Through the literature studies and accepted guidelines, Delphi method, confirmatory factor analysis, radar plots analysis of the collected data, the final conclusions are as follows. Firstly, our study proposed a proactive quality assessment consideration for IITs of four aspects: progress(including overall progress, enrollment progress, budget implementation rate), quality(including study protocol compliance, data management, subject management, quality control total 4 indexes), regulation(including ethical approval, subject safety, informed consent total 3 indexes), scientificity(including evidence-based medicine level, reasonable clinical research methods, study protocol dissemination total 3 indexes). Secondly, 272 IITs covering 30 tertiary first-class hospitals in shanghai were identified. Finally, 257 IITs were included for the validation of quality indicators. The majority of the studies (60.29%) were RCT, and 58.82% of the studies were single center. Thirdly, we further confirmed the structural validity of the one-class index and secondary indexes as latent variables. In the results of confirmatory factor analysis, CMIN/DF, GFI, CFI, TLI, RMSEA, RMR and other indicators used in the model test are all meet the requirements. The CFA model revealed strong positive links from four quality indexes to the overall quality of ITTs. Our study intends to develop a handy quality assessment tool for IITs. This panorama tool provides project management departments with a way to effectively and dynamically manage their studiesand a manner to improve the quality of IITs in the future.
The panorama quality assessment tool our study built can effectively evaluate the quality of research data, and can timely and dynamically find errors, take actions to prevent major bias. For the management side like NIH, the assessment tool can effectively improve the efficiency and effectiveness of funding. Our team used panoramic tools to evaluate projects. About 5% of the projects were terminated early and 20% got second round support. Adopting international advanced assessment methods is very important to conduct and improve the quality of clinical trials. Traditionally, the International Conference on Harmonization–Good Clinical Practices (ICH‑GCP) described two verification activities: quality control and quality assurance. The aims are to protect the rights and well-being of subjects and ensure protocol compliance and data integrity. Recently, FDA and EMA guidelines both issued in 2013, ICH GCP guidelines issued in 2016 and NMPA GCP issued in 2020 suggested focusing on critical data and critical processes, and encouraged to adopt risk-based approaches to monitor clinical trials. A serial of researches reported that risk-based monitoring has the potential to make trials more efficient and reduce costs[26, 27]. We, therefore, adopted risk-based approaches to identify critical data of IITs to improve the capacity of self-regulate overall quality. Due to distinct characters of IITs, monitoring practices are highly variable among IITs, and there is a need for standardization of practices in monitoring activities. It is a suitable method for the quality management of problems in IITs.
We further confirmed the structural validity of the IITs quality assessment tools by CFA. The model also presented the importance of progress and scientificity. Progress, measured jointly by overall progress, enrollment progress, budget implementation rate, has direct and indirect effects on the overall quality of IITs in our theory and confirmed by the model. Poor recruitment of participants is the most common reason for the RCT discontinuation, which reflects a large waste of scarce research resources.In this study, enrollment progress and budget implementation rate scored low, which were, 7.30 and 5.91, respectively. The reason for the low recruitment progress of subjects may be linked with funding, design, recruiter, or participant . In addition, there are differences in the progress of subject recruitment among different research types, and the recruitment progress of RCT is the lowest. Scientificity, measured jointly by evidence-based medicine level, reasonable clinical research methods, study protocol dissemination have direct and indirect impacts on the overall quality of IITs in our theory and confirmed by the model. Large and well-conducted clinical trials are widely regarded as the best source of evidence on the efficacy and safety of medical interventions. Therefore, RCT has a relatively higher evidence-based medicine level. Our study found that almost half of the research protocol would be adjusted in the implementation process, which may be associated with better implementation. Recently, it is important that all research findings, including negative and inconclusive results, are reported transparently and made publicly available in order to avoid unnecessary duplication of research or biases in the clinical knowledge base. It has reported that among registered clinical trials, slow dissemination of research results was common , with almost half of the studies remaining unpublished years after completion that may be aroused by 'a lack-of-time or low priority', followed by 'results not important enough' and 'journal rejection' , which was consistent with our study.
Our study has several advantages and limitations as well. First, the sample used to confirm the CFA was collected from in-planning studies, no previous research was identified discussing the in-planning studies. Our study includes a variety of research types, regardless of "high quality" and "low-quality" studies, which can objectively reflect the current research status. However, we only included the clinical research projects in Shanghai and did not cover the whole world. Second, the sample size was up to standard, we reach 200 samples for CFA and while CFI is a noncentrality parameter-based index, which designed to overcome the limitation of sample size effects. Third, our study adopts a risk-based monitoring method to identify critical data and processes, which in line with international trends and save resources. However, in addition to the indicators concluded in this study, IITs have more evaluation angles and quality indicators. IITs have a scientific exploration component, and the research purpose may change, so the research scheme and data collection are often more complex and changeable. The quality assessment tool for IITs showed here has enabled us to evaluate the overall quality of IITs and therefore helps us refine quality practices in IITs. However, due to limited resources, we failed to take all these details points into account. Future studies are needed with an improvement of quality assessment tools before strong recommendations can be made on its use.