Speaker
Description
In clinical trials involving time to disease progression that can only be assessed at clinical visits, the real time to event is interval censored between visits, eg tumour assessments in progression-free survival (PFS) outcomes in oncology trials. In the typical analysis of PFS, we systematically impute the event time to be the visit where the progression was detected.
In many cases the bias from this approximation is not large, but if the censoring intervals systematically differ between treatment groups, it is not ignorable. A sensitivity analysis using interval censoring can access this bias. For a proper sensitivity analysis, we must target the same analysis method as the main analysis (apart from the interval censoring).
Therefore we require an implementation of interval-censored semi-parametric stratified proportional hazards model with appropriate variance estimates and a corresponding log-rank test.
No existing R implementation fully met these requirements. I propose a new package icsp2, which extends the algorithm from 'icenReg' for stratification and implements Sun’s interval censored log rank test, in a package with minimal dependencies.
We present the results of the verification and performance comparison against other R packages, SAS and Stata.
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| Keywords: Please list up to 5 keywords to help us find the right session for your contribution. | survival, interval censoring, biostatistics, clinical trials |
|---|---|
| Virtual Option | This submission is for onsite presentation only |
| Video Recording | Video sharing is fine |
| The author(s) agree(s) to take responsibility and be accountable for the contents of the submission and is/are authorized to present it. | Confirm |
| Interested in serving as reviewer? | isaac.gravestock@roche.com |