Omissions & oops

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 - Candace Stuart - Headshot
Candace Stuart, Editor

As long as the government is on pause, let’s take a moment to reflect on one critical function that affects patient care: clinical trials.

The FDA hasn’t been completely moribund, in part because the panelists who review clinical trial data and make recommendations to the agency aren’t federal employees. The agency may run with a skeletal staff but some programs are plugging along, as can be seen in recent votes by FDA’s Circulatory System Devices Panel and drug approvals.

Regulators make decisions that affect practice and patient care based on evidence from supporting trials and the expert analysis of its panelists. How reliable is that evidence?

This week a study published on PLOS Medicine cast doubt on the validity of clinical trial research with an analysis that compared public reporting of patient outcomes with unpublished clinical study reports. Among their findings: The unpublished reports contained significantly more information about adverse outcomes than was reported in publicly available sources.

The authors, who are German, note Europeans support efforts to make data more transparent. The U.S. also has pushed for open access to industry-sponsored clinical trial data.

On one hand, we have cases of omission, where possibly pertinent information is withheld. On the other hand, we have proof that garbage science likely populates some publicly available journals.

Science magazine reports that dozens of open-access journals accepted a clearly flawed bogus research paper. PLOS One, which has been criticized in the past for less than rigorous review, rejected the paper, author John Bohannon wrote.

And yes, to use one of my favorite FDA phrases, “out of an overabundance of caution,” I checked Science’s website just to make sure its report wasn’t a gag. It and the PLOS Medicine study were serious investigations that remind us to question what we see, and what we don’t see.

Candace Stuart

Cardiovascular Business, editor

cstuart@cardiovascularbusiness.com