Utilizing Modeling Approach for Patient Enrollment Predication for Clinical Trials

• Activity Number: 318
• Type: Topic Contributed
• Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Weili He*+
• Companies: Merck
• Keywords: Clinical trial ; enrollment time ; Recruitment model ; adaptive design ; sample size

Abstract

The proposed session will focus on the discussion and methodologies of patient recruitment modeling. In the planning of a new multicentre clinical trial, it is of great importance to estimate the enrollment time (time when the desired sample size is reached). Inaccurate prediction of patient recruitment may result in the inaccurate planning of many downstream activities. This is particular true in adaptive designs trials, where too slow or too fast patient enrollment along with inaccurate enrollment prediction will imperil the timing of and/or invalidate the planned adaptations in AD trials. This is a timely topic and should appeal to a wide audience as how to accurately predict enrollment is of interest to any clinical trialist.