Objective To explore the current problems of training on ethics reviews in clinical trials in China. Methods We designed a quantitative survey to collect participants’ feedbacks on the training workshop on ethics reviews, which included contents, arrangement and structure, relevant to the workshop and their difficulties on ethics review work. Results A total of 60 questionnaires were sent and the response rate was 56.7% (34/60). A total of 120 participants from 18 provinces of China. Most of them were members of the virtual research center of evidence-base medicine of the Ministry of education. A total of 78.1% (25/32) participants thought they achieved their purpose after training, and 12.5% (4/32) did not meet their needs due to the poor language. The feedbacks of contents and quality of the workshop on ethics were shown in Table 1. The top useful contents (cents in 8-10) were: clinical trial registration, policies of WHO and China (93.8%, 30/32), data management and quality control in clinical trials, the roles of clinical trial registries and ethics committees (93.3%, 28/30), transparency in clinical trials (93.3%, 28/30), informed consent and beyond (91.8%, 31/34), and how to approach ethical review case studies (90.9%, 30/33), etc. Nobody considered workshop of less help.The majority (85.1%, 23/27) thought difficulties on ethic reviews existed and the main difficulties include: short of operational administrative rules (82.6%, 19/23), poor training opportunity (52.1%, 12/23), less supports from administrative (30.4%, 7/23) and financial (21.7%, 5/23), etc. The relevance (8-10 cents) to ethics workshop was: methods of teaching 75.9% (22/29), PPT 75% (21/28) and materials 42.9% (12/28). Conclusions There is some limitations in the first workshop on ethic reviews due to the lower response rate. However, it still shows the importance of training on ethics reviews. Training strategies should focus on different participants’ needs and the relevance to methods of teaching, and materials, etc. Workshopadopted lectures, cases studies analysis, more discussions and necessary translation will be welcome.
In recent years, CRO has developed rapidly in China, and has played an important role in improving the level of Chinese clinical trials and drug development. However, the development of CRO industry also has problems. This paper discusses the beneficial factors of the main problems and the future direction of CRO, in attempt to attract the attention of government supervision and management departments and CRO industries.
To declare the clinical value of lowing serum LDL-C level in coronary heart disease by reviewing the history of its clinical trials in the last 4 decades.
This article briefly introduces the management of clinical trials of investigational new drugs, hospital-made preparations, post-marketing drugs and other types of clinical trials. The WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) are also described. People conducting trials are advised to apply the basic philosophy of evidence-based medicine in their implementation, which is considered to be one of the guarantees of the validity of clinical trials.
In the clinical trials, the rights and interests of participants must be considered. Ethical principles including the Declaration of Helsinki for clinical research have been established, and the institutional review board (IRB) and informed consent are important for protecting the rights and interests of participants. Whether a clinical trial is in accordence with the ethics depends on if the available clinical evidence is valuable and credible. The better candomize controlled trial (RCT) is one of the best evidence which will make different results equal between the treatment group and the controlled group. Thus benefits and risks of participants are allocated equitably and useless treatment is prohibited when the effective treatment affirmed at the same time. Economic health evaluation and outcome measurements are emphasized in EBM, and the clinical evidence is updated regularly. It is EBM and its emphasis of evidence that need the high-quality clinical trials, therefore the problems of ethics involved in clinical trials is important.
The concept of clinical trial transparency has been promoted for more than 40 years. The act of clinical trial registration, report guidelines development, and data sharing has has been strongly pushed forward and become a common practice. The clinical trial process being the key procedure of trial operation and quality control, determines the accuracy of the results. However, the process report of clinical trials is insufficient. In this article, we summarize the importance of clinical trial process report and provide corresponding suggestions. We propose that medical journals, reporting guidelines developers and clinical trial registration platforms should work together to strengthen the process report of clinical trials and promote full transparency of clinical trials.
The complete, transparent, and standardized reporting of the outcome of a clinical trial is a key factor in ensuring the practicality, reproducibility, and transparency of the trial, and reducing bias in selective reporting. The consolidated standards of reporting trials (CONSORT) 2010 statement provides normative guidelines for reporting clinical trials. In December 2022, JAMA released the guidelines for reporting outcomes in trial reports (CONSORT-Outcomes) 2022 extension, aiming to explain the entries related to trial outcomes, sample size, statistical methods, and auxiliary analysis in the CONSORT 2010 statement, to further improve the standards for outcome reporting in clinical trial reports. This article combines research examples to interpret the CONSORT-Outcomes 2022 extension, in order to provide normative references for domestic scholars to report clinical research results.
In recent years, clinical trial research on stroke intervention measures has been developing rapidly. In order to provide reliable conclusions, the outcome assessment of clinical trials is crucial. Tools for functional status evaluation have been widely adopted as outcome assessment, and have become mandatory for qualified clinical trials of stroke treatment. In this paper, the classification of functional assessment scales in stroke is reviewed, and the applications of functional assessment scales in clinical trials of stroke treatment are presented. National Institute of Health Stroke Scale, Barthel Index, and modified Rankin Scale are the top three frequently applied assessment scales in stroke trials. Also, their validity, reliability, responsiveness, and feasibility are described. Furthermore, analytical methods used to assess those functional assessments are highly heterogenous, while dichotomy of scale score is the most widely used. Although there is no consensus on designation of the functional assessment time, three-month is the most popular, reliable, and feasible choice in stroke trails.
Survival data were widely used in oncology clinical trials. The methods used, such as the log-rank test and Cox regression model, should meet the assumption of proportional hazards. However, the survival data with non-proportional hazard (NPH) are also quite usual, which will decrease the power of these methods and conceal the true treatment effect. Therefore, during the trial design, we need to test the proportional hazard assumption and plan different analysis methods for different testing results. This paper introduces some methods that are widely used for proportional hazard testing, and summarizes the application condition, advantages and disadvantages of analysis methods for non-proportional hazard survival data. When the non-proportional hazard occurs, we need to choose the suitable method case by case and to be cautious in the interpretation of the results.