Noncompliance in randomized controlled trials

Blindness in Randomized Controlled Trials

In combination with randomization, blinding or masking is an important factor in randomized controlled trials (RCTs), particularly in trials that assess therapeutic effects. Here an attempt is made to explain blindness and why it is important. In clinical trials, blinding is defined as the condition imposed on a study in which study participants, health care providers and assessors collecting o...

Causal Inference in Randomized Trials with Noncompliance

blindness in randomized controlled trials

in combination with randomization, blinding or masking is an important factor in randomized controlled trials (rcts), particularly in trials that assess therapeutic effects. here an attempt is made to explain blindness and why it is important. in clinical trials, blinding is defined as the condition imposed on a study in which study participants, health care providers and assessors collecting o...

Intention-to-treat analysis in cluster randomized trials with noncompliance.

In cluster randomized trials (CRTs), individuals belonging to the same cluster are very likely to resemble one another, not only in terms of outcomes but also in terms of treatment compliance behavior. Although the impact of resemblance in outcomes is well acknowledged, little attention has been given to the possible impact of resemblance in compliance behavior. This study defines compliance in...

Informative noncompliance in endpoint trials

Noncompliance with study medications is an important issue in the design of endpoint clinical trials. Including noncompliant patient data in an intention-to-treat analysis could seriously decrease study power. Standard methods for calculating sample size account for noncompliance, but all assume that noncompliance is noninformative, i.e., that the risk of discontinuation is independent of the r...