White Paper: The Sequential Parallel Comparison Design for Reducing Placebo Response

About Sequential Parallel Comparison Design

In the past several decades, it is recognized that increasing spending of clinical research does not reflect an increase of the success rate of drug development. Moreover, the pharmaceutical industry has realized that the classical structured clinical trials do not offer enough flexibility to make use of continuously emerging knowledge that is generated as trial progresses.

One of the innovations strongly recommended by the authorities is the use of adaptive designs in clinical trials and the potential use of Bayesian approach in clinical research. Although planning such trials comes at the cost of additional operational complexity, adaptive designs offer the benefit of flexibility to update trial design and objectives as data accrue.

In this white paper, we will explore a two-stage adaptive design called the “Sequential Parallel Comparison Design” (SPCD) for enrichment of placebo non-responders.