What is a non-inferiority trial?
By definition, a non-inferiority trial aims to demonstrate that the test product is not worse than the comparator by more than a small pre-specified amount. This amount is known as the non-inferiority margin, or delta. Clinicians must know who has chosen the margin, and why.
What is modified ITT?
MODIFIED ITT CONCEPT It is a subset of the ITT population and allows the exclusion of some randomized subjects in a justified way (such as patients who were deemed ineligible after randomization or certain patients who never started treatment).
What is modified intent treatment population?
It implies that subjects are included in a trial and analysed regardless of whether they satisfied the entry criteria, the treatment to which they were originally allocated and subsequent withdrawal or deviation from protocol. Excluding patients from analysis may introduce bias and lead to misleading results.
Why would we use an intention to treat analysis?
Intention to treat analyses are done to avoid the effects of crossover and dropout, which may break the random assignment to the treatment groups in a study. ITT analysis provides information about the potential effects of treatment policy rather than on the potential effects of specific treatment.
What is a good number needed to treat?
As a general rule of thumb, an NNT of 5 or under for treating a symptomatic condition is usually considered to be acceptable and in some cases even NNTs below 10. Below are some NNTs for routine medical interventions.
What is the primary purpose of randomization?
The main purpose for using randomization in an experiment is that it automatically controls for all lurking variables. In a randomized controlled experiment, researchers control values of the explanatory variable with a randomization procedure.
What is on treatment analysis?
In many randomized clinical trials, assessment of safety relies on so-called on-treatment analysis, where data on adverse events are collected only while the participant is taking study medication and perhaps for a few (7, 14, or 30) days after stopping.১৬ নভেম্বর, ২০১৮
What is topline data?
Top Line Data means, with respect to a clinical study, a summary of demographic data, the data for the primary endpoint and a summary of safety data, which are based upon an unblinded, locked database.
What is safety population clinical trials?
The Safety Population is used for the analysis of safety, including adverse events, toxicity and laboratory evaluations. This set of patients are grouped for analysis according to the treatment they actually received, as opposed to the treatment they were allocated to receive at randomisation.১১ সেপ্টেম্বর, ২০১৭
What are topline results?
The top line is a reference to gross figures reported by a company, such as sales or revenue. A company that increases its revenue or sales is said to be generating top-line growth.