Active-control noninferiority trials are being performed with increas-ing frequency when standard placebo-controlled trials are consid-ered unethical. Three attributes are optimally required to establish noninferiority: 1) The treatment under consideration exhibits ther-apeutic noninferiority to the active control; 2) the treatment would exhibit therapeutic efficacy in a placebo-controlled trial if such a trial were to be performed; and 3) the treatment offers ancillary advantages in safety, tolerability, cost, or convenience. Trials de-signed to show noninferiority require an appropriate reference pop-ulation, a proven active control and dose, a high level of adherence to treatment, and adequate statistical power. However, the formal analy...
Background: The interpretation of the results of active-control trials regarding the efficacy and sa...
Non-inferiority clinical trials are being performed with an increasing frequency now-a-days, because...
Noninferiority trials, in which a new treatment is compared with a standard active treatment, are be...
Active-control noninferiority trials test the hypothesis that one intervention is no worse than anot...
Clinical investigators are increasingly testing treatments that have the primary benefit of decrease...
Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious...
Noninferiority trials comparing new treatment with an active standard control are becoming increasin...
The increasing popularity of noninferiority trials reflects the ongoing efforts to replace existing ...
The effect of a new treatment is proven through the comparison of a new treatment with placebo; howe...
Sometimes the goal of comparing a new treatment with a stan-dard treatment is not to find an approac...
Clinical trials are an essential part of the drug development life cycle. There are different types ...
A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In...
Noninferiority (NI) trials in drug research are used for the purpose of demonstrating that a new tre...
Understanding noninferiority trials Noninferiority trials test whether a new experimental treatment ...
Noninferiority trials are used to assess whether the effect of a new drug is not worse than an activ...
Background: The interpretation of the results of active-control trials regarding the efficacy and sa...
Non-inferiority clinical trials are being performed with an increasing frequency now-a-days, because...
Noninferiority trials, in which a new treatment is compared with a standard active treatment, are be...
Active-control noninferiority trials test the hypothesis that one intervention is no worse than anot...
Clinical investigators are increasingly testing treatments that have the primary benefit of decrease...
Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious...
Noninferiority trials comparing new treatment with an active standard control are becoming increasin...
The increasing popularity of noninferiority trials reflects the ongoing efforts to replace existing ...
The effect of a new treatment is proven through the comparison of a new treatment with placebo; howe...
Sometimes the goal of comparing a new treatment with a stan-dard treatment is not to find an approac...
Clinical trials are an essential part of the drug development life cycle. There are different types ...
A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In...
Noninferiority (NI) trials in drug research are used for the purpose of demonstrating that a new tre...
Understanding noninferiority trials Noninferiority trials test whether a new experimental treatment ...
Noninferiority trials are used to assess whether the effect of a new drug is not worse than an activ...
Background: The interpretation of the results of active-control trials regarding the efficacy and sa...
Non-inferiority clinical trials are being performed with an increasing frequency now-a-days, because...
Noninferiority trials, in which a new treatment is compared with a standard active treatment, are be...