Recurrent clinical trial events: Analyzing methodologies with cardiology examples 

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Cardiology trials often adopt composite endpoints that combine several events of clinical interest as the primary efficacy outcome.

Time-to-first-event approaches follow the recommendations of regulatory agencies. But composite outcomes that only consider the first event are suboptimal for a chronic disease such as heart failure (HF), which is characterized by recurrent HF hospitalizations since repeat events within individuals are ignored in analyses.

Recurrent HF hospitalizations indicate a worsening condition and disease progression, so considering all HF hospitalizations in analysis more accurately assesses the effect of treatment on the true disease burden. Currently, there is no recommendation as to the preferred approach. The CHARM-Preserved trial shows the impact of analyzing only the time-to-first event and ignoring repeat hospitalizations.1

Of th…

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How to make COVID-19 clinical trial statistics meaningful to the public

[Photo by Fusion Medical Animation on Unsplash]

COVID-19 has brought a newly heightened awareness of the need to better understand clinical trial statistics and their direct impact on the public. I cannot remember when statistical data was more in the limelight than now. The pandemic’s first wave put many countries into lockdown. All governments and their local representatives delivered press conferences regularly to update the masses on the newest statistics and safety precautions. There were statistics on how many people caught the disease, how many deaths, how many ICU beds were still available, and just about every interesting statistic you could think of related to the pandemic. 

Data collected from the COVID-19 pandemic continues to be used to inform decisions and make future projections related to drug development and beyond. Individuals are also using pandemic statistics to decide how to live th…

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