US bill seeks tighter reporting requirements for ClinicalTrials.gov

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Pharma Times online
CLINICAL NEWS | AUGUST 07, 2012

PETER MANSELL

A new bill introduced in the House of Representatives is looking to tighten up reporting requirements for ClinicalTrials.gov, the public online registry run since October 2008 by the US National Institutes of Health (NIH).

H.R. 6272, the Trial and Experimental Studies Transparency (TEST) Act of 2012, was introduced by Congressman Edward Markey (Democrat, Massachusetts), senior member of the House Energy and Commerce Committee, and referred to that committee last week.

It is co-sponsored by Congressional Democrats Rosa DeLauro, Janice Schakowsky and Henry Waxman, and has the support of the Patient, Consumer and Public Health Coalition and Consumers United for Evidence-Based Healthcare.

One-year ceiling

Among the TEST Act’s provisions are to strengthen reporting requirements so that results from all eligible clinical studies are posted on ClinicalTrials.gov within one year of the trial being completed.

It would also seek legislation obliging sponsors of trials studies conducted outside the US, yet used to support an application for marketing in the US, to comply with the registration and reporting requirements of the NIH database.

The TEST Act’s other provisions include:

• Requiring all interventional biomedical studies on humans to be registered on ClinicalTrials.gov before the first participant is enrolled in the trial.

• Delayed submission of results (up to two years after trial completion) for studies on medical interventions that have never before been approved for any use.

• Instructing the NIH and the US Food and Drug Administration to report to Congress on implementation of, and compliance with, the new database standards.

Call for action

Early this year, an editorial in the BMJ called on professional associations to take disciplinary action against clinical researchers who failed to disclose data from clinical trials, arguing that lack of transparency risked undermining clinical decision-making, harming patients and wasting public money invested in health systems.

As the editorial pointed out, the US Food and Drug Administration Amendments Act of 2007 made publication within 12 months of a results summary on ClinicalTrials.gov mandatory for all eligible trials in the US “initiated or ongoing as of September 2007”.

However, a review by Prayle et al published in the same issue of the BMJ found that only 22% of trials subject to mandatory reporting under the 2007 Act had results available within one year of completion.

In another linked article, a survey by Ross et al of US research conducted between 2005-2008 and primarily or partially funded by the National Institutes of Health showed that in less than half of the sample were the summary reports of trials registered with ClinicalTrials.gov published in a peer-reviewed, MEDLINE-indexed biomedical journal within 30 months of completion.

Moreover, one third of the trials remained unpublished 51 months after completion, the authors found.

Critical results

Many clinical trials involving human subjects are not registered in a publicly accessible federal database and are not reporting critical study results, the TEST ACT sponsors said.

The ACT is designed “to close these clinical trial loopholes and bring certainty and transparency to life-saving research studies”.

Moreover, the sponsors noted, 80% of the drugs entering the US market in 2008 were clinically tested overseas, while a growing number of medical device trials are moving abroad.

“Many of these trials are not required to be registered with the clinical trials database,” they added.