Robert. Eric Heidel
The University of Tennessee Medical Center, USA
Title: Valid statistical approaches for data driven analysis in breast cancer: Research avenues under patient protection and affordable care act (PPACA)
Biography
Biography: Robert. Eric Heidel
Abstract
Secondary data analysis is becoming a popular method for analyzing population data related to cancer outcomes. Large data repositories like the National Cancer Database (NCDB) and the Surveillance, Epidemiology, and End Result (SEER) provide researchers with a vast wealth of pertinent clinical, prognostic, demographic, confounding, and outcome variables in real patient populations. Subgroup and sensitivity analyses are also easier to conduct with large datasets because they are more likely to represent underserved and at-risk populations. The Patient Protection and Affordable Care Act (PPACA) put forth a call to compare established treatments on their clinical efficacy using comparative effectiveness research (CER). CER was defined in the PPACA as “research evaluation and comparing health outcomes and clinical effectiveness, risks, and benefits of two or more medical treatments, services, and items.” With access to millions of breast cancer outcomes and a reinvigorated focus on comparing treatments, services, and items, researchers are uniquely positioned to produce extensive CER evidence related to the diagnosis and treatment of breast cancer. Going further, these large databases allow for CER evidence to be generated for many underserved and vulnerable populations that are not represented in the current literature. The objective of generating evidence for these types of subgroups is written right into the legislation (PPACA) itself. Another beneficial aspect of the CER and secondary data is that the PPACA defines retrospective cohort designs as perfectly acceptable when generating evidence. These types of observational studies are very easy to conduct and are an excellent fit for large secondary databases.