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D-Optimal Designs for dose Finding in Phase I Clinical Trials
| Content Provider | Scilit |
|---|---|
| Author | Sujan, Hasan Mahmud Alam, M Iftakhar |
| Copyright Year | 2022 |
| Description | Determining the maximum tolerated dose (MTD) is the main challenge of phase I clinical trials. There are many methods in the literature to determine the MTD. The D-optimal design can also be used to find the MTD. The D-optimal design depends on the Fisher information matrix (FIM), and it minimizes the generalized variance of the parameter estimates. However, the D-optimal design is yet to receive much attention from clinicians. Since a dose-response model is usually non-linear, the FIM depends on the unknown model parameters. To optimize the FIM through the D-criterion, values need to be assumed for the model parameters. This paper focuses on investigating four different D-optimal designs depending on parameter values: design based on posterior Bayes estimators, design based on maximum likelihood estimators, sequential Bayesian design and two-stage Bayesian design. Six plausible dose-response scenarios and a real scenario are investigated through a simulation study. Except for the D-optimal design that utilizes maximum likelihood estimates in FIM optimization, all other D-optimal designs are found very competitive for the correct MTD recommendation. The D-optimal designs are also compared with an A optimal design. The performance of A-optimal design is not attractive as these designs. Because of its numerical simplicity compared to the others, the posterior-based D-optimal design is recommended for dose-finding in phase I clinical trials. Journal of Statistical Research 2021, Vol. 55, No. 2, pp. 313-334 |
| Ending Page | 334 |
| Page Count | 22 |
| Starting Page | 313 |
| ISSN | 0256422X |
| DOI | 10.3329/jsr.v55i2.58808 |
| Journal | Journal of Statistical Research |
| Issue Number | 2 |
| Volume Number | 55 |
| Language | English |
| Publisher | Bangladesh Academy of Sciences |
| Publisher Date | 2022-03-30 |
| Access Restriction | Open |
| Subject Keyword | Mathematical Social Sciences Optimal Design Clinical Trials |
| Content Type | Text |
| Resource Type | Article |
| Subject | Statistics and Probability Demography Social Sciences Modeling and Simulation |
