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Trimentum®


 

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 is an effective trial design and analysis methodology that enables clinical and statistical signal detection in the presence of high placebo response. Trimentum can significantly increase trial power with the benefits of:

  • Increased power with smaller sample sizes

  • Improved assay sensitivity

  • Reduced risk of negative or failed trials

  • Decreased time and cost of clinical studies

Trimentum

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:

Trimentum

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

Trimentum

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

Trimentum

Post-approval studies

Improved Phase IV study efficiency at reduced risk, time and cost

Smaller, meaningful and more effective rare disease and pediatric studies

Trimentum Webinar

Learn from experts about the benefits and applications of the Trimentum study design.

Trimentum Webinars


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