Analysis of cross-over clinical trials in the presence of baseline measurements
| Thesis title in Czech: | Analýza klinických studií se zkříženým designem a měřenými počátečními hodnotami |
|---|---|
| Thesis title in English: | Analysis of cross-over clinical trials in the presence of baseline measurements |
| Key words: | Zkřížený design|Počáteční měření|Odhad efektu léčby |
| English key words: | Crossover design|baseline measurements|treatment effect estimation |
| Academic year of topic announcement: | 2022/2023 |
| Thesis type: | diploma thesis |
| Thesis language: | angličtina |
| Department: | Department of Probability and Mathematical Statistics (32-KPMS) |
| Supervisor: | doc. Mgr. Michal Kulich, Ph.D. |
| Author: | hidden - assigned and confirmed by the Study Dept. |
| Date of registration: | 28.02.2023 |
| Date of assignment: | 01.03.2023 |
| Confirmed by Study dept. on: | 03.03.2023 |
| Date and time of defence: | 05.09.2023 08:20 |
| Date of electronic submission: | 16.07.2023 |
| Date of submission of printed version: | 24.07.2023 |
| Date of proceeded defence: | 05.09.2023 |
| Opponents: | doc. RNDr. Arnošt Komárek, Ph.D. |
| Guidelines |
| The question is how to do baseline adjustment in cross-over trials if separate baseline measurements are available at each of the treatment periods. The current approach is not to use baseline, or to include difference in baseline measurements as a covariate, together with subject-specific fixed effects. However, this does not work in non-linear models and does not take into account potential effects of treatment or period on the variance of the outcome.
The thesis will investigate and compare various options for the analysis of such trials by a linear and/or generalized linear model. |
| References |
| Senn S. (2002) Cross-Over Trials in Clinical research. John Wiley & Sons, Ltd, Chichester.
Fleiss J.L., Wallenstein S., and Rosenfeld R. (1985) Adjusting for Baseline Measurements in the Two-Period Crossover Study: A Cautionary Note. Controlled Clinical Trials, 6, 192-197. Willan A.R. and Pater J.L. (1986) Using Baseline Measurements in the Two-Period Crossover Clinical Trial. Controlled Clinical Trials, 7, 282-289. Dwan K., Li T., Altman D.G., and Elbourne D. (2019) CONSORT 2010 statement: extension to randomised crossover trials. BMJ, 366, I4378. Pacáková A. (2010) Analysis of change from baseline to post-intervention value. Diploma Thesis, MFF UK, Prague. |