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10.1007/s43441-020-00182-8 http://scihub22266oqcxt.onion/10.1007/s43441-020-00182-8 32583289!7313653!32583289     free     free     free Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Ther+Innov+Regul+Sci 2020 ; 54 (6): 1551-1556 Nephropedia Template TP {{tp|p=32583289|t=2020. Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic |pdf=|usr=}}{{32583289}} gab.com Text Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic JO: Ther Innov Regul Sci http://www.kidney.de/pget.php?&tw=1&pmid=32583289 #FOAvip When conducting clinical trials under COVID-19 pandemic, protocol deviations and/or protocol violations are inevitably encountered due to possible environment change which may have an impact on the accuracy and reliability of clinical evaluation of the test treatment under investigation. Protocol deviations and/or violations include, but are not limited to, eligibility criteria, testing procedure, dose and dose regiment, treatment duration and clinical operation of the intended trial. FDA published guidance in March 2020 to assist investigators and institutional boards (IRBs) in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during the COVID-19 pandemic. The purpose of this article is to proposal methods for statistical evaluation in terms of (i) possible shift in target patient population and (ii) assessment of reproducibility of clinical studies conduct under COVID-19 pandemic environment. The proposed methods can be used to determine whether the clinical results of the intended trials are acceptable from both statistical and regulatory perspectives. Twit Text FOAVip Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic ????Ther Innov Regul Sci http://www.kidney.de/pget.php?&tw=1&pmid=32583289 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=32583289 #FOAvip English Wikipedia <ref>{{Cite pmid|32583289}}</ref> Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic #MMPMID32583289 Chow SC; Zhang W Ther Innov Regul Sci 2020[Nov]; 54 (6): 1551-1556 PMID32583289show ga When conducting clinical trials under COVID-19 pandemic, protocol deviations and/or protocol violations are inevitably encountered due to possible environment change which may have an impact on the accuracy and reliability of clinical evaluation of the test treatment under investigation. Protocol deviations and/or violations include, but are not limited to, eligibility criteria, testing procedure, dose and dose regiment, treatment duration and clinical operation of the intended trial. FDA published guidance in March 2020 to assist investigators and institutional boards (IRBs) in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during the COVID-19 pandemic. The purpose of this article is to proposal methods for statistical evaluation in terms of (i) possible shift in target patient population and (ii) assessment of reproducibility of clinical studies conduct under COVID-19 pandemic environment. The proposed methods can be used to determine whether the clinical results of the intended trials are acceptable from both statistical and regulatory perspectives. |*COVID-19[MESH] |*Pandemics[MESH] |Clinical Protocols/standards[MESH] |Clinical Trials as Topic/standards/*statistics & numerical data[MESH] |Eligibility Determination[MESH] |Humans[MESH] |Reproducibility of Results[MESH] |Research Design[MESH] |Research Subjects[MESH]Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic (epmc).pdf DeepDyve Pubget Overpricing