Tips for Designing Studies Evaluating Medical Tests: An FDA Statistical Perspective

• Activity Number: 160
• Type: Topic Contributed
• Date/Time: Monday, August 3, 2009 : 10:30 AM to 12:20 PM
• Sponsor: Section on Statistics in Epidemiology
• Author(s): Kristen L. Meier*+ and Estelle Russek-Cohen
• Companies: FDA and FDA
• Keywords: medical test ; diagnostic ; study protocol design ; pre-IDE ; indications for use ; intended use

Abstract

The Center for Devices and Radiological Health, USFDA approves or clears medical tests marketed in the US. Medical tests include clinical lab tests, imaging systems, diagnostic or screening tests, monitoring devices and more. A manufacturer can seek FDA advice on how to evaluate their medical test prior to a formal FDA submission using a "pre-IDE" or pre-Investigational Device Exemption submission. Statisticians from the FDA and from the sponsor have key role to play in this context. FDA uses terms such as "intended use" and "indications for use" in specific ways to determine what study designs, hypotheses and subsequent statistical analyses are appropriate. This talk highlights statistical elements to be included in a pre-IDE and in particular, what statisticians should consider when they help prepare a pre-IDE. Examples for different types of medical tests will be provided.