You'd think adjustments for age and severity would
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Posted On: 03/19/2021 12:46:25 PM
You'd think adjustments for age and severity would be done automatically by the FDA; the latter was done in the remdesivir trial as stated in NEJM trial review:
"In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity)."
As for the age differential, a review of clinical trials for Covid and vaccines reported in JAMA showed that companies regularly excluded participants by age, thereby skewing the results. The JAMA report includes the disparity in mortality rates of higher age groups, prompting them to call out trials that had median ages as low as 40. (We're getting skewed if an EUA doesn't come soon, IMO). Their paper is offered here: https://jamanetwork.com/journals/jamainternal...le/2771091
"In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity)."
As for the age differential, a review of clinical trials for Covid and vaccines reported in JAMA showed that companies regularly excluded participants by age, thereby skewing the results. The JAMA report includes the disparity in mortality rates of higher age groups, prompting them to call out trials that had median ages as low as 40. (We're getting skewed if an EUA doesn't come soon, IMO). Their paper is offered here: https://jamanetwork.com/journals/jamainternal...le/2771091
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