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From bench to clinic: the development of VLA1553/IXCHIQ, a live-attenuated chikungunya vaccine.
J Travel Med
October 2024
Corporate Medical Affairs, Valneva SE, Ilot Saint-Joseph Bureaux Convergence, 12 ter Quai Perrache Bâtiment A, 69002 Lyon, France.
Background: Over the past 20 years, over 5 million cases of chikungunya, a mosquito-transmitted viral disease, have been reported in over 110 countries. Until recently, preventative strategies for chikungunya were largely ineffective, relying on vector control and individual avoidance of mosquito bites.
Methods: This review outlines the preclinical and clinical efficacy and safety data that led to the approval of VLA1553 (IXCHIQ®), a live-attenuated vaccine against chikungunya disease.
[Progress in methodological research on bridging the efficacy-effectiveness gap of clinical interventions(2): to improve the extrapolation of efficacy].
Zhonghua Liu Xing Bing Xue Za Zhi
April 2024
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China Administration of Hainan Boao Lecheng International Medical Tourism Pilot Zone, Hainan Institute of Real World Data, Hainan 571437, China.
Randomized controlled trials (RCT) usually have strict implementation criteria. The included subjects' characteristics of the conditions for the intervention implementation are quite different from the actual clinical environment, resulting in discrepancies between the risk-benefit of interventions in actual clinical use and the risk-benefit shown in RCT. Therefore, some methods are needed to enhance the extrapolation of RCT results to evaluate the real effects of drugs in real people and clinical practice settings.
View Article and Find Full Text PDF[Progress in methodological research on bridging the efficacy-effectiveness gap of clinical interventions (1): to improve the validity of real-world evidence].
Zhonghua Liu Xing Bing Xue Za Zhi
February 2024
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China Administration of Hainan Boao Lecheng International Medical Tourism Pilot Zone, Hainan Institute of Real World Data, Haikou 571437, China.
Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect. Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 December 2022 with detailed search strategies.
View Article and Find Full Text PDFOptimizing clinical nutrition research: the role of adaptive and pragmatic trials.
Eur J Clin Nutr
December 2023
Human Nutrition Research Unit, Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, Canada.
Evidence-based nutritional recommendations address the health impact of suboptimal nutritional status. Efficacy randomized controlled trials (RCTs) have traditionally been the preferred method for determining the effects of nutritional interventions on health outcomes. Nevertheless, obtaining a holistic understanding of intervention efficacy and effectiveness in real-world settings is stymied by inherent constraints of efficacy RCTs.
View Article and Find Full Text PDFSimultaneous portal and hepatic vein embolization is better than portal embolization or ALPPS for hypertrophy of future liver remnant before major hepatectomy: A systematic review and network meta-analysis.
Hepatobiliary Pancreat Dis Int
June 2023
Department of Hepato-Biliary and Liver Transplantation Surgery, Paul Brousse University Hospital, Paris-Saclay University, Villejuif 94800, France.
Background: Post-hepatectomy liver failure (PHLF) is the Achilles' heel of hepatic resection for colorectal liver metastases. The most commonly used procedure to generate hypertrophy of the functional liver remnant (FLR) is portal vein embolization (PVE), which does not always lead to successful hypertrophy. Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) has been proposed to overcome the limitations of PVE.
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