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 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 determine the effects recombinant human growth hormone (GH) and hypocaloric nutrition on postoperative convalescence, we performed a placebo-controlled randomized double-blind trial in 18 patients after elective gastrectomy or colectomy. Methods The subjects received parenteral nutrition containing 20 calories/kg per day and 1 g protein/kg per day. Daily injections of drug or placebo were given during the first postoperative week. Result The nine control subjects lost 3.3 kg (5.9% of preoperative weight) and had a cumulative nitrogen loss of 32.6 ± 4.2 g nitrogen at eight days. The patients receiving GH lost significantly less weight (1.3 kg) and nitrogen loss was 7.3 ± 3.1 g at eight days (Plt;0.001). Kinetic studies demonstrated that anabolic effects of GH were associated with increased protein synthesis, and amino acid flus studies across the forearm revealed increased uptake of amino acid nitrogen in the GH-treated patients. Body composition analysis revealed that the patients receiving GH maintained their lean body mass despite the major surgical procedure. Conclusion We conclude that the postoperative catabolic response can be modified with GH and hypocaloric nutrition. The metabolic and physiologic effects should now be studied in a larger number of patients to determine if this approach can reduce morbidity, mortality, and length of hospital stay for surgical patients.
Objective To assess the methodological quality of clinical studies using Shen-Mai injection as an adjunct therapy to tumor chemotherapy and to evaluate its efficacy and safety. Methods A comprehensive search strategy was designed to identify all randomized controlled trials (RCT) comparing Shen-Mai injection plus routine chemotherapy versus routine chemotherapy alone by searching for the CBMdisc (issue 3) and TCMLRS database (1981-2001). The methodological quality of the trials was assessed by two reviewers independently for which a meta analysis was perfermed. Results Thirteen RCTs met the inclusion criteria. methodological quality was poor (all the trials included were level C). Compared with the control group, the combined outcome of Shen-Mai injection increased the effect of chemotherapy (OR 1.73 95%CI 1.27 to 2.34, P＝0.000 4), reduced the side effect of bone marrow inhibition (OR 0.29, 95%CI 0.16 to 0.52, P＝0.000 04) in WBC counting and (OR 0.11, 95%CI 0.02 to 0.49, P＝0.004 in PLT count. And Shen-Mai injection relieved the symptoms of nausea and vomiting (OR 0.26, 95%CI 0.16 to 0.43, Plt;0.000 01). Conclusions The methodological quality of the trails using Shen-Mai injection should be improved. Based on the results of the review and the meta-analysis, Shen-Mai injection may have positive effects on chemotherapy in patients with malignant tumor, although the evidence is weak. No serious adverse events are reported. Further well-designed clinical trials should be performed.
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.
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.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
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.
ObjectivesTo analyze the development of acupuncture registered trials based on WHO international clinical trial registration platform (ICTRP) in the past 5 years.MethodsWHO ICTRP database was electronically searched to collect acupuncture-related clinical trials registered from January 1st, 2014 to December 31st, 2018. Two reviewers independently screened items, extracted data, and descriptive analysis was performed for the included trials.ResultsThe results showed that there were 1 556 registered clinical trials on acupuncture, and the most registered year was 2017. China was in the main country in applying for acupuncture-related clinical trials, however, the most registered unit was Kyung Hee University in Korea. The trials were mainly interventional research, mostly used randomized, blinded methods, and design modes were mainly based on parallel trials. In clinical trial phase, the majority were in the clinical trial period of treatment of new technologies. The field of clinical research was expected to be on pain in the future.ConclusionsAlthough acupuncture research is currently in a good stage of development, it should still value on the quality and innovative training of relevant trials, strengthen Chinese ties with other countries, focus on regional, domestic and international cooperation, expand research types, and enhance acupuncture applicability.
With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.
