Pictured above: former Secretary of the US Department of Human Health Services, Kathleen Sebelius.

We received a number of comments from my last blog post 87.5% of Pediatric Trials Don’t Have Published Results , which explored the high rate at which investigators are failing to disclose the results data of their trials online. The topic of trial disclosure has been gaining awareness and causing massive conversation on social media within life sciences circles. Since we published that post one month ago, there has been a major breakthrough in the legislation and enforcement around trial disclosure, which I write about below. But first, let's review the negative effects that a lack of trial disclosure has on the medical community.

Failing to disclose trial data to the public leads to:

  • Biased medical literature towards positive results
  • Repeated failed experiments because researchers were unaware of the results of a similar trial
  • Wasted research funding because of repeated failed experiments
  • Lack of awareness of negative side effects from specific interventions
  • Risking volunteer health in vein by not sharing learnings from intervention with the medical community
  • Reducing the volume of data to inform future clinical development teams and potentially slowing the rate at which we can advance healthcare innovation

The FDA put laws in place in 2007 that require all studies done for commercial development to publicly share results. The majority of investigators have been defying these laws because the FDA has never penalized anyone for noncompliance. However, on September 16th the US government, specifically the US Department of Human Health Services (HSS), issued a revision to the 2007 laws that requires clinical trials to be reported and published.

The new rules, laid out in a 701 page document, are more specific to describe what level of trial disclosure is required from investigators. Now, researchers must:

  1. Register trials within 21 days of enrolling the first patient
  2. Post results within one year of trial completion
  3. Disclose exact methodology and plans for analysis
  4. Update any changes to protocol within 30 days

The HHS has also mentioned potential financial, criminal, and grant funding consequences for noncompliance. Individual violators may be fined up to $100,000 for a misdemeanor and up to $250,000 for a felony conviction. Organizations who violate the new laws face fines up to $200,000 for a misdemeanor and $500,000 for a felony conviction.

It seems safe to say that if enforced the new penalties will be taken more seriously by researchers. Life sciences professionals and patients all stand to gain from the wider adoption of trial disclosure practices, which we can expect to start taking place with these new rules.

Do you have any questions or comments about the above issues? Leave us a note in the comments.

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