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Markey, House Dems Introduce Bill to Protect Human Subjects in Clinical Trials

TEST Act ensures disclosure of critical information about clinical trials and complete information about products on market

WASHINGTON (May 16, 2013) – Many clinical trials involving humans are still not registered in a publicly-accessible database and critical study results are not reported, putting people participating in the studies at risk due to lack of information sharing among studies. In order to protect study participants, close dangerous loopholes, and bring certainty and public transparency to life-saving research studies, Rep. Ed Markey (D-Mass.) and several other House Democrats introduced new legislation to take the errors out of clinical trial reporting.

The Trial and Experimental Studies Transparency (TEST) Act of 2013 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 registration and reporting requirements as domestic trials if they are used to support an application to market a product in the United States. 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. Many of these trials are not required to be registered with the clinical trials database.

The TEST Act is co-sponsored by Reps. Henry A. Waxman (D-Calif.), Rosa DeLauro (D-Conn.), and Jan Schakowsky (D-Ill.). A previous version of the legislation was introduced last year.

Led by the efforts of Reps. Markey and Waxman, clinicaltrials.gov was updated by Congress in 2007 to become a mandatory registry, directly addressing issues stemming from a lack of transparency of clinical trials. High-profile examples included Paxil®, Avandia®, and Vioxx® trials, in which safety concerns and negative results were suppressed by the drug companies, leading to injuries to patients and in some cases death. Today, Clinicaltrials.gov contains more than 145,000 trials and more than 8,000 results posted and has become a trusted and common resource for information about human trials.

“If we were issuing a grade on the clinical trials report card, it would be Incomplete,” said Rep. Markey, senior member of the Energy and Commerce Committee. “Unreported results and missing registrations leave participants, doctors and researchers vulnerable.
Significant strides have been made since we established this registry in 2007, and the TEST Act will create additional certainty regarding registration and reporting requirements and promote transparency in clinical trials. Strengthening standards for reporting outcomes will help maintain the trust of clinical trial participants and avoid putting people unnecessarily at risk. I look forward to working with my colleagues on this legislation.”

“We took a significant step forward in 2007 when we enacted legislation to establish the clinical trials database,” said Rep. Waxman, Ranking Member of the Energy and Commerce Committee. “Companies are no longer able to hide negative study results, while emphasizing the positive ones. But there is more to do. This legislation will bring to light critical additional information about clinical trials that companies are not currently required to disclose. It also clarifies that all clinical trials used to support an application for product approvals in the U.S. are subject to the database requirements, even if those trials are conducted abroad. That is good for patients, doctors, and researchers alike.”

“The Clinical Trial Registry Data Bank is a valuable source of public information on human clinical trials,” said Rep. DeLauro. “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. This bill will provide increased transparency to clinical trials and their results—both positive and negative—improving public health in the process.”

“This bill would strengthen enforcement of important mechanisms to improve patient and consumer safety. As a result, patients would have increased ability to make informed medical decisions and clinical trial participants would not be subject to unsafe risks that have been previously identified. Clarifying the registration and reporting requirements and increasing transparency will ensure the Clinical Trial Registry Data Bank remains a trusted resource for patients, doctors, and researchers,” said Rep. Schakowsky.

A copy of the legislation can be found HERE.

The TEST Act will:
--Require all interventional biomedical studies on humans to be registered with the database before the first participant is enrolled in the trial.
--Strengthen reporting requirements so that results from all covered trials are posted on the database within one year of the completion of the trial.
--Provide for delayed submission of results (up to two years after trial completion) for trials on medical interventions that have never before been approved for any use.
--Instruct the Secretary of HHS to undergo a rulemaking to require foreign trials that are used to support an application for marketing in the U.S. to comply with the registration and reporting requirements of the database.
--Instruct NIH and the FDA to provide a report to Congress regarding the implementation and compliance with the database requirements.

The legislation is supported by the Patient, Consumer and Public Health Coalition and Consumers United for Evidence-Based Healthcare, whose members include: American Medical Women’s Association, Annie Appleseed Project, Black Women’s Health Imperative, Breast Cancer Action, Center for Medical Consumers, Center for Science in the Public Interest, Childbirth Connection, Consumer Federation of America, Consumers Union, CT Center for Patient Safety, Jacobs Institute of Women’s Health, LymeDisease.org, National Coalition for LGBT Health, National Consumers League, National Physicians Alliance, National Research Center for Women & Families Cancer Prevention and Treatment Fund, National Women's Health Network, Our Bodies Ourselves, Public Citizen, Reproductive Health Technologies Project, The TMJ Association, Union of Concerned Scientists, U.S. PIRG, and Woody Matters

Contact: Eben Burnham-Snyder, Rep. Ed Markey, 202-225-2836

Posted: May 2013

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