of US Patients achieved MCI
Global biopharma study of ‘Multi-Clinical Improvement’ (MCI) in US PAH patients as comparator to phase III Clinical Trial results
SUMMARY
A top 5 global pharma needed data to support the Phase III trial of their latest blockbuster
Scientific Question
Multi-Clinical Improvement (MCI) was used as a novel endpoint in a phase III clinical trial for a new PAH treatment.
While MCI had been used in research contexts, data were limited in US patients regarding the association of MCI with morbidity or mortality.
Evidence Triaxia Provided
After developing a protocol that matched clinical trial inclusion and exclusion criteria with the client, TriAxia extracted a cross-center cohort of PAH patients with the clinically relevant demographic, phenotypic and clinical data to ensure measurement of MCI and outcome identification, including 6MWD, NT-proBNP, FC, hemodynamics, and treatment history.
We then analyzed this cohort to determine MCI achievement over time across the cohort and the relationship between MCI achievement and time to event (TTE) for morbidity and mortality.
Results
The study demonstrated a statistical relationship between the achievement of MCI and TTE for morbidity and mortality in US patients being treated for PAH
It also demonstrated that a very small percentage of these patients achieved MCI
Results were published at ATS and CHEST