Over 4,000 clinical trials violate U.S. law. The FDA sent only one warning letter.

The results of a clinical trial that had remained unreported for five years were submitted within two weeks of the FDA threatening to slap the company with a fine, public records show.

The company Light Sciences Oncology had enrolled 225 men with benign prostatic hyperplasia into a clinical trial to test a new drug treatment. Under U.S. law, the company was obliged to make the results public one year after completing the trial in March 2017 – but it failed to do so.

Five years later, the FDA finally wrote a letter “alerting” the company to its “potential noncompliance” with the law. Light Sciences Oncology requested an extension, which the FDA refused. Then, several more months more passed without the company uploading the results.

In July, the FDA finally sent a formal Notice of Non-Compliance, giving the company the choice between making its trial results public within the next 30 days, or facing a fine of up to $13,000 for each additional day it broke the law.

Only two weeks later, the company submitted the trial’s results to the public ClinicalTrials.gov registry.

Meanwhile, over 4,000 other trials results are still missing in violation of the law.

Update 17 August: FDA statement and TranspariMED comment added as new section below

What does the FDA say?

An FDA spokeswoman told STAT News that:

"[The FDA] takes its oversight of clinical trials very seriously and works to promote voluntary compliance with legal and regulatory requirements. To date, the agency has issued more than 100 preliminary notices of noncompliance, which have been largely effective at securing voluntary compliance.”

Till Bruckner, founder of TranspariMED, said:

"Over 4,000 missing clinical trial results are a clear sign of regulatory failure. The FDA's current approach of 'promoting voluntary compliance' is obviously not delivering the transparency that Congress demanded and that patients deserve."

What is the moral of the story?

• First, sanctions work, and sometimes they are necessary to get companies and institutions to follow the law. If the FDA wrote 4,000 letters tomorrow, the whole problem would be largely resolved within a month.

• Second, the FDA is still not taking enforcement seriously. This is the first such letter the FDA has sent in over a year. In contrast, the FDA reportedly sent over 100,000 letters to vape juice vendors last year.

• Third, the FDA lacks a regulatory strategy. Many trials for far worse conditions than benign prostatic hyperplasia are still missing results, and Light Sciences Oncology is an industry lightweight, with no other applicable trials in its portfolio. In comparison, 34 trials run by Massachusetts General Hospital are currently in violation of the law, but the hospital has yet to receive a single letter.

The final word

Nicholas DeVito, a researcher at Oxford University who studies clinical trials, commented on the FDA’s latest move on Twitter:

The trial was due in 2018 and 5 years later they’re just getting around to ‘ok you really need to report these results now!’

Amen.

For additional reporting see this story by STAT News.