Activities of the DIA-CER Scientific Working Group

• Activity Number: 374
• Type: Invited
• Date/Time: Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
• Sponsor: Section on Risk Analysis
• Author(s): Matthew David Rotelli*+
• Companies: Eli Lilly and Company
• Keywords: Randomized ; Observational ; Comparative Effectiveness ; Patuent Centered Outcomes Research ; Reliability ; Validity

Abstract

As health care costs continue to rise and as new diagnostic and treatment alternatives become available, it is natural to ask which approaches work best. Comparative Effectiveness Research or Patient Centered Outcomes Research aims to provide the answers. Ideally, randomized trials could be conducted to formally test superiority or non-inferiority of alternative treatments. However, such trials are not always feasible or ethical. When they can be done, it is not clear whose responsibility it should be to fund and conduct the trials, and they can often be very large, long, and expensive and yet still lack in external validity. So, more and more, interested groups are turning to observational data to try to answer relative effectiveness questions. Unlike the primary analysis of a well-designed randomized trial, the operating characteristics of even a similarly well-designed observational study are not known. This talk focuses on activities the DIA CER Scientific Working Group is undertaking to quantify and improve the reliability and validity of Comparative Effectiveness Research.