A Comparison of Sample Size Estimation Procedures Using Cost-Effective Methods

• Activity Number: 647
• Type: Contributed
• Date/Time: Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Sibabrata Banerjee*+
• Companies: Allergan, Inc
• Keywords: Power ; Sample Size ; Cost-per-patient

Abstract

Sample Size calculations in clinical trials are based on many components such as the design of the study, assumed efficacy of the treatment and control group, power and size conditions. Although sample size considerations play a huge role in the overall cost of the study, researchers and sponsors often fail to take into account some of the simple cost-effectiveness measures that can impact the calculation and eventually the sample size and overall cost. Some methods of calculating sample size based on cost-effectiveness are discussed and critiqued in this paper. Also, some examples comparing the conventional approaches with the cost-based approaches are discussed here. Hence, merits of considering these as alternatives to the current conventional approaches are critically evaluated.