中药临床试验是中医药研究中发展较快的一个领域，临床研究协调员（CRC）在中药临床试验中有重要作用，其工作范围涉及到中药临床试验的各个方面。由于中药临床试验有着不同于西药临床试验的特点，CRC在中药临床试验中的作用也有其特殊性，对提高临床试验的安全性、科学性及试验数据的可信度方面起重要作用。
Objective To evaluate the anti-tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM). Methods Randomised, double blind method, placebo control and add on design were applied. Forty-five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo. Results The incidences of obvious coughing in treatment and control groups were 66.67% and 70.83% (P=0.763 3) respectively. The cough alleviation time of patients was 14.64±16.30 h and 15.12±15.28 h (P=0.795 6) respectively. The loss of cough rates on the third day was 28.57%, 16.67% (P=0.337 7) respectively. The average scores decreased were 4.29 and 2.88 (P=0.054 8) respectively. Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L. has no significant anti-tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously. The trial was interrupted by the advice from experts who disagreed with the selection of drug indication.
Compared with traditional medical devices, artificial intelligence medical devices face greater challenges in the process of clinical trials due to their related characteristics of artificial intelligence technology. This paper focused on the challenges and risks in each stage of clinical trials on artificial intelligence medical devices for assisted diagnosis, and put forward corresponding coping strategies, with the aim to provide references for the performance of high-quality clinical trials on artificial intelligence medical devices and shorten the research period in China.
药物上市前须经过人体试验，参与药物临床试验的受试者将承担不同程度的风险，我国GCP明确规定要充分保障受试者的权益，伦理委员会和知情同意书是保障受试者权益的主要措施，但在实际中仍存在不少问题。为此，如何切实保障受试者的权益，是临床试验所要解决的一个重要问题。
Heart failure affects quality of life and life expectancy of tens of millions of individuals. There are no available economic and effective treatments for end-stage heart failure. Hydrogels are novel tissue engineering materials, which have the potential to ameliorate myocardium remodeling, increase cardiac output, improve quality of life and prolong life span by implantation into myocardium. The preclinical experiments and clinical trials have greatly explored the function of hydrogels in heart failure. In this review, we summarized the approaches of implantation, mechanism and clinical outcomes of the hydrogels.
ObjectiveTo analyze the status of real world studies (RWS) through registration information of the Chinese Clinical Trials Registry (ChiCTR). MethodsThe website of ChiCTR was searched with the real world as the search term to collect relevant registered items in the real world from inception to May 4, 2022. Descriptive analysis method was used. ResultsA total of 642 registered items were included. The median sample size was 482 cases. RWS were mainly observational studies, and the number of intervention studies was increasing year by year. There were 267 studies (41.59%) at the stage of post-marketing drugs or phase Ⅳ clinical trials. Most of the main measures were endpoints (56.23%), and the most commonly used was overall survival (15.79%). 62.15% of the registered projects met the minimum requirements for registration. ConclusionThe number of RWS registered by ChiCTR shows an increasing trend. At present, the research purpose of RWSs is unclear, and the completeness of registered studies and the overall content compliance of the studies need to be improved.
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.
The calculation of sample size is a critical component in the design phase of clinical trials incorporating health economic evaluations. A reasonable sample size is essential to ensure the scientific validity and accuracy of trial results. This paper summarizes the sample size calculation methods in the frequentist framework based on two health economic evaluation indicators: incremental cost-effectiveness ratio (ICER) and net benefit and examines these methods in terms of their applicable conditions, advantages, and limitations. The ICER method derives the sample size calculation formula by computing the ratio of incremental cost to incremental effect, while the net benefit method determines the economic viability of interventions by calculating incremental net benefit, subsequently leading to the formulation of the sample size calculation. Furthermore, this paper briefly discusses other sample size calculation methods, such as the classical Bayesian approach and the value of information analysis, providing a reference for calculating sample size in clinical trials with integrated health economic evaluations.
Early and mid-stage esophageal cancer can achieve a particular effect through surgeries or comprehensive treatment based on surgery. Once the esophageal cancer progresses to the advanced stage, it is still lack of effective remedy for the disease, and the patient's prognosis is poor. Immunotherapy has developed rapidly in recent years, bringing dawn to patients with advanced esophageal cancer. On July 31, 2019, the US Food and Drug Administration (FDA) approved KEYTRUDA (Merck) for the treatment of esophageal squamous cell carcinoma, and it became the first milestone drug for esophageal squamous cell carcinoma. In the paper, we will review the progress of immunotherapy in the treatment of advanced esophageal cancer on the basis of current clinical researches, which might provide ideas for further studies in the immunotherapy for esophageal cancer.