Devita, Hellman, and Rosenberg's Cancer

LWBK1006-47 LWW-Govindan-Review December 12, 2011 20:55

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

Question 47.14. Pharmaceutical companies submit a New Drug Application (NDA) to

the FDA for approval of the sales and marketing of a new drug. These

sponsors must provide evidence that the drug is safe and effective based on

“adequate and well-controlled clinical investigations.” Oncology drugs

have been approved by the FDA on the basis of supporting clinical trials

with which of the following primary end points?

A. Overall survival or disease-free survival

B. Tumor response rate

C. Palliation

D. All of the above

Question 47.15. Expanded access protocols are designed with what goal in mind?

A. Increasing the size of a clinical protocol for statistical robustness

B. Enabling access to investigational drugs when no viable alternative is

available

C. Providing medications to patients unable to afford prescribed drugs

D. Increasing market share of a newly approved medication

Question 47.16. Which of the following statements regarding IND is NOT true?

A. All studies for nonapproved drugs must be done under IND.

B. Some studies on approved drugs may be exempted from IND require-

ment.

C. The IND process spans the entire time of drug investigation.

D. Sponsors may initiate the proposed study as soon as they receive the

IND.