Mona Fiuzat, PharmD: Changing Tides in Cardiovascular Research

Findings from a study presented at the Heart Failure Society of America (HFSA) 2019 Scientific Sessions in Philadelphia, PA, showed since 2008, just 55% of heart failure-based clinical trials published online have since shared actual results.

One of the study’s authors—Mona Fiuzat, PharmD, a member of the HFSA Board of Directors—also presented results from the FDA/HFSA Collaborative Survey, which gave drug manufacturers and investigators a firsthand look toward what their patients truly value from clinical trial outcomes.

These studies—coupled with quality-of-life outcomes in the DEFINE-HF trial as well as other presented assessments—paint a unique picture of modern heart failure (HF) assessment. In an interview with MD Magazine®, Fiuzat explained the ways by which clinical priority has adopted a greater embrace of the patients’ wellbeing in cardiovascular pharmacotherapy.

MD Mag: Is cardiology research beginning to consider more measures for patient quality of life outcomes?

Fiuzat: Absolutely. There's a lot of work to be done. There are a lot of complexities with the kind of noise that you can pick up, with patient preferences. How far someone can walk could be different if they're in your office walking, versus they're really at home without someone who makes them feel like they need to perform.

There's still a lot of work to be done on how to standardize those measurements, and really how to interpret data that we get. I think this is going to be the next evolution of what happens in research. We've really been focused on life-saving therapies, and now we need to be focused on these types of therapies that may improve function or feeling, and how to measure that and how to be consistent.

MD Mag: Are there ways in which the FDA/HFSA Collaborative Survey results could influence cardiovascular care?

Fiuzat: Yeah, we're hopeful that this stimulates companies that maybe had abandoned drugs that they don't think may extend life, but could just help with feeling and function, especially in the hospital.

So we're hoping that we keep the industry engaged, and it could apply to devices as well. And we're also hoping that patients will start to understand how to quantify those things for us. They understand that these things are important too, and start paying attention maybe a little bit more, rather than just submitting to having a bad life.

MD Mag: Any thoughts on the limited rate of published heart failure trial results?

Fizuat: That one's a tough one, because there is a government mandate for clinical trials to report their findings. But we can't just say we need more mandating our regulation. I mean, it's got to go beyond the government.

The authors have a responsibility, I think the investigators have a responsibility, and companies have a responsibility when their trials are negative, to still get the data out there.

Dr. Connor and I run the Journal of the American College of Cardiology: Heart Failure, and another author is the editor of the European Journal of Heart Failure. And we have submitted that editors should do a better job accepting negative trials, so that people aren't discouraged from writing up the manuscript and submitting it to us.