Academic medical centers get an F for trial transparency

Print 24 February 2016
Ben Adams / FierceBiotech

Leading U.S. schools are failing to report their clinical trial results as just one-third are bothering to show their completed data for scrutiny.

This is according to a new report published in The BMJ by Harlan M. Krumholz of the Yale School of Medicine and his colleagues.

The study was set up to look at just how many U.S. academic centers published their completed clinical trials registered at the ClinicalTrials.gov site.

Their findings were dire: of the 4,347 interventional clinical trials across 51 leading academic medical centers, those who showed their results within 24 months of a study ending ranged from 16.2% to 55.3%--with an average of just 36% across the board.

And with regard to reporting of results on ClinicalTrials.gov, the authors found that only 13% of trials that were registered, completed and led by the faculty of an academic medical center reported results within 24 months of completion.

The report's authors marked this effort as a "poor performance", noting that despite the "ethical mandate and expressed values and mission of academic institutions," there is simply too much variation in the reporting of clinical trial results across leading academic medical centers.

Krumholz told MedPage Today: "We were surprised to find that no one is doing well. The fact that it's so pervasive suggests it's not about bad individuals, it's about a culture that allows for reporting to be discretionary rather than mandatory."

Previous studies have shown that between 25% and 50% of clinical trials remain unpublished, sometimes years after completion.

The heat for withholding trial data has been for many years focused on the pharmaceutical and biotech industry, but this report shows that it's not just the commercial sector which is failing to report.

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