Clinical Trial Researchers Routinely Violating Federal Laws

Rarely do the findings of a single journal study affect everyone. This is an exception.

Monique L. Anderson, MD of Duke University and colleagues are reporting in the New England Journal of Medicine that the overwhelming majority of clinical trials that take place at least partly in the United States fail to post their results to ClinicalTrials.gov, the federal registry, within one year of completion, despite the fact that failing to do so is against the law.

Research looked at clinical trials on all subjects over five year span

The researchers looked at over 13,000 completed or terminated trials in the registry between 2008 and 2013 which were subject to the reporting requirement.

They found result summaries for just 13.4 percent of them.

"Industry, the NIH, and other government and academic institutions all performed poorly with respect to ethical obligations for transparency," they wrote.

Trials funded by industry (by, for example, a pharmaceutical company) were most likely to report their results on time, followed by trials funded by the National Institutes of Health (NIH). Trials funded by non-NIH government agencies or academic institutions were worse than either the first two.

But collectively, they were only reporting on time 13.4 percent of the time. And five years down the road, they all performed equally poorly.

Kathy Hudson, PhD, NIH Deputy Director of Science Outreach and Policy, told MedPage Today in an email that the findings were unacceptable. "The study confirms the need for the NIH’s newly proposed policy that requires all NIH-funded investigators to submit clinical trial results information or risk losing their funding.”

The FDA Amendment Act of 2007 requires the sponsors of certain clinical trials to register and report basic results on ClinicalTrials.gov. This applies to medical devices, to biologics, and to all non-phase I trials testing drugs.

Some legal exemptions notwithstanding, these trials are required to report prespecified primary outcome data within a year of the final data collection or termination of the trial. Penalties for failing this basic demand include:

Issuance of a "failure to submit" notification on ClinicalTrials.gov
• Civil fines up to $10,000 per day
• loss of NIH funding

However, since some of the wording of the law is still under debate, not a single clinical trial sponsor has been hit with a penalty yet.

Doctors routinely recommend that patients join a clinical trial. This recommendation can be found all over the National Comprehensive Cancer Network's clinical practice guidelines.

Yet, this study, coupled with the work being done by Dr. Ben Goldacre and others in revealing just how often industry has chosen to bury trial data that they don't like (the campaign), and the recent revelation that many clinical trial researchers are not including their FDA violations along with their published reports, hardly amount to a ringing endorsement of the US clinical trial system.

Source: MedPage Today