You enroll 500 patients with liver cancer into a trial to determine whether you

Question

You enroll 500 patients with liver cancer into a trial to determine whether you can delay disease progression in these patients. To do this you randomly assign 250 patients to Drug A (New Drug) and 250 patients to the Standard of Care (SOC). It takes 1 year to enroll the 500 patients, and all patients are followed for at least 2 years (i.e., the last patient enrolled is followed for 2 years then the study stops). The study begins on Jan 1, 1982 and ends on Dec 31, 1984.

A ) If a patient has disease progression 1300 days after receiving Drug A would this patient’s data concerning this progression be considered as a censored event? Explain.

B ) If the median time to disease progression is 400 days for Drug A and 300 days for the Standard of Care (SOC) this would imply that

- Drug A is significantly better than the SOC.

- The SOC is significantly better than Drug A.

- Drug A shows an improvement in disease progression when compared to the SOC.

- None of the Above

Explanation / Answer

A) Here given that the last patient enrolled is followed for 2 years then the study sto. i.e. all patients are followed for at least 2 years i.e. minimum 730 days . And if a patient has disease progression 1300 days after receving Drug A So, progression days larger than the 730 days . therfore , For this given patient data concerning this progression be considerd as a censored event.

B) Median time to disease progression is 400 days for drug A. That means 150 patients has disease progression is before 400 days and remaining  patients has disease progression is after 400 days. And time to disease progression is 300 days for SOC. That means 150 patients has disease progression is before 300 days And remaining  patients has disease progression is after 300 days.

That is, here we see that, the disease progression time for Drug A is greater than the SOC. So , the SOC is significantly better than the Drug A.

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