PPD offers biopharmaceutical companies an alternative model for conducting clinical trials known as sequential parallel comparison design (SPCD). This patented clinical trial methodology, branded by PPD as Trimentum®, significantly increases assay sensitivity and reduces the adverse impact of high placebo response and heterogeneity on therapeutic efficacy signal detection. Trimentum is a randomized double-blind placebo-controlled two-stage trial design that combines the statistical analysis of all patients from the first stage with the placebo nonresponder patients from the second stage.
These benefits can result in significant reductions of risk, time and cost while ensuring the integrity, transparency, efficiency and representativeness of clinical studies in proof of concept to dose-finding, pivotal and post-marketing development.
Trimentum in Action
The benefits of Trimentum can be seen throughout the phases of clinical research. Beyond the impacts seen in Phase II-IIIb studies, Trimentum provides advantages in:
Early phase trials
Smaller, faster, more predictive and reliable proof of concept and dose-finding studies
Data-driven decisions based on clear signal detection
Cost-effective way to make early efficacy decision
Late phase trials
Significant reduction in clinical development risk, time and cost
More efficient, robust and reliable pivotal trials
Proven integrity, efficiency and representativeness
Clients have gained regulatory acceptance under this study design
Improved Phase IV study efficiency at reduced risk, time and cost
Smaller, meaningful and more effective rare disease and pediatric studies
Learn from experts about the benefits and applications of the Trimentum study design.