LWBK1006-47 LWW-Govindan-Review December 12, 2011 20:55
Chapter 47•Societal Issues in Oncology 587recommendations. Outcome measures refer to patient results, including
measures of quality of life, disease-free survival, and overall survival.Answer 47.11. The answer is D.
Quality data sources include medical records, patient surveys, administra-
tive databases (e.g., Medicare claims), and registries. The National Cancer
Data Base (NCDB) and the Surveillance Epidemiology and End Results
(SEER) program of the National Cancer Institute (NCI) are examples of
cancer registry programs in the United States. Each of these data sources
may provide useful information for quality research.Answer 47.12. The answer is D.
All of the above measures are examples of strategies to improve quality of
care delivered to patients with cancer. Guideline recommendations, such
as the National Comprehensive Cancer Network (NCCN), may help to
integrate evidence-based medicine into clinical practice. Improved doc-
umentation of cancer care can facilitate better care coordination, safety,
and efficiency. Health information technologies, when implemented in the
context of an overall process design, may improve efficiency and quality of
care through measures such as point-of-service reminders or standardized
order sets.Answer 47.13. The answer is A.
Investigational drugs must be administered under an IND application that
is submitted to the FDA. The initial IND application typically consists of
a proposed phase I clinical protocol and supporting data regarding safety.
These data may include in vitro, animal, or human evidence describing
drug toxicity and a predicted safe starting dose, as well as manufacturing
data regarding the drug product. A panel of scientific reviewers from
the FDA then determines if such data are sufficient to proceed with the
proposed study without unreasonable risk of injury or harm.Answer 47.14. The answer is D.
From 1990 to 2006, 94 oncology drug marketing applications were
approved by the FDA. End points supporting FDA approval included
overall survival and disease-free survival, tumor response rates, response
rate supported by additional data, and palliation or amelioration of symp-
toms (e.g., Neulasta, Leukine, and Ethyol approvals).Answer 47.15. The answer is B.
Expanded access protocols are designed to facilitate availability of inves-
tigational drugs when certain conditions are met: No satisfactory alter-
native treatment is available, the drug sponsor is pursuing marketing
approval with due diligence, the drug is nearing the end of its devel-
opment, and data support efficacy for use in the intended population.
The NCI has provided expanded access to investigational drugs through
an agreement with the FDA in these situations.