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Objective:To explore the key points and implementation of establishing a whole-process clinical research management system.Methods:Based on the problems in practice, combined with project management experiences, this article analyzed the construction of the whole-process clinical research management system.Results:The establishment of the management system provides a comprehensive and sustainable safeguard for clinical research, as well as the improvement of efficiency and quality of clinical research.Conclusions:The establishment of an effective whole-process management system for clinical research project is a useful exploration of the research service model in China.
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Objective:To explore the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of " government-application-industry-academia-research" , and facilitate faster and better conducting of clinical trials.Methods:Based the combination of literature review and the working practice in drug clinical trial management, problems existed during the implementation of clinical trials were summarized, and then the collaborative development of drug clinical trial institutions and Contract Research Organizations were discussed from the perspective of " government-application-industry-academia-research" partnership.Results:Problems identified during the implementation of clinical trials including uneven capacity of CROs, lack of effective supervision department and insufficient cooperation with clinical trial institutions, which resulted difficulties in sharing clinical trial resources and also negatively impacted the quality of clinical trials. Some proposals were offered in this article, including making good use of the " visible hand" of the government to strengthen the supervision of CROs, accelerating the construction of innovation alliance between clinical trial institutions and CROs, establishing the incentive mechanism of collaborative development and the talent team construction, strengthening the personnel professional training.Conclusions:The application of " government-application-industry-academia-research" model in clinical trials would promote the collaboration between drug clinical trial institutions and Contract Research Organizations, which play important roles in the development of clinical trials.
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Getting evidence in to practice tends to focus on strategies, theories and studies that aim to close the gap between research knowledge and clinical practice. The evidence to practice gap is more about systems than individual clinician decision making. The absence of evidence for administration and management in the organization of healthcare is persistent. Teaching nurses and providing evidence as the solution to evidence-based healthcare is no longer axiomatic. Previous studies have concluded that unit level strategies integrate multi-professional teams with organizational needs and priorities. This ‘best fit’ approach that characterizes how healthcare is structured and delivered. The published literature shows that increased readiness for change is aligned with integrated approaches informed by conceptual models. The Joanna Briggs Collaboration is the largest global collaboration to integrate evidence within a theory informed model that brings together academic centres, hospitals and health systems for evidence synthesis, transfer and implementation. The best approaches to implementation are tailored to local culture and context, benchmark against international evidence, combine a theory informed model and stakeholder perspectives to improve the structure and processes of health care policy and practice.
Subject(s)
Benchmarking , Cooperative Behavior , Decision Making , Delivery of Health Care , Evidence-Based Practice , Models, NursingABSTRACT
The nature of collaborative innovation is to share the resources for innovation through management,which would play great role in scientific policy change in China. Translational medicine actually is combine theory and daily practice,basic and clinic research,which need multidiscipline,collaboration between different areas.Collaborative innovation is the requirement of translational medicine.Therefore,establishing research organization with characteristic of collaborative innovation is the key for the development of translational medicine.
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translational research highly depends on Translational research organizations.America is the leading country in science and technology. It is very important to learn from America successful experience in order to develop perfect translational research organization.This paper analyzed the needs of changing the current research organization,and provided some suggestions for Chinese translational research organization based on understanding the differences between America and Chinese present research organization.
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Asset management of scientific research program is one of the vital factors for implementing it successfully.In this article,we analyzed the problems occurred in the process of fund management,permanent asset management and invisible asset management of the scientific research program.Meanwhile,we put forward the countermeasures to solve these problems.
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OBJECTIVE:To explore the innovation pattern of biopharmaceutical industry in China.METHODS:Three major problems encountered by the research and development (R&D) of new drug,the core of Chinese biopharmaceutical industry,including the weak construction of operation base for R&D of new drug,insufficient fund,difficulty in the transformation of achievements were analyzed.An innovation pattern of biopharmaceutical industry was founded based on the "Contract Research Organization(CRO)".RESULTS:An innovation industry pattern consisting of multiple-concurrent CRO R&D mode,venture capital and patent/new drug certificate tie-in financing form and new drug certificate oriented R&D process management has been put forward,which was integrated into an "advanced CRO"(CRO+) mode.CONCLUSION:The CRO+ mode is an open and integrative service system which can help shorten the R&D cycle,lower the cost and risk of R&D and promote the development of biopharmaceutical industry in China.
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OBJECTIVE:To promote the development of Contract Research Organization (CRO) in China. METHODS: The definition and function of CRO and the reason why CRO grows so quickly in recent years were introduced. Then a systematic analysis on the development and trend of CRO in China and abroad were conducted, and the problems in the developments were pointed out. RESULTS & CONCLUSIONS: Based on the condition in China, the following strategies for the development of CRO in China were put forward: firstly, the government should tighten control on the standardization and monitoring of domestic CRO; secondly, the pharmaceutical companies in China should get a better understanding and make full use of CRO; thirdly, the cooperation between CRO in China and CRO abroad should be emphasized; fourthly, it is advisable to cultivate more talents on outsourcing.