Massachusetts U.S. Rep. Ed Markey has announced the reintroduction of legislation that he says is intended to open up clinical trial data, introducing a measure of transparency and bringing the US closer toward reforms now underway in the EU.
The bill, known as the Trial and Experimental Studies Transparency (TEST) Act, was first introduced in August 2012 by Markey and Rep. Elijah Cummings, a fellow member of the House Energy and Commerce Committee on which they both serve.
At the time, Markey said the legislation was intended to close what he called "clinical trial loopholes." At present, companies conducting a clinical trial-be it for an initial approval, an additional approval, or postmarketing vigilance-are not required to make the results of those trials public. Instead, basic summary data about the trial is posted to the government's trials database, ClinicalTrials.gov, which tracks basic data like the intent of the trial, basic study design and its activity.
Transparency advocates like the EU's AllTrials initiative maintain that this type of secrecy ultimately hurts patients and can lead to undisclosed safety problems, pointing to historical incidents where companies purposefully hid negative trial data to make their product appear to be safer than it was.
Markey's statements are very much in the same vein as those transparency advocates. "Unreported results and missing registrations leave participants, doctors and researchers vulnerable," Markey said. "Strengthening standards for reporting outcomes will help maintain the trust of clinical trial participants and avoid putting people unnecessarily at risk."
Those vulnerabilities include patients' efforts not going toward advancing the public health, or future patients being enrolled in duplicative studies, potentially harming them in the process.
"Closing loopholes and strengthening reporting standards will help both Americans who want to do their due diligence on a particular drug or device and researchers evaluating the safety or efficacy of a drug," said Rosa DeLauro (D-CT), a co-sponsor of the legislation. "This bill will provide increased transparency to clinical trials and their results-both positive and negative-improving public health in the process."
Foreign Clinical Trial Data Reporting Required
At its core, the TEST Act requires companies to submit the results of their trials for any drug or device applications to a database to be maintained by the National Institutes of Health (NIH), which currently oversees the ClinicalTrials.gov website.
The bill would also expand requirements for companies to register clinical trials with a government database to include foreign-based trials conducted in support of an FDA product application.
"The TEST Act updates and expands the clinical trial registry data bank - clinicaltrials.gov - with stronger reporting requirements, and requires that all foreign clinical studies meet the same requirements as domestic trials if they are used to support an application for marketing in the United States," Markey explained in his 2012 statement. The congressman said this is necessary to combat an increasing trend of clinical trials being conducted overseas.
"Eighty percent of the drugs entering the U.S. market in 2008 were clinically tested overseas and a growing number of device trials are also moving abroad," Markey wrote in a 2013 statement. "Many of these trials are not required to be registered with the clinical trials database."
Sponsors would be required to list all studies with the database before the first patient is enrolled in a study, and the bill would mandate the results of the trial be posted to clinicaltrials.gov within one year of the conclusion of the trial. Studies on novel compounds or devices would be granted an extra year to report. Any requests to postpone or delay results would be made available to the public.
However, the legislation contains another important component as well: the publication of all trial protocols. "Supporting documents," such as the consent documents and protocol documents would need to be submitted along with results.
As noted last year by Paul Ivsin, author of the industry blog Placebo Control, that would mark a monumental shift in current policy.
"It would radically alter the dynamics of how pharmaceutical companies operate by ripping out a giant chunk of every company's proprietary investment - essentially, confiscating and nationalizing their intellectual property," Ivsin wrote. That could, in theory, lead to legal arguments similar to those raised by the Washington Legal Foundation last month regarding biosimilar data. Because that data was never intended to be made public, the legal group wrote, to require it would constitute a theft of private property without proper compensation under the Fifth Amendment.
The US Department of Health and Human Services (DHHS) would be required to implement final regulations regarding the foreign clinical trial components of the law no later than one year after the passage of the law.
With the exception of some extremely minor editorial changes, the legislation reintroduced by Markey on 16 May 2013 is identical to the one introduced in August 2012. The bill is co-sponsored by Reps. Cummings, Henry Waxman (D-CA), Rosa DeLauro (D-CT) and Jan Schakowsky (D-IL).
The legislation is H.R. 2031, and may be found on Markey's website here.
Congress: HR 2031
The TEST Act