Devita, Hellman, and Rosenberg's Cancer

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Chapter 16•Design and Analysis of Clinical Trials 189

Question 16.20. One of the most important features that makes survival data different

from other kinds of data is the presence of censoring. That is, the actual

survival times for some patients cannot be observed during study. Which

of the following is NOT true for the analysis of survival data?

A. Survival (or disease-free survival) curves provide a superior tool for

summarizing survival data.

B. Two methods are most frequently used for the estimation of survival

curves. The life table method requires relatively large sample size,

and the Kaplan-Meier product limit method is appropriate for any

sample size.

C. Traditional summary statistics, such as means and standard devia-

tions, can provide a sufficient summary for survival data without

censoring.

D. The statistical power of clinical trials using survival as a primary end

point will be mainly determined by the actual number of events (i.e.,

death or progression) rather than the total number of patients.

Question 16.21. An important assumption in the analysis of survival data is noninforma-

tive censoring. That is, censoring is not related to the outcome of interest.

For a clinical trial with cancer-specific survival as the primary end point,

which of the following patients is more likely to suffer from informative

censoring?

A. Alive at the time of study closeout

B. Withdrawal from the trial because of disease progression

C. Died of accident

D. Moving out of the region

Question 16.22. All of the following are characteristics of Phase 0 trials EXCEPT:

A. Requires an assay for measuring the pharmacodynamic end point.

B. Patients receive multiple doses of the experimental drug.

C. Identifies whether the experimental drug has an inhibitory effect

against its specified molecular target.

D. Drug doses used in these trials are not expected to cause toxicity.

Question 16.23. All of the following statements regarding clinical trials are true EXCEPT:

A. Response rate is the most commonly utilized end point in Phase II

trials.

B. More than 25% of current clinical trials select patients based on

biomarker testing.

C. Universities are listed as the primary sponsor for the majority of clin-

ical trials.

D. None of the above.