Journal of Biometrics & Biostatistics

Sandeep Menon

Publications

• Research Article
  Finding Critical Values to Control Type I Error for a Biomarker Informed Two-Stage Winner Design
  Author(s): Jing Wang, Sandeep Menon and Mark ChangJing Wang, Sandeep Menon and Mark Chang
  
  Adaptive clinical trial designs have been getting very popular in recent years. The PhRMA Working Group defines an adaptive design as a clinical study design that uses accumulating data to direct modification of aspects of the study as it continues, without undermining the validity and integrity of the [1]. These designs can assist in potentially accelerating clinical development and improving efficiency. However, the multiple interim looks and adaptive adjustments with the design can lead to inflation of type I error. Over the past decade, several statistical approaches have been proposed to control the inflation, some of which have been widely applied in practice. Some of these approaches include: error spending approach for classical group sequential plans [2-4]; Combination of p-values, such as Fisher’s combination test [5,6], Inverse Normal Method [7], sum of p-values appro.. Read More»
  DOI: 10.4172/2155-6180.1000207

  Abstract PDF