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10.1080/19466315.2020.1799857 http://scihub22266oqcxt.onion/10.1080/19466315.2020.1799857 34191979!8011492!34191979     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=34191979&cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 215       Stat+Biopharm+Res 2020 ; 12 (4): 461-477 Nephropedia Template TP {{tp|p=34191979|t=2020. Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?|pdf=|usr=}}{{34191979}} gab.com Text Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue JO: Stat Biopharm Res http://www.kidney.de/pget.php?&tw=1&pmid=34191979 #FOAvip Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic by the World Health Organization. The pandemic has a number of consequences for ongoing clinical trials in non-COVID-19 conditions. Motivated by four current clinical trials in a variety of disease areas we illustrate the challenges faced by the pandemic and sketch out possible solutions including adaptive designs. Guidance is provided on (i) where blinded adaptations can help; (ii) how to achieve Type I error rate control, if required; (iii) how to deal with potential treatment effect heterogeneity; (iv) how to use early read-outs; and (v) how to use Bayesian techniques. In more detail approaches to resizing a trial affected by the pandemic are developed including considerations to stop a trial early, the use of group-sequential designs or sample size adjustment. All methods considered are implemented in a freely available R shiny app. Furthermore, regulatory and operational issues including the role of data monitoring committees are discussed. Twit Text FOAVip Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue ????Stat Biopharm Res http://www.kidney.de/pget.php?&tw=1&pmid=34191979 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34191979 #FOAvip English Wikipedia <ref>{{Cite pmid|34191979}}</ref> Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue? #MMPMID34191979 Kunz CU; Jorgens S; Bretz F; Stallard N; Van Lancker K; Xi D; Zohar S; Gerlinger C; Friede T Stat Biopharm Res 2020[Aug]; 12 (4): 461-477 PMID34191979show ga Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic by the World Health Organization. The pandemic has a number of consequences for ongoing clinical trials in non-COVID-19 conditions. Motivated by four current clinical trials in a variety of disease areas we illustrate the challenges faced by the pandemic and sketch out possible solutions including adaptive designs. Guidance is provided on (i) where blinded adaptations can help; (ii) how to achieve Type I error rate control, if required; (iii) how to deal with potential treatment effect heterogeneity; (iv) how to use early read-outs; and (v) how to use Bayesian techniques. In more detail approaches to resizing a trial affected by the pandemic are developed including considerations to stop a trial early, the use of group-sequential designs or sample size adjustment. All methods considered are implemented in a freely available R shiny app. Furthermore, regulatory and operational issues including the role of data monitoring committees are discussed. ?Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to(epmc).pdf DeepDyve Pubget Overpricing