Devita, Hellman, and Rosenberg's Cancer

LWBK1006-16 LWW-Govindan-Review December 12, 2011 18:55

186 DeVita, Hellman, and Rosenberg’s CANCER: Principles and Practice of Oncology Review

Question 16.11. Which of the following is NOT true of Phase III trials?

A. The primary end points should be demonstrably related to patient

benefit.

B. Eligibility criteria should be broad to enhance generalizability of

results.

C. Conditions of treatment should be suited to community patient care.

D. A quality-of-life measure should be included to measure benefit to

patients.

Question 16.12. Which of the following is TRUE of randomized treatment assignment?

A. Trial participants are a representative sample of patients with the

disease of interest.

B. Randomization may fail to balance unknown prognostic factors in

small studies.

C. Randomization is unnecessary if controls can be matched closely

enough to trial participants.

D. Randomization is effective only if patients and treating physicians are

unaware of treatment assignment for the duration of the study.

Question 16.13. Randomization is generally NOT necessary in which of the following

scenarios?

A. Study of patients with a disease that will uniformly and rapidly

progress to an end-stage.

B. Phase III trial

C. Screening study on multiple cytostatic agents, such as molecularly

targeted drugs or cancer therapeutic vaccines

D. Phase II trial on cytotoxic agents using time to progression as the

primary efficacy end point

Question 16.14. Which of the following is NOT true of power and hypothesis testing in

clinical trials?

A. Statistical power mainly depends on the anticipated size of treatment

effect. Trials designed to detect a small effect will demand large sample

sizes.

B. Statistical power is also heavily influenced by the prespecified type I

error (probability of erroneously claiming a “positive” result), and a

two-sided type I error of 0.05 has been widely accepted, especially in

Phase III trials.

C. Because a confidence interval provides information about the size and

direction of treatment effect, it is more informative than significance

testing, especially for “negative” trials.

D. Because data from small randomized trials can be pooled for meta-

analysis, the calculation of sample size for a randomized clinical trial

is no longer as critical as it was.