Estimating Incidence Rate on Current Status Data with Application to a Phase IV Cancer Trial

Abstract

New drug discovery in the pediatrics has dramatically improved survival, but with long- term adverse events. This motivates the examination of adverse outcomes such as long-term toxicity in a phase IV trial. An ideal approach to monitor long-term toxicity is to systematically follow the survivors, which is generally not feasible. Instead, cross-sectional surveys are conducted in Hudson et al. (2007), with one of the objectives to estimate the cumulative incidence rates along with specific interest in fixed-term (5 or 10 year) rates. We present inference procedures based on current status data to our motivating example with very interesting findings.

Keywords:

• Cardiotoxicity
• Cross-section survey data
• Interval censored data
• K-M method
• Phase IV clinical trial

Mathematics Subject Classification:

• Primary 62N02
• Secondary 62P10

Acknowledgments

The authors are thankful to the referees for their very helpful comments which led to a substantially improved manuscript. We thank Mr. Christopher Barnes for his technical help and Dr. Donald Miller for his support for this work. The research work of Dr. Rai was in part supported by the Wendell Cherry Chair in Clinical Trial Research. The research work of Drs. Hudson and Srivastava was in part supported by the Grant CA21765 and the American Lebanese Syrian Associated Charities. Conflict of Interest: None declared.