Cancer immunotherapy trial design with long-term survivors
| Autor: | Xue Ding, Jianrong Wu |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Statistics and Probability
Hazard (logic) medicine.medical_treatment Crossover 01 natural sciences 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine Cancer immunotherapy Cancer Survivors Neoplasms Statistics medicine Humans Pharmacology (medical) 030212 general & internal medicine 0101 mathematics Proportional Hazards Models Pharmacology Clinical Trials as Topic business.industry Term (time) Clinical trial Sample size determination Research Design Sample Size Immunotherapy business |
| Zdroj: | Pharmaceutical statisticsREFERENCES. 20(1) |
| ISSN: | 1539-1612 |
| Popis: | Cancer immunotherapy often reflects the improvement in both short-term risk reduction and long-term survival. In this scenario, a mixture cure model can be used for the trial design. However, the hazard functions based on the mixture cure model between two groups will ultimately crossover. Thus, the conventional assumption of proportional hazards may be violated and study design using standard log-rank test (LRT) could lose power if the main interest is to detect the improvement of long-term survival. In this paper, we propose a change sign weighted LRT for the trial design. We derived a sample size formula for the weighted LRT, which can be used for designing cancer immunotherapy trials to detect both short-term risk reduction and long-term survival. Simulation studies are conducted to compare the efficiency between the standard LRT and the change sign weighted LRT. |
| Databáze: | OpenAIRE |
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