JACC Review Topic of the Week
We are proud to share the most recent JACC “Review Topic of the Week” featured by the Journal of the American College of Cardiology (JACC), co-authored by IDDI experts Marc Buyse, ScD Mickaël De Backer, PhD and Samuel Salvaggio, PhD
???? The article highlights the needs for true patient-centric approaches when it comes to #clinicaltrialdesign and #statisticalanalysis. Solutions allowing multiple outcomes assessment may bring global visibility on all benefits and risks for patients.
???? Reach out to us to further discuss your clinical needs and see how Generalized Pairwise Comparisons (GPC) may very concretely help improve the clinical relevance and statistical power of your clinical developments.
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Abstract:
A time-to-first-event composite endpoint analysis has well-known shortcomings in evaluating a treatment effect in cardiovascular clinical trials. It does not fully describe the clinical benefit of therapy because the severity of the events, events repeated over time, and clinically relevant nonsurvival outcomes cannot be considered. The generalized pairwise comparisons (GPC) method adds flexibility in defining the primary endpoint by including any number and type of outcomes that best capture the clinical benefit of a therapy as compared with standard of care. Clinically important outcomes, including bleeding severity, number of interventions, and quality of life, can easily be integrated in a single analysis. The treatment effect in GPC can be expressed by the net treatment benefit, the success odds, or the win ratio. This review provides guidance on the use of GPC and the choice of treatment effect measures for the analysis and reporting of cardiovascular trials.