clinical research, different from studies on pharmaceuticals, has inherent limitations, such as difficulties in establishing standardized intervention, designing rigorous control group, achieving real blinded randomization, or setting unified standards for multicenter practice. To overcome these obstacles, the following points should be considered before initiating: (1) clinical problems based on scientific rationale and the principle of "population-intervention-comparison-outcome" (PICO) should be raised. (2) research methods are applied normatively, and "idea, development, exploration, assessment, long-term follow up" (IDEAL) methodology published in Lancet 2009 is recommended for assessment of new surgical techniques. (3) professional research team is built up to accomplish protocol design, study execution, and efficient follow-up collaboratively and successfully. (4) authenticity of clinical data is ensured, and acquisition and verification of data are standardized. Aiming at clinical problems of laparoscopic gastric cancer, Chinese Laparoscopic Gastrointestinal Surgery Study Group (CLASS) established in 2009 has initiated a series of CLASS studies and has led to the rapid development of domestic surgical clinical researches on laparoscopic surgery of gastric cancer like a great fire initiated by spark kindles. Herein, based on the experience of CLASS studies, this review summarizes the difficulties and countermeasures of surgical clinical research, so as to humbly share some experience of our team with fellows and colleagues.


Asunto(s)
Investigación Biomédica/tendencias , Procedimientos Quirúrgicos del Sistema Digestivo , Laparoscopía , Humanos , Proyectos de Investigación , Neoplasias Gástricas/cirugía
20.
Zhonghua Wei Chang Wai Ke Za Zhi ; 23(2): 140-143, 2020 Feb 25.
Artículo en Chino | MEDLINE | ID: mdl-32074793

RESUMEN

Translational medicine refers to translating basic research achievements into the clinical application for diagnosis and treatment. There are still many issues of gastric cancer to be solved in clinical diagnosis and treatment. We need to focus on clinical questions, by means of basic research and multidisciplinary intersection approach, to further improve the overall efficacy of gastric cancer. Based on Ruijin Hospital's translational research experiences, in this paper, the authors describe the future direction in the field of translational research, such as the etiology and pathogenesis of gastric cancer, tumor markers for early diagnosis, prediction of recurrence and metastasis, classification criteria, evaluation of chemotherapy, tumor heterogeneity, targeted therapy, immunotherapy and research platform establishment. In addition, here we share our perspective of the research on serum biomarkers, specific antibodies and improvement of drug delivery for gastric cancer.


Asunto(s)
Investigación Biomédica/tendencias , Neoplasias Gástricas , Investigación en Medicina Traslacional , Biomarcadores de Tumor , Quimioterapia , Humanos , Inmunoterapia , Recurrencia Local de Neoplasia
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