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10.1016/j.cct.2021.106494 http://scihub22266oqcxt.onion/10.1016/j.cct.2021.106494 34186242!8234249!34186242     free     free     free Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Contemp+Clin+Trials 2021 ; 108 (ä): 106494 Nephropedia Template TP {{tp|p=34186242|t=2021. Why ITT analysis is not always the answer for estimating treatment effects in clinical trials |pdf=|usr=}}{{34186242}} gab.com Text Why ITT analysis is not always the answer for estimating treatment effects in clinical trials JO: Contemp Clin Trials http://www.kidney.de/pget.php?&tw=1&pmid=34186242 #FOAvip For many years there has been a consensus among the Clinical Research community that ITT analysis represents the correct approach for the vast majority of trials. Recent worldwide regulatory guidance for pharmaceutical industry trials has allowed discussion of alternatives to the ITT approach to analysis; different treatment effects can be considered which may be more clinically meaningful and more relevant to patients and prescribers. The key concept is of a trial "estimand", a precise description of the estimated treatment effect. The strategy chosen to account for patients who discontinue treatment or take alternative medications which are not part of the randomised treatment regimen are important determinants of this treatment effect. One strategy to account for these events is treatment policy, which corresponds to an ITT approach. Alternative equally valid strategies address what the treatment effect is if the patient actually takes the treatment or does not use specific alternative medication. There is no single right answer to which strategy is most appropriate, the solution depends on the key clinical question of interest. The estimands framework discussed in the new guidance has been particularly useful in the context of the current COVID-19 pandemic and has clarified what choices are available to account for the impact of COVID-19 on clinical trials. Specifically, an ITT approach addresses a treatment effect that may not be generalisable beyond the current pandemic. Twit Text FOAVip Why ITT analysis is not always the answer for estimating treatment effects in clinical trials ????Contemp Clin Trials http://www.kidney.de/pget.php?&tw=1&pmid=34186242 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34186242 #FOAvip English Wikipedia <ref>{{Cite pmid|34186242}}</ref> Why ITT analysis is not always the answer for estimating treatment effects in clinical trials #MMPMID34186242 Keene ON; Wright D; Phillips A; Wright M Contemp Clin Trials 2021[Sep]; 108 (ä): 106494 PMID34186242show ga For many years there has been a consensus among the Clinical Research community that ITT analysis represents the correct approach for the vast majority of trials. Recent worldwide regulatory guidance for pharmaceutical industry trials has allowed discussion of alternatives to the ITT approach to analysis; different treatment effects can be considered which may be more clinically meaningful and more relevant to patients and prescribers. The key concept is of a trial "estimand", a precise description of the estimated treatment effect. The strategy chosen to account for patients who discontinue treatment or take alternative medications which are not part of the randomised treatment regimen are important determinants of this treatment effect. One strategy to account for these events is treatment policy, which corresponds to an ITT approach. Alternative equally valid strategies address what the treatment effect is if the patient actually takes the treatment or does not use specific alternative medication. There is no single right answer to which strategy is most appropriate, the solution depends on the key clinical question of interest. The estimands framework discussed in the new guidance has been particularly useful in the context of the current COVID-19 pandemic and has clarified what choices are available to account for the impact of COVID-19 on clinical trials. Specifically, an ITT approach addresses a treatment effect that may not be generalisable beyond the current pandemic. |*COVID-19[MESH] |*Pandemics[MESH] |Humans[MESH]Why ITT analysis is not always the answer for estimating treatment eff(epmc).pdf DeepDyve Pubget Overpricing