Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data (IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and constructing new rules of clinical trials. Our viewpoint is that from the essential purpose of clinical research, IPD is a social public property. Sharing IPD is a one of the best ways for respecting the contributions of the participants, and one of the keys for changing face of clinical trials.
Objective To assess the effectiveness and safety of breviscapine on diabetic nephropathy. Methods All randomized or quasi-randomized controlled trials of breviscapine on diabetic nephropathy were performed. All of the clinical trials were searched from the Cochrane Controlled Trials Registered, Medline, Embase, National Knowledge Infrastructure Database, the Chinese Biological Medicine Database, the Chinese Science and Technology Journal Full-text and the references of all included trials. The selection of studies, assessment of methodological quality and data extraction were performed independently by two reviewers according to predefined inclusion and exclusion criteria. Results Thirty-three clinical trials including 2 322 patients of diabetic nephropathy met the inclusion criteria. But most included trials were of low quality and small sample. Until now, there were no clinical trials with multicentre, large sample and high quality. A “Funnel plot” showed asymmetry, which indicated possible publication bias and low quality in methodology. And publication bias showed that the trials with negative results might not be published. The results of meta-analysis indicated that: 1. Breviscapine showed more effects on the decrease of the 24-hour urinary albumin excretion rate (UAER), 24-hour urinary protein, serum creatinine (Scr), total cholesterol, triglyceride, plasma viscosity and fibrinogen. 2. Breviscapine showed less effect on the decrease of the 24-hour urinary protein when compared to angiotensin-converting enzyme inhibitor, it seemed as same effective as ACEI on decrease of 24-hour urinary albumin excretion rate (UAER), serum creatinine (Scr) and blood urea nitrogen (BUN); 3. Breviscapine showed more effect on the decrease of 24-hour urinary protein and fibrinogen when compared to other Chinese herbal medicine (Salvia miltiorrhiza); 4. Breviscapine showed less effect on decrease of the 24-hour urinary albumin excretion rate (UAER) when compeard to Prostaglandin E1. No significant adverse effects were reported. Conclusion Breviscapine shows some effects and relatively safe on diabetic nephropathy. However, the evidence is not b enough because of some of the low-quality trials and publications bias. Rigorous designs, randomized, double-blind, placebo-controlled trials of Breviscapine for diabetic nephropathy are needed to further assess the effect.
目的 為避免選擇和發表偏倚,系統評價者應采用多種查詢技術,并盡力獲得未發表的研究.本文試圖探討,英特網檢索對鑒定未發表和正在進行的臨床試驗是否有用.研究設計 利用七個Cochrane系統評價的查詢策略回顧性地在英特網上檢索未納入的隨機對照試驗.方法 檢索策略 以普通檢索式"研究方法學 NEAR干預措施NERA 條件"、用AltaVista在英特網上搜索.測量指標包括搜索時間、英特網搜索已發表研究的回溯率、精確度(已發表和未發表的隨機臨床試驗鏈接的網頁比例)、英特網檢索到的未納入的未發表和正在進行的研究數.結果 用21小時查詢了429個網頁,找到14個鏈接到未發表的、正在進行的或最近完成的試驗,至少有9個與4篇系統評價相關.英特網檢索已發表研究文獻的回溯率在0～43.6%,其鏈接已發表和未發表研究的精確度在0～20.2%.結論 未發表尤其是正在進行的試驗的信息可在英特網上找到.潛在的問題是如何評價未經同行評審的電子出版物的質量.急需更強的搜索工具.建議用"Open Trial Initiative"定義英特網發表試驗的語法,以加強試驗登記的共同操作性.因此,專門的搜索引擎可找到更多有關正在進行和已完成的臨床試驗信息.
Virtual clinical trials are clinical trials conducted through computer simulation technology, which breaks through the limitations of traditional clinical trials and has the advantages of saving time, reducing costs, and reducing the risk of human trials. With the application of new computer technologies such as population pharmacokinetics, physiologically-based pharmacokinetics, quantitative systems pharmacology, and artificial intelligence, the field of virtual clinical trials in healthcare has become an important development direction. This article will give a preliminary review of the connotation, methods and future development trends of virtual clinical trials, aiming to provide reference for the application of new technologies and methods in clinical trials.
Since the outbreak of the coronavirus disease (COVID-19), more than 200 interventional clinical trials have been registered in Chinese Clinical Trial Registry (www.chictr.org.cn) and the US Clinical Trials Registry (www.clinicaltrials.gov), testing or going to test treatments of COVID-19 in China from January 23rd, 2020 to March 5th, 2020. This situation has drawn attentions from various sectors of society. This article summarizes the basic design features of 249 registered COVID-19 clinical trials in China, compares them with National Clinical Trials Network practices in the USA, and describes a concept of national clinical trials network as a strategy to enhance quality and efficiency of clinical research in cases like COVID-19 outbreak as well as other disease fields.
The umbrella trial has received increasing attention in the design of clinical trials for oncology drugs in recent years. This trial design categorizes a single disease into multiple sub-types based on predictive biomarkers or other predictive factors, and simultaneously evaluates the efficacy of multiple targeted therapies. When compared with the traditional drug development model of phase Ⅰ, phaseⅡ, and phase Ⅲ randomized controlled trials, umbrella trials are a more scientifically rigorous trial design that can speed up drug evaluation to address the conflict between numerous untested drugs and diseases with a lack of effective treatment options. This article will focus on the concept, main characteristics, eligibility criteria, design and statistical considerations, ethical considerations, and future directions of umbrella trials, with the aim of providing methodological guidance for the design of clinical trials for oncology drugs.
Objective To evaluate the efficacy and safety of Salviae miltiorrhizae Injection (include Danshen Injection and Fufang Danshen Injection) for chronic cor pulmonale. Design A systematic review of randomized clinical trials. Method Randomized trials comparing Salviae miltiorrhizae Injection plus routine treatment versus muting treatment alone were identified by electronic and manual searches. No blinding and language limitations were applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n=2 161) were identified. The methodological quality of all trials included was low. The combined results (RR and 95%CI) of symptom scores was 1.20 (1.15 to 1.26). Because of the significant heterogeneity, many other markers of the blood rheology can not be combined. The reason for heterogeneity should include the differences among cases and studies. Because of lacking enough studies, the conclusions about mortality and oxidants/antioxidants markers were not b. Only a few studies had reported adverse events. Conclusions Based in the review, Salviae miltiorrhizae Injection may have positive effect on symptom scores in patients with chronic cor pulmonale. But for mortality, the markers of blood rheology and oxidants/antioxidants, there is no reliable conclusion. However, the evidence is not b due to the general low methodological quality, the variations among studies and experimental markers themselves, and lacking of more relevant and important markers. Further large trials are needed.
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.
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.
Objective To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of acute bacterial lower respiratory tract infection. Methods A randomized, single-blind, controlled clinical trial was performed. The positive control was imported cefepime. The dosages of cefepime were 1g for moderate infection and 2g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days. Results Thirty-one patients were enrolled in the trial, of whom 30 were evaluable (15 in the triagroup and 15 in the control group). No significant differences were observed between the trial group and the control group with respect to the cure rate (40% vs. 27%), the effective rate (80% vs. 87%), the bacterial clearance rate (92% vs. 100%), and the incidence of adverse drug reactions (12.5% vs. 13%) (Pgt;0.05). Conclusion Domestic cefepime injection is effective and safe in the treatment of acute bacterial lower respiratory tract infection.