Majority of Clinical Trials Violate Federal Law with Impunity

Medicine can advance only by way of the clinical trial – and only if the results of all clinical trials conducted are available for doctors, patients and others to see.

Yet, according to Monique L. Anderson, MD, of Duke University, the results of the overwhelming majority of clinical trials in the U.S. are not being reported to the federal registry (ClinicalTrials.gov) within one year of having been completed, despite a law in place requiring such reporting.

Additionally, almost as many trials remain unreported five years after completion. And although there is a law in place, the law is not being enforced.

The team looked at over 13,000 completed or terminated trials in the registry from 2008 to 2013 subject to the reporting requirement, and found result summaries for a mere 13.4 percent.

Kathy Hudson, PhD, NIH Deputy Director of Science Outreach and Policy, told MedPage Today that the failure described in this study was unacceptable. “[It] 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.”

Sponsors May Be the Problem

All of the trials have one of three sponsors: a private industry, the National Institutes of Health (NIH) or non-NIH government agencies or academic institutions.

After one year, the most likely trials to have been reported are industry-funded trials, followed by those supported by NIH and, lastly, those by non-NIH government agencies or institutions.

While there are differences at the one-year mark in terms of reporting, by the five-year mark they are all pretty much equally bad, although the overall reporting percentage went up to just over 38 percent.

"The medical-products industry has been more responsive to the legal mandate of the FDAAA [Food and Drug Administration Amendments Act]," the researchers wrote. "However, industry, the NIH, and other government and academic institutions all performed poorly with respect to ethical obligations for transparency."

Dating to 2007, as an aspect of FDAAA, this requirement has been in place and it applies to sponsors of certain clinical trials; specifically, it applies to "all non-phase I drug, including investigational new applications; medical device, including investigational device exemptions; or biologic clinical trials with at least one U.S. research site that had begun or were ongoing by the fall of 2007."

What Can You Do?

So what can the average patient or participant in the health care system do about the fact that the results of these trials aren't being reported? The truth is that you can't do a whole lot, but we have come up with at least two things you can do.

Demand Answers as a Clinical Trial Participant

If you are participating in a clinical trial, author and physician Dr. Ben Goldacre recommends that you present the trial administrators with four concerns before it gets underway:

1. Ask for a written guarantee that the trial has been publicly registered before patients are recruited, and ask where you can see it.
2. Ask for a written guarantee that the main outcome of the trial will be published within a maximum of one year after completion.
3. Ask for the name of the person who will be responsible for that.
4. Ask whether, as a participant in the trial, you will be offered a copy of the report describing its results.

At the very least, taking these four steps attempts to make somebody in the trial accountable. He goes so far as to say that any patient refused answers to any one of these questions should reach out to him via email at [email protected] or on Twitter.

Sign the All Trials Petition

The Duke University study was concerned with whether the results of trials were being reported to the federal registry in time or, in some cases, ever. Clearly, timely reporting is an issue. They did not directly address the question of why those trials were failing to be reported.

According to Goldacre and others who are behind a global initiative to convince major pharmaceutical companies to report all their trial data, the reason why, in many cases of industry-sponsored trials, is because the results may not be beneficial to the industry.

In his book, Bad Pharma, Goldacre writes that "when trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients."

Because of the critical importance to doctors and patients that results of all trials be published, Goldacre and several others recently launched an initiative to put pressure on the industry to publish their results, whether they are good or bad.

The All Trials Registered | All Trials Reported campaign has a rather simple goal: They are calling for all past and present clinical trials to be registered and their full methods and summary results reported.

Watch All Trials co-founder and author Goldacre explain how withholding trial data can actually hurt people and even lead to unnecessary deaths:

Read more about the initiative at the AllTrials homepage.

If you agree with them, you can help by signing their petition.

Source: MedPage Today