The guidelines for clinical research on new drugs provide unified standards for drug developers, researchers, and regulatory authorities, playing a crucial role in new drug development. This article systematically reviews the evolution of guidelines for clinical research on new traditional Chinese medicine(TCM) drugs in China, with a focus on analyzing the current status of these guidelines and the problems that exist. It also provides interpretations of three important guidelines. The article points out that with the continuous emergence of new clinical trial design methods, development concepts, and tools, and under the background of the "three combinations" evidence evaluation system for new TCM drugs, it is imperative to revise existing guidelines, formulate new ones, and develop new tools for clinical efficacy evaluation. It is hoped that relevant departments will adopt an open attitude and work together to build a technical system of clinical research guidelines for new TCM drugs that aligns with the characteristics of TCM.
Humans ; Biomedical Research/trends* ; China ; Clinical Trials as Topic ; Drugs, Chinese Herbal/therapeutic use* ; Guidelines as Topic ; Medicine, Chinese Traditional/standards*

As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.
Drugs, Chinese Herbal/therapeutic use* ; Medicine, Chinese Traditional/methods* ; Outcome Assessment, Health Care ; Reference Standards ; Reproducibility of Results ; Research Design ; Clinical Trials as Topic

To explore the basic principles and methods of quality control of clinical registry research in the field of acupuncture. This study drawed on the data quality control methods of clinical trials in the United States and combined clinical practice experience, based on the "International Patient Registry Platform of Acupuncture and Moxibustion", and the registry study of acupuncture treatment for early-onset ovarian insufficiency as a model. The principles of accuracy, authenticity, consistency and completeness were followed. A remote and on-site quality control method with remote quality control as the main and on-site quality control as the supplement is formed, with a view to providing ideas and reference for the quality control of registry research.
Acupuncture Therapy ; Clinical Trials as Topic ; standards ; Humans ; Moxibustion ; Quality Control ; Registries

By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Clinical Trials as Topic ; Equipment and Supplies/standards* ; Indicators and Reagents/standards* ; Reproducibility of Results ; Research Design/standards*

The Western China Gastric Cancer Collaboration (WCGCC) was founded in Chongqing, China in 2011. At the early stage of the collaboration, there were only about 20 centers. While now, there are 36 centers from western area of China, including Sichuan, Chongqing, Yunnan, Shanxi, Guizhou, Gansu, Qinghai, Xinjiang, Ningxia and Tibet. During the past few years, the WCGCC organized routinely gastric cancer standardized treatment tours, training courses of mini-invasive surgical treatment of gastric cancer and the clinical research methodology for members of the collaboration. Meanwhile, the WCGCC built a multicenter database of gastric cancer since 2011 and the entering and management refer to national gastric cancer registration entering system of Japan Gastric Cancer Association. During the entering and collection of data, 190 items of data have unified definition and entering standard from Japan Gastric Cancer Guidelines. Nowadays, this database included about 11 872 gastric cancer cases, and in this paper we will introduce the initial results of these cases. Next, the collaboration will conduct some retrospective studies based on this database to analyze the clinicopathological characteristics of patients in the western area of China. Besides, the WCGCC performed a prospective study, also. The first randomized clinical trial of the collaboration aims to compare the postoperative quality of life between different reconstruction methods for total gastrectomy(WCGCC-1202, ClinicalTrials.gov Identifier: NCT02110628), which began in 2015, and now this study is in the recruitment period. In the next steps, we will improve the quality of the database, optimize the management processes. Meanwhile, we will engage in more exchanges and cooperation with the Chinese Cochrane Center, reinforce the foundation of the clinical trials research methodology. In aspect of standardized surgical treatment of gastric cancer, we will further strengthen communication with other international centers in order to improve both the treatment and research levels of gastric cancer in Western China.
Cancer Care Facilities ; China ; Clinical Protocols ; standards ; Clinical Trials as Topic ; methods ; standards ; Databases, Factual ; statistics & numerical data ; trends ; Education, Medical, Continuing ; Gastrectomy ; methods ; Humans ; Minimally Invasive Surgical Procedures ; education ; Organizational Objectives ; Organizations ; statistics & numerical data ; trends ; Outcome Assessment (Health Care) ; Prospective Studies ; Quality of Life ; Randomized Controlled Trials as Topic ; Registries ; statistics & numerical data ; Research Design ; standards ; Retrospective Studies ; Stomach Neoplasms ; epidemiology ; therapy

The difficulty in the participant recruitment is the common question in acupuncture clinical trial study. The existing recruitment of clinical trial is most applicable for the clinical trial of medicines. Because the intervention of acupuncture clinical trial is different from that of medicines, characterized as the specialties in "theory, principle, acupoints, technique", it is very necessary to develop the strategy on the participant recruitment in acupuncture clinical trial. The free community medical consultation is one of the important means of recruitment. In the paper, by taking the participant recruitment of acupuncture clinical trial on chronic stable angina pectoris as the example, the discussion is given on the strategy on the recruitment of free community medical consultation in the aspects of feasible investigation of recruitment approach, recruitment plan, participant screening, etc. The revisiting after the free community medical consultation is the important approach to the improvement of successful recruitment. This strategy on the recruitment of free community medical consultation is highly practical and improves the successful rate and compliance of the participant recruitment. Hence, this strategy deserves to be promoted.
Acupuncture Therapy ; Clinical Trials as Topic ; standards ; Humans ; Personnel Selection ; standards ; Research Design ; standards

The current clinical efficacy evaluation system and evaluation methods of acupuncture have several limitations, and the application status is not optimistic. According to long-term observation, minimum clinically important difference (MCID) is consistent with the characteristics of clinical acupuncture, and has objective quanti- tative standard and wide applicability. Incorporating MCID into acupuncture clinical efficacy evaluation of tradition- al Chinese medicine can truly reflect the clinical effect of acupuncture and improve the disadvantages and shortcom- ings of acupuncture clinical evaluation, which could provide certain reference for building clinical efficacy evaluation system featured with TCM.
Acupuncture Therapy ; standards ; Clinical Trials as Topic ; standards ; Humans ; Moxibustion ; standards

There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.
China ; Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; standards

This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.
Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards

For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results