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Backfilling cohorts in phase I dose-escalation studies.
- Source :
- Clinical Trials; Jun2023, Vol. 20 Issue 3, p261-268, 8p
- Publication Year :
- 2023
-
Abstract
- Background: The use of 'backfilling', assigning additional patients to doses deemed safe, in phase I dose-escalation studies has been used in practice to collect additional information on the safety profile, pharmacokinetics and activity of a drug. These additional patients help ensure that the maximum tolerated dose is reliably estimated and give additional information to determine the recommended phase II dose. Methods: In this article, we study the effect of employing backfilling in a phase I trial on the estimation of the maximum tolerated dose and the duration of the study. We consider the situation where only one cycle of follow-up is used for escalation as well as the case where there may be delayed onset toxicities. Results: We find that, over a range of scenarios, the use of backfilling gives an increase in the percentage of correct selections by up to 9%. On average, for a treatment with a cycle length of 6 weeks, each additional backfilling patient reduces the trial duration by half a week. Conclusions: Backfilling in phase I dose-escalation studies can substantially increase the accuracy of estimation of the maximum tolerated dose, with a larger impact in the setting with a dose-limiting toxicity event assessment period of only one cycle. This increased accuracy and reduction in the trial duration are at the cost of increased sample size. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 17407745
- Volume :
- 20
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Clinical Trials
- Publication Type :
- Academic Journal
- Accession number :
- 164222120
- Full Text :
- https://doi.org/10.1177/17407745231160092