Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Data integrity, accuracy, and traceability are key elements of high-quality clinical research, as well as weak links in the promotion of clinical research transparency. How to promote data quality has become a major concern to all clinical research stakeholders. In this article, we dissected and analyzed data generation and capturing process in clinical research, and identified a key aspect in improving data quality: to promote electronic source data, especially to break the barrier between electronic health records and clinical research systems. Additionally, we summarized the experiences regarding this issue in China and overseas to propose a solution suitable for China to improve data quality in clinical research: to strengthen clinical research source data management by building clinical research source data platform and adopt common source data management process in hospitals.
Objective To analyze the therapeutic effect of olfactory ensheathing cells (OECs) transplantation for central nervous system diseases. Methods Between November 2001 and January 2008, 1 255 participants with central nervous system diseases were enrolled in this cl inical study for fetal OECs transplantation. There were 928 males and 327 femalesaged 1.2-87 (mean 40) years. The course of disease was (4.52 ± 4.67) years. Among them, 656 participants suffered from chronic spinal cord injury (SCI), 457 amyotrophic lateral sclerosis (ALS), 68 cerebral palsy (CP), 20 multiple sclerosis (MS), 11 the sequelae of stoke, 10 ataxia, and 33 residual diseases. The participants came from 71 countries or regions. Accidentally abortional fetal olfactory bulbs were donated voluntarily and were cultured for 2 weeks, then were transplanted. Results One thousand one hundred and twenty-eight cases were followed up for 2-8 weeks (mean 4 weeks) to obtain integrated data. Among them, the neurological functional amel ioration was noticed in 994 participants with the overall short-term improvement rate of 88.12%. Seventy-six patients experienced the various perioperative compl ications with the incidence rate of 6.74%. One hundred and twenty patients with SCI received over 1 year follow-up. And according to ASIA assessment, motor scores increased from (39.82 ± 20.25) to (44.55 ± 18.99) points, l ight touch scores from (51.56 ± 25.89) to (59.81 ± 27.72) points, pain scores from (50.36 ± 27.44) to (57.09 ± 28.51) points for foreign patients (P lt; 0.05); motor scores increased from (40.52 ± 20.80) to (46.45 ± 20.35) points, l ight touch scores from (55.64 ± 26.32) to (68.64 ± 25.89) points, pain scores from (57.05 ± 26.00) to (66.13 ± 24.29) points for good rehabil itation Chinese patients (overall P lt; 0.05); motor scores from (37.03 ± 18.52) to (38.03 ± 18.50 points (P lt;0.05), l ight touch scores from (45.88 ± 22.56) to (46.63 ± 23.09) points (P gt; 0.05), pain scores from (45.25 ± 23.68) to (45.28 ± 23.63) points (P gt; 0.05) for poor rehabil itation Chinese patients. Compared foreign patients and good rehabil itation Chinese patients with poor rehabil itation Chinese patients, difference in score change was remarkable (P lt; 0.05). One hundred and six cases of ALS, 32 CP, 8 MS, 7 ataxia, and 2 stroke sequelae were followed up for 3-48, 3-36, 2-20, 7-17, 6 and 24 months, One hundred and six cases of respectively. Majority of them (113/155, 72.9%）were benefited from OECs transplantation. Conclusion OECs transplantation into brain and spinal cord is feasible and safe . The therapeutic strategy is valuable treatment for such central nervous system diseases such as chronic SCI, ALS, CP and stroke sequelae and can improve the patients’ neurological functions and/or decrease the progressive deterioration.
Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial. In recent years, the number of drug clinical trial has been continuously improved, and the quality control requirements have been continuously improved. However, in clinical work, the workload of medical staff is heavy, and the energy devoted to clinical trial is limited. Clinical research coordinator (CRC), as a participant and coordinator of clinical trial, has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers, and has undertaken any specific work in clinical trial. Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University, this paper discusses the mode of nosocomial CRC participating in clinical trial quality control. By participating in the quality control of clinical trial, the nosocomial CRC has improved the quality control efficiency, enriched the quality control team and improved the overall level of CRC. This model enriches the quality control system of drug clinical trial.
As a science which focuses on evidence, the decision making process of evidence medicine encounters an opportunity for development in the big data era. The starting point is shifting forward from evidence to data. The big data technology is playing an active role in evidence's collection, process and utilization. Evidence is more objective, righteous, authentic, transparent and easier to collect. Thus, to initiate evidence-based medicine research in the big data era and to structure an evidence-based medicine intelligent service platform, a full-scaled strategy should be developed in order to improve the quality of evidence. To promote the complete publicity of clinical research data, structuralized clinical data standard should be constructed. To provide a pathway to patients' follow-up data, portable and wearable monitoring devices should be popularized. To avoid risks from utilization of clinical research big data, regulations of clinical data usage should be implemented.
In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
ObjectiveTo use the evidence map system to search and sort out the clinical research on the prevention and treatment of hyperlipidemia with proprietary Chinese medicine, and to understand the distribution of evidence in this field. MethodsThe literature on the treatment of hyperlipidemia with proprietary Chinese medicines was retrieved from CNKI, WanFang Data, VIP, SinoMed, PubMed, Cochrane Library, Embase and Web of Science databases from inception to December 2022. The distribution characteristics of evidence were analyzed and presented by means of text and graph. ResultsA total of 865 articles were included and 79 kinds of proprietary Chinese medicines were obtained. The Xuezhikang tablets or capsules were the most frequently used. In recent years, the number of published articles showed a downward trend, and the literature quality was generally low. Most of the research intervention programs only used Chinese patent medicine, and the sample size of a single study was mostly 60-100 patients, and the study course was 4-8 weeks. Clinical studies did not highlight the characteristics of traditional Chinese medicine, and only 12.7% of the studies limited the syndrome type of traditional Chinese medicine in the study population. In terms of the selection of outcome indicators, more attention was paid to blood lipid levels and safety indicators, while less attention was paid to indicators such as traditional Chinese medicine syndrome scores. ConclusionThe results show that Chinese patent medicine has certain advantages in the prevention and treatment of hyperlipidemia, but there are some deficiencies in the reports of methodology and clinical characteristics, and the overall quality of the research is low.
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 evidence, which were developed by different research groups. This article systematically analyzed the current reporting standards of clinical research of TCM. Achievements and problems were found in the review so as to provide insights for the ongoing reporting standards and to assist the construction of the reporting standard system so as to improve the reporting quality of clinical researches of TCM.
ObjectiveTo systematically search and sort out the clinical research literature on the treatment of AIDS by traditional Chinese medicine compound preparations by using the evidence map method, and to understand the distribution of evidence in this field. MethodsThe CNKI, WanFang Data, VIP, CBM, PubMed and Cochrane Library databases were electronically searched to collect studies on the treatment of AIDS with traditional Chinese medicine compound preparations from inception to August 2022. The distribution characteristics of evidence were analyzed and presented in the form of charts and words. ResultsA total of 337 articles were included, involving 268 intervention studies, 66 observational studies and 4 systematic reviews/meta-analysis. A total of 92 kinds of traditional Chinese medicine compound preparations were obtained, and the literature quantity of different preparations was obviously stratified, with Kangaibaosheng preparation being the most frequently reported. In recent years, the number of published literature has been declining, the quality of literature is generally low, and the level of evidence is not high. As for the intervention duration, this field tends to have a longer intervention observation period. As for the outcome indicators, the evaluation criteria of some indicators are not uniform, and the characteristics of TCM advantages are not reflected. The quantity and quality of systematic reviews/meta-analyses were insufficient. No normative consensus or guidelines for the treatment of AIDS with traditional Chinese medicine compound preparations had been formed. Conclusionstudies on the effectiveness and safety of traditional Chinese medicine compound preparations in treating AIDS has initially formed a certain scale of evidence group. In the future, it is necessary to further improve the quality of studies, explore outcome indicators that can reflect the advantages of TCM efficacy, and formulate relevant guidelines in a standardized manner.