Leveraging Real-World Evidence: A Paradigm Shift in Regulation.

The study methodology and regulatory frameworks for real-world data collection is quickly evolving, opening new avenues to use valid and robust real-world evidence (RWE) to support regulatory decision making. Although the Food and Drug Administration has historically accepted specific applications of RWE to support regulatory determinations, significant progress has been made in recent years to examine conditions in which this information can be used to support specific types of premarket decisions. Of note, hybrid study designs that incorporate aspects of randomized clinical trials, including randomization and pragmatic outcomes, are expected to be a driving factor to accelerate the adoption of RWE in regulatory contexts.

Advancing performance measurement in oncology: quality oncology practice initiative participation and quality outcomes.

The American health care system, including the cancer care system, is under pressure to improve patient outcomes and lower the cost of care. Government payers have articulated an interest in partnering with the private sector to create learning communities to measure quality and improve the value of health care. In 2006, the American Society for Clinical Oncology (ASCO) unveiled the Quality Oncology Practice Initiative (QOPI), which has become a key component of the measurement system to promote quality cancer care.

Advancing performance measurement in oncology.

The American healthcare system, including the cancer care system, is under pressure to improve patient outcomes and lower the cost of care. Government payers have articulated an interest in partnering with the private sector to create learning communities to measure quality and improve the value of healthcare. In 2006, the American Society of Clinical Oncology (ASCO) unveiled the Quality Oncology Practice Initiative (QOPI), which has become a key component of the measurement system to promote quality cancer care.