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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 discuss the scientificity and feasibility of risk-based monitoring strategies in Investigator initiated Trials.Methods:" Guideline for Good Clinical Practice" promulgated by NMPA, " Oversight of Clinical Investigations-a Risk-based Approach to Monitoring" and " A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry DRAFT GUIDANCE" promulgated by the US FDA and other documents were analyzed, the practical experience of Investigator initiated Trials was also summarized.Results:It was recommended that clinical investigators use risk-based monitoring strategies in Investigator initiated Trials. The main idea of risk-based monitoring is to determine the key process and key data of the study, carry out risk rating on the project, and adopt corresponding monitoring methods according to the risk level when formulating the monitoring plan. At the same time, during the clinical trial development process, the risk and data quality of the research center should be regularly evaluated to grasp the risk changes of different centers. In accordance with trends, adjust the method, content and frequency of monitoring.Conclusions:To apply risk-based monitoring strategies in Investigator initiated Trials is scientificity and feasibility. Risk based monitoring can meet the data quality requirements of clinical trials, without affecting the analysis results of the main outcomes, and can further improve the efficiency and effectiveness of monitoring.
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Objective:This paper aims to promote the standardization of ethics review of horizontal scientific research projects and improve the ethics review quality by analyzing the current ethics review practice in a certain tertiary hospital, identifying common problems during the review process, illustrating relevant causes and proposing corresponding solutions.Methods:Through introducing the current situation of ethics review of horizontal scientific research projects in a tertiary level hospital, the differences between the main points of ethics review of horizontal scientific research projects and government-funded scientific research projects were analyzed, so as to sort out the common problems and possible causes in the process of ethics review of horizontal scientific research projects, and then explore the possible corresponding solutions.Results:Based on the characteristics of horizontal research projects, ethics review should focus on their scientific and social values, potential conflicts of interest, protection of subjects′ rights and interests, and whole-process management and quality assurance. At present, there are still many problems, such as a large number of projects, but not many projects with high research value, inadequate project process management, and ineffective implementation of ethics review opinions.Conclusions:The hospital should further improve the management system of horizontal scientific research project approval, bring in more comprehensive review regarding to both scientific and ethics review, engage more experts at the outset of project funding decision-making, set up ethics specialists, strengthen the process management of horizontal scientific research projects, strengthen ethical publicity and education, and improve the ethical awareness of researchers to fully protect the rights and interests of subjects and promote the high-quality development of clinical research.
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Objective:In order to put forward relevant measures and suggestions to improve the quality of the Investigator-Initiated Trials of oncology in medical institutions.Methods:Through literature research, comparative study, combined with the implementation and management of investigator initiated trials, the current status and challenges of the administration of these trials were analyzed.Results:Investigator-Initiated Trials of oncology become increasingly important. However, its quality is poor compared with Industry-Sponsored Trials due to insufficient funds and lack of effective supervision. Besides, four main challenges as follows were identified: lack of clinical research professionals, the quality concerns of ethical review in some institutions, insufficient funding for clinical research, and imperfect quality management system.Conclusions:Based on the actual needs of IITs of oncology, medical institutions should strengthen the talent cultivation, establish electronic information management platform, increase project support, strengthen scientific research supervision and deepen the awareness of risk prevention to improve the quality of investigator initiated trials.
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Objective:Discuss the problems of multi-center pharmaceutical clinical trial which initiated by investigator (IIT), providing references for developing study management strategies.Methods:By analyzing the site recruitment, academic and ethical review, study contract, study training, quality control, influencing factors of subject enrollment, proposed management strategies of multi-center pharmaceutical clinical study which initiated by investigator.Results:While conducting multi-center pharmaceutical clinical study initiated by investigator, the study experiences, study team, hospital equipment, and the internal process of hospitals are the factors which ensure the progress and quality of clinical study. Most of the sites have no clear statement of scientific review, but most of the high-level hospitals do not use the ethical review results of the head hospitals, the ethics must be reviewed repeatedly; Contract also has different requirements due to different management departments. During the preparation and implement of IIT, the investigators should undergo a rigorous training which is a key element to ensure the quality of the study. Research quality and progress restrict each other and are affected by many factors, detailed quality control measures should be developed, training and inspection, and the cooperation of project management and data management, also with discover the data problems of sites and communicate with investigators timely to ensure the improvement measures are implemented.Conclusions:There are many factors have impact on study progress and quality of multi-center pharmaceutical clinical trial of IIT. Before conducting research, protocols should be developed scientifically, and fully assessing its feasibility, screening study sites strictly, shorten the time of ethical review and contract preparation. Study training, inspection, data management, risk management and document management should be implement strictly, and make full use of information platforms and means, improve management efficiency and IIT progress and quality.
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Objective:To explore the critical issues in the construction of management and supporting system of Investigator-Initiated trials (IIT) in pediatrics.Methods:Through summarizing related literature and considering the current status of pediatric clinical research, the critical issues in the construction of management and support system, for instance, the responsibility, training model, and performance evaluation in Europe and U. S. were evaluated, decision-making suggestions were put forward based on domestic pediatric IIT management system.Results:Besides IIT, clinical trials on children′s drugs are also supported by the pediatric clinical research management system in Europe and U. S.. The supporting service covers research consultation, ethical review, research design, trial implementation, patient education, risk control, and investigator training. The organizational structure and management system are relatively mature. Clinical trials are the majority of clinical research in children′s hospitals in China. Main issues identified in the construction of the management and supporting system include ethical review for pediatric clinical research, professional investigator training, multicenter cooperation scheme, performance assessment, and incentive strategies.Conclusions:Taking account into the current status of pediatric IIT in China, it is urgent to accelerate the training of pediatric investigators, set up standard IIT project management team, build the professional project management platform and Electronic Data Capture System, and promote the transformation of research outcomes. Finally, the whole process management of pediatric IIT will be developed to facilitate the development of pediatric medicine.
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Objective:Investigator Initiated Trials (IIT) play a key role in promoting comprehensively the development and homogeneity of clinical diagnosis and treatment, thus, this article aims to explore a set of recommendations for the construction and management of clinical research institutes that support IIT.Methods:Through the combination of literature review and institutional construction practice cases, based on the experience of domestic and foreign universities and well-functioning medical institutions in building clinical research centers, as well as summarizing the construction cases of the clinical research institute of Shanghai Jiao Tong University School of Medicine, to discuss the construction and management plan of such centers.Results:Propose recommendations for the construction and management standards of clinical research centers that support IIT, covering the principles of center construction, basic settings, organizational structure, functional departments, basic platforms, staffing, document management and institutional evaluation.Conclusions:We hope this study can provide reference to universities and medical institutions for the construction of the clinical research institute.
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Objective:To assess possible risk factors and their respective levels in the whole process of investigator initiated trial(IIT)projects proposed in the proposal stage, for reference in formulation of risk management plans.Methods:Through literature analysis and research group discussions, the risk factors of IIT projects and risk level assessment criteria were preliminarily identified, and a consultation questionnaire was developed as a result. Delphi method was used to further optimize the risk factors and determine their risk levels. Data obtained from the consulfation were analysied by descriptive.Results:The recovery rates of two rounds of expert consultation were both 100%, and the degree of expert authority was 0.942. The survey finalized 38 risk factors, including extremely high risk, high risk, medium risk, low risk and very low risk factors of 17(44.7%), 15(39.5%), 3(7.9%), 2(5.3%) and 1(2.6%) respectively.Conclusions:This study determined a risk evaluation system of IIT projects in the proposal stage. This system can identify risks of IIT projects at an early stage, facilitating early intervention of problems existing in such projects, and minimize risks to the rights and safety of patients.
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Objective By analyzing the problems existed in the Investigator Initiated Trial (IIT),this article put forward the corresponding countermeasures and therefore provides reference for the standardization of clinical research project management.Methods Four types of problems identified in the supervision of hospital IIT projects are analyzed according to literature review,data analysis of clinical research project,comparative study and summary.Identified problems are existed in the following aspects:scientific research supervision function,research method guidelines,technical specification of the diagnosis and treatment,scientific research design and project approval review,research funds,medical ethics committee,construction of Biobank and Regulation Conflicts.Results This article put forward 6 countermeasures for improvement:establishing and perfect IIT project scientific research supervision entity,bring in the IIT project steering group to strengthen the scientific review;Strengthen risk management to ensure medical safety,carry out IIT training,establish IIT management database information system,build a comprehensive integrated development multi-point application model of hospital BioBank.Conclusions The establishment of the hospital's IIT scientific research supervision system,management mode and technical standard system is of great importance to standardize clinical research,ensure research quality and guide the clinical research work of the hospital effectively.