A common perception about many commercially available medical treatments is that they are e!ective for every patient having the relevant indication and that developers have provided the regulatory authorities with evidence of such a property. We show that the standard of evidence is much lower and t
Ignorability and bias in clinical trials
โ Scribed by Daniel F. Heitjan
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 123 KB
- Volume
- 18
- Category
- Article
- ISSN
- 0277-6715
No coin nor oath required. For personal study only.
โฆ Synopsis
Patient non-compliance and drop-out can bias analyses of clinical trial data. I describe a parametric model for treatment cross-over and drop-out and demonstrate how the concept of ignorability, originally de"ned for incomplete-data problems, can elucidate sources of bias in clinical trials. I discuss some implications of the theory and present simulation examples that illustrate the potential e!ects of non-ignorable cross-over and drop-out on bias and power.
๐ SIMILAR VOLUMES
Two important papers by Schwartz and Lellouch have drawn distinctions between explanatory and pragmatic attitudes to clinical trials, and between individual and collective ethics. The pragmatic approach accords with the widespread use of 'intention-to-treat' analyses, but recent research has started