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@#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.
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OBJECTIVE To evaluate the effectiveness， safety， economy， innovation， suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein （EC）， and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin （TB-PPD） were analyzed by the method of systematic review. Cost minimization analysis， cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD， and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation， suitability and accessibility were determined by systematic review and improved Delphi expert consultation， and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness， safety， economy， innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent， while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight， the scores of effectiveness， safety， economy， innovation， suitability， accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD， EC performs better in all dimensions of effectiveness， safety， economy， innovation， suitability and accessibility. However， it is worth noting that EC should further improve its availability in the dimension of accessibility.
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China is stepping up its standardized management of investigator initiated trials(IIT)carried out by medical and health institutions, spotlighting the establishment and improvement of the quality control system of IIT projects than ever before. The authors retrieved official websites of clinical research related units of medical institutions and research institutes at home and abroad, and by means of literature review analyzed the current quality management of IIT projects at home and abroad. They found such setbacks as lack of quality management standards and norms, imperfect quality control mechanism, poor awareness of quality risk, insufficient quality supervision and poor quality control ability of clinical researchers. Based on the above, the paper made the following recommendations for building an IIT project quality control system in China: developing quality management standards and norms, setting up a systematic quality control mechanism(i.e., exploring a three-level quality control mode composed of the project team/department-hospital-national supervision institution/peer review expert team, and implementing the whole process quality control mechanism), strengthening policy guidance and system construction, and strengthening the standardized training of clinical researchers.
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This paper is aimed to analyze the correlation between serum free testosterone (FT) and total testosterone (TT) to acquire a cutoff about using total testosterone to diagnose hyperandrogenism in Chengdu females. We investigated 1854 women by cluster sampling method, detected their serum FT levels and TT levels, scored relative items, analyzed the correlation and made the ROC curve to get a cutoff of TT levels. Serum FT had a linear correlation with serum TT (r = 0.597, r2 = 0.356, P < 0.001). The cutoff value was 0.635 ng/mL. The specificity and sensitivity were 76.3% and 77.24%, respectively. No correlation found between serum FT and Ferriman-Gallway Score (P = 0.392). Positive correlations were seen between serum FT and Plewig-Kligman Score (r = 0.137, P < 0.001), serum TT and Ferriman-Gallway Score (r = 0.069, P = 0.003) and serum TT and Plewig-Kligman Score (r = 0.092, P < 0.001). There is a linear correlation between serum FT and TT. We can diagnose hyperandrogenism according to the serum TT cutoff value (0.635 ng/mL). Its clinical symptoms are not paralleled with the biochemical test results.
Subject(s)
Adolescent , Adult , Child , Female , Humans , Middle Aged , Young Adult , China , Hyperandrogenism , Blood , Reference Values , Sampling Studies , Testosterone , BloodABSTRACT
OBJECTIVE To evaluate the quality of follow-up in Chinese Archives Of Otolaryngology-Head And Neck surgery and offer evidence for the improvement of follow up. METHODS Chinese Archives Of Otolaryngology-Head And Neck surgery (January 1994 to December 2005) were searched,and clinical materials of follow-up was identified and analyzed. RESULTS Seventy-six issues were referred to and one hundred ninety-nine papers were finally identified and analyzed. CONCLUSION Although there are major problems on follow-up in Chinese Archives Of Otolaryngology-Head And Neck Surgery and Archives Of Otolaryngology-Head And Neck Surgery,much improvement has been made on the quantity and quality of clinical material follow-up in Chinese Archives Of Otolaryngology-Head And Neck Surgery.