Phase I designs that allow for uncertainty in the attribution of adverse events Journal Article
| Authors: | Iasonos, A.; O'Quigley, J. |
| Article Title: | Phase I designs that allow for uncertainty in the attribution of adverse events |
| Abstract: | In determining dose limiting toxicities in phase I studies, it is necessary to attribute adverse events to being drug related or not. Such determination is subjective and may introduce bias. We develop methods for removing or at least diminishing the effect of this bias on the estimation of the maximum tolerated dose. The approach that we suggest takes into account the subjectivity in the attribution of adverse events by using model-based dose escalation designs. The results show that gains can be achieved in terms of accuracy by recovering information lost to biases. These biases are a result of ignoring the errors in toxicity attribution. © 2016 Royal Statistical Society |
| Keywords: | clinical trials; dose limiting toxicity; phase i trials; continual reassessment method; sequential monitoring; dose finding algorithms |
| Journal Title: | Journal of the Royal Statistical Society Series C - Applied Statistics |
| Volume: | 66 |
| Issue: | 5 |
| ISSN: | 0035-9254 |
| Publisher: | Wiley Blackwell |
| Date Published: | 2017-11-01 |
| Start Page: | 1015 |
| End Page: | 1030 |
| Language: | English |
| DOI: | 10.1111/rssc.12195 |
| PROVIDER: | scopus |
| PMCID: | PMC5659366 |
| PUBMED: | 29085158 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 November 2017 -- Source: Scopus |
