Sequential parallel comparison design (SPCD), branded by PPD as Trimentum®, is a clinical trial design, conduct and analysis paradigm that enables accurate efficacy and safety signal detection when impaired by high placebo response and variability. Trimentum trials consist of two continuous, fully randomized, double-blind, placebo-controlled stages, without carry-over. The primary analysis of a Trimentum trial combines evidence from all patients in the first stage with placebo non-responder data from the second stage. This enables assay sensitivity with integrity, transparency and efficiency. Trimentum trials reduce risk, time and cost of Phase II, III and post-approval trials as well as in rare disease and special population studies.
Gain further understanding from our white paper on Trimentum and the tools developed by Massachusetts General Hospital and PPD to effectively implement SPCD trials. Actual trial examples illustrate the strengths, limitations and opportunities with Trimentum.