The Construction And Empirical Research Of Evaluation Index System For Investigator Initiated Clinical Trials

Background:With the advancement of medical research and the demand for high-quality clinical research in diagnosis and treatment guidelines,the number of clinical studies(Investigator Initiated Trials,referred to as IIT)initiated by investigators has grown rapidly.In addition,IIT and clinical trials of drugs for the purpose of marketing are in laws,regulations,Differences in regulatory departments and development procedures have brought huge regulatory pressures to the regulators-medical and health institutions.Except for the clinical research of new biomedical technology and low-risk observational IIT issued by countries such as stem cell and immune cell therapy,most of the interventional IIT involves the human body,and the complexity and high risk coexist,and the number of developments is relatively large.,Its risk control is the top priority of supervision.However,domestic IIT supervision is still in its infancy,and there is no specific policy,which causes medical institutions to rely mainly on "empirical" supervision,and the process and experience are difficult to quantify.There are few domestic related studies,there is no recognized authoritative intervention IIT risk assessment standard,and the supervision process and level are uneven.Therefore,according to the potential risk points of IIT,constructing a reasonable and effective IIT risk assessment scale,and exploring and formulating interventional IIT project management processes are the current research priorities in the field of IIT management..Objective:1.Develop an IIT risk assessment scale based on risk assessment to provide effective tools for accurately assessing the risks of IIT projects.2.Discuss IIT risk assessment indicators and their relationship with risk factors affecting the development of IIT,and put forward corresponding countermeasures and suggestions for improving the quality of IIT projects and optimizing the management process of IIT projects..Methods:1.Literature analysis methodSearch for relevant domestic and foreign literature,research reports and policies with keywords such as "Clinical Research Initiated by Researchers" and "Investigator Initiated Trials",sort out and analyze the included IIT risk points,combine the results of expert discussions,clarify the potential risk points of IIT,and form a preliminary formation IIT risk assessment index pool.2.Delphi expert consultation methodTwenty-two experts in related fields were invited to conduct three rounds of consultation.The experts were mainly from the clinical research management departments of large tertiary hospitals,most of whom had senior titles,graduate degrees and years of work experience.Combining expert opinions,index screening and calculation of importance scores,construct an IIT risk assessment index system and form the first draft of the IIT risk assessment scale.3.On-site investigation methodSelect interventional IIT projects for empirical research,and invite experts to use the IIT risk assessment scale as a tool to conduct on-site investigations of the project risk degree,using coefficient of variation,factor analysis,principal component analysis,Cronbach’s a coefficient,and Spearman correlation coefficient pair scale Carry out reliability and validity evaluation,and put forward suggestions on the optimization of IIT project management process in combination with risk assessment.The results of the study:1.Construct an IIT risk assessment index system.and form an IIT risk assessment scaleThrough the literature analysis method and the three-round expert consultation method,an IIT risk assessment index system including 5 first-level indicators and 25 second-level indicators has been established.The Kendall coefficient is 0.232,P<0.001,the coefficient of variation is less than 0.25,and the authority coefficient is 0.7773.Meet the statistical requirements.Combining expert authority coefficient and importance score to calculate the weight of each indicator,and finally form the IIT risk assessment scale.2.Reliability and validity analysis and empirical research(1)Invite 3 experts to conduct risk assessments on 14 interventional IIT projects.Full entry Cronbach coefficient 0.856,split-half reliability coefficient,0.833,Guttman split-half reliability coefficient 0.832,KMO statistic 0.604;using principal component analysis,a total of 5 factors with eigenvalues greater than 1 were extracted,and the cumulative variance contribution rate was 82.795%,Consistent with the research design of the index system,with high reliability and validity.(2)The rank sum test,Pearson correlation coefficient test,and non-parametric test all show that the IIT risk assessment scale can better assess the risk of interventional IIT projects.3.Put forward recommendations for optimizing the IIT project management process based on the risk assessment scaleAccording to the IIT risk assessment indicators,the project development standards are determined,and the project is divided into three levels of high,medium and low risk according to the scores of the scale,and corresponding management objectives are formulated,and countermeasures are proposed for improving the quality of IIT projects and optimizing the management process of IIT projects.And suggestions.Research conclusions and prospects:Based on the current situation of the number of IIT projects in my country,the lack of specialized policies and authoritative risk assessment standards,this research adopts the Delphi method to construct an interventional IIT risk assessment index system.The selected experts’ authority coefficient and opinion consistency coefficient are all statistically Requirements,indicating that the indicator system is reliable.Reliability and validity and empirical research results show that the indicator system has good reliability and validity,and the constructed IIT risk assessment scale is relatively reliable for the risk assessment ability of IIT projects.On the basis of the scale,the corresponding IIT project risk classification and management process optimization suggestions are put forward,which provides the management department with IIT management tools and method references.Due to time and funding constraints,the expert region is under-represented,and the sample size at the empirical stage is small,and further research is needed.