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En el cruce entre la revolución tecnológica y la educación en ciencias de la rehabilitación y del movimiento humano, la inteligencia artificial (IA) emerge como herramienta transformadora en los cursos de metodología de investigación. Este artículo destaca su potencial para optimizar la experiencia de aprendizaje y personalizar la instrucción, pero enfatiza la necesidad crucial de abordar desafíos éticos y pedagógicos. Propone orientaciones para equilibrar la innovación educativa y la responsabilidad académica, resaltando la importancia de la implementación consciente y planificada de la IA en los equipos de investigación en ciencias de la rehabilitación y del movimiento humano, garantizando así la integridad científica y ética en este campo en constante evolución.
In the intersection between technological advancements and education in rehabilitation science, artificial intelligence (AI) emerges as a transformative tool in research methodology. This article navigates the ethical and academic considerations tied to the incorporation of AI in rehabilitation and movement science courses. While acknowledging its potential to enhance learning experiences, it critically addresses the imperative to tackle ethical and pedagogical challenges. The paper offers guidance to strike a balance between educational innovation and academic responsibility. It emphasizes the need for a conscientious and planned implementation of AI, ensuring both scientific integrity and ethical adherence in this dynamically evolving field.
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Chronic obstructive pulmonary disease （COPD） is a common disease in clinical practice. It is associated with obvious exposure to toxic particles or gases and has become the leading cause of death and disability worldwide. The pathogenesis of COPD is complex， and the oxidative stress involved in COPD plays a crucial role in the pathological process of the disease. Patients with COPD usually have high levels of oxidative stress in the lungs， which will affect the whole body for a long time， causing a variety of complications and accelerating the development of the disease. On the one hand， oxidative stress can directly damage the airway and lung tissue. On the other hand， it also drives other pathological mechanisms to jointly promote the development of disease， such as participating in inflammatory reactions and protease/anti-protease imbalance， promoting mucus secretion， accelerating cellular senescence， causing autoimmunity， and involving in genetic regulatory pathways. At present， western medicine treatment is mostly based on conventional drug treatment， and antioxidant-targeted oxidative stress is adopted， but there are still some challenges in efficacy and safety. Traditional Chinese medicine has a long history of preventing and treating COPD. In particular， Chinese herbal medicine formulas have great potential to interfere with the oxidative stress of COPD. Whether it is the modified classical traditional Chinese medicine or the new formulation developed by modern doctors， the research results reflect the multi-target and multi-channel advantages of traditional Chinese medicine treatment， and their efficacy and safety are gradually verified. This paper reviewed the literature in recent years， starting with the basic and clinical research on the intervention of traditional Chinese herbal medicine formulas on oxidative stress of COPD， so as to provide further ideas for related research on the prevention and treatment of oxidative stress of COPD by traditional Chinese medicine.
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Lecanemab is a new drug used to treat early Alzheimer's disease (AD) with mild cognitive impairment or mild dementia. It is a human anti-Aβ fibril monoclonal IgG1 antibody, which is injected intravenously into the patient, through the blood-brain barrier into the brain, clearing amyloid plaque, thereby slowing the rate of cognitive decline in patients and delaying disease progression. This article reviews the pharmacological studies, clinical studies, safety and limitations of lecanemab, in order to help clinical understand the current research status and existing achievements of this drug.
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AIM: To investigate and analyze the current situation and needs of clinical research nurses in China, in order to provide scientific basis for constructing a training system for research nurses, promoting standardized training, and achieving standardized management for them. METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China. The contents of the questionnaire mainly included the general information, professional experience and work content of the research nurses, the sense of accomplishment and training needs of clinical trial work. RESULTS: Among the 102 research nurses surveyed, 92.15% have a bachelor's degree or above; 53.92% of those have intermediate or higher professional titles; 74.51% of them are part-time research nurse. Among professional experiences, 19.61% have more than 10 years of clinical trial experience; 47.06%, 40.20%, and 21.17% of surveyed research nurses were authorized to participate in clinical trial drug management, sample management, and quality control; 70.59% of research nurses have a high sense of achievement in their daily work. In terms of education and training needs, clinical trial related laws and regulations, standardized training for clinical trial protocol implementation, and good clinical practice (GCP) are the three most important aspects. CONCLUSION: Clinical research nurses in China have a relatively high level of education and nursing experience, but there is still a large gap in the amount of professional full-time clinical research nurses in China. Due to the rapid development of innovative drugs and devices, as well as the urgent need to improve the clinical research system, it is necessary to establish a training, assessment, and evaluation system for research nurses that is in line with China's national conditions in order to improve the professional level of research nurses, and improve the quantity and quality of clinical trial research on innovative drugs and devices in China.
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In order to understand the status quo of ethical review of clinical research on the defecation function of patients with rectal cancer after sphincter-preserving surgery, analyze its causes and put forward corresponding suggestions, to arouse researchers’ attention to ethical review in subsequent relevant clinical studies. The ethical review of literatures related to the defecation function of patients with rectal cancer after sphincter-preserving surgery published on CNKI in recent 10 years was sorted out and summarized. The results showed that the ethical review of clinical research papers on defecation function of patients with rectal cancer after sphincter-preserving surgery was not optimistic. We should strengthen the ethical training of researchers, improve the ethical awareness of researchers, strictly implement the ethical norms of paper publication, strengthen the ethical requirements of manuscript contracts, perfect the ethical review system, and pay attention to the examination and supervision of informed consent, so as to promote the construction of ethical examination and approval norms of clinical research documents.
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For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
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It is the responsibility of a clinical research institution to protect the rights and interests of research subjects. For the full process supervision of clinical research projects, the construction of a Human Research Protection Program (HRPP) which is suitable to the hospital’s situation can gradually improve the ethical review quality, and provide comprehensive protection measures for participants and potential participants throughout the entire clinical research process. Combined with the characteristics of clinical research and ethical review of Traditional Chinese Medicine(TCM), this paper introduced the construction of an HRPP system that highlights TCM characteristics. At the same time, this paper systematically analyzed the division of responsibilities, communication and cooperation of different committees and departments within the HRPP system to ensure the effective operation of the entire HRPP system, improve the quality of TCM clinical research and the protection level of the HRPP system, in order to achieve the goal of promote the healthy, orderly and scientific development of clinical research.
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From January 23, 2020 to May 29, 2021, there were 17,550 clinical research registrations on the China Clinical Trial Registry Platform. The index of clinical research on COVID-19 showed 840 registrations, accounting for 4.79% (840/17 550) of the total registrations. According to the trend chart of epidemic development, 487 clinical research projects of COVID-19 registered from January 23, 2020 to March 18, 2020 were set as the early stage of epidemic discovery in the region, the following 15 months were divided into stable initial stage, stable later stage and the later stage of the first wave of domestic epidemic every five months. The proportion of COVID-19 research projects registered in each stage was 29.80%, 5.87%, 0.76% and 1.15% of all registered projects respectively. The registration ratios of COVID-19 in each clinical stage was 57.98%, 28.81%, 5.95% and 7.26% respectively. Intervention studies were 61.60% (300/487) in the early stage of the epidemic, and most of them were in biological agent and drug therapy, which were 40.49%, 50.00% and 73.77% respectively in the later stages. Stable initial stage biological agent projects decreased. Then the vaccine research program became a focused research program. Among the 58 registration projects involving vaccines, 25 were clinical trials of vaccines in different stages, with the major research units being biopharmaceutical companies. Of the 487 clinical studies registered in the early stage, 10.23%(50/487) were withdrawn, of which 38 were intervention treatment studies, most notably drug studies (17) and blood biological products (16), but they were still registered in the stable initial stage. It is necessary to reflect on the scientific and ethical nature of early COVID-19 clinical trials or research, including whether the three core values of equal respect, help to alleviate pain and fairness can be achieved. Whether the "ethics review meeting should pay special attention to the scientificity, safety, fairness, subject protection, informed consent documents and informed consent process, avoidance of conflicts of interest, etc. of clinical trials or research" has been implemented. Competent government departments at all levels and all clinical medical research institutions should organize evaluation, and then establish an effective evaluation mechanism when new clinical trials or research projects are registered in the future.
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In order to speed up the review and approval of new drugs of Traditional Chinese Medicine (TCM) in China, it is accelerating the construction of TCM registration review evidence system, which combines the theory of TCM, human experience and clinical trials, and optimizing the technical requirements for the review of and approval of new drugs of TCM based on ancient classic prescriptions, famous old Chinese medicine prescriptions, and medical institution preparations. The United States has strict requirements on the application for the marketing of herbal medicines. According to the characteristics of herbal medicines and combined with human experience, the European Union has classified registration management, reflecting the regulatory concept of inheritance and innovation. TCM has a long history of human use experience in China, its application has a scope of application, basic requirements, and it is necessary to classify and exempt the declaration materials according to the evidence grading evaluation standards. When the ethics committee reviews the research scheme of human experience of TCM, it should pay attention to the review points such as scientific basis for new drugs or prescriptions of TCM, clinical positioning, applicable population, effectiveness and safety information, research design, sample size, conflict of interest management and informed consent. Finally, Human experience is helpful to formulate the research scheme of new drugs of TCM, which can not only improve the success rate of research and development, but also reduces the cost of research and development, accelerate the marketing of new drugs of TCM, and can benefit more patients.
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It is worth pondering how to seek advantages and avoid disadvantages in stem cell clinical research and give full play to the advantages of technology for the benefit of mankind. Through the analysis of the status of stem cell clinical research, including technology and related management methods, proposed the main problems existing in stem cell research, such as the risks of technological uncertainty, ambiguity between research and treatment, over-treatment and technological innovation. Then this paper discussed the ethical and legal risks of stem cell clinical research in China, mainly related to the problems that the construction of laws and regulations is lagging behind, the regulatory challenges of administrative departments are large, the ethical awareness of researchers needs to be further improved, the principle of fairness and justice is not taken into account, the research platform construction of medical institutions is not in place and the protection system of subjects is imperfect, and the organization construction and review capacity of the ethics committee is still lacking.
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Stem cell clinical research is a hot frontier research. The ethical review of stem cell clinical research is full of challenges. Currently, clinical researches lack specific operational guidelines. Considered the related laws and regulations, and the operability of practical work, experts from the field of stem cells, such as law, ethics and management, will form a consensus on the basis of full discussion and continuous revision. It will provide reference for the operation of the ethics committee of corresponding institutions, and lay a certain foundation for the establishment of national expert consensus in the future, so as to promote the effective guidance of ethical review practice and quality evaluation of stem cell research.
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In recent years, the vigorous development of clinical researches carried out by medical schools is inseparable from the effective participation of medical students. However, as the number and categories of clinical research projects that medical students participate in increase, medical ethics related issues gradually occur. This article sorts out the ethical issues that arose in clinical researches, in which medical students participated, analyzes the underlying causes, and proposes solutions for the above-mentioned ethical issues, aiming to provide reference for medical ethics education and research project management for medical schools.
La participación efectiva de los estudiantes de medicina ha contribuido en gran medida al desarrollo exitoso de la investigación clínica en las escuelas de medicina de China en los últimos años. Sin embargo, con el creciente número y tipos de proyectos de investigación clínica en los que participan estudiantes de medicina, las cuestiones éticas se exponen gradualmente. Este trabajo enumera las cuestiones éticas que han surgido en la participación de los estudiantes de medicina en la investigación clínica en los últimos años, analiza las causas subyacentes y propone soluciones a las cuestiones éticas mencionadas anteriormente, con el objetivo de proporcionar referencia para la enseñanza de la ética médica y la gestión de proyectos de investigación para las escuelas de medicina.
A participação efetiva dos estudantes de medicina tem contribuído muito para o próspero desenvolvimento da pesquisa clínica nas escolas médicas da China nos últimos anos. No entanto, com o aumento do número e tipos de projetos de pesquisa clínica dos quais os estudantes de medicina participam, questões relacionadas à ética e à alfabetização são gradualmente expostas. Este artigo lista as questões éticas que surgiram na participação de estudantes de medicina em pesquisas clínicas nos últimos anos, analisa as causas subjacentes e propõe soluções para as questões éticas acima mencionadas, com o objetivo de fornecer referência para o ensino de ética médica e gestão de projetos de pesquisa para escolas médicas.
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Humans , Male , FemaleABSTRACT
Patients with rare diseases frequently face unmet medical needs due to the high costs, lengthy development times, and slow approval processes for new treatments. This case study discusses innovative access alternatives for rare diseases in Brazil, focusing on early access to pabinafusp-alfa for mucopolysaccharidosis type II (MPS-II), a rare genetic lysosomal storage disease characterized by a deficiency of the enzyme iduronate-2-sulfatase. From September 2018 to March 2023, 20 Brazilian MPS-II patients received pabinafusp-alfa through a clinical research protocol. This enzyme replacement therapy (ERT) crosses the blood-brain barrier to address central nervous system manifestations unmet by existing treatments. Patients' participation in the clinical study resulted in an estimated BRL 65 million in cost savings for the public healthcare system compared to conventional ERT with idursulfase-alfa and potentially better clinical outcomes. The case study underscores the importance of innovative mechanisms in addressing patients' medical needs. Early access alternatives include: a) clinical study access, with execution/development aligned with healthcare managers and linked to future access strategies; b) regulatory-level risk-sharing, considering effectiveness uncertainties and the possibility of market withdrawal and/or reimbursement in case of negative results; and c) drug pre-delivery, with payment contingent on positive phase III clinical study outcomes. Although public-private partnerships in clinical research are underused, they could benefit all stakeholders by accelerating drug development, facilitating early patient access to innovative medicines, and generating healthcare system savings, particularly for rare diseases.
Pacientes com doenças raras frequentemente enfrentam necessidades médicas não atendidas devido aos altos custos, longos tempos de desenvolvimento e processos de aprovação lentos para novos tratamentos. Este estudo de caso discute alternativas inovadoras de acesso para doenças raras no Brasil, com foco no acesso precoce ao alfapabinafuspe para mucopolissacaridose tipo II (MPS-II), uma doença lisossômica de armazenamento genético rara, caracterizada por uma deficiência da enzima iduronato-2-sulfatase. De setembro de 2018 a março de 2023, 20 pacientes brasileiros com MPS-II receberam alfapabinafuspe por meio de pesquisa clínica. Essa terapia de reposição enzimática (TRE) atravessa a barreira hematoencefálica para tratar manifestações do sistema nervoso central não atendidas pelos tratamentos existentes. A participação dos pacientes no estudo clínico resultou em uma economia estimada de 65 milhões de reais para o sistema público de saúde, em comparação com a TRE convencional com idursulfase alfa, além de potencialmente melhores resultados clínicos. O estudo de caso destaca a importância de mecanismos inovadores no atendimento das necessidades médicas dos pacientes. As alternativas de acesso precoce incluem: a) acesso por meio de estudos clínicos, com execução/desenvolvimento alinhada aos gestores de saúde e vinculada a estratégias futuras de acesso; b) compartilhamento de risco em nível regulatório, considerando as incertezas de eficácia e a possibilidade de retirada do mercado e reembolso em caso de resultados negativos; e c) pré-entrega do medicamento, com pagamento condicionado aos resultados positivos do estudo clínico de fase III. Embora as parcerias público-privadas em pesquisa clínica sejam subutilizadas, elas poderiam beneficiar todas as partes interessadas ao acelerar o desenvolvimento de medicamentos, facilitar o acesso precoce dos pacientes a medicamentos inovadores e gerar economias para o sistema de saúde, especialmente para doenças raras.
Subject(s)
Mucopolysaccharidosis II , Rare Diseases , Access to Essential Medicines and Health TechnologiesABSTRACT
With the continuous progress of research methodology in the real world and the growing maturity of artificial intelligence technology， a method for conducting “quantitative” research to guide clinical practice based on traditional Chinese medicine （TCM） diagnosis and treatment data was gradually developed. However， there is still a need for further improvements in the overall design of studies and the transformation of findings into clinical practice. Based on this， we put forward a comprehensive overall design concept and application approach for real-world study and artificial intelligence research based on clinical diagnosis and treatment data of TCM. This approach consists of five steps： Constructing a research-based database with a large sample size and high data quality； Mining and classification of core prescriptions； Conducting cohort studies to evaluate the effectiveness of core prescriptions； Utilizing case-control studies to clarify the dominant population； Establishing predictive models to achieve precision medicine. Additionally， it is imperative for researchers to establish a standardized system for collecting TCM variables and processing data， optimize the determination and measurement methods of confounding factors， further improve and promote methodologies， and strengthen the training of interdisciplinary talents. By following this research method， we anticipate that the clinical translation of research findings will be facilitated， leading to advancements in TCM precision medicine. Real-world study and artificial intelligence research share similar research foundations， and clinical applications complement each other. In the future， the two will merge together.
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@#At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.
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@#Telephone follow-up is one of the important ways to follow up patients. High-quality follow-up can benefit both doctors and patients. However, clinical research-related follow-up is often faced with problems such as time-consuming, laborious and poor patient compliance. The authors belong to a team that has been committed to the study of patient-reported outcomes for a long time. The team has carried out long-term follow-up of symptoms, daily function and postoperative complications of more than 1 000 patients after lung cancer surgery, and accumulated certain experience. In this paper, the experience of telephone follow-up was summarized and discussed with relevant literatures from the aspects of clarifying the purpose of clinical research follow-up, understanding the needs of patients in follow-up, and using follow-up skills.
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In recent years, some large public hospitals in China had successively opened scientific research outpatients to provide consulting services for clinical research, but there were generally problems such as insufficient audience and single role of expert teams. In July 2021, Shanghai Clinical Research Center established a multidisciplinary scientific research outpatient for the entire clinical research cycle, providing medical staffs with such services as clinical research design and project application, paper revision and achievement transformation. It also provided clerkship for medical students on campus to cultivate their standardized clinical research thinking. As of July 2022, the outpatient had provided research consulting services 16 times, teaching 8 class hours to medical students, and collaborated to solve multi-dimensional clinical research practical problems throughout the entire cycle, such as clinical trial design, project application, and paper publication. Good results had been achieved by this outpatient to provide reference for promoting the development of scientific research outpatients in China and improving the clinical research level of hospitals.
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Objective:In the context of China′s increasing standardized management requirements of clinical research, this article aims to explore the management methods of investigator-initiated trials in the new period, to provide possible reference for other medical institutions dedicated to clinical research.Methods:According to the requirements set forth by the＂Administrative Measures for Investigator-Initiated Trials in Medical and Health Institutions (Trial)", combined with the hospital management practice, experiences regarding the research management system construction and implementation, management system construction and its implementation effects are summarized and analyzed.Results:By exploring and summarizing the connotation of high-quality clinical research under the New Policy, tailored clinical research management system in our hospital was developed and implemented. And the hospital′s clinical research capability and level have been greatly improved, which enhancing the hospital academic influence, as well as its competence for serving the development of national and regional clinical research.Conclusions:Along with the rapid progress of clinical research, hospitals need to assure the compliance of national laws and regulations, and develop appropriate and applicable institutional management measures to empower the conduct of high quality clinical research.
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Objective:To explore the development, application and practical experience of investigator-initiated integrated clinical research information platform.Methods:The process of developing and constructing an integrated clinical research platform in a tertiary hospital in Beijing was introduced, the functions and advantages of the platform were described and displayed, and the main problems and risk points in the development and construction process were analyzed.Results:The integrated clinical research platform meets the management requirements of clinical research initiated by investigators, and the standardized management of the whole life cycle of the project can be realized through the platform, and the key issues of data security, information capture, sharing and interoperability need to be further explored in terms of platform docking.Conclusions:The integrated clinical research platform effectively improves the standardization, management quality and efficiency of investigator-initiated clinical research.
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Objective:Clinical research is widely carried out in medical institutions, and there are differences in the use of research and conventional medical funds. This paper aimed to analyze the compliance issues of insurance fund in clinical research and explore the management strategies in the institutions conducting clinical trials or research.Methods:By consulting the literature, questionnaire, and work practice, this paper analyzed the current situation and existing problems of the compliance of the medical insurance fund in domestic clinical trials, proposed targeted management measures for the use of funds, and standardizes the corresponding workflow.Results:This paper summarized three payment methods of research-related funds and analyzed the main problems at present, including the definition of trial requirements, the payment of combined drugs specified in the protocol, the particularity of medical device trials, the payment of adverse events in clinical trial, the insurance of post-marketing research and clinical trial. According to the regulatory requirements and work practices, the corresponding management countermeasures were sorted out, including that the project funds and insurance audit should be carried out inside the medical institution. Clinical research, medical insurance management departments, ethics committees, and other departments should collaborate on establishing and improving a compliance management system. The research team should strengthen the management of adverse events, strengthen the publicity and education of the participants, and make good use of the sharing platform.Conclusions:The research institution should establish standardized and feasible processes, the research team should strengthen the management, and the use of the sharing platform is conducive to ensuring the compliance of the medical insurance fund and protecting the interests of the participants.