True endpoint reduction by surrogate endpoints

ABSTRACT

The use of surrogate endpoint, which is becoming widely popular now a days, was introduced in medical research to reduce the time of experiment required for the approval of a drug. Through cost cutting and time saving, the surrogate endpoints can bring profit to the medicine producers. We obtain the expression for the reduction of true samples, in proportion, at an expense of surrogates to achieve a fixed power while comparing the two treatments. We present our discussion in the two-treatment set up in the context of odds ratio as a measure of treatment difference. We illustrate the methodology with some real dataset.

KEYWORDS:

• Odds ratio
• Sample size
• Surrogate responses
• Validation sample

MATHEMATICS SUBJECT CLASSIFICATION:

• Primary 62P10
• Secondary 62H17

Acknowledgment

The authors thank the reviewer for careful reading and constructive suggestions which led to some improvement over an earlier version of the manuscript.