Sharing clinical trial data can increase the transparency of clinical trials and improve the its authenticity. The current requirements of clinical research data transparency is not fully adequate, and it is still difficult to create an environment in which the sharing of the clinical trial data becomes the norm. The article analyzed various concerns on data sharing and proposed solutions in data ownership, technology, implementation, and legal issues systematically, calling for clinical trial data sharing in order to promote transparency of clinical trials, and looking forward to minimize the risks and maximize the benefits of data sharing.
Objective
To review the current progress of clinical and experimental research of vascularized lymph node transfer for lymphedema.
Methods
The domestic and abroad literature about vascularized lymph node transfer in treatment of lymphedema was reviewed and analyzed.
Results
Experimental studies in animal model indicate that vascularized lymph node transfer can improve lymph node survival and show a promising effectiveness in reducing lymphedema. " Lymphatic wick” and " lymph pump” were the two main hypotheses proposed to explain the potential functional mechanism of vascularized lymph node transfer in treatment of lymphedema. Improvement in lymphedema symptoms are reported in most of the clinical trials, but the level of evidence to advocate this procedure in the treatment of lymphedema remains low because of the small number of the cases and problems in their methodologies.
Conclusion
Based on current evidence, vascularized lymph node transfer seems to be a promising treatment for lymphedema, but long-term well-designed studies are required to further explore the effectiveness of this procedure.
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.
Objective To investigate the quality of the randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) integrated with western medicine for severe acute respiratory syndrome (SARS). Method All the randomized controlled trials of traditional Chinese medicine integrated with western medicine for SARS worldwide were gained by electronic searching and hand searching. The quality of the RCTs was analyzed by the quality grade evaluation used in Cochrane handbook.The sample size, the baseline data, the results indexes were also analyzed. Results Seven RCTs included 501 SARS cases were identified. The quality grade of one RCT is B, the other six RCTs were graded C. None pre-specified sample size. One RCT tested the differences of the baseline data by statistic method. One RCT reported quality of life as result index. None reported the adverse events.Conclusions Current RCTs of TCM integrated with western medicine can’t provide b evidence for clinical practice because of the poor quality.
Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second- line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.
Objective To assess the safety and effect of different intravenous chemotherapic regimens in patients with gastric carcinomas who had received gastrectomy. Method A systematic review of all the relevant randomized controlled trials (RCTs) was performed. RCTs were identified from Medline and Embase (1980-2001.4), Chinese Bio-medicine Database (1990-2001.1). Literature references were checked at the same time. We included randomized andquasi-randomized trials in patients with confirmed gastric carcinomas who had received gastrectomy comparing the effect of intravenous chemotherapy after gastrectomy with that of gastrectomy alone.Results Twenty trials involving 4 171 patients were included. Meta-analysis was done with fixed effects model. Heterogeneity analyses was performed also. The effects of intravenous chemotherapy with 5FU + MCCNU, 5FU + MMC, 5FU + BCNU or FAM after gastrectomy were failed to show have better effects than that of surgery alone. There were eleven trials which detailed the side effects according to the toxicity grade by WHO standard. The side effects halting treatment were haematologic and biochemical toxicity, debilitating nausea and vomiting. There were twenty-two patients died of chemotherapic toxicity. Conclusions Based on the review, there is no enough evidence to show that intravenous chemotherapy after gastrectomy have positive treatment effect on gastric cancer.
In phase II clinical trial of Compound Prescription of Huangyaozi (Dioscorea bulbifera L.), 7 cases out of 37 developed (18.92%) impairment of liver function. As a result, the ethic committee required researchers to report all data of safety of the drug and have all subjects rechecked about their liver function so as to provided reasonable evidence for the scientifical evaluation of the relationship between the drug and the adverse event and the succedent suspending of the clinical trial.
Objective
To explore the feasibility of breast cancer patients in China with 1–2 positive sentinel lymph nodes (SLN) to avoid axillary lymph node dissection (ALND).
Methods
A total of 328 patients who received sentinel lymph node biopsy (SLNB) in our hospital from 2010 to 2016 were collected retrospectively, and patients met the criteria of Z0011 clinical trials (which required no acceptance of neoadjuvant therapy, clinical tumor size was in T1/T2 stage, two or less positive SLNs were detected, received breast-conservation surgery, acceptance of whole breast radiotherapy after surgery and neoadjuvant systemic treatment) were enrolled to breast-conservation group. Patients met the criteria of Z0011 clinical trials, excepting the surgery (received non-breast-conservation surgery), were enrolled to non- breast-conservation group. Comparison of clinicopathological features between the breast-conservation group/non-breast-conservation group and the Z0011 ALND group was performed.
Results
Among the 328 patients, only 29 patients (8.8%) completely correspond with the results of Z0011 clinical trials. There was no statistical significance between the breast-conservation group and the Z0011 ALND group in the age, clinical T stage, expression of estrogen (ER), expression of progesterone (PR), pathological type, histological grade, number of positive lymph nodes, and incidence of non-sentinel node metastasis (P>0.05). A total of 81 patients were included in the non-breast-conservation group. It showed no statistical significance between the non-breast-conservation group and the Z0011 ALND group in expressions of ER and PR, and histological grade (P>0.05), while there was statistically significant difference in age, clinical T stage, pathological type,number of positive lymph nodes, and incidence of non-sentinel node metastasis (P<0.05). Patients in the non-breast-conservation group showed a lower age, higher percentage of lobular carcinoma and T2 stage, more positive lymph nodes, and high incidence of non-sentinel node metastasis.
Conclusion
It’s feasible for Z0011 clinical trials results to be used in the clinical practice of our country, but the actual situation of breast conservation in our country may lead to low adaptive population.
At present a better way for the treatment of SARS is to search and apply the best evidence that comes from the same kind of diseases and symptoms in the past and include personal experiences of clinicians. The intervention should be adjusted with the development of basic research. In this paper the important of projects are predicted and necessity of randomized controlled trials are discussed emphasizing scientific value of case reports and case series for such disease. It is essential to well justify priority and integrate resources for the trials against SARS.
Multilevel models are applicable to both the quantitative data and categorical variables. We used the methods, including the multilevel models, analysis of covariance and CMH chi-square test, to analyse different types of data, to explore the application of multilevel models in the analysis of the multicenter clinical trial center effect. The results showed that the analysis of covariance is more sensitive to find the center effect for quantitative data, while multilevel models are more sensitive to categorical variables. It can be seen that results with different analytical methods for center effect are not the same, and the most appropriate method should be selected in accordance with the characteristics of data, the objective of research, and the applicable conditions of the various methods in practical use.
