Enhanced Placebo Effect or Other Nontreatment-Specific Effects in Therapeutic Device Studies

• Activity Number: 393
• Type: Topic Contributed
• Date/Time: Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jianxiong Chu*+
• Companies: FDA/CDRH
• Keywords: placebo effect ; medical devices ; sham control ; non-inferiority

Abstract

Unlike self-administrated drug pills, many therapeutic device treatments involve surgical procedures and more intense interaction between care providers and patients. There are accumulating evidence supporting the notion that non-treatment specific effects such as placebo effect tend to be greater in device studies as compared to drug studies. However, a sham device control is often not feasible or unethical leading to two-arm non-inferiority trial design using current standard care or a previously cleared/approved medical device as the control despite the lack of any randomized superiority trial data in supporting the control treatment. In this talk, the implications of this dilemma for device study design will be discussed, e.g., how to mitigate the risks associated with sham control so that including the sham control could become ethical, how to address the compromised ability to reach a reasonable assurance of device effectiveness from the demonstration of non-inferiority.