Study Design

To meet our clients’ needs, BSSI provides statistical consulting on the power and sample size requirements, design of the study including the statistical analysis plan (SAP), and protocol development. Our personnel have extensive experience in the development and review of study protocols for clinical as well as non-clinical studies. We have experience with stratification, randomization and blinding methods for clinical trials.

Before initiating any study the sample size needs to be carefully evaluated to meet the power requirements and budget of the study. Through parametric methods and simulation, our staff has the expertise to evaluate type I error probability and power associated with the planned analyses under a variety of scenarios to help ensure a successful and meaningful study. BSSI has extensive experience in the development and evaluation of various study designs, including, multi-reader, multi-case study designs, support device approvals, and development of pivotal animal trials.

With the Precision Medicine initiative, the use of adaptive designs will grow especially in the oncology space, and the area of rare diseases. From the more commonly used group sequential design to more complex biomarker based designs, these study designs reflect the need to get the most effective and least toxic treatment to the patient as quickly as possible. The development of such designs (including sample size and power considerations) requires advanced statistical methodology and experience. BSSI has supported and advised various clients in the initiation and implementation of adaptive design studies.