Evidence-based research in traditional Chinese medicine (TCM) has made many important achievements and promoted the modernization and internationalization of TCM. The ability to produce research evidence to guide clinical practice in an emergency treatment situation is a major test of the development of evidence-based Chinese medicine (EBCM) when emerging infectious diseases outbreaks. Along with the development of EBCM, TCM has experienced emerging infectious disease events such as atypical pneumonia (SARS), influenza A (HIN1), and corona virus disease 2019 (COVID-19), and the ability of TCM to conduct clinical research in emergency treatment work has been continuously improved. This article provides an overview of the clinical research conducted in TCM to resist emerging infectious diseases in the past, focusing on the clinical research results obtained in the present time of COVID-19 rescue and treatment, and discusses the role of EBCM development to enhance the clinical research capacity of TCM in emerging infectious diseases.
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.
ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
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.
Repeated measurement quantitative data is a common data type in clinical studies, and is frequently utilized to assess the therapeutic effects of the intervention measures at a single time point in clinical trials. This study clarifies the concepts and calculation methods for sample size estimation of repeated measurement quantitative data, in order to explore the research question of "comparing group differences at a single time point", from three perspectives: the primary research questions in clinical studies, the main statistical analysis methods and the definitions of the primary outcome indicators. Discrepancies in sample sizes calculated by various methods under different correlation coefficients and varying numbers of repeated measurements were examined. The study revealed that the sample size calculation method based on the mixed-effects model or generalized estimating equations accounts for both the correlation coefficient and the number of repeated measurements, resulting in the smallest estimated sample size. Secondly, the sample size calculation method based on covariance analysis considers the correlation coefficient and produces a smaller estimated sample size than the t-test. The t-test based sample size calculation method requires an appropriate approach to be selected according to the definition of the primary outcome measure. The alignment between the sample size calculation method, the statistical analysis method and the definition of the primary outcome measure is essential to avoid the risk of overestimation or underestimation of the required sample size.
Regarding the working hours generated by clinical trial project services under the guidance of good clinical practice (GCP), taking the standard process of a cancer project screening period as an example, and relying on a standardized management model, this paper uses standard time measurement methods to calculate the standard time of the 12 regular tasks in the GCP project. On this basis, it analyzes the GCP project process in detail to find out the reasons for wasted performance hours, and proposes a series of improvement methods and suggestions, such as formulating and implementing a target assessment mechanism, developing standard format cards, using double-line operations research to carry out parallel operations, using quadrant method to divide tasks, using site management organization and resources of hospital departments to reduce coordination loss, and introducing big data management systems, so as to make the work process of clinical research coordinators more refined and professional.
Object As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
Telephone follow-up is one of the important ways to follow up patients. High-quality follow-up can benefit both doctors and patients. However, clinical research-related follow-up is often faced with problems such as time-consuming, laborious and poor patient compliance. The authors belong to a team that has been committed to the study of patient-reported outcomes for a long time. The team has carried out long-term follow-up of symptoms, daily function and postoperative complications of more than 1 000 patients after lung cancer surgery, and accumulated certain experience. In this paper, the experience of telephone follow-up was summarized and discussed with relevant literatures from the aspects of clarifying the purpose of clinical research follow-up, understanding the needs of patients in follow-up, and using follow-up skills.
