𝔖 Bobbio Scriptorium
✦   LIBER   ✦

MODELLING AND DESIGN OF CROSS-OVER TRIALS

✍ Scribed by B. JONES; A. N. DONEV


Book ID
102650303
Publisher
John Wiley and Sons
Year
1996
Tongue
English
Weight
789 KB
Volume
15
Category
Article
ISSN
0277-6715

No coin nor oath required. For personal study only.

✦ Synopsis


There are many diseases and conditions that can be studied using a cross-over clinical trial, where the subjects receive sequences of treatments. The treatments are then compared using the repeated measurements taken 'within' subjects. The actual plan or design of the trial is usually obtained by consulting a published table of designs or by applying relatively simple rules such as using all possible permutations of the treatments. However, there is a danger is this approach because the model assumed for the data when the tables or rules were constructed may not be appropriate for the new trial being planned. Also, there may be restrictions in the new trial on the number of treatment sequences that can be used or on the number of periods of treatment particular subjects can be given. Such restrictions may mean that a published design of the ideal size cannot be found unless compromises are made. A better approach is to make the design satisfy the objectives of the trial rather than vice versa. In this paper we describe an approach to constructing such tailor-made designs which we hope will lead to ill-fitting 'off the peg' designs being a thing of the past. We use a computer algorithm to search for optimal designs and illustrate it using a number of examples. The criterion of optimality used in this paper is A-optimality but our approach is not restricted to one particular criterion. The model used in the search for the optimal design is chosen to suit the nature of the trial at hand and as an example a variety of models for three treatments are considered. We also illustrate the construction of designs for the comparison of two active treatments and a placebo where it can be assumed that the carry-over effects of the active treatments are similar. Finally, we illustrate an augmentation of a design that could arise when the objectives of a trial change.


πŸ“œ SIMILAR VOLUMES


A MODEL FOR CROSS-OVER TRIALS EVALUATING
✍ J. K. LINDSEY; B. JONES πŸ“‚ Article πŸ“… 1996 πŸ› John Wiley and Sons 🌐 English βš– 362 KB πŸ‘ 2 views

A preference trial is a special form of cross-over trial where clinical conditions determine when patients change treatment, in a prescribed order. This can be modelled using a geometric distribution. The model can be simply fitted using standard logistic regression methodology. The procedure is app

ANALYSIS OF CROSS-OVER TRIALS FOR DURATI
✍ J. K. LINDSEY; B. JONES; J. A. LEWIS πŸ“‚ Article πŸ“… 1996 πŸ› John Wiley and Sons 🌐 English βš– 641 KB

Survival models and cross-over designs both have an established place in biomedical research. Surprisingly, there are few examples of proper exploitation of the two in combination. A number of advantages and disadvantages of such studies are discussed. Two examples are used to illustrate the applica

Treatment–patient interactions for diagn
✍ J. K. Lindsey; B. Jones πŸ“‚ Article πŸ“… 1997 πŸ› John Wiley and Sons 🌐 English βš– 96 KB πŸ‘ 1 views

In cross-over trials, various types of responses may be recorded, not all of which can be appropriately modelled by a Normal distribution. Widening the class of models to the generalized linear model family has a number of advantages. An important one is that certain interactions, especially that be

An Operator Model of Crossing-Over
✍ WHITEHOUSE, H. L. K. πŸ“‚ Article πŸ“… 1966 πŸ› Nature Publishing Group 🌐 English βš– 662 KB