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

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Date:
Location: Washington, DC

Despite containing valuable information that could benefit patients and protect additional ones from risk, many clinical trials involving human subjects are not registered in a publicly-accessible federal database and are not reporting critical study results. Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, today introduced H.R. 6272, the Trial and Experimental Studies Transparency (TEST) Act of 2012 to close these clinical trial loopholes and bring certainty and transparency to life-saving research studies. One of these loopholes results in registered trials never reporting study results, putting future human participants at risk if a different company decides to develop the same drug, but without important safety information from the previous study. 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. 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.).

Updated by Congress in the Food and Drug Administration Amendments Act (FDAAA) of 2007 to become a mandatory registry, clinicaltrials.gov directly addresses issues stemming from a lack of transparency of clinical trials. High-profile examples included Paxil®, Avandia®, and Vioxx®, trials where safety concerns and negative results were suppressed by the drug companies. Clinicaltrials.gov now contains more than 130,000 trials and more than 6,000 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."

"It is important to close existing loopholes in requirements for registration and reporting of clinical trials to ensure patients can make informed medical decisions and are not subject to unsafe risks," said Rep. Schakowsky. "This bill would strengthen enforcement of important mechanisms to improve patient and consumer safety. Not only would all clinical trials be required to report their data regardless of FDA approval, it would allow for analysis of the safety as well as efficacy of drugs and devices. Increasing transparency while clarifying the registration and reporting requirements will maintain the Clinical Trial Registry Data Bank as a trusted resource."

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.

"Women and their doctors can't make good decisions about their health care without good information," said Cynthia Pearson, Executive Director, National Women's Health Network. "The TEST Act will help women get the information they need by closing loopholes that allow companies to avoid registering the existence and results of clinical trials. This bill will improve access to evidence-based information so that patients and consumers can make informed medical decisions."

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, Childbirth Connection, Consumer Federation of America, Consumers Union, CT Center for Patient Safety, Jacobs Institute, LymeDisease.org, National Coalition for LGBT Health, National Consumers League, 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.

In November 1986, Congressman Markey released a report entitled "American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens". The report documented thirty-one human radiation experiments on nearly 700 individuals. As a result of the report, President Clinton in 1994 created the Advisory Committee on Human Radiation Experiments and tasked it with reviewing human radiation experiments conducted between 1944 and 1974. The final report, released in 1996, included recommendations on protection for human subjects in future clinical trials.


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