H. Shang's scientific contributions

Publications (16)

Article
Reporting standard system of clinical research of traditional Chinese medicine (TCM) is composed of ten reporting standards in the areas of the design and preparation of TCM clinical researches, researches of different types, randomized controlled trials of various interventions, systematic reviews of the trials and the translation of research evid...
Article
Poor compliance in clinical studies is a risk factor leading to bias of results of clinical research. However, while the subject compliance has received extensive attention, researcher compliance has not been paid enough attention. The problem of researcher compliance runs through the whole process of clinical research. How to control and evaluate...
Article
Clinical research reports are the main form of clinical evidence. Based on the requirements of clinical research reports and the characteristics of clinical research on traditional Chinese medicine, it is an important basic systematic project to construct a standardized system of clinical curative effects study report on Chinese medicine. This arti...
Article
Evidence produced by clinical trial is the main basis for health care decision-making at all levels. In recent years, some problems been revealed in the national data audit of new drug clinical trials have sounded the alarm for the quality of clinical research in China. In addition to strengthening the implementation of clinical trial process manag...
Article
Objectives To explore potential important factors that impacts the quality of Chinese trials. Methods We randomly selected clinical studies registered in the Chinese Clinical Trial Registry during March 15th, 2016 to December 31st, 2016. The randomized controlled trials protocols were retrieved to assess the quality based on the SPIRIT guideline, t...
Article
Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data (IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and con...
Article
Data management system is a major factor affecting the quality of clinical trial. Development of data management system include a steering group and data safety and monitoring board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of the five parts so as to h...
Article
It is crucial to select outcomes in clinical trials. Appropriate outcomes can improve value and significance of trials and reduce the cost of investment. This paper describes how to develop core outcome sets and core outcome measurement instrument sets with the theory of mixed methods research, so as to standardize the choice of outcomes and outcom...
Article
Compared with traditional clinical trials, the real-world studies set higher requirements on the authenticity (reality), applicability, and timeliness of the evidence obtained. In this paper, we brought up a hypothesis that creating synergies between observational and experimental studies may meet these requirements. And then it was discussed in th...
Article
The quality of clinical trials is key to determine the value of a clinical research and whether it can transform achievements. In this paper, the characteristics and direction of the implementation of quality control in clinical trials in China, and the characteristics of quality control in clinical trials of Chinese medicine are discussed, and the...
Article
Evidence-based Chinese medicine is a relatively new discipline which applies the concepts and methods of evidence-based medicine (EBM) to the clinical research and practice of Chinese medicine. It is not only a branch of EBM but also a natural product of the development of Chinese medicine. This paper introduces the theoretical concepts of evidence...
Article
Ethical issues in clinical research are receiving increasing attention. The application of research projects, the registration of clinical trials and the publication of scientific researches have always been involved with ethical issues. This paper elaborates ethical development and changes in Chinese clinical research from the aspects of the devel...
Article
This paper introduces the development and changes of clinical practice guidelines based on the enlightenment of the Reporting Items for Practice Guidelines in Health Care (RIGHT), and provides policy recommendations. © 2018, West China University of Medical Science. All rights reserved.
Article
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 attentio...
Article
A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by including more studies with the same outcome. It can...

Citations

... To scientifically express the high-quality research evidence produced by the evidencebased practice of TCM in the internationally used language, and to continuously promote the benign development of TCM discipline. [40] Financial support and sponsorship ...
... Clinical trials are studies based on population, human body, or samples, such as tissues and fluids [1]. Evidence from clinical trials provides a meaningful reference for doctors and policymakers in health care [2]. ...
... Finally, after the meeting, working group members edited the STRIC-TOC checklist, identified one or more examples of good reporting for each item, and drafted the manuscript. The STRICTOC working group members presented the rationale of development of STRICTOC among different academic conferences to solicit the comments [26][27][28], and finalized the manuscript in October 2019. ...
... Other items, including baseline data (item 15), ancillary analyses (item 18), harms (item 19), limitations (item 20), registration (item 23), protocol (item 24), and funding (item 25) in the "Results" and "Other information" sections, were also reported poorly. Inadequate reporting of trial registration, protocol, and ethical approval significantly compromises the value of massage RCTs, inviting skepticism and criticism [28]. At the same time, we identified a considerable number of NPT Extension items that were missing or incompletely reported; the average reporting rate was only 10%, with a range of 0.04% to 57%. ...
... Traditional Chinese Medicine (TCM) therapies have been used in China for centuries and have attracted increasing attention in the world, yet lack of reliable evidence on its effectiveness and safety could be one of the impediments for its wider application. Although more and more TCM researchers acknowledge the importance of clinical trials [1,2], methodological appraisals and systematic reviews on the published TCM clinical trials suggest poor methodological and reporting quality [1,3,4], pointing out the need for quality improvement. TCM clinical trials discussed in this study are clinical experiments intended to evaluate the efficacy/effectiveness and/or safety of interventions (medicinal or nonpharmacologic) based on TCM theories. ...
... e COS is a standardized minimum outcome set for application in clinical trials and systematic reviews, which helps translate the results into high-quality evidence. e potential bias related to the reporting of outcomes exists in Chinese medicine clinical trials due to a lack of standardization in outcome assessments [34,35]. Varied selection of outcomes impacts on comparing and evaluating different remedies. ...
... Evidence-based Chinese medicine is an applied discipline, based on the theories and methods of EBM. It collects, evaluates, produces, and transforms the evidence of the effectiveness, safety, and economics of TCM, reveals the characteristics and laws of the clinical role of TCM, and guides clinical guidelines, pathways and health decision-making (2). Evidence is the cornerstone of EBM, and randomized controlled trials (RCTs) are the internationally recognized gold standard for clinical trials. ...
... Besides, researchers may estimate standardization, accuracy, and completeness of the trial implementation process based on a registered protocol. 29,30 The past few years have witnessed an increase in the number of registrations, but merely 2 (4.55%) articles mentioned, and none reported specific access to full trial protocol. This may reflect the lack of awareness among researchers in the registration of trials on AT for COPD. ...
... In the field of TCM, some scholars found that the primary applications of real-world research are the effectiveness and safety evaluation of the proprietary Chinese medicines after entering the market. Because 49.60% of the data were from HIS [41], HIS-based data analysis is the main mode of real-world research in the present field of TCM. e real-world evidences obtained by the HIS-based analysis make up to a certain degree the extrapolation limits of randomized controlled trial conclusions and can better evaluate the actual therapeutic effect and safety of a proprietary Chinese medicine in the practical medical environment [42]. Although the efficacy of Yinzhihuang granules in treating jaundice has been confirmed by a number of randomized controlled trials, the questions have not been answered by relevant research studies such as the actual effects of clinical application and the influence upon the liver enzyme indicators. ...
... It was obviously lower than the proportion of 86% revealed by a survey, which randomly sampled 457 studies registered in 2016 on ChiCTR and downloaded the research plan for analysis. 42 Although the researchers are willing to share the original data of their research, the accessibility of participant-level data is still a challenge. 42 Only 28% of the studies described a correct data management system, and 67% of the researchers may not know that clinical studies should adopt professional and standard data management systems to manage their data. ...