Interim Timing in Adaptive Two-Stage Dose-Finding Studies: What Happens to the Expected Benefit?

• Activity Number: 422
• Type: Topic Contributed
• Date/Time: Tuesday, August 2, 2016 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Tobias Mielke*
• Companies: ICON PLC
• Keywords: Adaptive Designs ; Interim Timing ; Dose Finding

Abstract

Adaptive Two-Stage Designs in Dose-Finding are generally considered to improve modelling and dose-estimation. However, looking at simulations results, improvements are rarely as high as expected by experimental design theory. Some considerations on the interim timing and uncertainty will lead to some insight into the limitations by early interim decision making.